Articles

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.

EMA Commences Rolling Review of Regdanvimab

NICE has issued guidance recommending the use of TheraSphere Y-90 Glass Microspheres, from Boston Scientific, as a treatment for patients with HCC.

NICE Recommends TheraSphere as Treatment for HCC

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

Eli Lilly and Welldoc to Collaborate on New Digital Insulin Management Solution

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.

Yokogawa Electric Corporation and ICQ Consultants to Collaborate on Bioreactor Systems Consulting and Engineering

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

AMRI to Develop and Manufacture Lipid Excipients for Pfizer-BioNTech COVID-19 Vaccine

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.

Celonic to Establish New Cell and Gene Therapy Production Site in Switzerland

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

VIVEbiotech to Expand Facilities for Lentiviral-Vector Manufacturing

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

PharmaLex Completes Acquisition of ERA Consulting

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.

Michael J. Hennessy: MM&M 40 Under 40 Award

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.

Bristol Myers Squibb to Open New Cell Therapy Facility in Massachusetts

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.

Catalent to Acquire Delphi Genetics to Expand Plasmid DNA Capabilities 

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

Pfizer and BioNTech Submit New Vaccine Stability Data to FDA

Aprecia's compression-free 3DP manufacturing platform and Glatt’s multiparticulate technologies offer solutions to pharmaceutical dosage design challenges.

Glatt and Aprecia Collaborate on 3D-Printing for Solid-Dosage Drugs

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

FDA Gives Guidance on COVID-19 Variants

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

Eli Lilly to Collaborate with Rigel Pharmaceuticals for $960 Million 

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

Eurofins to Expand Drug Discovery Capabilities Through Beacon Discovery Acquisition

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.

Sanofi to Support the Manufacturing of Janssen’s Single-Dose COVID-19 Vaccine

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

Avid Bioservices Expands Biologics Manufacturing Capacity

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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

FDA Blasts Misleading Opioid Promotion

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

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