News

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

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.

In an agreement with MaaT Pharma, Skyepharma will build MaaT a dedicated 1500-m² microbiome ecosystem therapies manufacturing site.

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.

Bio-Rad’s four new antibodies will develop highly selective and sensitive assays for bioanalysis and drug monitoring of pertuzumab and its biosimilars.

Gandeeva raisded $40 million to advance its AI-driven cryo-EM platform, with which it will develop new therapeutics based on the precise imaging of protein–drug interactions.

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

The acquisition will include Rewrite’s DNA writing platform, expanding Intellia’s genome editing tools.

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.

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

Eli Lilly and Company is investing $1 billion to establish a new manufacturing stie in Concord, N.C., to manufacture parenteral products and devices.

Eli Lilly and Company has entered into a research and collaboration agreement with Entos Pharmaceuticals to develop new therapeutics for treating neurologic disorders.

Arranta Bio will use Cytiva’s FlexFactory single-use manufacturing platform to produce mRNA vaccines.

Recipharm will build up its biologics service offering with the acquisition of GenIbet.

Metagenomi has successfully raised $175 million for use toward its research pipeline.

Both Pfizer and Moderna have started clinical trials for their respective Omicron COVID-19 variant vaccine.

The draft PREVENT Pandemic Act aims to secure supply chains, expand health data collection, and support access to vital medical products

IonSense’s DART-MS technology offers rapid drug analysis without the need for sample preparation.

BIA and Clarivate have released new data that show there was a jump of 60% in investments into biotech and life sciences companies in the UK during 2021.

Gerresheimer is adding capacity in Germany, China, and the United States.

Texcell North America’s new lab facility in Frederick, Md., will expand the CRO’s capabilities in R&D cell culture, viral clearance studies, and viral safety testing.

Refeyn’s SamuxMP enables routine quantification of empty/full AAV capsid ratios, even in smaller labs, to set a new standard in AAV characterisation

Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.