Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clearpoint Neuro, Precisis, Pulse Biosciences.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amniotics, Avenue, Bausch + Lomb, Biontech, Ferring, Glenmark, Infant Bacterial, Oncopeptides, Pfizer, Rebiotix, Spectrum.
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.
Colorectal cancer (CRC) is expected to increase steadily through the decade to reach more than 2.2 million cases and 1.1 million deaths by 2030 as two concurrent trends tick up—an aging population, that typically has higher rates of the disease, and an alarming increase in cases in younger people. Iterative Scopes Inc. hopes to help gastroenterologists find precancerous lesions before they progress with its Skout device, which received U.S. FDA 510(k) clearance this week.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dyansys, Iterative Scopes.
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.
A subcommittee of the Senate Judiciary Committee met recently to review the current state of antitrust enforcement in the U.S., and heard from both the Department of Justice (DOJ) and the Federal Trade Commission (FTC) about their enforcement activities. FTC chairwoman Lina Khan acknowledged that the agency had coordinated with the European Commission about the transaction between Illumina Inc., and Grail Inc., activities which she claimed were nothing more than an attempt to promote regulatory efficiency.
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.
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