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The FDA plans to channel more resources to the Center for Biologics Evaluation and Research (CBER)’s Cell and Gene Therapy Program (CGTP) to deal with its rapidly growing workload, agency officials said at the first round of public meetings on the next reauthorization of the Prescription Drug User Fee Act (PDUFA). Read More
Catalent is expanding its cell therapy product line by adding ALLOB, an investigational product derived from bone marrow cells, through the purchase of Bone Therapeutics’ cell therapy manufacturing subsidiary, Skeletal Cell Therapy Support (SCTS). Read More
AstraZeneca is selling off the global rights for two hypertension drugs, Atacand and Atacand Plus, to German drugmaker Cheplapharm Arzneimittel in a $400 million deal covering 70 countries. Read More
The Cambridge, Mass., company is developing photoreceptor-protein-based therapies that it believes could deliver “functional vision to patients in need.” Read More
The international medical aid group Doctors Without Borders has called on Sanofi and GlaxoSmithKline (GSK) to make their COVID-19 vaccine available at cost once approved. Read More
“We believe that machine learning and data generated by novel experimental platforms offer the opportunity to rethink how we discover and design novel medicines,” BMS said. Read More
Bayer will pay up to $4 billion to acquire North Carolina-based gene therapy company Asklepios BioPharmaceutical (AskBio) in a move that will extend the German pharma giant’s reach into regenerative therapies. Read More
Gilead Sciences said Friday that it had completed its $21 billion purchase of Immunomedics that will extend Gilead’s reach into oncology drugs. Read More
Roche and Atea Pharmaceuticals have struck a deal to develop a COVID-19 antiviral pill, AT-527, currently being evaluated in a phase 2 study. Read More