LONDON – The EMA’s safety committee has concluded that unusual blood clots with low blood platelets are a rare side effect of Johnson & Johnson Inc.’s COVID-19 vaccine and that a warning should be added to the label. The decision is based on all available evidence, which currently consists of eight reports from the U.S. of serious cases of thrombosis, one of which was fatal. All cases were in people under 60 years of age, and within three weeks after vaccination, the majority in women. One case occurred during the clinical trials. 

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Argenx, Bluebird, Can-Fite, Cannabics, D&D, Elektrofi, Gain, Gamut, Hoth, Immunomic, Lamassu, Lineage, Oncotelic, Resverlogix, Seqirus, Sparingvision, Zentalis.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 180 Life Sciences, Alnylam, Bioarctic, Eisai, Eli Lilly, Incyte, Ionis, Janssen, Jazz, Leading, Medincell, Morphosys, Ripple, Siteone, Sorrento, Steba, Syndax, T3D.

The latest global regulatory news, changes and updates affecting biopharma, including: Enhertu gets first nod in Europe; At-home COVID-19 remedies sought; Fed Circuit: Appeal based on misreading of court’s decision; Russia expands access to certain pediatric treatments.

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.

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.

Keeping you up to date on recent developments in cardiology, including: PCI still the treatment of choice for COVID-positive STEMI patients; Utility of risk scores for TAVR patients questioned; Plaque similarly predictive in women and men.

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.