The third time proved the charm for Adamis Pharmaceuticals Corp.’s high-dose naloxone injection, Zimhi, which gained FDA approval for use in treating opioid overdose, nearly three years after the San Diego-based company first submitted an NDA.
Omeros Corp.’s complete response letter (CRL) from the FDA regarding its BLA for narsoplimab did not come as much of a surprise to Wall Street, but still was enough to drive shares (NASDAQ:OMER) down 26.6% to close Oct. 18 at $5.67, a loss of $2.06.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Apellis, BMS, Chiesi, Gilead, Janssen, Lava, Merck, Pfizer, Rhythm, Sobi.
PERTH, Australia – Australia’s TGA issued new guidance to help device manufacturers better understand new classifications for active medical devices, including software-based medical devices, and clinical decision support software.
Feops SA reported that its Heartguide product has received de novo authorization from the FDA for pre-operative planning of left atrial appendage occlusion (LAAo) with the Boston Scientific Corp. Watchman device. The software platform is designed to help physicians virtually model clinical scenarios with different implant positions and sizes of the Watchman device using digital twin technology based on patient-specific virtual replicas of the heart. It is currently commercially available in the EU, U.K., Canada and Australia for transcatheter aortic valve implantation and LAAo workflows.
The FDA reported Oct. 14 that software used with the Alinity m test kit by Abbott Laboratories is being recalled for the potential for false positive results, a problem due to software used to automate the processing of the test. This recall was originally issued in mid-September, but the Abbott Park, Ill.-based company is advising labs to treat any test result as presumptive at best.
A few months after disclosing its merger with Chiasma Inc., Amryt plc rolled out second quarter financials pleasing to Wall Street, where considerable interest has begun to manifest in the company’s epidermolysis bullosa program with Filsuvez, also known as Oleogel-S10.
LONDON – The EMA recommended approval of Apellis Pharmaceuticals Inc.’s C3 complement inhibitor, Aspaveli (pegcetacoplan), to treat paroxysmal nocturnal hemoglobinuria, but has diverged from the FDA, excluding treatment-naïve patients adding its use should be restricted to those who have failed to respond to C5 inhibitor drugs.
The FDA’s Vaccines and Related Biological Products Advisory Committee unanimously agreed to recommend a booster dose of Janssen Biotech Inc.’s COVID-19 vaccine for those age 18 years and older at least two months following the first dose. In the end, the vote swung on numbers from Janssen showing a booster significantly improved efficacy among study participants. Janssen’s data leaped to 94% protection after a booster dose, up from 70% efficacy following the first dose. That higher efficacy rate nearly matches that of the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE.
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