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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Industry considers automation and digitalization lessons learned from COVID-19 pandemic.
Mechanistic models provide process understanding for developing robust manufacturing processes.
While process chromatography has advanced, there is room for improvement.
Advance planning is essential to ensure a reliable supply for parenteral drug packaging
Establishing predictive analytical workflows for complex biopharmaceutical molecules.
UK Approves Moderna for Adolescents; Updates on Solidarity Plus Trial
September 21, 2021
The topline data from Pfizer and BioNTech’s trial suggests that a 10 µg vaccine is safe and effective among the 5 to 11 age group.
The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.
Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.
September 20, 2021
FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.
September 17, 2021
UCR scientists are researching whether a plant-based messenger RNA vaccine can be created and aim to eliminate the need for the refrigeration of mRNA vaccines during transport and storage.
Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.
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.
September 16, 2021
CPC’s MicroCNX Series Connectors provide an alternative to tube welding at small tubing sizes.