Dear Pharmalot folks:
After weeks of planning, Pharmalot will be moving to Stat, the smashing new life sciences site, on Monday, Nov. 16. What does this mean? Well, all future posts - including our weekly column, which also runs in The Boston Globe - will appear on Stat, instead of this location. Read More
Several drug makers were handed an unexpected victory this week when a federal judge ruled they weren’t required to update product labels to warn about risks of pancreatic cancer with their diabetes medicines.
In a 35-page ruling, US District Court Judge Anthony Battaglia explained the labeling changes were not required because the Food and Drug Administration would not have approved those changes. As a result, approximately 750 cases are being tossed. At issue is a legal concept known as preemption, which refers to federal law trumping state law. Read More
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share it with others. That’s right. Send us your changes and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the ongoing layoffs. Despite the downsizing, there is movement. Here are some of the latest comings and goings. Recognize anyone? Read More
And so, another working week will soon come to a close. Not a moment too soon, yes? This is, as you know, our treasured signal to daydream about weekend plans. Our agenda is extremely modest this time around. We expect to remove leaves from the Pharmalot campus, promenade with our official mascots and catch up on some work. And what about you? The great outdoors continue to beckon. There is still time to plan a holiday get-away. Or you could debate Starbucks coffee cups. Whatever you do, have a grand time. But be safe. See you soon...
The Trans-Pacific Partnership trade pact could limit the availability of affordable medicines, according to World Health Organization chief Margaret Chan; A federal appeals court backed an earlier ruling invalidating four of five patents on the Cubicin antibiotic that Merck acquired with its $8.4 billion deal to buy Cubist Pharmaceuticals; Roche plans to close or sell four manufacturing sites and pare about 1,200 jobs in a restructuring program; and Mylan is poised to lose its hostile bid for Perrigo. Read More
When it comes to disclosing clinical trial data, some drug makers are still keeping secrets. A new study finds that 35 percent of all trial results for 15 drugs that were approved in 2012 by the Food and Drug Administration were not publicly disclosed. And nearly 30 percent of the trials conducted for those drugs failed to meet legal disclosure requirements.
The findings come amid growing clamor from academics and consumer groups to press drug and device makers to release trial data. If research is not published or reported in accessible registries, physicians and patients are prevented from having a complete picture of the risks and benefits of medicines. Read More
In yet another setback for Valeant Pharmaceuticals, a federal judge ruled that a lawsuit accusing the drug maker and one of its biggest shareholders of insider trading can proceed.
The lawsuit, which was filed by shareholders, alleges that Valeant, hedge fund manager William Ackman and his Pershing Square Capital Management violated securities laws by failing to disclose legally required information in connection with their failed effort to buy Allergan. The unsolicited $51 billion bid for Allergan, which is best known for selling Botox, was launched in April 2014. Read More
Hello, folks, and how are you today? Cloudy skies are, once again, hovering over the Pharmalot campus this morning, but our spirits remain as sunny as ever. As you may recall, the Morning Mayor taught us long ago that every brand new day should be unwrapped like a precious gift. Speaking of new days, next week we will migrate to Stat, our new home. So please adjust your habits. Now, though, it is time to get cracking. Have a successful day and do drop us a line when you hear something fascinating...
When Perrigo shareholders cast their votes on Mylan's $26 billion takeover proposal by Friday’s deadline, it will mark the biggest hostile bid ever settled at the ballot box; a small cadre of employees at Valeant Pharmaceuticals were deeply involved in directing the daily operations of a specialty pharmacy that has drawn scrutiny for its billing practices; and a new vaccine developed by the University of New Mexico and the National Institutes of Health shows promise in lowering cholesterol and may be more effective than the statins millions of Americans currently take. Read More
For the past two years, patient advocates have complained that many insurers are trying to discourage HIV patients from enrolling in policies sold on health insurance exchanges created by the Affordable Care Act. Now, a new analysis provides fresh evidence that their concerns are justified.
Just 16 percent of the so-called silver exchange plans in 2015 cover all 10 of the most widely used HIV drug regimens. These also cost patients less than $100 per month per regimen, according to Avalere Health, a consulting firm that ran the analysis. Read More
In the latest fallout over the role that specialty pharmacies play in boosting prescription drug sales, Express Scripts has ended a contract with a company that is used by Horizon Pharma to distribute some of its medicines.
Express Scripts cancelled its contract with Linden Care after determining the mail-order pharmacy was apparently dispensing drugs that are mostly made by Horizon. Express Scripts, which is the nation’s largest pharmacy benefits manager, is scrutinizing what it calls captive pharmacies. Those captive pharmacies appear to sell products for mostly one drug maker. Read More
Hello, everyone, and how are you today? We are doing fine, thank you, especially given that this is the middle of the week. Perhaps you can relate. Of course, we will forge ahead, as always, since the alternatives appear bleak. This calls for a cup of stimulation and we invite you to join us. By the way, we would like to note that, next week, we will shift over to Stat, so please adjust your reading habits. Meanwhile, here are some tidbits. Have a smashing day...
Valeant Pharmaceuticals is offering discounts and, in some cases, giving dermatological drugs away for free in a bid to retain market share; The Japanese health ministry plans to censure Novartis for failing to report serious side effects from some of its drugs within a certain period of time; Pfizer and Allergan are moving toward a plan to make Brent Saunders chief executive officer if the two drug giants reach a takeover agreement; and India has taken step to ease norms for testing and clinical trials needed for introduction of drugs already approved in other countries. Read More