All News

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.

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.

PhoreMost has entered into separate collaboration agreements with Polaris Quantum Biotech and NeoCura Bio-Medical Technology to discover and develop novel cancer therapeutics.

Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval process.

Merck and Ridgeback Therapeutics will supply UNICEF with up to three million capsules of molnupiravir through the first half of 2022.

UCB and Zogenix have agreed to an acquisition deal totaling nearly $2 billion.

A report by international regulators reviews the effectiveness of current COVID-19 vaccines against the omicron variant.

The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.

Air France KLM Martinair Cargo and Envirotainer are collaborating on more sustainable air transport of pharmaceuticals.

The agency discusses its response to COVID-19 and other milestones in its year-end review.

The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.