And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, escorting Mrs. Pharmalot to a musical happening and visiting a new eatery. We also hope to have yet another listening party, where the rotation will include this, this, this, this and this. And what about you? This may be an opportunity to enjoy the great outdoors, perhaps a stroll by the seashore or a walk in the woods. A long drive in the country may be nice, although it will cost you. Or perhaps simple pleasures such as noshing on a pastry with a hot cup of stimulation will do. You could also catch up on your reading or reach out to someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon…

A flood of cheap copies of Novo Nordisk’s blockbuster weight-loss drug in India is already reshaping the country’s fast-growing obesity medicine market, showing how quickly the patent cliff will affect GLP-1 makers like Eli Lilly, Bloomberg News explains. Within days of dozens of generics hitting the Indian market after Novo’s patent expired locally, the drug’s share in the country’s GLP-1 segment jumped to 33% in March from 25% a month earlier, according to researcher Pharmarack. That gain came at the expense of Lilly’s Mounjaro, which is still under patent protection in India and whose share fell to 64% from 71%. The data marks the first meaningful snapshot of how market dynamics will change for GLP-1 makers as their patents near expiry.

The U.S. Food and Drug Administration withdrew approval of a GSK drug that the Trump administration had promoted as a treatment for autism, adding another twist to the unusual story of a decades-old drug, Bloomberg News informs us. The agency is pulling its approval of Wellcovorin, a branded version of leucovorin from GSK, according to a post in the Federal Register. GSK had requested that the approval be withdrawn. The FDA first approved leucovorin decades ago and it has been used to blunt the side effects of chemotherapy for some cancer patients. In September, Trump administration officials endorsed leucovorin as an autism treatment. Last month, the FDA approved its use for cerebral folate deficiency, which is seen in some people with autism.

Continue to STAT+ to read the full story…

Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel’s. Yes, this is a real thing. And remember, a prescription is not required. So no need to mess with rebates, coupons, or TrumpRx. Meanwhile, here are a few items of interest. Hope you have a smashing day and conquer the world. And of course, do stay in touch. We appreciate feedback, criticism and tips. …

Steve Ubl, the chief executive of Pharmaceutical Research and Manufacturers of ​America, plans to step down at the end of the ‌year, after more than a decade of leading the main trade group for brand-name drug makers, STAT notes. Ubl led the organization during tumultuous times that included the Covid-19 pandemic and aggressive political attacks on prescription drug pricing. Democrats passed a law directing Medicare to negotiate drug prices and the Trump administration struck  voluntary deals with individual drugmakers aimed at lowering U.S. prices to levels in other high-income countries. The next head of PhRMA will face increasing political pressure on prices and an increasingly populist mood. 

Specific changes in two genes appear to help predict whether patients will lose substantial weight on GLP-1 drugs used to treat obesity — and whether the drugs will cause nausea or vomiting, which are some of their most common side effects, STAT writes, citing a paper in Nature. “I think we have proof of concept here that genetics is playing a role in terms of GLP-1 efficacy and side effects,” said Adam Auton, a vice president at the 23andMe Research Institute and the senior author on the paper. Outside researchers were impressed and intrigued by the findings, but some doubted whether the genetic results would impact patient care. Still, consumers who use what 23andMe calls its Total Health platform will have access to information about these genes and what they predict about GLP-1 use.

Continue to STAT+ to read the full story…

Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and comfortable breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is ginger peach. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips. …

The U.S. Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs, STAT notes. FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers. The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. One of the legislative proposals in the FDA’s budget justification would let domestic manufacturers of generic drugs challenge brand drug patents a month before foreign companies, a major advantage in an intensely competitive process. 

Two more drugmakers, AbbVie and Genentech, will officially start selling their medicines on the TrumpRx website, CBS News tells us. Abbvie, which struck a deal with the Trump administration in January to cut the cost of certain medicines, will sell Humira, a popular medication used to treat rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, on the site at an 86% discount. The prescription prices on the site, however, are only available to patients who are uninsured, or whose insurance does not cover it, and who must pay the full list price out of pocket. Those with insurance coverage generally pay lower prices already. TrumpRx now sells over 61 drugs at a lower price, up from about 40 when the website went live in February. 

Continue to STAT+ to read the full story…

An experimental HIV prevention pill being developed by Merck could be mass produced for less than $5 per patient a year according to a new analysis. Advocates argue the low cost means the company should find it easier to license the drug so that low- and middle-income countries can gain easy access.

The pill, dubbed MK 8527, is currently undergoing a pair of late-stage clinical trials that are expected to determine whether the medicine can lower HIV transmission when given to people at high risk of infection. The results are due in the latter half of 2027, according to separate postings on ClinicalTrials.gov.

Already, the pill is generating considerable interest after Merck released mid-stage results last summer showing its drug holds promise. In addition to being safe and effective, the study found it could protect against infection, a form of prevention known as pre-exposure prophylaxis or PrEP, within 24 hours after being taken. Merck noted the pill works in a novel way.

Continue to STAT+ to read the full story…

For the second time in two years, a bill is moving through the Colorado legislature that would exempt orphan drugs, which are used to treat rare diseases, from pricing caps that might be pursued by the state’s Prescription Drug Affordability Board — a panel whose work is being closely watched elsewhere in the country.

The effort reflects concerns that patients may lose access to these drugs if pharmaceutical companies halt sales of such treatments in the state. But opponents argue exemptions would unnecessarily extend to numerous big-selling medicines for common conditions that — thanks to regulatory endorsements — also happen to have an orphan designation.

As a result, consumer advocates complain the maneuver would only increase the risk that countless patients could have trouble paying for a wide variety of medicines. They further argue that the legislation would preserve profits for drug companies at the expense of the state government — and its taxpayers — as it tries to cope with budgetary strains.

Continue to STAT+ to read the full story…

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because 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 cups of stimulation. Our choice today is laced with traces of cocoa. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today and, of course, do keep in touch. …

In February, a small biotech company called Kezar Life Sciences reached a breakthrough with the U.S. Food and Drug Administration, agreeing to a plan for a clinical trial it hoped could lead to the approval of its treatment for a rare, debilitating liver disease called autoimmune hepatitis. The problem: The agreement came four months too late, STAT explains. The meeting to discuss trial design, a critical step in the drug development process, had been scheduled for last October. But the FDA abruptly canceled it without explanation. The company could no longer proceed as planned and, without clarity from regulators, its path forward was unclear. Kezar’s investors wanted out, and the biotech was forced to start the process of winding down.

Americans starting weight loss medicines for the first time want lower cost and greater convenience as they consider pills from Novo Nordisk and Eli Lilly, Reuters says, citing seven doctors who specialize in obesity. Novo’s Wegovy pill ​has been on the market since January, while Lilly’s newly approved Foundayo joins the fray this week. Interviews with the specialists show a promising landscape for oral weight loss drugs as ‌the companies compete for share in the fast-changing obesity treatment market that is seen topping $100 billion a year in the next decade. All seven doctors said they had begun prescribing oral Wegovy, and three said they have prescribed the pill to ⁠about 10% of their patients. Of those patients, most are taking a GLP-1 for the first time, rather than switching from injectables, and have not yet reached the highest dose. 

Continue to STAT+ to read the full story…