Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cuppa stimulation. Our choice today is ginseng peach, a favorite from our pantry. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. We appreciate feedback, tips and criticism. …

In a pair of late-stage trials, an AstraZeneca drug reduced the dangerous flare-ups that worsen COPD, positioning it as a potential new option for the vast number of patients with the debilitating lung condition, STAT explains. According to data released Tuesday, the results also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that the injectable drug could reap billions in annual sales if approved, both in COPD and in other conditions including asthma. 

The Trump administration permanently filled four key leadership roles at the U.S. Food and Drug Administration on Tuesday, after nominating Heidi Overton to lead the agency late last month, STAT says. Three of the officials are serving in an acting capacity, and will take the same roles permanently. They are Michael Davis, a psychiatrist who will be director of the Center for Drug Evaluation and Research; former Merck official Karim Mikhail, who will be director of the Center for Biologics Evaluation and Research; and Bret Koplow, an attorney who has been at the FDA since 2011 and will serve as director of the Center for Tobacco Products. 

Continue to STAT+ to read the full story…

Residue and stains plastered on production walls, floors, and manufacturing equipment. Corrosion on a product line. An employee wearing open-toed sandals.

These were among the unsanitary conditions found last April by a Food and Drug Administration inspector during a visit to Shoolin Pharma in Gujarat, India, where the company makes active pharmaceutical ingredients for more than a dozen medicines, including erectile dysfunction and anti-convulsant pills, that are sold to compounding pharmacies in the U.S., according to the agency.

The concerns about filth and possible contamination in the production and packaging areas — as well as incomplete laboratory testing records — prompted the agency last month to halt all product shipments by the company into the U.S., the FDA disclosed in an Aug. 18 warning letter that was posted on the FDA web site last week.

Continue to STAT+ to read the full story…

Good morning, everyone, and welcome to another working week. We hope the weekend respite — longer than usual thanks to a holiday on this side of the pond — was relaxing and invigorating. Now, though, that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cup of stimulation. Our choice today is butter pecan. Feel free to join us. Remember, no prescription is required. Meanwhile, here are a few items of interest. Best of luck accomplishing your goals, and we hope you conquer the world. And, of course, do keep in touch. …

An experimental Novartis drug for a rare neuromuscular condition failed to improve muscle function in a pivotal study, its second major trial collapse in a matter of days, STAT writes. The two study flops will likely stoke concerns about its pipeline and acquisition strategy as it navigates a major patent cliff, though the company did see a victory with a multiple sclerosis drug last week. The stock was down by as much as 10% in early trading in Switzerland. The Phase 3 HARBOR trial was testing the drug del-desiran in a condition called myotonic dystrophy type 1, known as DM1, which causes progressive muscle stiffness and weakness.

Novo Nordisk stopped two trials of a drug that aims to tame inflammation as a way to improve cardiovascular health, another blow for the approach, STAT notes. The company said it had halted the HERMES and ATHENA trials of its drug, ziltivekimab, after a data monitoring committee found they were unlikely to succeed. Novo informed trial investigators on Friday. The move follows the earlier failure of the drug in the ZEUS trial, which showed that the medicine, despite lowering markers of inflammation, did not reduce the risk of major clinical complications, including deaths and heart attacks.

Continue to STAT+ to read the full story…