Moderna Inc.’s and Pfizer Inc.-Biontech SE’s COVID-19 bivalent boosters could be coming to the U.S. in the first week or so of September – even though the U.S. FDA just received the completed emergency use authorization (EUA) requests for the vaccines this week. The CDC is already taking pre-orders from providers, states and other jurisdictions for the yet-to-be authorized booster doses as part of its fall-winter booster campaign strategy. It also scheduled a Sept. 1-2 meeting of its Advisory Committee for Immunization Practices, signaling that it expects the FDA to grant the EUAs by the end of August. Read More
Takeda Pharmaceutical Co. Ltd.’s dengue fever vaccine, Qdenga, was approved in Indonesia Aug. 23, making it the first global approval for the tetravalent vaccine. The approval marks Takeda’s first marketed vaccine outside of Japan. Indonesia’s National Agency for Drug and Food Control approved the vaccine for prevention of dengue disease caused by any serotype in individuals 6 years to 45 years of age. Read More
With potential regulatory approvals and filings for lymphoproliferative disease and mastocytosis drugs on the horizon, as well as high-money antibody-drug conjugate deals, the BioWorld Cancer Index (BCI) has shown some signs of life this summer. BCI is still down by 23.4% in 2022, but that is significantly better than the end of May when the index was down by 41%. Read More
Nuvectis Pharma Inc. has been in business for barely two years, but thanks to a business model involving in-licensing promising late preclinical drug candidates, it has already begun a trial with a molecule targeting a little-known pathway that cancer cells depend on for protection. The firm is also close to the clinic with a drug that could give a new twist to tyrosine kinase inhibition after a $16 million financing round in early August. Read More
Hansoh Healthtech Co. Ltd., part of Jiangsu Hansoh Pharmaceutical Group Co. Ltd., has acquired exclusive worldwide rights to develop and commercialize an oral SARS-CoV-2 3C-like protease inhibitor from Beijing Huayi Health Drug Discovery Institute, also known as the Global Health Drug Discovery Institute (GHDDI). The deal includes ¥12 million (US$1.8 million) up front and up to ¥1.68 billion in potential milestone payments, plus tiered royalties on net sales. Read More
Biopharmas raising money in public or private financings, including: Advancell, Bright Minds, Freedom, Regenacy, Relief, Sanotize, Shuttle, Third Harmonic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asklepios, Beigene, Bristol Myers Squibb, Foghorn, Iecure, Jaguar, K36, Merck, Northwest, Synlogic. Read More
