News

EMA's CHMP has started a rolling review of regdanvimab (CT-P59), which is a monoclonal antibody being developed by Celltrion for the treatment of COVID-19.

The site will house development and GMP production capacities for cell and gene therapies, next-generation vaccines, and biopharmaceuticals, to support clients from early clinical trials through commercialization.

The company will join the network of approved manufacturers of the lipid excipients.

Under the terms of the partnership, ICQ Consultants will provide consulting and engineering services for the installation, maintenance, qualification, and support of Yokogawa's bioreactor systems and related products in the US.

The companies will integrate Welldoc’s digital insulin management solution, BlueStar, into Eli Lilly’s connected insulin solutions.

Through the acquisition, PharmaLex will expand its capabilities in the biopharma sector while enhancing its global market reach with a new location in Australia.

Michael J. Hennessy Jr., president and CEO of MJH Life Sciences™, parent company to BioPharm International, named to MM&M’s second annual 40 Under 40 list.

The expansion, to be completed in April 2021 aims to increase the CDMO’s viral-vector production capacity in Spain.

The new facility is part of Bristol Myers Squibb’s investment into the clinical and commercial manufacturing of cell therapies for patients with aggressive hematological cancers.

New data shows that the COVID-19 vaccines can be stored at standard freezer temperatures for up to two weeks.

With the acquisition, Eurofins gets Beacon’s G-protein coupled receptor research knowledge and its compound library.

Once the vaccine has been authorized, Sanofi will provide Johnson & Johnson with access to its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of the vaccine, at a rate of 12 million doses per month.

The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

The second phase of the Myford facility expansion in California will add upstream and downstream processing suites.

The companies will co-develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications.

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.