DUBLIN – In what is a truly transformative deal for each company, Gilead Sciences Inc. and Galapagos NV are entering a 10-year research and development alliance under which Galapagos is getting $3.95 billion up front in hard cash plus another $1.1 billion in equity, in return for which Gilead will essentially have an option to ex-European rights on everything emanating from the Belgium firm's clinical and preclinical pipeline. That includes six clinical-stage programs, another 20 in preclinical research and whatever else Galapagos may bring forward – or bring in through its own business development efforts – over the term of the agreement. Read More
LONDON – AM-Pharma BV has raised €116 million (US$130.7 million) in a series E round to fund phase III development of its recombinant alkaline phosphatase, Recap, in the treatment of sepsis-associated acute kidney injury (SA-AKI). Read More
Some new investors pitched in to Recursion Pharmaceuticals Inc.'s $121 million series C financing, adding to the industry's vision of the importance of AI and machine learning. Read More
"We tried to land on Mars and we got to the moon," Novavax Inc. President of R&D Gregory Glenn told BioWorld, referring to the Gaithersburg, Md.-based firm's phase III trial with the respiratory syncytial virus (RSV) vaccine called Resvax. And it was more than anyone had done thus far, he added. Read More
In the largest U.S. opioid-related settlement yet, Reckitt Benckiser Group plc agreed to pay a total of $1.4 billion to end federal civil and criminal investigations into its role in delaying generic competition to Suboxone, an opioid-addiction treatment drug. Read More
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Read More
Flex Pharma Inc., of Boston, said its stockholders approved all proposals relating to its planned merger with Houston-based Salarius Pharmaceuticals LLC at its special meeting. The merger is expected to be completed within the next two weeks. Read More
Two decades in the making, a mutual recognition agreement between the FDA and EMA is now fully implemented. Slovakia was the last EU member state to get the FDA's seal of approval for its conduct of drug manufacturing inspections. Read More
Valeo Pharma Inc., of Montreal, said it filed its final short form prospectus in each of the provinces and territories of Canada in connection with its sale of a minimum of 4 million units and a maximum of 16 million units at CA50 cents each for gross proceeds of between CA$2 million (US$1.53 million) and CA$8 million (US$6.13 million). Read More
