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This podcast discusses the results of Vital Transformation’s latest research study outlining the impact of proposed changes to the Accelerated Approval pathway, and what this would mean for patients with rare conditions. The study quantifies the impact of the Accelerated Approval pathway in bringing new therapies for unmet needs to market, and the vital role…
MichBio is among over 400 groups from all 50 states that have signed the Prevent Cancer Foundation’s letter to Congress encouraging passage of the Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 1946 / S. 1873). The legislation has reached an exciting milestone with over half of the U.S. House of Representatives having co-sponsored the bill. As a reminder,…
Congress is considering several pieces of legislation requiring the FDA to regularly update cybersecurity guidance and better coordinate efforts with other agencies to better safeguard of medical and healthcare technologies from digital threats. A bipartisan proposal, the Strengthening Cybersecurity for Medical Devices Act, would require the agency to review and update premarket medical device cybersecurity guidance…
The Senate Commerce Committee passed legislation, Pharmacy Benefit Manager Transparency Act of 2022 (S. 4293) , that is designed to address how PBMs control drug prices and can potentially reduce the amount independent pharmacies and consumers pay for medicine. PBMs manage prescription drug benefits for insurance plans and payers. They receive rebates and discounts on…
Reauthorization of the FDA user fee agreement (UFA) package – that sets terms, conditions and costs for review of prescription drug (PDUFA), medical device (MDUFA), generic drug (GDUFA), and biosimilar (BsUFA) applications – is inching forward in Congress. In addition to codifying the agreements, these bills are often vehicles for other FDA policy changes. On…
Grand River Aseptic Manufacturing (“GRAM”), a leading parenteral contract development and manufacturing organization (CDMO), has signed a multi-year contract with the U.S. Department of Health and Human Services and the U.S. Department of Defense. Under the agreement, GRAM will invest $160 million and receive $120 million from the U.S. government to fund the expansions of…
Original Source The Gilbert Family Foundation, a private fund established by Dan and Jennifer Gilbert, announced Thursday it is funding more than $18 million in grants toward a cure for Type 1 neurofibromatosis. The money will fund a three-year campaign as part of the organization’s Gene Therapy Initiative. Four grants totaling $4.4 million will be invested…
Original Source Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the source of obstructive HCM Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo PRINCETON, N.J.–(BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Camzyos™ (mavacamten, 2.5…
May 16, 2022 – (RTP, North Carolina) – Vestaron, a leader in peptide-based biological crop protection, is pleased to announce the official closing of the Series C fundraising efforts at $82M as of May 12, 2022. The financing was significantly oversubscribed with high demand from both existing and new investors. Lead investors joining Vestaron in…
Governor Gretchen Whitmer joined the Michigan Economic Development Corporation (MEDC) to announce that Michigan has been approved for up to $236,990,950 in State Small Business Credit Initiative (SSBCI) funding from the U.S. Department of Treasury. “Ensuring small businesses can thrive and create good-paying jobs in every region of Michigan is critical as we continue growing…
Plymouth, MI – May 23, 2022 – Phenomics Health Inc., a bioinformatics-based precision medicine company, today announced the commercial integration of six PrecīsMed® pharmacometabolomic (PMx) and PredictScript™ pharmacogenomic (PGx) clinical products to comprehensively support individual patient medication treatment. Phenomics Health novel product platforms can now provide clinicians with multiple tools to enhance treatment outcomes through…
CANTON, Mich. (05/24/2022) – MMS Holdings Inc. (MMS) – an award-winning, data-focused contract research organization (CRO) – announced a collaboration with THREAD® as its partner of choice for its decentralized clinical trial platform (DCT) and DCT-enabled services. THREAD’s next-generation DCT technology enables faster, more efficient clinical trials while improving access for research participants with higher quality data…
The U.S. House Energy and Commerce (E&C) Health Subcommittee on Wednesday advanced to the full committee legislation reauthorizing user fee programs, including PDUFA and MDUFA. The legislation, H.R. 7667, the Food and Drug Amendment Act, passed 30-0 on a bipartisan vote with provisions to increase clinical trial diversity, modify the accelerated approval pathway and promote generics. On the…
May 2022 Update: In last month’s newsletter we informed that State Rep. Matt Koleszar asked the Michigan Attorney General (AG) for an opinion on the requirement to register facilities who use of animals in research and only permit those doing so in a “humane” manner. Due to several administrative reorganizations and transference of powers some…
The Advanced Medical Technology Association (AdvaMed) announced its revised Code of Ethics on Interactions with Health Care Professionals (HCPs)on March 18, 2022. The medical device industry has relied on the AdvaMed Code for decades to assist with navigating complex rules concerning compliance—particularly rules regarding fraud and abuse stemming from interactions with HCPs. Notable updates to the…