The FDA’s Vaccines and Related Biological Products Advisory Committee rejected an sBLA for a third, booster dose of the COVID-19 vaccine Comirnaty from Pfizer Inc.-Biontech SE for ages 16 and over, then unanimously approved a recommendation for those ages 65 and older along with individuals at high risk of severe COVID-19 to get the booster. Read More
LONDON – Researchers in the U.K. have applied the heft of national population-level databases to devise a new algorithm that predicts those people who are most at risk of hospitalization and death from COVID-19, despite having received two doses of vaccine. Read More
European regulators have rejected Pfizer Inc.’s tanezumab, casting further doubts on whether the FDA will okay the troubled drug that is intended as a non-opioid alternative for osteoarthritis pain. Read More
Shares of Protagonist Therapeutics Inc. (NASDAQ:PTGX) fell 62% to $17.53 on Sept. 17 after it reported finding malignant skin tumors in a mouse model test of its most advanced candidate, rusfertide for blood disorders. After the company notified the FDA, the regulator put the program on a clinical hold, leading dosing of patients in all ongoing trials of rusfertide to be halted for now. The development could impact Protagonist's ability to start phase III testing of the candidate in polycythemia vera (PV) early in 2022, as well as efforts to expand its development to a third indication beyond PV and hereditary hemochromatosis (HH) by the end of this year, as it has planned. Read More
DUBLIN – Treefrog Therapeutics SA closed a $75 million series B round this week, which will help to increase its reach and its profile, as it pursues its highly ambitious objective to drive the adoption of a new way of making induced pluripotent stem cells (iPSCs) at scale. The Bordeaux, France-based firm is not a CDMO in any sense, however. It is a fully fledged biotech, with early stage iPSC-based programs in Parkinson’s disease, cardiovascular disease and bone marrow transplant, among others. It’s just that it is also attempting to revolutionize how those cells are cultivated before it administers them as therapies. Read More
PERTH, Australia – After raising AU$20 million (US$14.62 million) in a series A round, serial entrepreneur Paul Hopper is unveiling his newest venture, Radiopharm Theranostics Ltd., which is developing a platform of radiopharmaceutical and nuclear medicine products for both diagnostic and therapeutic uses. Read More
Researchers have retrospectively divided more than 16,000 non-small-cell lung cancer (NSCLC) patients with EGFR mutations into four structure-based subgroups, and looked at how the members of each subgroup fared depending on which EGFR inhibitor they were given. Read More
Rune Labs Inc. is on a mission to make the mysteries of the brain easier to read for both clinicians and biopharma companies. Having a fresh $22.8 million in a series A financing on the books will no doubt make the goal easier to reach. Read More
Nearly 18% of clinical data reported in August were focused on the COVID-19 pandemic, representing the highest percentage for any single month this year. During the month, as the Delta variant took hold throughout the U.S., news of COVID-19 efforts spiked, doubling the amounts seen in both June and July, in which about 9% of the news was pandemic-related, and up significantly from 10% in May. Read More
New and updated preclinical and clinical data presented by biopharma firms at the European Society for Medical Oncology Congress 2021, including: Acepodia, Aileron, Allarity, Amgen, Athenex, Ayala, Bayer, Beyondspring, Bioxcel, Carrick, Exelixis, Gilead, Instil, Laekna, Leap, Macrogenics, Medigene, Medivir, NGM, Nouscom, Oncologie, Psioxus, Second Genome, Shasqi, Silverback, Targovax, Transgene, Zymeworks. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Clene, Elucida, Gritstone, Rottapharm, Takis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amivas, Biocryst, Calliditas, Camurus, Cour, GSK, Golden, NFL, Pfizer, Stada, Takeda. Read More
