As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines. Read More
Persistent U.S. drugs supply chain vulnerabilities, troublesome even before the COVID-19 pandemic, are drawing new attention in Washington. Now, with growing calls to increase supply chain resilience and a Biden administration executive order calling for an assessment of the situation, experts are looking for new paths to limit the risk of drug shortages, protect patient health, and to address pandemic preparedness and other national and health security threats. Read More
The race to tame COVID-19 has morphed from a sprint to a long game as companies continue their development to handle a pandemic that is becoming endemic to the planet. That’s the case with Adagio Therapeutics Inc. as it chases clinical studies and an emergency use authorization (EUA) for its monoclonal antibody, ADG-20, to treat and prevent COVID-19. Read More
LONDON – Adaptate Biotherapeutics Ltd. has raised $18 million in the second close of its series A, bringing the total for the round to $34 million and providing the means to accelerate development of a portfolio of antibodies targeting tissue-resident gamma delta T cells. Read More
At the recent American Association for Cancer Research (AACR) meeting, Blueprint Medicines Corp. unveiled results from the registrational phase II Pathfinder study with Ayvakit (avapritinib) in systemic mastocytosis (SM), adding more promise to the KIT inhibitor class. Read More
Now drugmakers can gain instant access to hospitals in Hainan province right after their innovative drugs are approved by China’s National Medical Products Administration to skip market entry hurdles. Read More
The FDA lost another hearing in the lawsuit filed against the agency by Genus Medical Technologies LLC in a case that yet again resurrects the product classification question. Both courts that heard the lawsuit asserted that the FDA does not enjoy unfettered discretion to classify a device as a drug merely as part of its authority under the Administrative Procedures Act (APA). Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Academy of Neurology Annual Meeting, including: Autobahn, Avadel, Lundbeck, Prothena, Teva. Read More
Biopharmas raising money in public or private financings, including: Gyroscope, Impel, Otonomy, Pharmcadd, Rain, Rezolute, Sagimet, Synlogic, Talaris. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aegis, Alzecure, Bergenbio, Checkmate, Erytech, Humanigen, Lyndra, Medivir, Pharmabcine, Sirnaomics, Todos Medical, Transcenta, Ziopharm, Zyus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Active Biotech, Aerie, Agenus, Alk, Allogene, Anixa, Astellas, BMS, Curevac, Curis, Cytodyn, Eli Lilly, Istari, Mannkind, Mayne, Mithra, Sanofi, Seagen, Stuart, United, Xbiotech. Read More
