One month after acquiring Five Prime Therapeutics and the company’s Phase III ready anti-FGFR2b antibody bemarituzumab for $1.9 billion, Amgen announced that the U.S. Food and Drug Administration awarded Breakthrough Therapy Designation to the asset as a first-line treatment for certain types of gastric cancer.
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Europe’s drug regulator found a possible link between Johnson & Johnson’s Covid-19 vaccine and rare blood clotting issues in adults who received doses in the United States, but backed its overall benefits against any risks.
The U.S. Food and Drug Administration placed a clinical hold on KalVista Pharmaceuticals’ proposed Phase II trial of KVD824, a prophylactic treatment of hereditary angioedema. The regulatory agency requested additional information and analysis of preclinical studies regarding KVD824 before giving the go-ahead to the Phase II trial.
Vertex Pharmaceuticals expanded the company’s collaborative partnership with CRISPR Therapeutics to develop and commercialize a possible cure for sickle cell disease (SCD) and transfusion-dependent beta-thalassemia (TDT). The focus is on the development of CTX001, an autologous, ex vivo CRISPR-CAS9 gene-edited therapy.
Dentsu International announced on April 20 the launch of dentsu health, a global solution. Drawing upon the expertise of dentsu’s global network of 2,000 health marketing experts across 85 markets in EMEA, APAC and the Americas, dentsu health is poised to become one of the top global healthcare agencies.
Havas Health & You announced that HH&Y is the first health network to become a Global Content Partner as part of Veeva Systems’ Content Partner Program.
Omnicom Health Group, the largest healthcare marketing and communications group in the world and part of Omnicom Group Inc., announced the launch of Omni Health on April 20. Omni Health is the first end-to-end healthcare-centric data platform designed for the specific requirements of healthcare marketers and clients.
Everyone in the United States aged 16 years and above is now eligible for Covid-19 vaccination, the U.S. Centers for Disease Control and Prevention (CDC) said on April 20. People aged 16 years and above who have underlying medical conditions that increase the risk of serious, life-threatening complications from Covid-19, should be among those offered the vaccine first.
The U.S. State Department will boost its “Do Not Travel” guidance to about 80 percent of countries worldwide, citing “unprecedented risk to travelers” from the Covid-19 pandemic.
Less than a month after submitting an Investigational New Drug (IND) application, Anixa Biosciences ran into a snag with the U.S. Food and Drug Administration as the government agency asked for more information before approving a clinical study on the company’s Chimeric Antigen Receptor-T cell therapy (CAR-T).