A study involving more than 1.25 million people in the U.S. has shown there is an increased risk of developing certain neurological and psychiatric conditions for up to two years after COVID-19 infection, and that despite causing less serious disease in the acute phase, the risk with omicron is the same as with the delta variant of SARS-CoV-2. Read More
The U.S. FDA has approved the first cell-based gene therapy for treating adult and pediatric patients with beta-thalassemia requiring frequent red blood cell transfusions. The $2.8 million wholesale acquisition cost for the one-time I.V. infusion will make it one of the most expensive drugs in the U.S. Read More
“No good data goes unpunished in this market,” H.C. Wainwright analyst Andrew Fein wryly noted in an Aug. 17 research report highlighting Wall Street’s dismal response to Blueprint Medicines Corp.’s positive top-line readout of the registrational Pioneer study, in which KIT inhibitor Ayvakit (avapritinib) met the primary and all key secondary endpoints in patients with non-advanced systemic mastocytosis. Read More
Sanofi SA has terminated development of amcenestrant, an oral selective estrogen receptor degrader (SERD), following an interim analysis of data from a phase III trial in estrogen-receptor-positive advanced breast cancer patients. The company has also halted all other studies of the drug, including a phase III study in patients with early stage breast cancer. Read More
Blue Water Vaccines Inc. is ready to try its hand at developing a monkeypox vaccine. The company is launching an exploratory program to develop a vaccine attempting to present antigens within its norovirus shell and protrusion virus-like particle (VLP) platform. Read More
Growing the international competitiveness of Taiwan’s biotech sector is one of six key strategies Taiwan’s government is heavily invested in, Taiwan President Tsai Ing-wen told attendees via video during the recent BIO Asia-Taiwan conference in Taipei. Read More
Regardless of the grading scale, the U.S. NIH would have gotten an “F” for its failure to ensure that intramural and extramural clinical trials it funded complied with government reporting requirements in 2019 and 2020. Read More
Staidson Biopharmaceuticals Co. Ltd. is testing a combination of two monoclonal antibodies (MAb), STSA-1002 and STSA-1005, in China for the potential treatment of people with severe-to-critical COVID-19. Read More
An Emergent Biosolutions Inc. facility in Baltimore is under U.S. FDA scrutiny after a February 2022 inspection revealed manufacturing problems, some of which resulted in multiple customer complaints. Read More
New hires and promotions in the biopharma industry, including: Ambrx, Foghorn, Kriya, Magenta, Mallinckrodt, Moderna, Pyxis, Relief, Sonoma, Titan. Read More
Biopharmas raising money in public or private financings, including: Bluejay, Ichor Life Sciences, In8bio, Jupiter Neurosciences, Mitochem, Palisade, Ryvu, Viridian. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Antengene, Aptinyx, Gannex, Greenwich, Mersana, Newamsterdam, Palatin, Pfizer, Pneumagen, Revive, Unity, Ventyx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Albireo, BMS, Crestone, Endure, Everst, Gilead, J Ints, Medison, Nektar, Praedicare, Saniona, Simcha, Sinamoics, Turning Point. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bridge, Index, Inhibrx, Merck, Roche. Read More
