While U.S. FDA approvals are down by 27% in 2022, the agency was busy throughout the month of September, clearing seven new molecular entities (NMEs), the most for any month this year.
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) took up the matter of Oncopeptides AB’s long-storied multiple myeloma (MM) drug, Pepaxto (melphalan flufenamide), and briefing documents ahead of the meeting – which provided little cause for optimism – proved predictive of ODAC’s vote. Shares of Oncopeptides (Stockholm:ONCO) have dropped more than 64% over the past five days as investor jitters worsened.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Keymed, Kinnate, Krystal, Merck & Co., Relief.
Emphasizing April’s vote of concern about the safety of PI3K inhibitors, the U.S. FDA’s Oncologic Drugs Advisory Committee said privately held Secura Bio Inc.’s Copiktra (duvelisib) is more of a hindrance than a help. The adcom voted 8-4 on Sept. 23 that it sees a detriment in overall survival (OS) and some other safety issues that were revealed in newly updated data for the cancer treatment. Approved in 2018 for treating adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies, Secura argued that its data continue to show a statistically significant and clinically meaningful benefit in OS and also in progression-free survival.
DBV Technologies SA blindsided investors by disclosing that the U.S. FDA had placed a partial clinical hold on its phase III Vitesse trial of its Viaskin Peanut patch immunotherapy for peanut allergy, calling for several changes to the study protocol. Its demands came just two weeks after the company claimed to have finalized the protocol in consultation with the agency.
Although it wasn’t a shutout, Spectrum Pharmaceuticals Inc. didn’t get the support it needed from a U.S. FDA advisory committee Sept. 22 for its non-small-cell lung cancer candidate, poziotinib, which it has proposed marketing as Pozenveo.
Inspectors from the U.S. Public Company Accounting Oversight Board (PCAOB) have reportedly arrived in Hong Kong to inspect audit records for the Chinese companies listed by the U.S. SEC as being noncompliant with U.S. accounting standards.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Argenx, Astrazeneca, Biocodex, Cellenkos, Cidara, Fennec, Frontera, Immunitas, Verve.
It took resolving issues from two complete response letters for Fennec Pharmaceuticals Inc. to finally land U.S. FDA approval of Pedmark. The injectable formulation of sodium thiosulfate is for reducing the risk of platinum-induced ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors. Approval of the NDA arrived Sept. 20, three days before its Sept. 23 PDUFA date.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alligator, Alnylam, Antengene, Aptevo, Artiva, Astrazeneca, Beigene, Bluebird, Bristol Myers Squibb, Cyxone, First Wave, Genentech, Heron, Leo, Medexus, Psyence, Roche, Seagen, Xortx.
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