U.S. drug regulators issued a report detailing quality control lapses at Novo Nordisk’s main factory in North America as early as May last year, according to the report obtained by Reuters via a Freedom of Information Act request.
Bringing in an additional $50 million in a Series B extension, ReCode Therapeutics’ total haul for the funding round totaled $260 million, which it will use to further its experimental mRNA therapies.
The U.S. health regulator has declined to approve a nasal spray that would have been the first needle-free emergency treatment for allergic reactions, a surprise decision that sent shares of its developer ARS Pharmaceuticals down 47% premarket.
The companies have announced the impending closures of their respective businesses. Histogen will lay off most of its employees by the end of September. Fresh Tracks will do so by early October.
In a settlement on September 1, the U.S. Federal Trade Commission cleared Amgen to proceed with its $27.8 billion acquisition of Horizon Therapeutics after several months of scrutiny. Some experts say the agreement is a setback for the agency.
Ypsomed said it would expand its manufacturing capacities over the coming years, with Novo Nordisk contributing a significant part of the investment for the additional production infrastructure.
The study will use a robot to surgically place a brain-computer interface (BCI) implant in a region of the brain that controls the intention to move, Neuralink said, adding that its initial goal is to enable people to control a computer cursor or keyboard using their thoughts alone.
Nearly three years after European approval, the U.S. regulator has accepted Orchard Therapeutics’ BLA for its gene therapy OTL-200, being proposed for metachromatic leukodystrophy.
The French pharma company continues to pare down its central nervous system business by divesting 11 brands to U.K.-based Pharmanovia, which is expanding its neurology portfolio.
Medical device maker Boston Scientific said on Tuesday it would buy private medical tech company Relievant Medsystems for an upfront cash payment of $850 million, in a bid to expand treatment options for chronic low back pain.
