In one of the biggest collaboration deals of the year, Shape Therapeutics Inc. entered a collaboration and license agreement with Roche Holding AG to develop gene therapies for targets in areas that include Alzheimer’s disease, Parkinson’s disease and rare diseases. Seattle-based Shape is eligible to receive an initial payment, development, regulatory and sales milestone payments that could exceed $3 billion in aggregate value. Read More
Facing inevitable challenges ahead beyond peak performance for its wildly successful cystic fibrosis franchise, Vertex Pharmaceuticals Inc. is continuing to look to the future, announcing Aug. 24 it licensed rights to CRISPR gene-editing technology from Arbor Biotechnologies Inc. Co-founded by Feng Zhang and David Walt, Arbor's tech could figure into new Vertex cell therapies for diabetes, hemoglobinopathies and other diseases. Read More
The FDA has approved Korsuva (difelikefalin) from Cara Therapeutics Inc. for pruritis in patients undergoing hemodialysis, following a fast review. Korsuva is the first therapy approved by the FDA in the indication and is the first ever approval for the Stamford, Conn.-based company. Read More
Theravance Biopharma Inc.’s phase IIb fizzle with izencitinib in ulcerative colitis (UC) put a dent in shares, as Wall Street mulled the ongoing phase II study in Crohn’s disease (CD) as well as prospects regarding the deal with Johnson & Johnson. Read More
Atavistik Bio Inc. has raised $60 million in a series A financing round to advance its preclinical molecules targeting genetically validated targets in metabolic diseases and cancer. Read More
As talk increases of third doses of COVID-19 vaccine, a game-changing option is delivering them intranasally instead of intramuscularly. “It’s all about nasal carriage. It’s a better way to not carry the virus and not make others sick,” Bluewillow Biologics Inc. CEO Chad Costley told BioWorld. “The most important thing is that it’s safe.” Read More
Less than two weeks after Fibrogen Inc. received an FDA complete response letter for its hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, Evrenzo (roxadustat), Astellas Pharma Inc. and Fibrogen have won European Commission approval for the drug to treat symptomatic anemia associated with chronic kidney disease (CKD) in adults. The approval, which followed a positive CHMP opinion in June, triggered a $120 million milestone payment from Astellas to Fibrogen. In addition, Fibrogen will receive royalties on EU sales of the drug. Read More
The U.S. Federal Trade Commission (FTC) is hardly alone in its antipathy toward Illumina Inc.'s acquisition of Grail Inc., and FTC attorney Susan Musser said Aug. 24 that Illumina’s dominance of the market for next-generation sequencing (NGS) is perhaps the key aspect of the FTC’s case. Musser invoked the wide number of companies that jumped into the fray to develop a vaccine for the COVID-19 pandemic as an illustration of the need to maintain competition in the multicancer testing space. Read More
As many lower and middle-income countries continue to scramble for COVID-19 vaccine doses, which are largely being manufactured in Europe and the U.S., their own regulatory rules may be getting in the way in some instances. Read More
Advancing efforts from PDUFA VI, the seventh iteration of the user fee agreement negotiated between the U.S. FDA and drugmakers is intended to take patient involvement in drug development to the next level, support a new wave of biologics, and provide more tools for developing therapies and cures for rare and ultra-rare diseases. Read More
Biopharma company deals with nonprofit entities, as well as grants, are not keeping the same pace as last year, but the proportion of money flowing into COVID-19 efforts continues to account for the majority of those recorded overall. Read More
After years of transitioning in the requirement for drug and biologics sponsors to submit applications to the U.S. FDA in the electrical common technical document format (eCTD), the agency is getting serious about the proper use of eCTD. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bavarian Nordic, Foghorn, Hepagene, Kezar, Lexicon, Orphazyme Plus, Puretech, Sen-Jam. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axsome, Beigene, BMS, GSK, Jupiter, Kalvista, Pfizer, RDIF, Ultragenyx, Valneva, Vir, Xeris, Zydus. Read More
