At its October meeting, the EMA’s Committee for Human Medicinal Products (CHMP) voted in favor of 11 new therapies, two of them for treating cancers and two for treating HIV-1. The European Commission will review the recommendations and make its decisions by the end of 2020.
Eli Lilly and Co.’s definitive agreement to acquire privately held Disarm Therapeutics Inc. brings Cambridge, Mass.-based Disarm $135 million up front and as much as $1.225 billion in additional future payments for potential development, regulatory and commercial milestones if Lilly successfully develops and commercializes therapies tied to the agreement.
In Regeneron Pharmaceuticals Inc.’s Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn), the FDA has approved its first ever treatment for the Ebola virus in pediatric and adult patients.
Privately held Dyno Therapeutics Inc., an early stage biotech company applying artificial intelligence to gene therapy, entered a collaboration and license agreement with Spark Therapeutics Inc. that could bring Dyno milestone payments exceeding $1.8 billion.
In a deal that could bring the company as much as $1.04 billion, Arrowhead Pharmaceuticals Inc. will collaborate with Takeda Pharmaceutical Co. Ltd. to co-develop and co-commercialize an investigational RNAi-based liver disease treatment. Arrowhead’s candidate, ARO-AAT, is designed to reduce mutant alpha-1 antitrypsin protein production, which causes the disease to progress. Arrowhead will receive a $300 million up-front payment on closing in addition to development, regulatory and commercial milestones that could total $740 million.
The regulatory path for Saniona AB’s Tesomet for treating two rare eating disorders, Prader-Willi syndrome (PWS) and hypothalamic obesity, continues to be a winding one with surprises along the way. The newest twist is pre-IND feedback from the FDA that knocked the stock down 10.5% on Oct. 9.
Janpix Inc., of Cambridge, Mass., has raised a $10 million series B designed to progress its monovalent small-molecule protein degraders of STAT3 and STAT5 into final preclinical studies and eventually into the clinic to treat various hematological and solid tumor cancers.
In a deal that could bring the company as much as $1.04 billion, Arrowhead Pharmaceuticals Inc. will collaborate with Takeda Pharmaceutical Co. Ltd. to co-develop and co-commercialize an investigational RNAi-based liver disease treatment. Arrowhead’s candidate, ARO-AAT, is designed to reduce mutant alpha-1 antitrypsin protein production, which causes the disease to progress. Arrowhead will receive a $300 million up-front payment on closing in addition to development, regulatory and commercial milestones that could total $740 million.