Innovent Biologics Inc.’s PCSK9 inhibitor, IBI-306, intended for the treatment of heterozygous familial hypercholesterolemia (HeFH), has met its primary endpoint in a phase III study in Chinese patients.
Tobacco firm Philip Morris International Inc. has announced another acquisition as it adopts a “beyond nicotine” strategy, snapping up Otitopic Inc., of Los Angeles, for an undisclosed sum.
Rivus Pharmaceuticals Inc. has emerged from stealth and disclosed a $35 million series A round to fund development of its pipeline of “controlled metabolic accelerators,” or CMAs, for treating cardiometabolic diseases.
Cytokinetics Inc. CEO Robert Blum declined to remark upon what one analyst called “the elephant in the room” as the company popped the lid off positive top-line data from the first and second cohorts of the phase II study with CK-3773274 (known by the shorthand CK-274) in hypertrophic cardiomyopathy (HCM).
Despite assembling the largest body of data the FDA said it may ever see for a drug intended to treat anemia due to chronic kidney disease, Fibrogen Inc. will have to get even more trial data to push roxadustat over the finish line in the U.S. – if the FDA follows the advice of its Cardiovascular and Renal Drugs Advisory Committee.
Approval could come next year for Furoscix from Scpharmaceuticals Inc. (Scpharma), a solution of the standard-of-care heart failure diuretic furosemide formulated to a neutral pH and designed for outpatient use.
Recent findings with the sodium glucose transporter-2 inhibitor Jardiance (empagliflozin) from Boehringer Ingelheim International GmbH and Eli Lilly and Co. drew more attention to the cardiovascular space.
In a new chapter for the ongoing story of sodium glucose transporter-2 inhibitor (SGLT2) inhibitors, Boehringer Ingelheim International GmbH and Eli Lilly and Co.'s Jardiance (empagliflozin) has become the first therapy of the class to significantly reduce the risk of cardiovascular death or hospitalization vs. placebo for heart failure patients with preserved ejection fraction (HFpEF). The finding comes from the phase III Emperor-Preserved study, which tested once-daily Jardiance 10 mg vs. placebo in nearly 6,000 adults living with HFpEF, with and without diabetes.
PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.
The U.S. Supreme Court will not take up Amarin Corp. plc’s appeal of a September Federal Circuit decision that opened the door for generics of the company’s fish oil-derived cardiovascular drug, Vascepa (icosapent ethyl), to enter the U.S. market.
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