Against the backdrop of the global spread of COVID-19, India announced restrictions Tuesday on the export of 26 active pharmaceutical ingredients (APIs) and formulations of those ingredients.
With new phase III multiple myeloma (MM) data in hand from Newton, Mass.-based Karyopharm Therapeutics Inc.’s Xpovio (selinexor), Wall Street began speculating about what the results might mean in the marketplace.
Paris-based Sanofi SA won FDA clearance of the intravenously given CD38-directed cytolytic antibody Sarclisa (isatuximab-irfc) in combination with pomalidomide (Pomalyst, Celgene Corp.) and dexamethasone (dex) for adults with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene Corp.) and a proteasome inhibitor.
COVID-19 is bringing more pressure to bear on Congress to pass S. 2723, the Mitigating Emergency Drug Shortages (MEDS) Act, which has been sitting in the Senate Health, Education, Labor and Pensions (HELP) Committee since Sen. Susan Collins (R-Maine) introduced it in October 2019 – a few months before the novel coronavirus emerged.
With the FDA’s blessing, Biohaven Pharmaceutical Holding Co. Ltd.’s Nurtec ODT (rimegepant) enters a massive market for treating migraine in adults. In the U.S. alone, more than 25 million people have been diagnosed and seek treatment.
Aptevo Therapeutics Inc.’s chief scientific officer, Jane Gross, told BioWorld that the sale of the firm’s marketed recombinant hemophilia B therapeutic, Ixinity, to Medexus Pharmaceuticals Inc. allowed for a “cleaner message” to Wall Street. “It was a little difficult to explain having a commercial asset and an R&D pipeline,” she said.
SAN DIEGO – At Biocom's 10th Annual Global Life Sciences Partnering Conference, a panel of players intimately familiar with last year's approval of myelofibrosis treatment Inrebic (fedratinib) explained the backstory of how they got the JAK2 kinase inhibitor off an FDA clinical hold, wrangled the rights to the drug back from the big pharma owner that had acquired the drug from Targegen Inc. and eventually helped the drug gain FDA approval after selling the rights to another large company.
DUBLIN – The EMA’s Committee for Medicinal Products for Human Use (CHMP) diverged from the FDA on a key decision at its monthly meeting, which concluded Feb. 28. It refused to back an application from Eli Lilly and Co. for a line extension to its migraine prevention drug, Emgality (galcanezumab), which would have authorized the drug for preventing attacks during an episode of cluster headaches.
BEIJING – There was encouraging news when vaccine developer Moderna Inc. announced this week it that has shipped the first vials of its mRNA vaccine against COVID-19 for a phase I trial in the U.S. The vaccine was created just 42 days after the genetic sequence of the COVID-19 virus was released. That is record speed. Other vaccine developers are also working around the clock to respond to the epidemic.
LONDON – It was third time lucky for Acacia Pharma Group plc, as the FDA finally gave approval to Barhemsys (amisulpride) as a rescue treatment for surgical patients suffering postoperative nausea and vomiting (PONV), despite standard-of-care treatment.
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