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February 26, 2021
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.
NICE has issued guidance recommending the use of TheraSphere Y-90 Glass Microspheres, from Boston Scientific, as a treatment for patients with HCC.
February 25, 2021
The companies will integrate Welldoc’s digital insulin management solution, BlueStar, into Eli Lilly’s connected insulin solutions.
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 company will join the network of approved manufacturers of the lipid excipients.
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.
February 24, 2021
The expansion, to be completed in April 2021 aims to increase the CDMO’s viral-vector production capacity in Spain.
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 Pharmaceutical Technology, named to MM&M’s second annual 40 Under 40 list.
February 23, 2021
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.
Through the acquisition, Catalent will establish pDNA development and manufacturing services at its Rockville, MD, facility and will gain Delphi’s team of R&D and genetic engineering scientists, technicians, and regulatory specialists.
New data shows that the COVID-19 vaccines can be stored at standard freezer temperatures for up to two weeks.
Aprecia's compression-free 3DP manufacturing platform and Glatt’s multiparticulate technologies offer solutions to pharmaceutical dosage design challenges.
February 22, 2021
The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.
The companies will co-develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications.
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 second phase of the Myford facility expansion in California will add upstream and downstream processing suites.
February 19, 2021
FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.
February 18, 2021
The company has completed the expansion of its laboratory facilities to accommodate the development of APIs.