Medicaid misclassification bill inspired by EpiPen snafu passes Congress

FiercePharma | April 03, 2019

Medicaid misclassification bill inspired by EpiPen snafu passes Congress
How long does it take Congress to reach an agreement on drug prices? On the topic of drug misclassifications in Medicaid, about two and a half years. That’s the time that’s passed since Mylan’s famous EpiPen saga and the Justice Department settlement that followed. Finally, lawmakers have passed the Right Rebate Act, hoping to crack down on drug misclassifications that lower drugmaker rebates and cost taxpayers. And now the bill is headed to the president's desk. The legislation allows the Department of Health and Human Services to closely monitor the Medicaid Drug Rebate Program for misclassifications and requires regular reports to make sure it keeps an eye out. Under the bill, the HHS secretary could require drug companies to reclassify medications and impose penalties for drugs that are “knowingly misclassified.”

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B&A Health is a medical device and pharmaceutical packaging contract manufacturing firm in Hyderabad, India. Our entire facility is equipped with cleanroom technology, ISO Class 8 in the production area and ISO Class 7 in assembly, packaging and sterilization areas. Our technical staff has more than 40+ years of experience working in International and Domestic medical device manufacturing firms.

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Virpax Announces MMS019 Manufacturing and Supply Agreement

Virpax Pharmaceuticals | August 27, 2021

Virpax® Pharmaceuticals, Inc., a company specializing in developing product candidates for pain management, CNS and anti-viral indications, today announced that it has entered into a commercial manufacturing and supply agreement with Seqens, an integrated global leader in pharmaceutical solutions with 24 manufacturing sites worldwide and seven research and development facilities throughout the U.S. and Europe. The agreement with Seqens provides for both the supply material for Virpax’s clinical studies as well as the long-term commercial supply of MMS019. Seqens will conduct process development and validation of additional large scale commercial quantities of MMS019 at its facilities in Devens and Newburyport, Massachusetts. “Establishing a collaboration with a strong partner capable of supplying clinical and commercial scale quantities of MMS019 is another important advancement in our MMS019 product development strategy. Seqens has a demonstrated expertise in developing and manufacturing highly-complex molecules for large scale production,” said Anthony Mack, Chairman and CEO of Virpax. “Importantly, we expect this collaboration to support future development and supply additional Molecular Envelope Technology programs under development, including Envelta™ and PES200, our post-traumatic stress disorder product candidate,” concluded Mr. Mack. About MMS019 MMS019 is a drug product candidate based on a type of nanotechnology that enables the exclusive delivery of a metabolically labile peptide drug into the brain via intranasal delivery. MMS019 is manufactured using industrially relevant equipment and processes (high pressure homogenization and spray drying). There is pharmacological evidence of activity of molecular envelope technology (MET) enabled enkephalin in morphine-tolerant animals. The MET nanoparticles are well tolerated via the nasal route at the dose administered. MMS019 demonstrated comparable preclinical activity to morphine in all animal pain models tested without the drug seeking and tolerance associated with opioids. About Seqens SEQENS is an integrated global leader in pharmaceutical solutions and specialty ingredients. With 24 production sites and 7 R&D centers in Europe, North America and Asia, SEQENS develops and manufactures tailor-made solutions and ingredients for the most demanding industries such as healthcare, electronics, cosmetics, food and home care. Driven by a culture of excellence and a strong entrepreneurial spirit, our 3,200 employees are committed to providing our customers with the highest level of service and quality while acting ethically in accordance with our corporate social responsibility program.” About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management product candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval using its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac metered-dose spray film formulation being developed to manage acute musculoskeletal pain and osteoarthritis. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal molecular-envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop its PES200 product candidate to manage post-traumatic stress disorder (PTSD) and its MMS019 product candidate to inhibit viral replication caused by influenza or SARS-CoV-2.

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Innovation Pharmaceuticals grants intellectual property and commercialization rights to Fox Chase Chemical Diversity for antifungal technology

Innovation Pharmaceuticals, Fox Chase Chemical Diversity Center | July 23, 2020

Innovation Pharmaceuticals, a clinical stage biopharmaceutical company, announces today that the Company and Fox Chase Chemical Diversity Center, Inc. have amended an earlier collaborative research agreement related to antifungal drug discovery work. Under the amended terms, and in exchange for a six (6) percent fee tied to all potential future proceeds—including upfront payments, milestone payments and royalties—the Company is granting FCCDC all discovery, intellectual property and commercialization rights related to its share of their joint antifungal drug program. Both parties believe the new agreement is favorable to each, with FCCDC continuing to advance discovery and drug development, and Innovation Pharmaceuticals benefiting from potential future commercialization. Over $5 million in government grants have helped fund antifungal work conducted to date.

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Takeda, debt in mind, offloads 18 drugs in Asia Pacific to Celltrion for $278M

Fiercepharma | June 11, 2020

Takeda has earmarked another chunk of business for divestment to help it pay down debt. The Japanese pharma is offloading 18 over-the-counter and prescription drugs marketed in the Asia-Pacific region to South Korea’s Celltrion for $278 million, it said on Thursday. The portfolio generated sales of about $140 million in the fiscal year ended in March 2019, mainly driven by DPP-4 diabetes drug Nesina and hypertension med Edarbi, Takeda said. It will continue to manufacture the products and supply them to Celltrion after the transaction closes. Takeda expects the deal to wrap up by the end of the year. As is the case with its previous deals, the sold-off drugs fall outside of Takeda’s chosen focus business areas—gastroenterology, rare diseases, plasma-derived therapies, oncology and neuroscience.

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Spotlight

B&A Health is a medical device and pharmaceutical packaging contract manufacturing firm in Hyderabad, India. Our entire facility is equipped with cleanroom technology, ISO Class 8 in the production area and ISO Class 7 in assembly, packaging and sterilization areas. Our technical staff has more than 40+ years of experience working in International and Domestic medical device manufacturing firms.