NIH To Stop Trial On Controversial Anti-Malarial Drug; Scientists Excited About Osteoperosis Medication
The decision from NIH is just the latest to signal that hydroxychloroquine, the drug President Donald Trump touted as a "game changer," doesn't work for COVID-19 patients. Meanwhile, scientists urge caution on a promising steroid treatment.
The New York Times:
Federal Agency Halts Studies Of Hydroxychloroquine, Drug Trump Promoted
The National Institutes of Health said Saturday that it had stopped two clinical trials of hydroxychloroquine, the malaria drug that President Trump promoted to treat and prevent the coronavirus, one because the drug was unlikely to be effective and the other because not enough patients signed up to participate. The agency halted a trial that had aimed to enroll more than 500 patients after an independent oversight board determined that the drug did not appear to benefit hospitalized patients. The same day, the N.I.H. said it had closed another trial — of hydroxychloroquine and the antibiotic azithromycin — because only about 20 patients had enrolled in the planned study of 2,000 people. (Thomas, 6/20)
Reuters:
Novartis Halts Malaria Drug Trial Against COVID-19 Amid Participant Shortfall
Swiss drugmaker Novartis (NOVN.S) is halting its trial of malaria drug hydroxychloroquine (HCQ) against COVID-19 after struggling to find participants, it said on Friday, as data emerged from other studies raising doubts about its efficacy. (Miller, 6/19)
The Hill:
Researchers Request Clinical Trials For Osteoperosis Drug To Treat COVID-19
Researchers backed by the European Union have requested clinical trials to study the potential of an osteoporosis drug, raloxifene, as a potential treatment for the novel coronavirus. The Exscalate4CoV research consortium virtually screened more than 400,000 molecules for possible efficacy as an antiviral treatment with a supercomputer and then analyzed 7,000 specimens that showed potential through laboratory and biological tests, according to Politico. (Budryk, 6/18)
WBUR:
Doctor Warns Of Risks In Rush To Embrace A COVID-19 Treatment
Earlier this week, researchers in the United Kingdom announced preliminary results from a clinical trial that showed a low-cost steroid called dexamethasone appeared to lower the risk of death in patients with COVID-19. The researchers said the anti-inflammatory drug reduced the number of deaths in COVID-19 patients on ventilators or oxygen alone by one-third. (Simon, 6/20)
In other pharmaceutical news —
Stat:
What To Know About A Crucial Study Of Bellus Health's Chronic Cough Drug
Bellus Health, a small Canadian drug maker, is seeking to develop a potential blockbuster medicine for chronic cough that could surpass a competing drug from Merck. Now, it’s nearing the completion of a mid-stage clinical trial that will serve as a pivotal test of whether it can pull that off. Here are five things to know about the Bellus drug, its Phase 2 study, and expectations heading into the results. (Feuerstein, 6/22)
Stat:
Court Invalidates Biogen's Patent On Blockbuster Multiple Sclerosis Drug
Shares of Biogen fell Thursday after a federal court judge ruled in favor of generic drug maker Mylan in a patent case involving the biotech’s top-selling multiple sclerosis drug, Tecfidera. The U.S. District Court in West Virginia declared invalid Biogen’s so-called “514” patent protecting Tecfidera from generic competition. The ruling gives Mylan the right to launch its own version of Tecfidera within days, although Biogen said Thursday that an appeal will be filed. (Feuerstein, 6/18)
Stat:
A ‘Semi-Wartime’ Effort: Thermo Fisher COO On Adapting To Covid-19 World
Way back in January, Thermo Fisher Scientific (TMO), the world’s largest maker of scientific tools, monitored the speedy sequencing in China of an unnamed coronavirus that would soon blaze around the world. Gearing up to produce diagnostic test kits and keep hospitals and labs supplied with the instruments to read them, the Waltham, Mass.-based company raced to deliver 5 millions tests per week by mid-April, as did two other giants in biopharma, Roche (RHHBY) and Abbott (ABT). (Cooney, 6/19)
Stat:
Finch Touts Positive Results For Its Microbiome Pill For C. Diff Infections
Three-quarters of the people who got Finch Therapeutics’ microbe-based pill for potentially deadly C. difficile infections appeared to be cured, an improvement over rates for the current standard treatment, the company announced Friday. Finch’s announcement makes it the second microbiome company to announce positive results for a microbe-based drug this year. But it is the first to do so with an oral treatment; Rebiotix, announced that its Phase 3 trial for an enema-based therapy succeeded in early May. (Sheridan, 6/19)
Stat:
Clinical Trial Costs To Develop A New Drug Might Be Modest, Study Suggests
For years, the pharmaceutical industry has maintained that the costs to develop medicines accounts for rising prices. But a new analysis contends that expenses for at least one crucial component of drug development — the clinical trials — are actually modest. (Silverman, 6/18)
