After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be approving the Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec). Re-examination of the file led to a happier outcome for another drug that has attracted considerable controversy, Eli Lilly and Co. Inc.’s Kisunla (donanemab) for treating the early stages of Alzheimer’s disease.
Abivax SA is positioning to change the treatment landscape in ulcerative colitis after delivering positive results and a favorable safety profile in two phase III trials of its orally available miRNA-124 enhancer, obefazimod. Abivax stock rocketed in Europe and the U.S. on news of the data. Shares (Paris:ABVX) rose €45.40, or 510%, to close at €54.30 July 23. In the U.S., shares (NASDAQ:ABVX) leapt 586%, or $58.60, to close at $68.60.
Respiratory vaccines specialist Vicebio Ltd. is to be acquired by Sanofi SA in a $1.6 billion deal, of which $1.15 billion will be paid up front. The acquisition rests on an ongoing phase I trial of the lead asset, VXB-241, a bivalent vaccine that is intended to provide protection against both respiratory syncytial virus and metapneumovirus. The interim analysis of the study showed a favorable safety and tolerability profile in adults, ages 60 and older, and validated the underlying vaccine technology, which is applicable to a wide range of respiratory viruses.
After two decades of research elucidating the basic science, Tafalgie Therapeutics SA has delivered the first clinical data for its non-opioid analgesic.
The pharmaceutical industry in Europe has taken the lead in pulling together a coalition of 17 industry groups, academics and clinicians to call for the urgent implementation of the EU Life Science Strategy published earlier this month, in order to rescue the clinical trial ecosystem from “a perilous situation.”
Scientists at Newcastle University U.K., have reported the births of eight healthy babies following mitochondrial transfer, in which the fertilized egg of a woman carrying mutations in their mitochondrial DNA was placed in the enucleated egg of a non-carrier.
The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.
“Pharmaceuticals will be tariffed, probably at the end of the month,” U.S. President Donald Trump said, as he provided a few more details about his proposed global biopharma sector tariff. “We’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build. And then we’re going to make it a very high tariff.”
After a 10-year project and a £60 million (US$80 million) investment, the UK Biobank has completed the whole body scans of 100,000 volunteers and is making the 1 billion images available for researchers worldwide.
Under a new licensing deal announced July 8, JCR Pharmaceuticals Co. Ltd. granted Alexion Pharmaceuticals Inc. rights to its adeno-associated virus (AAV) capsids for use in up to five of Alexion’s genomic medicines programs.
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