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.
As Acceleron Pharma Inc.’s phase II trial of sotatercept hit its primary endpoint and some key secondary endpoints in significantly reducing pulmonary vascular resistance, the stock (NASDAQ:XLRN) reacted accordingly, gaining 50% on Jan. 28. The stock ended the day at $79.39, up $26.52.
The pending Abbvie Inc. merger with Allergan plc, expected to close in the first quarter, brought good tidings to another “A” company on Monday, allowing Astrazeneca plc to regain global rights to its late-stage Crohn’s disease and ulcerative colitis (UC) drug, brazikumab, an anti-IL-23 therapy that was out-licensed to Allergan in a $1.27 billion deal in 2016.
Novo Nordisk A/S' Ozempic, a once-weekly injectable version of the company's glucagon-like peptide-1 (GLP-1) receptor agonist, semaglutide, first FDA-approved in late 2017, has won the agency' approval for a new indication: reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (T2D) and known heart disease.
With a label broadened by the FDA in December and two aspiring competitors apparently picked off via late-stage trial blowups, Amarin Corp. plc finds itself in strong position with fish oil therapy Vascepa (icosapent ethyl) – at least pending the outcome of court proceedings that involve challengers to patents for the cardiovascular (CV) drug.
DUBLIN – Compared to other indication areas, gene therapy for cardiac disease is still at the “caveman” stage, according to Dinaqor AG CEO and Chairman Johannes Holzmeister. The Pfäffikon, Switzerland-based firm aims to drag it into the modern era by applying a novel locoregional delivery system to its adeno-associated virus 9 (AAV9) vector technology.
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