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FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.

The company has completed the expansion of its laboratory facilities to accommodate the development of APIs.

The companies have expanded their agreement to include the research and development of new therapies for influenza and other respiratory viruses.

The companies have expanded their existing partnership to include 40 Million Doses of COVID-19 vaccine for South Korea.

The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

The foundation will provide funding support for the discovery and development of a single-administration, in-vivo gene therapy to cure sickle cell disease, a hereditary blood disease.

The acquisition will allow Charles River to expand its cell and gene therapy development, testing, and manufacturing capabilities, while adding to its existing portfolio of non-clinical capabilities.

FDA published recommendations on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the pandemic.

Salipro Biotech has been granted a European Patent for its novel method of direct extraction of membrane proteins and for the generation of libraries with Salipro particles.

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

PwC has teamed up with CPI on the Medicines Manufacturing Innovation Center to strengthen the UK’s position in advanced medicines manufacturing.

Connecticut Innovations has launched a campaign to highlight the growing companies, top talent, cutting-edge research, and quality of life in Connecticut’s life sciences ecosystem.

The VerderFlex Vantage 5000 peristaltic pump is suitable for low to medium flow at low to medium pressures.

The company has pleaded guilty to violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators and will pay a criminal fine of $30 million, and forfeit an additional $20 million.

Integration of Brooks Life Sciences BioStore III automated storage and inventory monitoring solution with Cytiva’s Chronicle software will improve traceability, process control, and monitoring capabilities.

MTEM will handle research activities for the discovery of the next generation of engineered toxin bodies using its ETB platform, while Bristol Myers Squibb will obtain a license to develop and commercialize the ETBs.

The US government will pay $1.95 billion for the additional 100 million doses, bringing the total number of doses supplied by the companies up to 300 million.

Nanoform and Herantis have signed a biologics proof of concept agreement for formulation proof of concept projects aimed at improving nasal drug delivery to the brain.

Rentschler Biopharma will establish its manufacturing capability for advanced therapy medicinal products at the CGT Catapult site in Stevenage, UK.

4D pharma has signed a clinical trial collaboration and supply agreement with Merck and Pfizer for Bavencio (avelumab).

Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients.

The EC has granted Vico Therapeutics with orphan drug designation for its investigational antisense oligonucleotide therapy for the treatment of SCA.

Exscientia has formed a partnership with the ARUK-ODDI for the development of medicines targeting neuroinflammation to treat Alzheimer’s disease.

The new business services site will house the company’s North American human resource operations, along with certain finance and information technology teams.

The EUA is based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.

Evonik has revealed plans for investment in the short-term expansion of its specialty lipids production, which are used with mRNA-based COVID-19 vaccines.

EMA has clarified its position on the European approval process of the Sputnik V vaccine.

The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.

The companies will build capacity in Germany that will be ready in 2022 and are exploring options for increasing volume in 2021.

The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates.