Shares of Oncopeptides AB dropped 35% Dec. 7 on the U.S. FDA’s request to withdraw marketing authorization of Pepaxto (melflufen), a drug that had gained accelerated approval in early 2021 for use in relapsed/refractory multiple myeloma. The move followed a negative advisory committee vote in September 2022 and is based on the outcome of the confirmatory phase III Ocean study.
Six months after a merger deal fell through, leaving the company to face possible bankruptcy, Therapeuticsmd Inc. agreed to license U.S. commercialization rights for its women’s health care products to Australian firm Mayne Pharma Group Ltd. in exchange for $140 million up front plus milestone and royalty payments.
Six months after a merger deal fell through, leaving the company to face possible bankruptcy, Therapeuticsmd Inc. agreed to license U.S. commercialization rights for its women’s health care products to Australian firm Mayne Pharma Group Ltd. in exchange for $140 million up front plus milestone and royalty payments.
When the COVID-19 pandemic effectively shut down travel and conferences starting in the first part of 2020, the general lament was that the lack of face-to-face interaction would hamper biopharma companies’ ability to secure deals and investments. Instead, the opposite happened. Now, coming off two years of record-breaking financing, the biopharma sector is facing an inevitable correction, though a handful of venture capital panelists suggested there’s room for optimism.
GSK plc said it will restrict the second-line maintenance indication for ovarian cancer drug Zejula (niraparib) to only patients with deleterious or suspected germline BRCA mutations, at the request of the FDA, in a sign that U.S. regulators aren’t going to relax scrutiny on PARP inhibitors any time soon.
GSK plc said it will restrict the second-line maintenance indication for ovarian cancer drug Zejula (niraparib) to only patients with deleterious or suspected germline BRCA mutations, at the request of the FDA, in a sign that U.S. regulators aren’t going to relax scrutiny on PARP inhibitors any time soon.
Atriva Therapeutics GmbH, a small firm founded in 2015 to develop a host-targeted antiviral approach for treating respiratory viral infections, seems to have found itself in thick of it. As the U.S. CDC and other health agencies warn of an uptick in respiratory viral infections – the so-called “tripledemic” of influenza, respiratory syncytial virus and COVID-19 – the German company is gearing up to launch a basket trial testing lead candidate zapnometinib in all three indications.
Verve Therapeutics Inc.’s heart disease candidate, VERVE-101, is the latest gene editing-based therapy to hit a snag at the FDA, which issued a clinical hold, delaying the start of phase I testing in the U.S. News of the hold, which followed preclinical presentations over the weekend at the American Heart Association 2022 meeting, sent shares of Verve (NASDAQ:VERV) falling 30.5% to close Nov. 7 at $21.75.
Heading into the readout of the phase III Mont Blanc study testing Nicox SA’s NCX-470, a nitric oxide-donating version of prostaglandin analogue bimatoprost, analysts were looking for a superior intraocular pressure-lowering profile vs. latanoprost, predicting such data could position the drug as a new standard of care in a crowded market.
The U.S. FDA declined to approve Gilead Sciences Inc.’s Hepcludex (bulevirtide), issuing a complete response letter (CRL) citing manufacturing and delivery concerns for the antiviral aimed at treating confirmed chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease. Acquired in Gilead’s 2021 buyout of Myr GmbH, Hepcludex received conditional approval from the European Commission in 2020 and would have been the first drug cleared for HDV in the U.S. Its delay, however, could give a boost to Eiger Biopharmaceuticals Inc., which is expected to report phase III data for lonafarnib by the end of 2022.
