Valneva SE confirmed that the European Medicines Agency accepted the filing of a marketing authorization application (MAA) for the specialty vaccine company’s inactivated, whole-virus COVID-19 vaccine candidate, VLA2001.
PTC Therapeutics Inc. announced that the company completed the Scientific Advisory Group and Oral Explanation meetings for its gene therapy treatment for AADC deficiency (PTC-AADC) with the Committee for Advanced Therapies (CAT).
Merck’s Acceleron Integration To Take Out 143 Jobs in Cambridge, MA
Anemia, Blockbusters, Blood Vessels, Business, Cambridge, Clinical Trials, Committee for Medicinal Products for Human Use (CHMP), Erythroid maturation agents, First-In-Class, Job Cuts, Keytruda, Massachusetts, Pulmonary Arterial Hypertension, R&D, Royalties, Therapeutics, Transforming Growth Factor-beta (TGFb)Merck announced that the company will lay off 170 people from Cambridge, Massachusetts-based Acceleron Pharma, which was acquired during November 2021 for about $11.5 billion.
Pharma giant AbbVie and Iceland-based Alvotech settled a case filed with the International Trade Commission. The dispute centered around Alvotech’s adalimumab biosimilar drug, which AbbVie posited had been developed through theft of trade secrets of the company’s Humira product.
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative trend vote on the Marketing Authorization Application for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab).
FDA Issues CRL to Merck
Acquisitions, Agreements, Blockbusters, Business, Chemotherapy, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), FDA, Keytruda, Merck, Metastatic Urothelial Carcinoma (mUC), PD-1/PD-L1 inhibitors, Spin-offs, Therapeutics, Triple Negative Breast Cancer (TNBC)The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Merck for the company’s supplemental Biologics License Application for Keytruda (pembrolizumab) in high-risk early-stage triple-negative breast cancer.
U.S. DoD Awards $1.97 Billion Covid-19 Vaccine Contract to Moderna
"Operation Warp Speed" Initiative, AstraZeneca, Canada, Committee for Medicinal Products for Human Use (CHMP), COVID-19 Vaccines, Department of Defense, Emergency Use Authorization, European Commission, Moderna, mRNA-1273/Moderna COVID-19 Vaccine (Moderna), Oxford University, United StatesThe United States Department of Defense (DOD) awarded Moderna a contract valued at $1,966,598,000 for an additional 100 million doses of the company’s Covid-19 vaccine.
CHMP Recommends Approval of Lilly’s Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis
Adults, Atopic Dermatitis, Clinical Trials, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), FDA/Regulatory, Janus Kinase (JAK) Inhibitors, R&D, TherapeuticsCHMP Recommends Approval of Lilly’s Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis — Positive Opinion is the First Regulatory Action for Baricitinib as an Atopic […]
bluebird bio Presents New Results from Clinical Development Program of eli-cel Gene Therapy for CALD
Biologics License Application (BLA), Cerebral Adrenoleukodystrophy (CALD), Clinical Trial Endpoints, Clinical Trials, Committee for Medicinal Products for Human Use (CHMP), Data, Efficacy, European Medicines Agency (EMA), Gene Therapy, Major Functional Disabilities (MFDs), Marketing Authorization Application (MAA), Neurological function, R&D, Rare Metabolic Disordersbluebird bio Inc. announced updated results from the clinical development program for the company’s investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including long-term results from the Phase 2/3 Starbeam study and data from the Phase 3 ALD-104 study.
San Diego-based Ligand Pharmaceuticals is acquiring San Diego-based Pfenex for a total deal transaction of up to $516 million.