Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.
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FDA has revised the Emergency Use Authorization for sotrovimab.
Hovione has announced that Jean-Luc Herbeaux will take over for Guy Villax as CEO on April 1, 2022.
Califf will face challenges that include COVID-19, opioids, and user fees.
UCB has announced that it is extending its tender offer to acquire Zogenix.
EMA has recommended approval of Spikevax for children aged 6 to 11.
Johnson & Johnson has confirmed advancement of the nationwide opioid settlement agreement.
Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU.
FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure.
FDA licenses Certara’s Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics.
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Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.
USP is developing mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.
Scottish Enterprise has awarded £20 million (US$27 million) to Valneva Scotland to advance vaccine development.
Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.
Sanofi and GSK announce they are seeking regulatory authorization for COVID-19 vaccine.
Novavax announces the first doses of Nuvaxovid COVID-19 vaccine have begun shipping to European Union member states.
The Center for Breakthrough Medicines and BioAnalysis LLC have formed a strategic alliance to offer novel analytical testing services for CGT clients.
Semarion raises £2.14 million GBP (US$2.89 million) seed funding to support the commercial development of Semarion’s SemaCyte cell assaying platform.
The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines in the European Union.
FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards.
Quotient Sciences announces that it has integrated drug substance into its flagship Translational Pharmaceutics platform.
The turnkey facilities will promote scalable vaccine production for an end-to-end manufacturing network for mRNA-based vaccines in Africa.
Health Canada authorizes Novavax COVID-19 vaccine for individuals 18 years of age and older.
PETA Science Consortium International e.V. and PETA scientist Jeffrey Brown share goals with new FDA Commissioner Dr. Robert Califf.
The EC approved AstraZeneca’s Saphenlo (anifrolumab) for the treatment of active autoantibody-positive systemic lupus erythematosus.
FDA will hold a symposium discussing the identification of concepts and terminology for multi-component biomarkers from March 23–24, 2022.
FDA has granted Eli Lilly and Company’s bebtelovimab, a monoclonal antibody designed for treatment of COVID-19, an Emergency Use Authorization (EUA).
The agency recommended 53 new active substances in 2021, up 35% from 2020.
The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.
Guidance published during the pandemic has been updated to include content requirements for summary safety reports.
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