Six months to the day that the World Health Organization (WHO) declared it a public health emergency, the SARS-CoV-2 virus, with its hideous red spikes, continues to taunt the world, hopping from host to host and haunting humans, many of whom wonder the same thing: What’s next? Read More
By filing an IND with the FDA to initiate a phase II/III study of EB-05, a monoclonal antibody, Edesa Biotech Inc. joined the handful of companies developing COVID-19 treatments that inhibit Toll-like receptor 4 (TLR4) signaling. The Toronto-based company’s stock (NASDAQ:EDSA) responded by rocketing 81.38% upward Thursday to close at $9.45, after trading as high as $19.10. Read More
Sangamo Therapeutics Inc. continued its collaboration spree, signing up its sixth big pharma/biotech partner: Novartis AG. The three-target deal will use Sangamo's zinc finger protein transcription factors to up-regulate undisclosed genes to treat autism spectrum disorder and other neurodevelopmental disorders. Read More
In a move that Lexicon Pharmaceuticals Inc. chief Lonnel Coats said will focus the company on its phase II neuropathic pain program, The Woodlands, Texas-based venture has agreed to sell one of its two approved products, the carcinoid syndrome diarrhea therapy Xermelo (telotristat ethyl), to Tersera Therapeutics LLC for $159 million in cash. Read More
Unraveling the eagerly awaited data from Genocea Biosciences Inc.’s phase I/IIa study with neoantigen cancer vaccine GEN-009 turned out less than simple, and the rollout of results – characterized by the company as positive, albeit early – were followed by a haircut for shares (NASDAQ:GNCA), which closed at $3.45, down $1.52, or 31%. Read More
LONDON – Privately held U.K. biotech F-star Therapeutics Ltd. is gaining a Nasdaq listing via a reverse merger with Spring Bank Pharmaceuticals Inc., with F-star’s shareholders due to own 61% of the new entity, to be named F-star Therapeutics Inc. Read More
In a time when the FDA needs its best and brightest people onboard, nearly half the senior leadership at the agency will be eligible for retirement by Sept. 30. Read More
HONG KONG - California-based Iacta Pharmaceuticals Inc. and Hong Kong-based Zhaoke Ophthalmology Pharmaceutical Ltd. have inked a definitive license agreement for two of Iacta’s products. Read More
Terns Pharmaceuticals Inc., a NASH specialist based in San Francisco and Shanghai, has out-licensed the Greater China rights of its BCR-ABL inhibitor, TRN-000632, for treating chronic myeloid leukemia (CML) to Chinese pharma giant Hansoh Pharmaceutical Group Co. Ltd. to move the preclinical oncology asset to the clinic faster. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Boehringer, Cynata, Eisai, Eli Lilly, Enterome, Genocea, Onconova, Redhill, Sab, Salarius, Sanofi, Terns, TFF, Theralase, Trillium, Tychan, Xeris. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affinity, Altum, American Gene Technologies, Appili, Betterlife, Cerevel, FSD, Gen1e, Inovio, Johnson & Johnson, Neurotrope, Nichi-Iko, Pharvaris, PDL, Takeda, Teva, Worldwide Clinical Trials. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adocia, Astrazeneca, Aytu, Bluebird, BMS, Celltrion, Direct, Diurnal, Dynacure, Edesa, Eton, Imago, Marinus, Merck, Poxel, Siga, Sumitomo, Synthetic, Takeda. Read More