Medical scopes still causing superbug infections, deaths

DEBRA GOLDSCHMIDT | April 12, 2019 | 299 views

(CNN) - Three people died and 45 people developed infections from contaminated endoscopes, the US Food and Drug Administration said Friday. The reports of contamination are with a side-viewing duodenoscope used for a medical procedure called endoscopic retrograde cholangiopancreatography or ERCP. "These flexible lighted scopes are vital for minimally invasive procedures to diagnose and treat conditions of the pancreas and bile duct," said Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health. The reusable scopes, which are made by three manufacturers -- Fujifilm Medical Systems USA Inc.

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

Article | July 15, 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.

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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.

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Pharmacy Market

Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | July 7, 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.

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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.

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Infant Bacterial Therapeutics today announces new patent protection approvals in Brazil and in Hong Kong

Infant Bacterial Therapeutics | December 28, 2021

Infant Bacterial Therapeutics AB announces that the Patent Offices of Brazil and Hong Kong have approved a patent of Lactobacillus reuteri covering IBP-9414. IBT is currently developing its drug candidate IBP-9414 in Phase III for the prevention of necrotizing colitis and improvement of feeding tolerance in preterm infants. The patent covers a novel way to activate the bacteria. Corresponding patent applications are currently pending across several important future markets. This patent reinforces the existing protection of IBT’s drug candidate IBP-9414. Additional market protection, beyond patent exclusivity, is also anticipated in the form of Orphan Drug Exclusivity and biological data protection in the US and EU. The patent provides coverage until 2036. IBP-9414 is intended to be marketed in Brazil and Hong Kong upon marketing authorization. “We are pleased to have strengthened our intellectual property protection for IBP-9414 through the approved patents in Brazil and Hong Kong. Brazil is in particular a substantial market with about 215 million inhabitants, which makes it a very interesting commercial opportunity for our future product", CEO Staffan Strömberg, IBT About Infant Bacterial Therapeutics AB Infant Bacterial Therapeutics AB is a public company domiciled in Stockholm. The company’s Class B shares are listed on Nasdaq Stockholm, Mid-cap. Infant Bacterial Therapeutics AB is a pharmaceutical company with a product in clinical phase III with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants. IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the world’s first approved probiotical drug with the goal to prevent life threatening diseases in premature infants including NEC and sepsis by promoting healthy stomach-and bowel development in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. The product portfolio also includes another project, IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.

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Pharmacy Market

Titan Pharmaceuticals to Explore Strategic Alternatives

Titan Pharmaceuticals, Inc. | December 22, 2021

Titan Pharmaceuticals, Inc. announced that it has commenced a process to explore and evaluate strategic alternatives to enhance shareholder value. Titan has engaged Maxim Group LLC as its exclusive financial advisor to assist in this process. Potential strategic alternatives that may be explored or evaluated as part of this process include an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other strategic transactions involving the Company. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. Titan does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. Ultimate validation of the ProNeura® delivery system has been exemplified by approval of Probuphine in the US, EU and Canada. Key ongoing ProNeura implant programs include IND-enabling, non-clinical assessment of TP-2021, a potent peptide kappa opioid agonist for the long-term treatment of severe, chronic pruritis, and nalmefene, a mu opioid receptor blocker designed to decrease relapse and potential death from overdose in detoxed patients with Opiate Use Disorder.

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Business Insights

TriMas Closes on Acquisition of Omega

TriMas | December 21, 2021

TriMasannounced that it has closed the acquisition of Omega Plastics (“Omega”), a manufacturer of custom components and tooling for medical, as well as industrial applications, adding to TriMas’ Packaging group. Omega leverages its core injection molding capabilities, ISO Class 8 clean room and advanced in-house tool making capabilities, to provide its customers a faster product development cycle, from prototype development, testing and validation, to short and medium run production and assembly. Omega’s medical components are currently used in drug delivery, including consumable intravenous applications, as well as diagnostic testing and orthopedic applications. As of September 30, 2021, TriMas’ Packaging group’s last twelve months sales were approximately $534 million, representing approximately 64% of TriMas’ total sales. TriMas plans to expand Omega’s production capacity, as required in order to benefit its customers’ longer-term needs, while also leveraging Omega’s advanced tool making capabilities to add to TriMas Packaging’s speed-to-market advantage on innovation and new product designs. Omega is expected to generate approximately $18 million in revenue in fiscal year 2021. “We welcome Omega to TriMas’ family of businesses and look forward to working with the Omega leadership team to unleash future growth opportunities. I’d like to thank all the teams from Omega, TriMas and our respective advisors that supported the work to complete this transaction.” Thomas Amato, TriMas President & CEO The addition of Omega further expands TriMas Packaging’s Pharmaceutical & Nutraceutical product offering into supporting medical device contract development manufacturing customers.

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Practice Management

Infant Bacterial Therapeutics today announces new patent protection approvals in Brazil and in Hong Kong

Infant Bacterial Therapeutics | December 28, 2021

Infant Bacterial Therapeutics AB announces that the Patent Offices of Brazil and Hong Kong have approved a patent of Lactobacillus reuteri covering IBP-9414. IBT is currently developing its drug candidate IBP-9414 in Phase III for the prevention of necrotizing colitis and improvement of feeding tolerance in preterm infants. The patent covers a novel way to activate the bacteria. Corresponding patent applications are currently pending across several important future markets. This patent reinforces the existing protection of IBT’s drug candidate IBP-9414. Additional market protection, beyond patent exclusivity, is also anticipated in the form of Orphan Drug Exclusivity and biological data protection in the US and EU. The patent provides coverage until 2036. IBP-9414 is intended to be marketed in Brazil and Hong Kong upon marketing authorization. “We are pleased to have strengthened our intellectual property protection for IBP-9414 through the approved patents in Brazil and Hong Kong. Brazil is in particular a substantial market with about 215 million inhabitants, which makes it a very interesting commercial opportunity for our future product", CEO Staffan Strömberg, IBT About Infant Bacterial Therapeutics AB Infant Bacterial Therapeutics AB is a public company domiciled in Stockholm. The company’s Class B shares are listed on Nasdaq Stockholm, Mid-cap. Infant Bacterial Therapeutics AB is a pharmaceutical company with a product in clinical phase III with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants. IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the world’s first approved probiotical drug with the goal to prevent life threatening diseases in premature infants including NEC and sepsis by promoting healthy stomach-and bowel development in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. The product portfolio also includes another project, IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.

Read More

Pharmacy Market

Titan Pharmaceuticals to Explore Strategic Alternatives

Titan Pharmaceuticals, Inc. | December 22, 2021

Titan Pharmaceuticals, Inc. announced that it has commenced a process to explore and evaluate strategic alternatives to enhance shareholder value. Titan has engaged Maxim Group LLC as its exclusive financial advisor to assist in this process. Potential strategic alternatives that may be explored or evaluated as part of this process include an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other strategic transactions involving the Company. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. Titan does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. Ultimate validation of the ProNeura® delivery system has been exemplified by approval of Probuphine in the US, EU and Canada. Key ongoing ProNeura implant programs include IND-enabling, non-clinical assessment of TP-2021, a potent peptide kappa opioid agonist for the long-term treatment of severe, chronic pruritis, and nalmefene, a mu opioid receptor blocker designed to decrease relapse and potential death from overdose in detoxed patients with Opiate Use Disorder.

Read More

Business Insights

TriMas Closes on Acquisition of Omega

TriMas | December 21, 2021

TriMasannounced that it has closed the acquisition of Omega Plastics (“Omega”), a manufacturer of custom components and tooling for medical, as well as industrial applications, adding to TriMas’ Packaging group. Omega leverages its core injection molding capabilities, ISO Class 8 clean room and advanced in-house tool making capabilities, to provide its customers a faster product development cycle, from prototype development, testing and validation, to short and medium run production and assembly. Omega’s medical components are currently used in drug delivery, including consumable intravenous applications, as well as diagnostic testing and orthopedic applications. As of September 30, 2021, TriMas’ Packaging group’s last twelve months sales were approximately $534 million, representing approximately 64% of TriMas’ total sales. TriMas plans to expand Omega’s production capacity, as required in order to benefit its customers’ longer-term needs, while also leveraging Omega’s advanced tool making capabilities to add to TriMas Packaging’s speed-to-market advantage on innovation and new product designs. Omega is expected to generate approximately $18 million in revenue in fiscal year 2021. “We welcome Omega to TriMas’ family of businesses and look forward to working with the Omega leadership team to unleash future growth opportunities. I’d like to thank all the teams from Omega, TriMas and our respective advisors that supported the work to complete this transaction.” Thomas Amato, TriMas President & CEO The addition of Omega further expands TriMas Packaging’s Pharmaceutical & Nutraceutical product offering into supporting medical device contract development manufacturing customers.

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