MUMBAI - Four leaders of the U.S. Congressional Committee on Energy and Commerce - John Dingell, Bart Stupak, Joe Barton and John Shimkus have expanded their investigations into U.S. FDA's handling of Ranbaxy's anti-AIDS drugs that are supplied to African and other developing nations as part of the President's Emergency Plan for AIDS Relief program
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Data from the BROADWAY trial testing LDL-C reduction in adults with ASCVD showed that obicetrapib improved Alzheimer’s disease biomarkers, including tau and amyloid. Analysts think the data could differentiate obicetrapib against competitors in the cholesterol market.
Merck’s newly approved Enflonsia for RSV is one of the products that was expected to be recommended for use by the CDC advisory committee in June.
The firm has its ‘foot on the gas’ to accelerate development of its FRα-targeting antibody-drug conjugate, Rina-S, but rival Lilly is also moving rapidly into Phase III.
