Stealth Biotherapeutics Corp.’s refusal to file (RTF) letter from the FDA regarding the NDA for elamipretide, a candidate that targets mitochondria in the treatment of Barth syndrome, hardly knocked the stock, as investors likely saw the bad news coming.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Aim, Alphageneron, Ambulero, Biogen, Biontech, Chipscreen, First Wave, Genmab, Janssen, Innocare, Moleculin, Pfizer, Plus, Sage.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Avadel, Avidity, Boehringer, Enochian, Gilead, I-Mab, Leo, Omeros, Oyster Point, Regeneron, Revance, Roche, Saniona, Sanofi, Som, United, UCB, Xilio.
With a 14% increase in regulatory news over this time last year, 2021 has proved to be the busiest that the biopharma industry has ever seen, as companies continue to seek clearances of their late-stage pipeline products with a backdrop of an unprecedented number of COVID-19 pandemic efforts.
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.
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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