The pace of biopharma mergers and acquisitions has quickened with Johnson & Johnson’s $6.5 billion all-cash acquisition of Momenta Pharmaceuticals Inc. Bringing Momenta into the fold strengthens the Janssen Pharmaceutical Companies of Johnson & Johnson’s immune-mediated disease portfolio and grows its interest in autoantibody-driven disease therapies. Read More
Biomarin Pharmaceutical Inc.’s complete response letter (CRL) for Roctavian (valoctocogene roxaparvovec; Valrox) gene therapy for severe hemophilia A shocked the company, its investors and analysts mere days before its Aug. 21 PDUFA date. Now an approval and launch for what would have been the first approved hemophilia gene therapy is likely pushed back roughly two years. Read More
An FDA rejection of Galapagos NV's rheumatoid arthritis (RA) drug filgotinib, announced Aug. 18, was "disappointing and unexpected," CEO Onno van de Stolpe said, adding that "there is so much more" to his company's story and pipeline. Gilead Sciences Inc., the Belgian company's partner and a substantial backer of both the drug and the pipeline, said it would "evaluate the points raised" by the CRL, but continued to believe in the drug. Read More
Innovent Biologics Inc., of Suzhou, has out-licensed ex-China rights for its PD-1 drug Tyvyt (sintilimab) to Eli Lilly and Co. in an expanded license deal. The Chinese firm will receive $200 million upfront in the deal, the value of which could approach up to $1.03 billion. Read More
PERTH, Australia – As Victoria suffers through a second COVID-19 wave, bringing the death toll to 430 for Australia, Prime Minister Scott Morrison said that Australians could be among the first in the world to receive a COVID-19 vaccine through an agreement with Astrazeneca plc. Under the deal, every Australian would be able to receive AZD-1222, which is being developed with the University of Oxford. Read More
While the retail, security and entertainment sectors dove in early with the adoption of artificial intelligence (AI) and machine learning (ML) technologies, the life sciences sector has “been a bit of a laggard, frankly,” said Pratap Khedkar, a principal at the Evanston, Ill.-based consultant firm ZS Associates. Read More
Shanghai-based nanobody specialist Novamab Biopharmaceuticals Co. Ltd. is developing a new neutralizing nanobody, Nb11-59, as a potential inhaled therapy for COVID-19 – a convenient treatment if developed successfully. Similar research is being conducted worldwide. Read More
Life science companies doing business during a pandemic may believe that patients, judges and juries will look kindly on products that don’t perform as promised, but that may be an empty wish. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Molecular, Acelrx, Albireo, Biolinerx, Epitopoietic Research, Jaguar Health, Kamada, Merck, Northwest, PCI, Pluristem, Qu, Trefoil, Turning Point, Verona. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive Phage, Anavex, Brainstorm Cell, Cytokinetics, Eagle, Elicio, Humanetics, Ingenza, Maverick, Morphosys, Regeneron, Roche, Sapience, Surrozen, Theralase, Tolmar. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Cannformatics, Galapagos, Mylan, Precision, Sorrento. Read More
