With new a FDA approval for a years-old type 2 diabetes drug, Astrazeneca plc's Farxiga (dapagliflozin) has become the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to be approved to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure patients with reduced ejection fraction, a measure of how much blood the left ventricle pumps out with each contraction.
A U.S. district court in Nevada ruled in favor of two ANDA filers in Amarin Corp. plc.’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), increasing the possibility of generics crowding Amarin’s U.S. sales.
Despite earlier signs it might meet the primary endpoint of a phase III trial testing its ability to terminate supraventricular tachycardia (SVT) episodes in patients with paroxysmal supraventricular tachycardia (PSVT), a short-acting calcium channel blocker tested by Milestone Pharmaceuticals Inc. failed to do so.
DUBLIN – For quite some time, cardiometabolic disease has been largely off the map for most small biotechs and for the venture capital investors that support them. Is that situation about to change? Maybe, maybe not was the mixed message arising from a Bio-Europe Spring 2020 virtual panel discussion on cardiometabolic disease.
PERTH, Australia – While the coronavirus captures the world’s attention, another global pandemic is quietly killing 100 million people under the age of 60, and Australian investors are putting up AU$53 million (US$34.58 million) to back late-stage projects at the George Institute for Global Health.
DUBLIN – Redx Pharma plc has put together a rescue package with two heavyweight investors that should ensure the company’s immediate future. Redmile Group LLC and Sofinnova Partners plan to provide up to £26.3 million (US$33.6 million) in funding to the struggling drug discovery and development firm.
Less than a month after landing a positive opinion from the EMA's CHMP, Esperion Therapeutics Inc. has won FDA approval for bempedoic acid as an adjunct to diet and maximally tolerated statin therapy.
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, on Feb. 21 launched a pre-revenue listing on Shanghai’s STAR market, a Nasdaq-style tech board, to reap $241 million at a valuation of almost $2 billion. Its share price soared more than 83% during its first trading day.
DUBLIN – The witty Twitter account @justsaysinmice, run by Northeastern University research scientist Jim Heathers, offers a very useful corrective to the misleading and unwarranted hype that often accompanies preclinical studies in mice. What looks good in murine models is all too often lost in translation, for a whole host of reasons, and never has any useful effect in patients. That’s not a concern for a group led by Thomas Thum, of the Institute of Molecular and Translational Therapeutic Strategies at Hannover Medical School in Germany, who just published in Nature Communications the outcome of what is probably the largest ever pig study in heart failure.
Bayer AG and Merck & Co. Inc. took Wall Street by surprise in November with their phase III success testing vericiguat in heart failure (HF), such that the guanylate cyclase stimulator’s odds not only have improved significantly but also in a different way than imagined before.
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