Morning Briefing
Summaries of health policy coverage from major news organizations
Drugs That Target Neurological Diseases Are Tricky, Risky And Expensive. But Two Start-Ups Think They Have A Short-Cut.
Stat: Neurological Drugs Are Hard. Two Companies Bet ‘Chemogenetics’ Can Help
For years, pharmaceutical companies have cut back on drug development that targeted neurological conditions. After trials and failures in dementia, depression, and epilepsy, companies learned that finding medicines that might work well in the brain is a very hard, very risky, and very expensive proposition. But two startups on opposite sides of the country believe they’ve found a shortcut — and have convinced venture capital firms to give them tens of millions of dollars so they can test it. (Sheridan, 4/2)
Stat: FDA Asks Manufacturers To Recall Heartburn Drugs Over Traces Of Possible Carcinogen
After months of deliberation, the Food and Drug Administration has asked all manufacturers of a particular heartburn medicine known as ranitidine, sold under several brands including Zantac, to withdraw their drugs because “unacceptable levels” of a possible carcinogen may develop in the pills over time. Specifically, the agency determined that levels of NDMA, an organic chemical that was once used to make rocket fuel and is an unintended byproduct of certain chemical reactions, may gradually increase and can increase significantly when stored in higher heat than room temperature. (Ed Silverman, 4/1)
The Associated Press: FDA Wants Heartburn Meds Off The Market Due To Contamination
The move from the Food and Drug Administration Wednesday applies to all prescription and over-the-counter versions of ranitidine, best known by the brand name Zantac. The drugs are widely used to treat stomach acid and ulcers. Patients should stop taking any of the medications they currently have and throw them away, the FDA said. (Perrone, 4/1)
Stat: FDA Warns Pfizer Over Another Former Hospira Plant
Amid ongoing concerns over the pharmaceutical supply chain, the Food and Drug Administration has issued numerous warning letters to domestic drug makers in India about manufacturing issues. But even global companies running plants there are not immune from problems. On March 25, the agency warned Pfizer (PFE) of signification violations at its Hospira facility in Visakhapatnam, Andhra Pradesh, which makes sterile injectable medicines. The issues involved a failure to adequately investigate various manufacturing deficiencies and an inability to ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs made there. (Ed Silverman, 4/1)
Stat: Biotech Scorecard For The Second Quarter: 18 Stock-Moving Events To Watch
Here is STAT’s Biotech Scorecard, our regular ledger of stock-moving biotech events, for the second quarter — with an asterisk shaped like the novel coronavirus. You may have heard something about a global, all-hands push to develop new medicines to treat Covid-19. This work will extend way beyond the second quarter, but the first (and therefore most highly anticipated) effort is expected to read out Phase 3 results in the next few weeks. All eyes will be on Gilead Sciences, which hopes to show that intravenously infused doses of the antiviral drug remdesivir are safe for patients and effective against Covid-19. (Feuerstein, 4/1)
