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Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The Center for Disease Analysis Foundation announced that it received an $8 million grant from Gilead Sciences as part of Gilead’s Relink grant program.
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Read our takes on the biggest stories happening in the industry.
Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
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On the heels of an FDA approval for its monoclonal antibody Bizengri, Merus will generate three novel cancer-targeting antibodies that it will pass over to Biohaven to link into antibody drug-conjugates.
Biogen’s proposed acquisition comes after two difficult years of regulatory and clinical challenges, during which shares of Sage Therapeutics have fallen by more than 90%.
Among Intra-Cellular’s neuropsychiatric assets is Caplyta, a pill approved for schizophrenia and bipolar depression and proposed for major depressive disorder.
Gilead’s investment will let it assess the therapeutic potential of targeting STAT6, a transcription factor involved in IL-4 and IL-13 signaling, which in turn are known inflammatory targets.
Emraclidine was the centerpiece of AbbVie’s $8.7 billion acquisition of Cerevel in December 2023 but failed two mid-stage trials. Tavapadon, meanwhile, has been a more rewarding asset for the pharma, clearing three Phase III Parkinson’s studies in 2024.
Metsera will use its IPO proceeds to fund the Phase III development of its injectable, ultra-long-acting GLP-1 therapy MET-097i, which last week achieved 11.3% weight loss in a Phase IIa study.
The first major deal of JPM 2025 will give GSK a promising small molecule drug for gastrointestinal stromal tumors.
Benefiting from technological and conceptual groundwork and positive early data, gene therapies are advancing in the clinic for cardiovascular diseases including congestive heart failure, chronic refractory angina and cardiomyopathy.
An FDA committee’s September 2024 vote to limit the use of Merck’s Keytruda and BMS’ Opdivo in stomach and esophageal cancers based on PD-L1 expression levels reflects an emerging trend that leverages ever-maturing datasets.
Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming particularly in the oncology and neurosciences spaces.