Category:

US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products…Last week, a European ban took effect on…medicines that were approved based …on what regulators called flawed clinical studies… US Food and Drug Administration isn’t taking any action on products sold here that included data from GVK’s studies in their applications,…

Open your medicine chest and you’ll find bottles and vials that contain so much more than a needed remedy…Each container actually holds a fascinating tale about the drawn-out process it took to develop the drug, the delicate dance required to win regulatory approval, the sometimes controversial steps taken to persuade doctors to prescribe the medicine, or the complicated calculus that was used to set pricing

• You can have sex or you can drink, but you can’t do both.
• Drug makers have free speech rights, too. Seriously, they do.
• My medicine costs how much?
• Is the sky the limit . . . or is the sky falling?
• No, Virginia, we don’t yet have a cure for cancer, but . . .
• You’re dying, but getting access to experimental medicine may be nearly impossible.

Dutch public employees' pension fund, the world's third largest, has sold all its shares in pharmaceuticals maker Mylan after it emerged that one of the company's products is in stock at a U.S. prison where death sentences are carried out…European companies are barred from selling drugs for use in executions, forcing states that still impose the death penalty to scrabble for alternative substances, some of which have led to widely publicized and gruesome botched executions.

...evolutionary underpinnings of diabetes are actually quite strong: Animals go through cycles in which their metabolism changes. Animals become obese and insulin-resistant when food availability is very low, and their metabolism kicks into gear when the environment is flush with food…all aligns with Circadian rhythms, Rhode Island-based biotech VeroScience asserts, which is why it’s developing its line of therapeutics around the waxing and waning of mammal metabolic function. In short, it’s studying how the biology behind the hibernation patterns of a bear,.. might be harnessed to spark new therapeutic modalities.

Kardashian's #CorrectiveAd came during MTV's Video Music Awards...Kim Kardashian West took to social media…to belatedly acknowledge the side effects of a controversial morning-sickness drug she endorses (Diclegis)… Aug. 7 warning from the U.S. Food and Drug Administration to drugmaker Duchesnay saying that Kardashian's original paid endorsement omitted important safety information.

precision medicine is more complicated than portrayed by politicians and even some top health officials. Contrary to its name, precision medicine is often inexact, which means that for some patients, it will offer false hope rather than a cure…

All 11,000 workers, retirees and family members insured by the Washoe County School District are being put on health plans with Renown Health starting in January, but their coverage won’t be restricted to Renown-branded facilities and providers, company representatives emphasized this week following concerns about the new contract.

Attorney General Maura Healey announced Monday that a manufacturer of a drug that can help reverse opioid overdoses will pay the state $325,000, resolving her concerns about a sharp price increase…. settlement with Amphastar Pharmaceuticals Inc. will help make the drug, naloxone (nasal administration),..more widely available for less money to cities and towns across the state…The $325,000 will go into the Municipal Naloxone Bulk Purchase Trust Fund, created in this year’s state budget. That fund is aimed at helping communities gain cheaper access to the drug.

New US drug shortages this year are running roughly at the same levels as the last two years, and far below the record highs seen earlier this decade,…several significant products remain difficult to find, and hospitals, still shaken by the critical shortages of the recent past, remain concerned that key drugs could once again become scarce..

PharmTalk is a special production from the University of Arizona, College of Pharmacy that features Keith and Kevin Boesen.

They are often in the basement, and patients seldom visit. But the pharmacy department in a big hospital is a vital unit for making sure the right medicines get to the patients on time and safely.