LONDON – Astrazeneca plc is to get up to $1.2 billion from the new U.S. COVID-19 vaccines program, Operation Warp Speed, to support further development and manufacturing of a vaccine developed at Oxford University’s Jenner Institute. The company said it will begin to ship the product in September 2020, with the U.K. and U.S. first in line for deliveries. Read More
Gilead Sciences Inc. and partner Galapagos NV touched off a round of Wall Street chin-scratching as they disclosed phase IIb/III data showing that JAK1 inhibitor filgotinib in ulcerative colitis (UC) at the 200-mg dose achieved all primary endpoints in the study called Selection. Read More
The $65 million that Hotspot Therapeutics Inc., of Boston, raised will help advance its lead programs to the clinic, including protein kinase C antagonists for Th2 and T-reg-driven autoimmune disease and S6 kinase antagonists for rare metabolic disease. Read More
Shares of Entera Bio Ltd. (NASDAQ:ENTX), a lightly traded Israeli drug delivery specialist, fell 27% on May 21 after the company said an ongoing phase II trial of its oral parathyroid hormone (PTH) candidate in osteoporosis patients found the two lowest doses tested demonstrated "suboptimal increases" in P1NP, an important biomarker of bone formation. Read More
BEIJING – Besides advancing its recombinant adenovirus type-5 vector (Ad5) vaccine for COVID-19, Cansino Biologics Inc. is making a new attempt to develop an mRNA lipid nanoparticle (mRNA-LNP) vaccine together with Canadian company Precision Nanosystems Inc., of Vancouver, British Columbia. Read More
BEIJING – CAR T-cell therapeutics developer Carsgen Therapeutics Co. Ltd., of Shanghai, won IND clearance from the FDA for its first-in-class CT-041 for advanced gastric and pancreatic cancers. The company said it is the first claudin18.2 (CLDN18.2)-targeted CAR T-cell therapy cleared for clinical trials in the world. Read More
Biopharmas raising money in public or private financings, including: Arcturus, American Brivision, Flexion, FSD, Midatech, Nanoviricides, Nautilus, Nervgen, Pharmadrug, Scpharmaceuticals, Ultragenyx. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antisense, Apollomics, Arvelle, Entera Bio, Galapagos, Gilead, Kadmon, Poseida, Tonix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Alethia, Anavex, Appili, Astellas, Calcimedica, Chiesi, Fibrogen, Genexine, I-Mab, Passage Bio. Read More
