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3D Bioprinting Forefronts Technology in Pharmaceutical & Regenerative Medicine

Kutubkhan Bohari | July 15, 2022 | 1074 views | Read Time : 01:00 min

3D Bioprinting
3D printing technology has emerged as a significant driver in the ongoing radical shift across several industrial domains' production processes. The incorporation of 3D printing into tissue engineering, through the use of life cells encapsulated in specialized synthetic or natural biomaterials (e.g. chitosan) as bioinks. This is laying the groundwork for numerous innovative solutions for healthcare and biomedical challenges, heralding new frontiers in medicine, pharmaceuticals, and biotechnology. 

3D Bioprinting: A New Pathway in Medicine

Additive manufacturing, which is the process of joining materials to create objects using computer-aided design (CAD) model data, such as 3D bioprinting, has the potential to disrupt the global pharmaceutical and regenerative medicine industry.

Today, this technology has permeated countless industries, including pharmaceuticals, automobiles, dental, electronics, and others. The successful implementation of additive manufacturing in the healthcare sector has led to the development of surgical instruments, medical devices, and body implants. 

The past ten years have seen significant progress in the bioprinting arsenal, with many revolutionary and cutting-edge innovations, helping 3D bioprinting emerge as one of the most exciting and promising technologies. This advanced additive manufacturing has the potential to impact a wide variety of medical applications. Some of the applications making use of 3D bioprinting are

  • Medical Education and Training
  • Drug Delivery
  • Manufacturing of Surgical Instruments
  • Surgery Preparation
  • Production of Personalized Prosthetics

It has been estimated that 3D bioprinting in the medical field will be worth $3.8 billion by 2026, in comparison to the $1.4 billion registered in 2020. The domain’s compound annual growth rate is forecast to reach 18.2% between 2021 and 2026.


The Way Ahead

A large number of medical researchers and pharmaceutical companies are experimenting with printing de novo organs such as hearts, kidneys, livers, lungs, and skin, among others, to assist with the study of organs in-vitro, the development of drugs for specific diseases, and decrease the shortage of organs for transplant.
For instance, Organovo, a medical laboratory and research company based in the United States, presented pre-clinical data for the functionality of its liver tissue in a program for type 1 tyrosinemia, a disease that makes it difficult for the body to metabolize the amino acid tyrosine. A multiplicity of such developments will increase the penetration of 3D bioprinting in the medical field, presenting opportunities for pharmaceutical leaders to invest in the domain.

Spotlight

Rational Vaccines

Rational Vaccines (RVx) was formed in 2015 for the purpose of offering better solutions to stop the spread of herpes and alleviate the problems faced by people suffering with unrelenting, chronic disease. Based on the life work of Dr. Bill Halford, Associate Professor, Southern Illinois University Medical School, who studied herpes simplex virus 1 and 2 (HSV-1 and HSV-2) in a laboratory setting for 25 years, RVx has developed the world’s first line of rationally-engineered live HSV-1 and HSV-2 vaccines that have been shown across 10 years of pre-clinical studies to be safe and highly immunogenic. RVx has also developed a novel type-specific diagnostic method, the ABVIC test, for serological testing of patients for HSV-1 and/or HSV-2 infection, which greatly improves upon the existing standard of care. Through the development of rationally-engineered live viral vaccines and a more accurate and reliable HSV diagnostic test, RVx is forging the path ahead to a brighter future.

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Pharma Tech

How long will the world wait for the next pandemic of antimicrobial resistance before we act?

Article | June 2, 2022

Antimicrobial resistance (AMR) has become an increasingly serious global health problem in recent years. World Health Organization (WHO) estimates that more than 700,000 people die each year due to drug-resistant infections, and the number is expected to increase in the coming years. How does antimicrobial resistance emerge? Antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi, and parasites change over time and no longer respond to medicines. It makes infections harder to treat and increases the risk of disease, severe illness, and death. When we use antibiotics, some bacteria die, but resistant bacteria can survive and even multiply. The overuse of antibiotics and substandard antibiotics make resistant bacteria more common. So, the more we use antibiotics, the more chances bacteria have to become resistant to them. The rise in AMR is caused by multiple factors including the misuse and overuse of antibiotics by humans as well as in livestock and agriculture. Although these are the main drivers in the development of drug-resistant pathogens, the emergence of substandard and falsified antibiotics is another lesser-known, huge contributory factor. Even though AMR is a leading cause of death around the world, it is tracked most closely in clinical high-income settings and developed countries. Unfortunately, this is not the case in low and middle-income countries, where the highest burden is in low-resource settings and low-and middle-income countries (LMICs). These countries are disproportionately affected, in part due to the high burden of communicable diseases. Consequences to human health of AMR AMR poses significant risks to human health, resulting in prolonged and more severe infections, extended hospitalizations, and increased healthcare expenses. It can also lead to an increased risk of death, as an infection may become untreatable. Additionally, it can reduce the effectiveness of medicines and treatments, making it more difficult to manage existing medical conditions. It is even more concerning that it can lead to the emergence of new, more dangerous strains of bacteria, viruses, and other microbes. This would mean medical procedures, such as surgery, including caesarean sections or hip replacements, cancer chemotherapy, and organ transplantation, will become riskier. Counterfeit medicines and antibiotics: Antibiotics are the most counterfeited medicines in the world, as they account for 28% of global counterfeit medicines. Substandard and falsified antibiotics are medicines that do not meet the quality standards set by regulatory authorities. Counterfeit antibiotics are estimated at 5% of the global antibiotic market. These medicines are often of inferior quality or contain incorrect ingredients or incorrect amounts of active ingredients. They may also contain toxic contaminants or be expired, posing serious consequences for patients. Sadly, counterfeit antibiotics are mostly found in LMICs due to a lack of regulation and enforcement, as well as a lack of access to quality healthcare. In many of these countries, the demand for antibiotics is higher than the supply, and counterfeit antibiotics are seen as a cheaper and more accessible alternative. Furthermore, there is a lack of awareness around the dangers of taking counterfeit antibiotics, and there is a lack of resources for health authorities to test for the authenticity of these medicines. Why are antibiotics so rife for counterfeit drugs? Counterfeiters of pharmaceuticals succeed in large part by exploiting weaknesses in supply chains, which are often fragmented with poor regulatory frameworks. Antibiotics are often counterfeited because they are in high demand and can be sold for a large profit. To combat the problem of substandard and falsified antibiotics, governments must take a multi-pronged approach. This should encompass enacting laws and regulations to ensure the quality and safety of medicines, conducting surveillance for detecting and removing substandard and falsified products from the market, as well as providing training and education to healthcare professionals and patients regarding the responsible use of antibiotics. In addition, governments must work to strengthen the pharmaceutical supply chain. This includes increasing the transparency of the supply chain, improving the quality control systems, and introducing traceability systems to track the movement of medicines from the manufacturer to the patient. Medical investment in low and middle-income countries Another neglected aspect by international NGOs and governments is investment in building local laboratory capacity in LMICs to combat antimicrobial resistance. Localized laboratory facilities can help identify, track, and prevent the spread of antimicrobial-resistant infections, as well as provide early warnings of emerging drug-resistant strains. Localized microbiology, surveillance, and quality control laboratories can also play an important role in developing new treatments and interventions for combating antimicrobial resistance. In addition, having localized laboratory capacity can provide more accurate standardized data on the prevalence of drug-resistant infections, which can help inform policy decisions and public health interventions. Affordable medicines Finally, governments must work to increase access to high-quality, affordable medicines. This includes improving the availability of generic medicines, which are typically cheaper alternatives to brand-name drugs. They also need to increase access to newer, more effective antibiotics.

Read More
Pharma Tech

Driving Down Drug Costs: How Real-Time Transparency in PBMs Can Make a Difference

Article | July 7, 2022

In the ever-evolving healthcare landscape, transparency in pharmacy benefit management (PBM) has emerged as a critical issue. The discussion surrounding driving down prescription drug costs and increasing access to affordable medications has brought attention to the practices of PBMs. However, achieving true transparency requires more than just buzzwords; it necessitates access to real-time data that empowers consumers to make informed decisions about their healthcare. In this piece, we will explore the importance of real-time transparency in PBMs and highlight how Xevant, a leading platform, is revolutionizing the industry. The Current State of PBM Legislation With over 100 bills to reform PBM practices, legislative efforts are intensifying to address the business practices associated with PBMs. However, one common concern is the absence of language surrounding real-time automation in many of these bills. The lack of such provisions threatens to undermine the effectiveness of the proposed reforms. It is crucial to examine the available resources and insights to gain a comprehensive understanding of the issue. The current state of PBM legislation and the efforts to reform PBM practices highlight the pressing need for transparency and accountability in the pharmaceutical industry. PBMs play a critical role in the drug pricing ecosystem. Still, concerns about “traditional” PBM business practices, such as lack of transparency and opaque rebate systems, have raised questions about their impact on drug prices and patient access to affordable medications. Xevant's Groundbreaking Solution Xevant, led by CEO Brandon Newman, stands at the forefront of the drive for transparency in PBM practices. As the only platform capable of providing PBMs and consumers with real-time, automated, and completely transparent data from the entire pharmacy benefits ecosystem, Xevant is poised to revolutionize the industry against the backdrop of the political landscape. The absence of language surrounding transparency and real-time automation in many proposed bills threatens the effectiveness of the reforms. Yet, innovative companies like Xevant are leading the charge for openness in PBM practices. Xevant's real-time data automation and optimization capabilities empower consumers with timely, comprehensive, and transparent information, enabling them to make informed decisions about their healthcare and potentially save money. With the potential passage of these bills, the pharmaceutical industry could see a shift towards greater accountability, fairer pricing practices, and improved access to affordable medications. The reforms could also create a more level playing field for generic drug manufacturers, fostering competition and lowering prices. Real-Time Data Automation and Optimization Newman emphasizes that transparency cannot be achieved without access to real-time data automation and optimization. This real-time, customized data enables individuals to compare prices, explore alternatives, and understand the specific cost components related to their medications. By bringing together various parts of lowering drug costs, such as drug rebates, 340B contracts, sell-side discounts, copay assistance, and employer negotiations, Xevant offers a solution that empowers consumers with the information they need when required. The Implications of Timely Access to Data The scarcity of timely access to data among many traditional PBMs is a significant challenge in achieving transparency in the pharmaceutical industry. These PBMs typically collect data annually, which leaves a substantial margin of error and can result in millions of dollars lost from consumers' pockets. In contrast, Xevant's capabilities offer a game-changing solution. With Xevant's platform, consumers gain immediate access to critical information regarding drug rebates, markups during spread pricing, competitive alternatives, and the vast landscape of the pharmaceutical ecosystem. Having these complete datasets available in real-time allows individuals to make informed decisions about their healthcare and potentially save lives. The significance of timely access to data cannot be overstated, as transparency becomes meaningful only when it happens in the present rather than months, or even a year, later than when the impact has already occurred. Navigating Proposed Legislation and Questionable Business Practices Another critical aspect of the PBM landscape that Xevant addresses is the moral implications associated with cost-sharing, clawbacks, spread pricing, and the pass-through of rebates. These practices have long been criticized for their opacity and their negative consequences on patients' access to affordable medications. Xevant's transparency-focused approach highlights these practices, allowing stakeholders to evaluate their ethical implications and work towards fairer alternatives. Xevant recognizes that proposed legislation may have potential cracks that allow for slip-through and the continuation of questionable business practices. Delayed and inaccurate reporting are loopholes that can hinder the effectiveness of reform efforts. By actively engaging with legislators and industry stakeholders, Xevant aims to identify these potential shortcomings and advocate for comprehensive robust legislation that leaves no room forexploitation. The Future of Healthcare and the Role of Real-Time Automation As the discussion surrounding PBM reform gains momentum, the future of healthcare in America hangs in the balance. Xevant sets a new standard for efficiency and consumer empowerment in healthcare decision-making by employing AI-driven technology. Xevant's visionary approach to real-time data automation and optimization paves the way for greater transparency and cost savings in the pharmaceutical industry. Wrapping Up Transparency in pharmacy benefit management is crucial to addressing the soaring costs of prescription drugs and enhancing access to affordable medications. Without access to real-time data and automation, the pursuit of transparency remains elusive. Xevant's groundbreaking platform solves this pressing challenge, enabling PBMs and consumers to access complete, transparent data in real-time. As legislative efforts progress, the need for real-time transparency becomes increasingly evident, and Xevant emerges as the leading legal solution for PBMs. When harnessing the power of real-time data automation, the vision of affordable healthcare can be transformed into a reality, benefiting individuals and the entire healthcare ecosystem.

Read More
Pharma Tech

Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | September 29, 2022

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

Read More

What are the advantages of PCD Pharma Company?

Article | February 17, 2020

PCD Pharma stands for propaganda distribution. A PCD company gives brand name and support to its franchises. They also provide distribution rights and monopoly rights within a particular region. If a person wants to establish their business, it is a must for them to know the pros and cons of the business to make a sound decision. Needless to mention that PCD company has a lot to contribute in the medical filed. Worldwide in a medical field, A PCD Pharma Company is playing an essential and crucial role in the rapid growth. The pharma industry is progressing t a fast pace. The company uses the latest technologies for each brand which ensures the safety of products and accepts the responsibility of human health & life by providing better outcomes. To have a drug license number and company registration, the cost to establish the company is quite cost-effective that is15000-20000rs. So this gives people a brilliant opportunity to have their unit without digging a big hole in their bank balance. Indian produces exquisite quality products, which make pharma companies a considerable success.

Read More
Pharma Tech

Modern Phenotypic Drug Discovery

Article | June 2, 2022

Antimicrobial resistance (AMR) has become an increasingly serious global health problem in recent years. World Health Organization (WHO) estimates that more than 700,000 people die each year due to drug-resistant infections, and the number is expected to increase in the coming years. How does antimicrobial resistance emerge? Antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi, and parasites change over time and no longer respond to medicines. It makes infections harder to treat and increases the risk of disease, severe illness, and death. When we use antibiotics, some bacteria die, but resistant bacteria can survive and even multiply. The overuse of antibiotics and substandard antibiotics make resistant bacteria more common. So, the more we use antibiotics, the more chances bacteria have to become resistant to them. The rise in AMR is caused by multiple factors including the misuse and overuse of antibiotics by humans as well as in livestock and agriculture. Although these are the main drivers in the development of drug-resistant pathogens, the emergence of substandard and falsified antibiotics is another lesser-known, huge contributory factor. Even though AMR is a leading cause of death around the world, it is tracked most closely in clinical high-income settings and developed countries. Unfortunately, this is not the case in low and middle-income countries, where the highest burden is in low-resource settings and low-and middle-income countries (LMICs). These countries are disproportionately affected, in part due to the high burden of communicable diseases. Consequences to human health of AMR AMR poses significant risks to human health, resulting in prolonged and more severe infections, extended hospitalizations, and increased healthcare expenses. It can also lead to an increased risk of death, as an infection may become untreatable. Additionally, it can reduce the effectiveness of medicines and treatments, making it more difficult to manage existing medical conditions. It is even more concerning that it can lead to the emergence of new, more dangerous strains of bacteria, viruses, and other microbes. This would mean medical procedures, such as surgery, including caesarean sections or hip replacements, cancer chemotherapy, and organ transplantation, will become riskier. Counterfeit medicines and antibiotics: Antibiotics are the most counterfeited medicines in the world, as they account for 28% of global counterfeit medicines. Substandard and falsified antibiotics are medicines that do not meet the quality standards set by regulatory authorities. Counterfeit antibiotics are estimated at 5% of the global antibiotic market. These medicines are often of inferior quality or contain incorrect ingredients or incorrect amounts of active ingredients. They may also contain toxic contaminants or be expired, posing serious consequences for patients. Sadly, counterfeit antibiotics are mostly found in LMICs due to a lack of regulation and enforcement, as well as a lack of access to quality healthcare. In many of these countries, the demand for antibiotics is higher than the supply, and counterfeit antibiotics are seen as a cheaper and more accessible alternative. Furthermore, there is a lack of awareness around the dangers of taking counterfeit antibiotics, and there is a lack of resources for health authorities to test for the authenticity of these medicines. Why are antibiotics so rife for counterfeit drugs? Counterfeiters of pharmaceuticals succeed in large part by exploiting weaknesses in supply chains, which are often fragmented with poor regulatory frameworks. Antibiotics are often counterfeited because they are in high demand and can be sold for a large profit. To combat the problem of substandard and falsified antibiotics, governments must take a multi-pronged approach. This should encompass enacting laws and regulations to ensure the quality and safety of medicines, conducting surveillance for detecting and removing substandard and falsified products from the market, as well as providing training and education to healthcare professionals and patients regarding the responsible use of antibiotics. In addition, governments must work to strengthen the pharmaceutical supply chain. This includes increasing the transparency of the supply chain, improving the quality control systems, and introducing traceability systems to track the movement of medicines from the manufacturer to the patient. Medical investment in low and middle-income countries Another neglected aspect by international NGOs and governments is investment in building local laboratory capacity in LMICs to combat antimicrobial resistance. Localized laboratory facilities can help identify, track, and prevent the spread of antimicrobial-resistant infections, as well as provide early warnings of emerging drug-resistant strains. Localized microbiology, surveillance, and quality control laboratories can also play an important role in developing new treatments and interventions for combating antimicrobial resistance. In addition, having localized laboratory capacity can provide more accurate standardized data on the prevalence of drug-resistant infections, which can help inform policy decisions and public health interventions. Affordable medicines Finally, governments must work to increase access to high-quality, affordable medicines. This includes improving the availability of generic medicines, which are typically cheaper alternatives to brand-name drugs. They also need to increase access to newer, more effective antibiotics.

Read More
Pharma Tech

How Pharma Is Utilizing AI and Analytic Capabilities to Produce Positive Results

Article | July 7, 2022

In the ever-evolving healthcare landscape, transparency in pharmacy benefit management (PBM) has emerged as a critical issue. The discussion surrounding driving down prescription drug costs and increasing access to affordable medications has brought attention to the practices of PBMs. However, achieving true transparency requires more than just buzzwords; it necessitates access to real-time data that empowers consumers to make informed decisions about their healthcare. In this piece, we will explore the importance of real-time transparency in PBMs and highlight how Xevant, a leading platform, is revolutionizing the industry. The Current State of PBM Legislation With over 100 bills to reform PBM practices, legislative efforts are intensifying to address the business practices associated with PBMs. However, one common concern is the absence of language surrounding real-time automation in many of these bills. The lack of such provisions threatens to undermine the effectiveness of the proposed reforms. It is crucial to examine the available resources and insights to gain a comprehensive understanding of the issue. The current state of PBM legislation and the efforts to reform PBM practices highlight the pressing need for transparency and accountability in the pharmaceutical industry. PBMs play a critical role in the drug pricing ecosystem. Still, concerns about “traditional” PBM business practices, such as lack of transparency and opaque rebate systems, have raised questions about their impact on drug prices and patient access to affordable medications. Xevant's Groundbreaking Solution Xevant, led by CEO Brandon Newman, stands at the forefront of the drive for transparency in PBM practices. As the only platform capable of providing PBMs and consumers with real-time, automated, and completely transparent data from the entire pharmacy benefits ecosystem, Xevant is poised to revolutionize the industry against the backdrop of the political landscape. The absence of language surrounding transparency and real-time automation in many proposed bills threatens the effectiveness of the reforms. Yet, innovative companies like Xevant are leading the charge for openness in PBM practices. Xevant's real-time data automation and optimization capabilities empower consumers with timely, comprehensive, and transparent information, enabling them to make informed decisions about their healthcare and potentially save money. With the potential passage of these bills, the pharmaceutical industry could see a shift towards greater accountability, fairer pricing practices, and improved access to affordable medications. The reforms could also create a more level playing field for generic drug manufacturers, fostering competition and lowering prices. Real-Time Data Automation and Optimization Newman emphasizes that transparency cannot be achieved without access to real-time data automation and optimization. This real-time, customized data enables individuals to compare prices, explore alternatives, and understand the specific cost components related to their medications. By bringing together various parts of lowering drug costs, such as drug rebates, 340B contracts, sell-side discounts, copay assistance, and employer negotiations, Xevant offers a solution that empowers consumers with the information they need when required. The Implications of Timely Access to Data The scarcity of timely access to data among many traditional PBMs is a significant challenge in achieving transparency in the pharmaceutical industry. These PBMs typically collect data annually, which leaves a substantial margin of error and can result in millions of dollars lost from consumers' pockets. In contrast, Xevant's capabilities offer a game-changing solution. With Xevant's platform, consumers gain immediate access to critical information regarding drug rebates, markups during spread pricing, competitive alternatives, and the vast landscape of the pharmaceutical ecosystem. Having these complete datasets available in real-time allows individuals to make informed decisions about their healthcare and potentially save lives. The significance of timely access to data cannot be overstated, as transparency becomes meaningful only when it happens in the present rather than months, or even a year, later than when the impact has already occurred. Navigating Proposed Legislation and Questionable Business Practices Another critical aspect of the PBM landscape that Xevant addresses is the moral implications associated with cost-sharing, clawbacks, spread pricing, and the pass-through of rebates. These practices have long been criticized for their opacity and their negative consequences on patients' access to affordable medications. Xevant's transparency-focused approach highlights these practices, allowing stakeholders to evaluate their ethical implications and work towards fairer alternatives. Xevant recognizes that proposed legislation may have potential cracks that allow for slip-through and the continuation of questionable business practices. Delayed and inaccurate reporting are loopholes that can hinder the effectiveness of reform efforts. By actively engaging with legislators and industry stakeholders, Xevant aims to identify these potential shortcomings and advocate for comprehensive robust legislation that leaves no room forexploitation. The Future of Healthcare and the Role of Real-Time Automation As the discussion surrounding PBM reform gains momentum, the future of healthcare in America hangs in the balance. Xevant sets a new standard for efficiency and consumer empowerment in healthcare decision-making by employing AI-driven technology. Xevant's visionary approach to real-time data automation and optimization paves the way for greater transparency and cost savings in the pharmaceutical industry. Wrapping Up Transparency in pharmacy benefit management is crucial to addressing the soaring costs of prescription drugs and enhancing access to affordable medications. Without access to real-time data and automation, the pursuit of transparency remains elusive. Xevant's groundbreaking platform solves this pressing challenge, enabling PBMs and consumers to access complete, transparent data in real-time. As legislative efforts progress, the need for real-time transparency becomes increasingly evident, and Xevant emerges as the leading legal solution for PBMs. When harnessing the power of real-time data automation, the vision of affordable healthcare can be transformed into a reality, benefiting individuals and the entire healthcare ecosystem.

Read More
Pharma Tech

Emergence of CRM in Pharmaceutical: Types & Features

Article | September 29, 2022

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

Read More

What are the advantages of PCD Pharma Company?

Article | February 17, 2020

PCD Pharma stands for propaganda distribution. A PCD company gives brand name and support to its franchises. They also provide distribution rights and monopoly rights within a particular region. If a person wants to establish their business, it is a must for them to know the pros and cons of the business to make a sound decision. Needless to mention that PCD company has a lot to contribute in the medical filed. Worldwide in a medical field, A PCD Pharma Company is playing an essential and crucial role in the rapid growth. The pharma industry is progressing t a fast pace. The company uses the latest technologies for each brand which ensures the safety of products and accepts the responsibility of human health & life by providing better outcomes. To have a drug license number and company registration, the cost to establish the company is quite cost-effective that is15000-20000rs. So this gives people a brilliant opportunity to have their unit without digging a big hole in their bank balance. Indian produces exquisite quality products, which make pharma companies a considerable success.

Read More
MORE ARTICLES

Spotlight

Rational Vaccines

Rational Vaccines (RVx) was formed in 2015 for the purpose of offering better solutions to stop the spread of herpes and alleviate the problems faced by people suffering with unrelenting, chronic disease. Based on the life work of Dr. Bill Halford, Associate Professor, Southern Illinois University Medical School, who studied herpes simplex virus 1 and 2 (HSV-1 and HSV-2) in a laboratory setting for 25 years, RVx has developed the world’s first line of rationally-engineered live HSV-1 and HSV-2 vaccines that have been shown across 10 years of pre-clinical studies to be safe and highly immunogenic. RVx has also developed a novel type-specific diagnostic method, the ABVIC test, for serological testing of patients for HSV-1 and/or HSV-2 infection, which greatly improves upon the existing standard of care. Through the development of rationally-engineered live viral vaccines and a more accurate and reliable HSV diagnostic test, RVx is forging the path ahead to a brighter future.

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PHARMACY MARKET, PHARMA TECH

Timber Pharmaceuticals to be Acquired by LEO Pharma

Globenewswire | August 22, 2023

Timber Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to be acquired by LEO US Holding, Inc. a wholly-owned subsidiary of LEO Pharma A/S, in a total transaction value of up to $36 million with (i) an initial upfront consideration of $14 million and (ii) up to an additional $22.0 million in contingent value rights (CVRs) payable upon achievement of certain milestones described below. All of the issued and outstanding shares of capital stock and other equity interests of Timber will be converted into the right to receive the initial upfront consideration, less the payments for certain outstanding warrants that contain a Black Scholes cash payout value. For example, based on a current estimate of the Black Scholes value of such warrants of approximately $5.1 million, subject to change based on the assumptions detailed below, Timber expects the initial amount per share to be paid to Timber stockholders to be approximately $2.62 based on approximately 3.4 million shares of Timber common stock and restricted stock issued and outstanding as of August 20, 2023. The current estimated value to stockholders is based on an implied value assigned to certain outstanding warrants based on Black Scholes option pricing model as of August 18, 2023. This value will not be finalized until the closing of the merger and is subject to increase or decrease based on certain variables, including the actual trading price of Timber at the time of the merger and the trading volatility of Timber common stock prior to the merger. The CVRs that Timber stockholders will receive provide for the payment of up to an additional $22 million with respect to specific milestones for TMB-001, of which up to $12 million is related to FDA approval of TMB-001 by October 1, 2025 for the treatment of congenital ichthyosis, and up to $10 million of which is related to the first achievement of TMB-001 net sales exceeding $100 million within four consecutive calendar quarters by December 31, 2028. As part of the transaction, LEO Pharma has agreed to provide Timber with a bridge loan of up to $3.0 million, subject to certain conditions. The payments of the CVRs are subject to certain deductions relating to the repayment of 50% of the bridge loan provided by LEO Pharma to Timber in connection with the merger. John Koconis, Chairman and Chief Executive Officer of Timber, said, “We are very pleased to deliver a transaction that will maximize long term value for Timber’s shareholders. LEO Pharma is a leader in global dermatology with a mission that matches our own - a relentless pursuit to help patients suffering from skin diseases. “LEO’s expertise and global footprint make it the best choice to advance and achieve the full potential of Timber’s portfolio of product candidates. We believe that LEO has the potential to establish TMB-001 as the standard of care in the treatment of congenital ichthyosis, a devastating, rare disease. “Finally, I would like to sincerely thank our dedicated team at Timber for their tireless efforts, and the clinical investigators, medical professionals, patients and families whose personal contributions have been instrumental in shaping our understanding of TMB-001.” The transaction has been unanimously approved by the Boards of Directors of both companies and is expected to close in the fourth quarter of 2023, subject to customary closing conditions, including approval by the holders of a majority of the shares of Timber’s common stock. Following completion of the transaction, Timber will become a privately held company and shares of Timber’s common stock will no longer be listed on any public market. Timber will file a Current Report on Form 8-K with the Securities and Exchange Commission (“SEC”) that will include a copy of the merger agreement and the CVR agreement and will contain a more detailed description of the merger and the consideration to be received by Timber stockholders. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,700 people, serving millions of patients across the world. In 2022, LEO Pharma generated net sales of DKK 10.6 billion. About Timber Pharmaceuticals, Inc. Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing, and control) and safety profiles. Timber is focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, visit www.timberpharma.com.

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PHARMACY MARKET

Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment

businesswire | September 26, 2023

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain, addiction and neurological disorders, today announced that Health Canada has authorized the use of Quillivant® ER (extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 12. Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR® and QuilliChew ER®, respectively). Quillivant ER is the first once-daily, long-acting, chewable and oral suspension formulations of methylphenidate to be approved for the treatment of ADHD in Canada. “Children with ADHD around the world need medications that provide fast-acting and long-lasting relief in a range of formulations that are easy for them to take. Since the launch of our Quillivant XR product in the United States, we have been approached by potential partners to make our portfolio of ADHD products available around the world,” said Ketan Mehta, founder and chief executive officer at Tris Pharma. “We are truly delighted by this milestone, which will make this important medication available to millions of patients in Canada.” Ontario-based KYE Pharmaceuticals, Inc. will make Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets available to patients in Canada beginning in Q1 2024. Tris will manufacture Quillivant ER in the United States and export to KYE Pharmaceuticals for Canadian patients. ADHD is one of the most common neurodevelopmental disorders diagnosed among children. Many therapies approved to treat ADHD have well-established and significant drawbacks, including early symptom rebound, limited duration of release and efficacy, delayed onset, inability to customize or control titration, and patient difficulty taking the medications (e.g., children unable to swallow a tablet). In Canada, Quillivant ER is authorized for administration to children aged 6 to 12 diagnosed with ADHD as a once-daily liquid suspension or as a chewable tablet to overcome the difficulty of swallowing pills while still achieving the duration needed to control ADHD symptoms for the desired timeframe. Quillivant ER has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant ER Oral Suspension allows for personalized dosing with ease of titration and the Quillivant ER chewable tablets are scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet. Tris developed both formulations using the company’s proprietary LiquiXR® technology. “Quillivant ER has the potential to address a significant unmet market need in the treatment of ADHD by overcoming drawbacks associated with many other ADHD medications, particularly among children,” said John McKendry, president at KYE Pharmaceuticals. “Our strategic partnership with Tris allows us to apply our extensive regulatory and commercial expertise to ensure this unique ADHD medication is made available to patients in Canada.” About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma. About KYE Pharmaceuticals Kye Pharmaceuticals Inc. is a private company headquartered in Mississauga, Canada focused on bringing medications to the Canadian market which fulfill clinically significant and unmet needs. KYE has licensed many innovative products and was founded on an entrepreneurial spirit that optimizes our team’s strengths and brings unique value to our partners, Canadian healthcare professionals, and most importantly, patients across Canada.

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PHARMA TECH

GoodRx and MedImpact Announce Program to Ensure Seamless Access to Affordable Prescriptions

businesswire | September 14, 2023

GoodRx a leading resource for healthcare savings and information, and MedImpact, the independent pharmacy benefit manager (PBM) and health solutions company, announced a new savings solution designed to integrate GoodRx’s prescription pricing in a seamless experience at the pharmacy counter. Now, when an eligible MedImpact member fills a prescription for a generic medication, it will automatically compare their benefit and the GoodRx price and then deliver the lowest one. The amount paid will be applied to the member’s deductible. “This solution allows us to meet Americans where they are by providing them with low prices on their prescriptions without the need for them to compare costs on their own,” said Cynthia Meiners, Strategic Program Development Officer at GoodRx. “We are bringing together the best of what GoodRx does with the best of what MedImpact does to make it incredibly convenient for MedImpact’s members to start and stay on their prescribed treatments, and to fully integrate their clinical data. We truly feel the future of healthcare lies in these types of integrations.” The collaboration achieved by integrating GoodRx’s price comparison technology with MedImpact’s advanced technology platform allows both companies to deliver more savings without any additional work on the part of the consumer. In addition, members will benefit from the seamless data integration this program provides. Through MedImpact’s rigorous drug safety review, which includes thousands of health and safety checks, patients will be alerted about any negative drug interactions. “We are delivering to clients a full portfolio of health, wellness and savings solutions and we see this program as an important part of it,” Marcus Sredzinski, Pharm D, General Manager and MedImpact Senior Vice President. “This delivers hassle-free savings to members, while helping payers capture clinical and adherence data they may have otherwise missed.” GoodRx is actively working to access new lives by expanding its prescription savings reach by partnering with pharmacy benefit managers and their plan sponsors to collaboratively integrate into the insurance benefit market. Through these programs with CVS Caremark, Express Scripts, and MedImpact, GoodRx savings are seamlessly integrated at point-of-sale with three major PBMs that reach over 60% of insured lives. This new program will become available to eligible MedImpact members starting January 1, 2024. About GoodRx GoodRx is a leading resource for healthcare savings and information that makes healthcare affordable and convenient for all Americans. We offer consumers free access to transparent and lower prices for brand and generic medications, affordable and convenient medical provider consultations via telehealth, and comprehensive healthcare research and information. Since 2011, we have helped consumers save over $60 billion and are one of the most downloaded medical apps over the past decade. GoodRx periodically posts information that may be important to investors on its investor relations website at https://investors.goodrx.com. We intend to use our website as a means of disclosing material nonpublic information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors and potential investors are encouraged to consult GoodRx’s website regularly for important information, in addition to following GoodRx’s press releases, filings with the Securities and Exchange Commission (the “SEC”) and public conference calls and webcasts. The information contained on, or that may be accessed through, GoodRx’s website is not incorporated by reference into, and is not a part of, this press release. About MedImpact For more than 30 years, MedImpact has been building, delivering, and reimagining pharmacy benefit solutions for healthcare payers who face complex and dynamic challenges. As the leading independent PBM, we offer clients the clarity they need to make care and cost decisions; control over a powerful suite of solutions that manage pharmacy spend; and confidence that comes from a proven PBM partner who is fully aligned with their goals and invested in their future.

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PHARMACY MARKET, PHARMA TECH

Timber Pharmaceuticals to be Acquired by LEO Pharma

Globenewswire | August 22, 2023

Timber Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to be acquired by LEO US Holding, Inc. a wholly-owned subsidiary of LEO Pharma A/S, in a total transaction value of up to $36 million with (i) an initial upfront consideration of $14 million and (ii) up to an additional $22.0 million in contingent value rights (CVRs) payable upon achievement of certain milestones described below. All of the issued and outstanding shares of capital stock and other equity interests of Timber will be converted into the right to receive the initial upfront consideration, less the payments for certain outstanding warrants that contain a Black Scholes cash payout value. For example, based on a current estimate of the Black Scholes value of such warrants of approximately $5.1 million, subject to change based on the assumptions detailed below, Timber expects the initial amount per share to be paid to Timber stockholders to be approximately $2.62 based on approximately 3.4 million shares of Timber common stock and restricted stock issued and outstanding as of August 20, 2023. The current estimated value to stockholders is based on an implied value assigned to certain outstanding warrants based on Black Scholes option pricing model as of August 18, 2023. This value will not be finalized until the closing of the merger and is subject to increase or decrease based on certain variables, including the actual trading price of Timber at the time of the merger and the trading volatility of Timber common stock prior to the merger. The CVRs that Timber stockholders will receive provide for the payment of up to an additional $22 million with respect to specific milestones for TMB-001, of which up to $12 million is related to FDA approval of TMB-001 by October 1, 2025 for the treatment of congenital ichthyosis, and up to $10 million of which is related to the first achievement of TMB-001 net sales exceeding $100 million within four consecutive calendar quarters by December 31, 2028. As part of the transaction, LEO Pharma has agreed to provide Timber with a bridge loan of up to $3.0 million, subject to certain conditions. The payments of the CVRs are subject to certain deductions relating to the repayment of 50% of the bridge loan provided by LEO Pharma to Timber in connection with the merger. John Koconis, Chairman and Chief Executive Officer of Timber, said, “We are very pleased to deliver a transaction that will maximize long term value for Timber’s shareholders. LEO Pharma is a leader in global dermatology with a mission that matches our own - a relentless pursuit to help patients suffering from skin diseases. “LEO’s expertise and global footprint make it the best choice to advance and achieve the full potential of Timber’s portfolio of product candidates. We believe that LEO has the potential to establish TMB-001 as the standard of care in the treatment of congenital ichthyosis, a devastating, rare disease. “Finally, I would like to sincerely thank our dedicated team at Timber for their tireless efforts, and the clinical investigators, medical professionals, patients and families whose personal contributions have been instrumental in shaping our understanding of TMB-001.” The transaction has been unanimously approved by the Boards of Directors of both companies and is expected to close in the fourth quarter of 2023, subject to customary closing conditions, including approval by the holders of a majority of the shares of Timber’s common stock. Following completion of the transaction, Timber will become a privately held company and shares of Timber’s common stock will no longer be listed on any public market. Timber will file a Current Report on Form 8-K with the Securities and Exchange Commission (“SEC”) that will include a copy of the merger agreement and the CVR agreement and will contain a more detailed description of the merger and the consideration to be received by Timber stockholders. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,700 people, serving millions of patients across the world. In 2022, LEO Pharma generated net sales of DKK 10.6 billion. About Timber Pharmaceuticals, Inc. Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing, and control) and safety profiles. Timber is focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, visit www.timberpharma.com.

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PHARMACY MARKET

Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment

businesswire | September 26, 2023

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain, addiction and neurological disorders, today announced that Health Canada has authorized the use of Quillivant® ER (extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 12. Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR® and QuilliChew ER®, respectively). Quillivant ER is the first once-daily, long-acting, chewable and oral suspension formulations of methylphenidate to be approved for the treatment of ADHD in Canada. “Children with ADHD around the world need medications that provide fast-acting and long-lasting relief in a range of formulations that are easy for them to take. Since the launch of our Quillivant XR product in the United States, we have been approached by potential partners to make our portfolio of ADHD products available around the world,” said Ketan Mehta, founder and chief executive officer at Tris Pharma. “We are truly delighted by this milestone, which will make this important medication available to millions of patients in Canada.” Ontario-based KYE Pharmaceuticals, Inc. will make Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets available to patients in Canada beginning in Q1 2024. Tris will manufacture Quillivant ER in the United States and export to KYE Pharmaceuticals for Canadian patients. ADHD is one of the most common neurodevelopmental disorders diagnosed among children. Many therapies approved to treat ADHD have well-established and significant drawbacks, including early symptom rebound, limited duration of release and efficacy, delayed onset, inability to customize or control titration, and patient difficulty taking the medications (e.g., children unable to swallow a tablet). In Canada, Quillivant ER is authorized for administration to children aged 6 to 12 diagnosed with ADHD as a once-daily liquid suspension or as a chewable tablet to overcome the difficulty of swallowing pills while still achieving the duration needed to control ADHD symptoms for the desired timeframe. Quillivant ER has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant ER Oral Suspension allows for personalized dosing with ease of titration and the Quillivant ER chewable tablets are scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet. Tris developed both formulations using the company’s proprietary LiquiXR® technology. “Quillivant ER has the potential to address a significant unmet market need in the treatment of ADHD by overcoming drawbacks associated with many other ADHD medications, particularly among children,” said John McKendry, president at KYE Pharmaceuticals. “Our strategic partnership with Tris allows us to apply our extensive regulatory and commercial expertise to ensure this unique ADHD medication is made available to patients in Canada.” About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma. About KYE Pharmaceuticals Kye Pharmaceuticals Inc. is a private company headquartered in Mississauga, Canada focused on bringing medications to the Canadian market which fulfill clinically significant and unmet needs. KYE has licensed many innovative products and was founded on an entrepreneurial spirit that optimizes our team’s strengths and brings unique value to our partners, Canadian healthcare professionals, and most importantly, patients across Canada.

Read More

PHARMA TECH

GoodRx and MedImpact Announce Program to Ensure Seamless Access to Affordable Prescriptions

businesswire | September 14, 2023

GoodRx a leading resource for healthcare savings and information, and MedImpact, the independent pharmacy benefit manager (PBM) and health solutions company, announced a new savings solution designed to integrate GoodRx’s prescription pricing in a seamless experience at the pharmacy counter. Now, when an eligible MedImpact member fills a prescription for a generic medication, it will automatically compare their benefit and the GoodRx price and then deliver the lowest one. The amount paid will be applied to the member’s deductible. “This solution allows us to meet Americans where they are by providing them with low prices on their prescriptions without the need for them to compare costs on their own,” said Cynthia Meiners, Strategic Program Development Officer at GoodRx. “We are bringing together the best of what GoodRx does with the best of what MedImpact does to make it incredibly convenient for MedImpact’s members to start and stay on their prescribed treatments, and to fully integrate their clinical data. We truly feel the future of healthcare lies in these types of integrations.” The collaboration achieved by integrating GoodRx’s price comparison technology with MedImpact’s advanced technology platform allows both companies to deliver more savings without any additional work on the part of the consumer. In addition, members will benefit from the seamless data integration this program provides. Through MedImpact’s rigorous drug safety review, which includes thousands of health and safety checks, patients will be alerted about any negative drug interactions. “We are delivering to clients a full portfolio of health, wellness and savings solutions and we see this program as an important part of it,” Marcus Sredzinski, Pharm D, General Manager and MedImpact Senior Vice President. “This delivers hassle-free savings to members, while helping payers capture clinical and adherence data they may have otherwise missed.” GoodRx is actively working to access new lives by expanding its prescription savings reach by partnering with pharmacy benefit managers and their plan sponsors to collaboratively integrate into the insurance benefit market. Through these programs with CVS Caremark, Express Scripts, and MedImpact, GoodRx savings are seamlessly integrated at point-of-sale with three major PBMs that reach over 60% of insured lives. This new program will become available to eligible MedImpact members starting January 1, 2024. About GoodRx GoodRx is a leading resource for healthcare savings and information that makes healthcare affordable and convenient for all Americans. We offer consumers free access to transparent and lower prices for brand and generic medications, affordable and convenient medical provider consultations via telehealth, and comprehensive healthcare research and information. Since 2011, we have helped consumers save over $60 billion and are one of the most downloaded medical apps over the past decade. GoodRx periodically posts information that may be important to investors on its investor relations website at https://investors.goodrx.com. We intend to use our website as a means of disclosing material nonpublic information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors and potential investors are encouraged to consult GoodRx’s website regularly for important information, in addition to following GoodRx’s press releases, filings with the Securities and Exchange Commission (the “SEC”) and public conference calls and webcasts. The information contained on, or that may be accessed through, GoodRx’s website is not incorporated by reference into, and is not a part of, this press release. About MedImpact For more than 30 years, MedImpact has been building, delivering, and reimagining pharmacy benefit solutions for healthcare payers who face complex and dynamic challenges. As the leading independent PBM, we offer clients the clarity they need to make care and cost decisions; control over a powerful suite of solutions that manage pharmacy spend; and confidence that comes from a proven PBM partner who is fully aligned with their goals and invested in their future.

Read More

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