Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advent, Astria, Biophytis, Excision, Hutchmed, Ipsen, Junshi, Pharmala.
A day after a U.S. House committee, on a party-line vote, advanced two bills to reauthorize emergency preparedness programs, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 17-3 July 20 to send its bipartisan reauthorization of the Pandemic and All Hazards Preparedness Act to the Senate floor with a do-pass recommendation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambrx, Aqualung, Bloomsbury, Fosun, Hoth, Mabwell, Qihan, Sensorion.
Nearly 13 years after Congress created a biosimilars path to bring competition to the U.S. biologics market, new rules of the road are coming into play, via the Inflation Reduction Act (IRA), that could change the course for biosimilars in the long haul – if the IRA’s prescription drug price negotiation mandate withstands numerous constitutional challenges.
The U.S. Federal Trade Commission and the Department of Justice have floated a new set of guidelines that would govern their reviews of mergers in a variety of markets, including the drug and device industries. While many of these guidelines are vaguely worded and open to interpretation, one of the more ambiguously worded passages states that a merger may be rejected if it could create “a clog on competition,” a phrase that appears in a Supreme Court decision handed down more than 60 years ago.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Aridis, Astrazeneca, Biocorrx, Karyopharm, Sanofi.
Johnson & Johnson and its Janssen pharmaceutical companies added their name July 18 to the growing list of biopharma companies and organizations challenging the Inflation Reduction Act’s (IRA) mandated drug price negotiations.
The U.S. SEC is settling insider trading charges against Nirdosh Jagota, former vice president of global regulatory affairs at Merck & Co. Inc., stemming from Merck’s $1.85 billion acquisition of Pandion Therapeutics Inc. in 2021.
Elevar Therapeutics Inc. said that the U.S. FDA accepted its NDA for oral tyrosine kinase inhibitor rivoceranib in combination with PD-1 inhibitor camrelizumab (Airuika) as a first-line treatment for liver cancer. The FDA stamped an official PDUFA target action date of May 16, 2024.
Responding to medical advances and new standards of care in Alzheimer’s, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to end its 10-year-old coverage with evidence development policy that has limited Medicare reimbursement of amyloid PET scans to once in a lifetime for beneficiaries – and then only when they’re used in a CMS-approved trial.
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