HONG KONG – In a surprisingly candid statement, the director of China’s Centers for Disease Control conceded that the efficacy of Chinese coronavirus vaccines is "not high" and may require improvements. George Gao, the director of China’s CDC, stated that Chinese vaccines “don’t have very high protection rates” at the National Vaccines and Health conference in the southwestern city of Chengdu on Saturday. Read More
PERTH, Australia – The Australian government is recommending that Australians under 50 take the Pfizer Inc. COVID-19 vaccine due to the risk of rare blood clots associated with Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S). The move jeopardizes Australia’s vaccine rollout as it had planned for the majority of Australians to receive the Astrazeneca vaccine, which is being locally manufactured by CSL Ltd. Read More
Among a spate of COVID-19-related therapy developments to start the week, Kiniksa Pharmaceuticals Inc. produced positive phase II data of its monoclonal antibody, mavrilimumab, in treating non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation. Read More
LONDON – C4X Discovery Holdings plc has out-licensed its preclinical oral interleukin-17 (IL-17) inhibitor to Sanofi SA in a potential €414 million (US$493.4 million) deal. Under the terms of the agreement, Sanofi is paying €7 million up front and a further €11 in short-term preclinical milestones, with the balance to follow on reaching development, regulatory and commercialization milestones. Read More
In a move that Sanofi SA said will bring it an mRNA-based research platform with applications in oncology, immunology and other diseases, the company has acquired Tidal Therapeutics Inc. for $160 million up front and up to $310 million in milestone payments. The preclinical startup, led by Merrimack Pharmaceuticals Inc. and Torque Therapeutics Inc. co-founder Ulrik Nielsen, is based in Cambridge, Mass. Read More
Cachexia, Teresa Zimmers told the audience at the Annual Meeting of the American Association for Cancer Research (AACR), is "woefully understudied for the outsized impact it has on cancer patients." The condition, which is currently defined as weight loss and muscle wasting, is the direct cause of death in an estimated 25% to 30% of cancer patients. But it is the main subject of only 0.1% of research papers and 0.2% of clinical trials. Read More
The Biden administration has released an exceedingly brief budget framework for fiscal year 2022 that includes $6.5 billion for an advanced research program at the NIH, which mimics a similar program at the Department of Defense (DoD). Beyond that, there is a clear indication that the CDC would see an uptick in monies, but the proposal offers no numbers for the FDA budget, making this one of the skinnier budget proposals to come out of the White House in recent memory. Read More
If the U.S. Congress is receptive to recommendations approved by the Medicaid and CHIP Payment and Access Commission (MACPAC) April 9, the FDA's accelerated approval path for innovative new drugs could lose a bit of its appeal. And sponsors using that path may speed the pace of seeking full approval. Read More
With shortages of the COVID-19 drug, remdesivir, being reported in several states in India, the country’s Central Drugs Standard Control Organization is calling on state regulators to “immediately initiate remedial action to ensure supply of remdesivir injection to public and private hospitals.” Read More
New hires and promotions in the biopharma industry, including: Biogen, Cellgenix, Day One, F2G, Homology Medicines, Intellia, Jounce, Marinus, Precision, Tollys. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research Annual Meeting 2021, including: Achilles, Advaxis, Affimed, Agenus, Alpine, Amphivena, Amunix, Arch, Arcus, Bayer, Beigene, Bio-Path, Black Diamond, Briacell, C4, Cardiff Oncology, Checkmate, Clovis, Codiak, Crispr, Elevation, Eli Lilly, Essa, F-star, Fusion, Gennao, Genprex, Glycomimetics, Gracell, GT, Hookipa, Hummingbird, Mirati, Instil, Intra-Cellular, Immune-Onc, Immunogen, Iteos, Jubilant, Kezar, Kineta, Kintara. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akston, Allogene, Alnylam, Antengene, Arcutis, Artelo, Astrazeneca, Biogen, Cardiff, Cardiol, Kiniksa, Lyra, Marinomed, Regeneron, Rubius, Sage, Springworks, Turning Point, VBI Vaccines. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Airway, Akari, Biontech, Generex, Genmab, Jazz, Junshi, Nugenerex, Pfizer, Resverlogix, Scolex, Seagen, Sorrento. Read More
