Top News

GlaxoSmithKline will focus on vaccines and specialty medicines while spinning off consumer healthcare business.

The US government will invest $3 billion from the American Rescue Plan into a COVID-19 antiviral development strategy.

Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

The acquisition of Advanz Pharma by Nordic Capital has now completed, in a deal worth $846 million.

MilliporeSigma has launched SAFC, a high-purity synthetic cholesterol product, nine months ahead of schedule to meet the lipid demands for COVID-19 messenger RNA therapeutics.

Pfizer and BioNTech have entered into a new agreement with the European Commission to supply 900 million doses of Comirnaty to the European Union with an option to request up to 900 million additional doses.

Bristol Myers Squibb has entered into a definitive agreement with Agenus for a global exclusive license to Agenus’ proprietary bispecific antibody program, AGEN1777, that blocks TIGIT and a second undisclosed target.

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Vertex and CRISPR have amended their collaboration agreement to include the development, manufacture, and commercialization of CTX001, an investigational CRISPR/Cas9-based gene editing therapy for sickle cell disease and transfusion-dependent beta-thalassemia.

Pending a completed FDA inspection, Emergent BioSolutions halts manufacture of vaccine drug substance at Maryland facility.

The acquisition, which is expected to be completed by the end of 2021, will give Thermo Fisher access to PPD’s drug development platform, patient recruitment capabilities, and laboratory services.

In collaboration with the Singapore Economic Development Board, the new site will supply the Asian region and will include multiple fully digitalized modules for the production of three to four vaccines simultaneously

Set to be operational in 2026, the new facility will provide added antigen and filling capacity for Sanofi’s influenza vaccine, increasing its availability in Canada, the United States, and Europe.

The new facility, which is expected to be operational by spring 2025, will feature 8 x 20,000-L bioreactors with the potential to add further 24 x 20,000-L bioreactors based on market demand.

Currently, supporters of the plan include the governments of Germany, Norway, and Ethiopia; Wellcome and the Bill and Melinda Gates Foundation; the World Economic Forum; and WHO, Gavi, and UNICEF.

Through the acquisition, Takeda will have access to Maverick’s T-cell engager COBRA platform, along with its development portfolio.

The investments are expected to double Thermo Fisher’s manufacturing capacity while creating more than 1500 jobs at 11 manufacturing sites in the Americas, Europe, and Asia.

Through the acquisition, Amgen will have access to Five Prime’s oncology portfolio, which includes bemarituzumab, Five Prime’s Phase-III ready anti-FGFR2b antibody.

Through the acquisition, Merck will have access to Pandion’s pipeline of precision immune modulators targeting critical immune control nodes, including its lead candidate, PT101.

Distribution of the first one-dose vaccine for COVID-19 to start in early March.

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

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.

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.

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.

The company has divested its specialty ingredients business and operations to Bain Capital and Cinven, two private equity firms.

FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus.