Home > Resources > Articles > FDA Sent These Warning Letters To Pharma/Device Companies

FDA Sent These Warning Letters To Pharma/Device Companies

BARBARA W. UNGER | August 20, 2019 | 324 views

We cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter and one in the food area that is a ‘first of its kind’.  One of the drug warning letters is issued to a firm that recovered solvents that were used in the manufacture of the API of valsartan products that contained the multiple potential carcinogens.  Note that Swiss Medic inspected the firm 6 days before FDA did and issued a report of non-compliance.

Spotlight

Pharma Resource Group, Inc.

Pharma Resource Group, Inc. (PRG) is a full-service pharmaceutical resource and services provider. PRG provides strategic and tactical solutions for the ethical pharmaceutical, OTC, nutraceutical and biotech industries that are scientifically based and built upon three distinct characteristics.

OTHER ARTICLES
Pharma Tech

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

Article | July 20, 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 | September 29, 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
PHARMACY MARKET

Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | September 26, 2023

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

Precision Medicine: New Horizons in Pharmaceuticals

Article | July 20, 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

Emergence of CRM in Pharmaceutical: Types & Features

Article | September 29, 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
PHARMACY MARKET

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

Article | September 26, 2023

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

Pharma Resource Group, Inc.

Pharma Resource Group, Inc. (PRG) is a full-service pharmaceutical resource and services provider. PRG provides strategic and tactical solutions for the ethical pharmaceutical, OTC, nutraceutical and biotech industries that are scientifically based and built upon three distinct characteristics.

Related News

PHARMACY MARKET

Cytel continues expansion of market access and medical communication capabilities with the acquisition of co.faktor

businesswire | September 28, 2023

Cytel Inc., provider of quantitative insights and health data analytics to leaders in the life sciences, has acquired the Berlin-based company co.faktor GmbH with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. As a result, Cytel’s services for biopharma commercialization will gain new and complementary specialist consultancy capabilities and localized expertise for successful market access in Germany, a first wave launch country. The acquisition marks another milestone in Cytel’s strategic growth in Europe, and follows the recent acquisition of stève consultants, specialists in market access, real-world evidence (RWE), and health economics and outcomes research (HEOR) in France. Cytel now boasts a 200-person-strong access consultancy team, making it one of the only providers that offers the full fleet of advisory services, from clinical trial and real-world data and evidence analytics to global market access and local in-country Health Technology Assessment (HTA) support. Cytel is now primed to provide global drug sponsors and their affiliate teams with advanced analytical support across the lifecycle through commercialization. Achieving favorable market access in today’s global healthcare industry is challenging and requires deep knowledge of EU national regulations. Cytel has long excelled at using proven quantitative techniques to help pharmaceutical manufacturers successfully enter new markets. To continue supporting global and local clients on their road to commercial success, Cytel has invested heavily in specialized, national capabilities in key launch markets with the recent acquisitions of stève consultants in June 2023 and SDS Life Sciences in 2022. Cytel’s most recent acquisition of the co.faktor businesses continues this investment, augmenting and extending localized regulatory support through product launch and commercialization. “The co.faktor team is recognized as a highly specialized biopharma services provider, with a broad spectrum of services including HTA, pricing, medical communication, patient relations, and strategic consultancy in Germany. It’s no surprise they’ve shaped the field there,” said Radek Wasiak, General Manager, Real-World & Advanced Analytics at Cytel. “We look forward to welcoming them to Cytel, where they will now be supported by the full depth and breadth of our unparalleled biometrics, RWE, HEOR, and market access advisory talent.” “Cytel and co.faktor have clear synergies, particularly when it comes to Cytel’s data know-how and co.faktor’s understanding of Germany’s uniquely complex market access and HTA requirements,” said Dr. Marc Esser, CEO, co.faktor. “By combining our deep expertise in the German HTA process with Cytel’s unique capabilities, we will be able to help our clients survive the upcoming European Health Technology Assessment (EU-HTA), a key challenge for all stakeholders in the European pharma market.” About Cytel Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty-five years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence, and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 1,900 resources across North America, Europe, and Asia. About co.faktor For more than ten years, Berlin-based co.faktor GmbH has been providing specialized consulting services with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. By synergistically combining the expertise in these areas, co.faktor offers efficient launch support with consistent messaging to all relevant stakeholders.

Read More

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

PHARMACY MARKET

Biofourmis Accelerates and Simplifies Drug Development with Expanded Digital Clinical Trials Solution

prnewswire | September 21, 2023

Biofourmis, a leading global technology-enabled care delivery company, announced today the release of its expanded Digital Clinical Trials solution within the Biofourmis platform for biopharma and other life sciences companies. The solution offers robust digital tools and resources for trial sponsors and investigators aimed at accelerating drug development and improving access and diversity while also reducing costs. Biofourmis' Digital Clinical Trials solution includes a technology-enabled, scalable platform and services that support digital tools enablement, trial decentralization, safety monitoring, personalized care, easier participant recruitment and more equitable access to treatment options for patients everywhere. The solution helps sponsors and researchers accelerate clinical development with remote data collection and novel digital endpoints from Biofourmis' library of biomarkers across multiple therapeutic areas. The expanded solution offers a more holistic workflow, new data management automations and a seamless integration of essential clinical trial documentation, participant scheduling and data collection elements. Because the artificial intelligence (AI)-powered platform is highly configurable, study start-up timelines can be reduced from months to days. The connected platform seamlessly integrates with 40+ devices, enabling study teams the freedom to select the right device for the right disease area. Biopharma companies can also tap into Biofourmis' growing principal investigator (PI) network. The network includes experienced and esteemed PIs from leading academic medical centers as a valuable resource to manage digitally driven research and accelerate the pace of recruitment with access to patient databases. Health systems that already use the Biofourmis platform for technology-enabled care delivery at home can easily and quickly expand their clinical research initiatives by leveraging the connected platform to include the Digital Clinical Trials functionality. "We have consistently earned high satisfaction scores from both researchers and trial participants for our solutions. Now, we have identified additional ways to accelerate access to digital clinical trials, lower costs, and improve the experience for all stakeholders," said Biofourmis COO Jaydev Thakkar. "These new technology and service elements create a more holistic, turnkey solution that achieves those aims while offering greater synergies from drug development to commercialization and creating equitable access to treatment options and clinical research for patients everywhere." Market-leading enhancements to the Digital Clinical Trials solution include Robust eConsent and ePROs Capabilities: Robust screening and informed consent tools are integrated into workflows to accelerate recruitment, decrease enrollment time, and help ensure that participants fully understand risks and benefits associated with the trial. The documentation content is easily configurable and compliant with regulatory requirements. The enhanced ePROs (electronic patient-reported outcomes) collection capabilities drive adherence through automated reminders of participants' reporting requirements while offering them the ability to easily share outcomes beyond traditional clinical measures. Reporting flexibility offers investigators increased visibility into participant safety, health and experience. Dynamic Participant Scheduling: Upon enrollment, the Digital Clinical Trials solution helps research stay on course while encouraging participant adherence and engagement through a virtual visit and schedule of assessment module that streamlines all the "to-do" items for the participant and caregiver, intuitively listing all the required patient reporting and external assessment tasks. Reminders and notifications help participants stay adherent; but if a task is missed, the schedule can automatically adjust so the participant can remain enrolled, and the trial can move forward. InHome Services: As with all solutions within Biofourmis Connect and Care, In-Home Services such as nurse visits, phlebotomy, infusion, imaging, and other ancillary services delivered within the home are available via the connected platform to support decentralized clinical trials—which further reduces burden on investigators and participants. Unmatched Safety Monitoring: The solution leverages AI to monitor the efficacy and side effects of drugs. A specific example includes pre-screening for clinical events triggered by high potassium levels (hyperkalemia), which can reduce clinical trial costs by decreasing frequent manual checks by medical professionals while still protecting patient safety. In addition, cardiac safety monitoring capabilities such as auto-detection of QTc prolongation (an extended interval between the heart contracting and relaxing) can improve the safety of trials by detecting patients earlier who are at risk of developing critical heart arrhythmias due to drug side effects. "Leveraging digital tools and automating and accelerating trial processes for both researchers and participants can increase the likelihood that endpoints will be reached sooner, which lowers costs and simplifies tasks for everyone involved," Thakkar said. "More importantly, shorter trials with more meaningful results mean that groundbreaking new therapies can be discovered and developed faster to improve outcomes for patients worldwide." About Biofourmis Biofourmis brings the right care to every person, no matter where they are. The company's AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, in-home services, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis' connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier.

Read More

PHARMACY MARKET

Cytel continues expansion of market access and medical communication capabilities with the acquisition of co.faktor

businesswire | September 28, 2023

Cytel Inc., provider of quantitative insights and health data analytics to leaders in the life sciences, has acquired the Berlin-based company co.faktor GmbH with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. As a result, Cytel’s services for biopharma commercialization will gain new and complementary specialist consultancy capabilities and localized expertise for successful market access in Germany, a first wave launch country. The acquisition marks another milestone in Cytel’s strategic growth in Europe, and follows the recent acquisition of stève consultants, specialists in market access, real-world evidence (RWE), and health economics and outcomes research (HEOR) in France. Cytel now boasts a 200-person-strong access consultancy team, making it one of the only providers that offers the full fleet of advisory services, from clinical trial and real-world data and evidence analytics to global market access and local in-country Health Technology Assessment (HTA) support. Cytel is now primed to provide global drug sponsors and their affiliate teams with advanced analytical support across the lifecycle through commercialization. Achieving favorable market access in today’s global healthcare industry is challenging and requires deep knowledge of EU national regulations. Cytel has long excelled at using proven quantitative techniques to help pharmaceutical manufacturers successfully enter new markets. To continue supporting global and local clients on their road to commercial success, Cytel has invested heavily in specialized, national capabilities in key launch markets with the recent acquisitions of stève consultants in June 2023 and SDS Life Sciences in 2022. Cytel’s most recent acquisition of the co.faktor businesses continues this investment, augmenting and extending localized regulatory support through product launch and commercialization. “The co.faktor team is recognized as a highly specialized biopharma services provider, with a broad spectrum of services including HTA, pricing, medical communication, patient relations, and strategic consultancy in Germany. It’s no surprise they’ve shaped the field there,” said Radek Wasiak, General Manager, Real-World & Advanced Analytics at Cytel. “We look forward to welcoming them to Cytel, where they will now be supported by the full depth and breadth of our unparalleled biometrics, RWE, HEOR, and market access advisory talent.” “Cytel and co.faktor have clear synergies, particularly when it comes to Cytel’s data know-how and co.faktor’s understanding of Germany’s uniquely complex market access and HTA requirements,” said Dr. Marc Esser, CEO, co.faktor. “By combining our deep expertise in the German HTA process with Cytel’s unique capabilities, we will be able to help our clients survive the upcoming European Health Technology Assessment (EU-HTA), a key challenge for all stakeholders in the European pharma market.” About Cytel Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty-five years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence, and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 1,900 resources across North America, Europe, and Asia. About co.faktor For more than ten years, Berlin-based co.faktor GmbH has been providing specialized consulting services with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. By synergistically combining the expertise in these areas, co.faktor offers efficient launch support with consistent messaging to all relevant stakeholders.

Read More

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

PHARMACY MARKET

Biofourmis Accelerates and Simplifies Drug Development with Expanded Digital Clinical Trials Solution

prnewswire | September 21, 2023

Biofourmis, a leading global technology-enabled care delivery company, announced today the release of its expanded Digital Clinical Trials solution within the Biofourmis platform for biopharma and other life sciences companies. The solution offers robust digital tools and resources for trial sponsors and investigators aimed at accelerating drug development and improving access and diversity while also reducing costs. Biofourmis' Digital Clinical Trials solution includes a technology-enabled, scalable platform and services that support digital tools enablement, trial decentralization, safety monitoring, personalized care, easier participant recruitment and more equitable access to treatment options for patients everywhere. The solution helps sponsors and researchers accelerate clinical development with remote data collection and novel digital endpoints from Biofourmis' library of biomarkers across multiple therapeutic areas. The expanded solution offers a more holistic workflow, new data management automations and a seamless integration of essential clinical trial documentation, participant scheduling and data collection elements. Because the artificial intelligence (AI)-powered platform is highly configurable, study start-up timelines can be reduced from months to days. The connected platform seamlessly integrates with 40+ devices, enabling study teams the freedom to select the right device for the right disease area. Biopharma companies can also tap into Biofourmis' growing principal investigator (PI) network. The network includes experienced and esteemed PIs from leading academic medical centers as a valuable resource to manage digitally driven research and accelerate the pace of recruitment with access to patient databases. Health systems that already use the Biofourmis platform for technology-enabled care delivery at home can easily and quickly expand their clinical research initiatives by leveraging the connected platform to include the Digital Clinical Trials functionality. "We have consistently earned high satisfaction scores from both researchers and trial participants for our solutions. Now, we have identified additional ways to accelerate access to digital clinical trials, lower costs, and improve the experience for all stakeholders," said Biofourmis COO Jaydev Thakkar. "These new technology and service elements create a more holistic, turnkey solution that achieves those aims while offering greater synergies from drug development to commercialization and creating equitable access to treatment options and clinical research for patients everywhere." Market-leading enhancements to the Digital Clinical Trials solution include Robust eConsent and ePROs Capabilities: Robust screening and informed consent tools are integrated into workflows to accelerate recruitment, decrease enrollment time, and help ensure that participants fully understand risks and benefits associated with the trial. The documentation content is easily configurable and compliant with regulatory requirements. The enhanced ePROs (electronic patient-reported outcomes) collection capabilities drive adherence through automated reminders of participants' reporting requirements while offering them the ability to easily share outcomes beyond traditional clinical measures. Reporting flexibility offers investigators increased visibility into participant safety, health and experience. Dynamic Participant Scheduling: Upon enrollment, the Digital Clinical Trials solution helps research stay on course while encouraging participant adherence and engagement through a virtual visit and schedule of assessment module that streamlines all the "to-do" items for the participant and caregiver, intuitively listing all the required patient reporting and external assessment tasks. Reminders and notifications help participants stay adherent; but if a task is missed, the schedule can automatically adjust so the participant can remain enrolled, and the trial can move forward. InHome Services: As with all solutions within Biofourmis Connect and Care, In-Home Services such as nurse visits, phlebotomy, infusion, imaging, and other ancillary services delivered within the home are available via the connected platform to support decentralized clinical trials—which further reduces burden on investigators and participants. Unmatched Safety Monitoring: The solution leverages AI to monitor the efficacy and side effects of drugs. A specific example includes pre-screening for clinical events triggered by high potassium levels (hyperkalemia), which can reduce clinical trial costs by decreasing frequent manual checks by medical professionals while still protecting patient safety. In addition, cardiac safety monitoring capabilities such as auto-detection of QTc prolongation (an extended interval between the heart contracting and relaxing) can improve the safety of trials by detecting patients earlier who are at risk of developing critical heart arrhythmias due to drug side effects. "Leveraging digital tools and automating and accelerating trial processes for both researchers and participants can increase the likelihood that endpoints will be reached sooner, which lowers costs and simplifies tasks for everyone involved," Thakkar said. "More importantly, shorter trials with more meaningful results mean that groundbreaking new therapies can be discovered and developed faster to improve outcomes for patients worldwide." About Biofourmis Biofourmis brings the right care to every person, no matter where they are. The company's AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, in-home services, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis' connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier.

Read More

Events