Industry News

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.

FDA has approved Pyrukynd (mitapivat) tablets to treat hemolytic anemia in adults with pyruvate kinase (PK) deficiency.

The company has announced plans to establish a commercial presence in six European countries.

EC has approved Oxbryta (voxelotor) as a treatment for hemolytic anemia in patients with Sickle Cell Disease (SCD) age 12 years and older.

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).

Guidance published during the pandemic has been updated to include content requirements for summary safety reports.

The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.

The agency’s safety committee is reviewing the use of Janus kinase inhibitors to treat inflammatory disorders because of the potential for major cardiovascular problems.

The agency recommended 53 new active substances in 2021, up 35% from 2020.

While companies today outsource numerous processes, from early development through to manufacturing, there are still many opportunities to realize the full potential of outsourcing services.

Novavax’s COVID-19 vaccine has received conditional marketing authorization from MHRA and provisional approval from Medsafe.

EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.

EMA has started the establishment of its Data Analysis and Real World Interrogation Network (DARWIN EU) Coordination Centre.

FDA has approved sutimlimab-jome as a treatment for hemolysis in individuals with CAD.

Sartorius Stedim Biotech has completed the acquisition of the chromatography equipment division of Novasep.

The European Patent Office has granted another patent to Salipro Biotech, covering the composition-of-matter, methods, and uses of the company’s novel antigen technology.

CGT Catapult has partnered with MICA Biosystems to advance MICA’s regenerative medicine technology to the UK’s MHRA.

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.

A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.

ABPI has responded to the publication of a white paper on ‘Levelling Up’ by the government of the United Kingdom.

Janssen has submitted a MAA to the EMA for teclistamab as a treatment of relapsed or refractory multiple myeloma (RRMM).

pharmasol has completed the strategic merger with PharmaLex.

The UK’s NICE issued a Final Appraisal Document recommending marketing authorization for AstraZeneca’s chronic kidney disease treatment, Forxiga (dapagliflozin).

As company revenues are gaining a boost from COVID-19, the issue of pricing is being debated once more.