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. Once again, our agenda is rather modest. We expect to manicure the Pharmalot campus grounds, catch up on our reading, and escort Mrs. Pharmalot to the latest installment in our “Let’s-see-them-before-they-die” concert series. And what about you? This is a wonderful time of year to enjoy the great outdoors. Perhaps you can look for the Great Pumpkin. Speaking of which, the election is nearing, so maybe you can find time to place a big bet. Or simply plan the rest of your life. Well, whatever you do, have a grand time, but be safe. Enjoy and see you soon …
To avoid scandals, Novartis chief executive Joe Jimenez advises companies not to hire people who do not follow the the rules, Finews says. The drug maker, you may recall, has paid fines and settled cases involving bribes to doctors. “We tell people, we don’t want you to deliver at any cost. We want you to deliver, but we want you to deliver in the right way,” Jimenez told a leadership symposium, according to the news site.
A Food and Drug Administration advisory panel voted 15-13 to increase the minimum dose of naloxone, which is widely used to reverse the effects of opioid and heroin overdoses, MedPage Today reports. The panelists who voted to raise the dose mostly cited the increasing use of more potent opioids, such as fentanyl and carfentantil, which might require more doses or higher doses of naloxone to revive patients.
The FDA released a final rule that revises and clarifies regulations in hopes of reducing litigation that can delay the approval and marketing of generic drugs, Regulatory Focus tells us. “FDA has described this as clarifications,” said Kurt Karst of Hyman, Phelps & McNamara, who writes the FDA Law Blog. But “this is a pretty significant re-write of the regulations. It’s a lot of small clarifications adding up to a lot.”
The US Patent Trial and Appeal Board rejected arguments by the Coalition for Affordable Drugs, which is run by hedge fund manager Kyle Bass, that a Shire patent on a colitis drug was not novel. The decision is a setback for Bass, who argues drug makers hold some patents that are designed only to fend off competition and challenges can lower prices. However, Bass also shorts the stocks. Bass says he is “frustrated by the ruling.”
Pfizer’s Hungarian subsidiary was fined approximately $180,000 by the Hungarian Competition Authority for misleading advertising about the affects of its Multi-tabs Multi Kid tablets, the Budapest Business Journal says. The advertising suggested the product can substitute for a balanced, varied diet for children, which amounted to an unsubstantiated claim. Pfizer plans to appeal.
More than a quarter of European patients with advanced melanoma lack access to new treatments that could extend their lives due to the high cost of the medicines, Reuters reports, citing a survey presented at a cancer conference. In the past five years, novel medicines have revolutionized prospects for people with metastatic melanoma, the most deadly form of skin cancer. But thousands don’t get the new drugs because they cost $100,000 or more.
The US Drug Enforcement Administration mandated significant cuts in the production of powerful prescription opioid painkillers, including Oxycontin, Vicodin, and fentanyl, according to HealthDay News. The agency made these changes because legal prescriptions for the opioid medications have decreased, while illegal use of the drugs is on the rise.
In 2017, 85 percent of Medicare Part D regional prescription drug plans will have a preferred pharmacy network, according to DrugChannels. “Such narrow pharmacy networks, either preferred or limited models, are now an unstoppable and widely accepted element of pharmacy benefit design,” writes Adam Fein, who runs the blog. And he predicts that pharmacies will continue to see their prescription profit margins terminated.
Pfizer plans to sells its midtown Manhattan headquarters, where the drug maker has been based since 1961, and move to a new location elsewhere in Manhattan no sooner than 2019, the Wall Street Journal writes.
Pfizer agreed to sell its global infusion therapy business to ICU Medical for $1 billion in cash and stock, which will give the drug maker a major stake in the company, Reuters reports.
PTC Therapeutics says a study showed its experimental Duchenne muscular dystrophy drug, which was rejected by earlier this year by the FDA, may have helped some patients preserve lung function, Bloomberg News says.
The UK’s National Institute for Health and Care Excellence recommended the use of an AstraZeneca triple therapy for regulating blood sugar in type 2 diabetics, PM Live informs us.
AstraZeneca will sell the rights outside the US to its Rhinocort Aqua allergy spray to Johnson & Johnson’s Cilag unit for $330 million, according to MarketWatch.
About the Author Reprints
Joe Jimenez knows there’s a difference between bending and breaking rules. Anybody who has worked in the drug industry receives on Day 1 a copy of the company’s SOP. In my case the SOPs ran well over 1000 pages. Seeing that I was concerned about learning this tome in a short time my boss told me this, “If you try to get your job done by following every single SOP you will never get anything accomplished”. That’s where the idea of working smarter, not harder originated with me, and I’ll bet it’s how Jimenez got to the top.