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September 17, 2021
FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.
Moderna’s newest insights include an overall efficacy review, a study on breakthrough infections, and a study on long-term immunity.
Democrats failed to gain sufficient support to advance long-debated legislation to permit Medicare drug price negotiations.
The new FDA office will reorganize IT, data, and cybersecurity functions to an agency level.
Takeda’s Exkivity (mobocertinib) was approved by FDA for the treatment of patients with lung cancer.
BMG Pharma has signed an agreement with HTL for the development and commercialization of injectable products with sodium hyaluronate lipoate formate.
Apellis Pharmaceuticals has announced the top-line results from two Phase III studies, evaluating intravitreal pegcetacoplan as a treatment for geographic atrophy.
Symbiosis Pharmaceutical Services has successfully completed an on-site inspection, performed by the MHRA, of its expanded facility in Stirling, UK.
SGS has selected the European Centre for Clinical Research Training (ECCRT) for the provision of good manufacturing practice (GMP) training of its pharmacy team.
Exscientia has entered into a four-year agreement with the Bill & Melinda Gates Foundation for the development of small-molecule therapeutics that can tackle coronavirus and other viruses with pandemic potential.