LONDON – Bridgebio Inc. has made a huge turn on the initial $65 million it invested in 2018 to acquire rights to infigratinib from Novartis AG, sealing a $2 billion commercialization deal with Swiss oncology specialist Helsinn Group for the fibroblast growth factor receptor (FGFR) inhibitor just four years later. Helsinn will work with Bridgebio affiliate QED Therapeutics Inc. on U.S. co-commercialization of infigratinib in oncology and all other indications apart from skeletal dysplasias, with profits and losses shared on a 50-50 basis. Read More
Marking its second acquisition this year after snapping up cancer-focused Five Prime Therapeutics Inc., Amgen Inc. is adding to its inflammatory disease portfolio through the purchase of Seattle-based Rodeo Therapeutics Corp. The deal includes $55 million up front for the private company's shareholders, plus contingent milestone payments worth up to an additional $666 million. Rodeo's lead preclinical program targets 15-prostaglandin dehydrogenase to increase tissue levels of prostaglandin PGE2. Read More
If these top-line phase III results were a grade card for 12- to 15-year-olds, they would be on the honor roll: The Pfizer Inc.-Biontech SE COVID-19 vaccine is 100% effective for the age group and produced robust antibody responses. Read More
CEO Dipal Doshi of Boston-based Entrada Therapeutics Inc. said the field of Duchenne muscular dystrophy (DMD) therapeutics has seen “a lot of first-generation, interesting programs that have kickstarted more focus” on the disease, “but no one really is fundamentally moving the needle in a robust clinical way.” His firm, with $116 million in new series B money, wants to change that. “Our focus on DMD is very direct and very specific,” he told BioWorld. Read More
Scribe Therapeutics Inc. raised $100 million in a series B round to continue its engineering-intensive approach to developing CRISPR-based therapies that employ custom-designed CasX enzymes. Read More
Lianbio Co. Ltd. has inked a $200 million deal with Tarsus Pharmaceuticals Inc. for greater China rights to the phase IIb/III-stage candidate, TP-03 (lotilaner ophthalmic solution, 0.25%), designed to treat Demodex blepharitis and Meibomian gland disease. Read More
With the massive amounts of capital raised by global public and private biopharmaceutical companies last year generating approximately $134 billion – a total that was almost double the previous record of about $69 billion raised in 2015 – it is not surprising that financing for the regenerative medicine and advanced therapy sector also set an annual record. Read More
HONG KONG – Seikagaku Corp. and Ono Pharmaceutical Co. Ltd. have cleared the final hurdle for Joyclu (diclofenac etalhyaluronate sodium), with Japan’s Ministry of Health, Labour and Welfare granting manufacturing and marketing approval for the osteoarthritis (OA) therapy, the first agent to be approved in Japan for improving hip joint function in OA. The intra-articular injection was also approved for the treatment of knee joint OA. Read More
The Made in America Tax Plan President Joe Biden is proposing to pay for his $2 trillion U.S. American Jobs Plan could change the way multinational drug and device companies do business, as well as curb M&As that take advantage of global tax benefits. Read More
“Our position has not changed,” said Emer Cooke, executive director of the EMA, giving an update on the agency’s investigation into cases of the rare clotting disorder cerebral venous sinus thrombosis (CVST) in people vaccinated with Astrazeneca plc’s COVID-19 vaccine. “There is no evidence to support restricting use of the vaccine in any population,” she said. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: FDA to hold adcom on T1D drug; GHIT invests $21M; MHRA updates guidance. Read More
New hires and promotions in the biopharma industry, including: Acelrx, Frontier, Lattice, Lyndra, Mirati, Montis, Myeloid, Rentschler, Surface. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Aptorum, Athersys, Biontech, Equillium, Flexion, Istari, Kamada, Nascent, Outlook, Pfizer, Pharnext, Regeneron. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Amryt, Celltrion, Cstone, CTI, Everest, Evive, Exelixis, Innovent, Ipsen, Jazz, Mabxience, Nkmax, Opthea, Provention, SK, Surface Oncology, Syndax, Zai. Read More
