Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, ASC, Astrazeneca, Beigene, Biogen, Enveric, Triact.
Following a priority review, the FDA approved Bayer AG’s Kerendia (finerenone) for chronic kidney disease (CKD) associated with type 2 diabetes (T2D). A non-steroidal mineralocorticoid receptor antagonist, Kerendia targets a key driver in CKD and has proven positive as well with regard to cardiovascular outcomes – risked especially by patients with loss of kidney function.
With 15 more U.S. states signing on, a bankruptcy settlement appears to be in sight for privately owned Purdue Pharma LP. It also has U.S. lawmakers calling for reforms to the country’s bankruptcy laws.
U.S. Rep. Carolyn Maloney (D-N.Y.) came out swinging against the biopharma industry’s innovation talking point July 8 when she released a House Oversight Committee staff report on U.S. drug prices and the games drug manufacturers play to delay competition.
DUBLIN – Shares in Oncopeptides AB dropped 26% July 8 on news that the FDA had placed a partial clinical hold on a raft of trials involving its newly approved multiple myeloma drug Pepaxto (melphalan flufenamide; melflufen), following a bizarre incident involving the incomplete handover to an independent review committee of data from a phase III head-to-head trial in myeloma, which had pitted melflufen against Pomalyst (pomalidomide).
Following battles over its price and accelerated approval, Biogen Inc. and Eisai Co. Ltd.’s Aduhelm (aducanumab) now has newly approved prescribing information from the FDA that limits the patient population and sales along with it. The updated Indications and usage now reads that the anti-amyloid beta monoclonal antibody should be used only in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. That’s the patient population in which treatment was initiated in clinical trials that led to approval. The company said the new wording “clarifies the indication.” The original FDA-approved language cleared the drug for much broader use in Alzheimer’s.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arbutus. Bold, Eucure, Jazz, Replicel, Scisparc, Sorrento.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Athenex, Immutep, Janssen-Cilag, Levo, Merck, Opthea, Orgenesis, Sciclone, Y-Mabs.
The U.S. Federal Trade Commission (FTC) reported a series of moves recently that promise more scrutiny of companies in the life sciences industry, such as the more routine use of subpoenas and other compulsory processes during investigations. However, the FTC has also announced a broader revamp of the agency’s rulemaking authorities that some critics argue would allow the commission to promulgate rules that are in defiance of standing FTC practice.
The U.S. Supreme Court has agreed to take up one piece of the 340B conundrum that’s pitting biopharma against hospitals and catching the Department of Health and Human Services in between. The case the court agreed to hear, the American Hospital Association (AHA) v. Becerra, focuses on whether HHS has the authority to cut Medicare reimbursement rates to reflect the steep discounts 340B hospitals get on certain prescription drugs.
RSS
