Category Archives: Safety

Ranbaxy Suspends Shipments, Addresses Quality and Integrity Problems

Following the U.S. ban on all imports from Ranbaxy’s Toansa, India, facility, the drug maker has voluntarily suspended all shipments of bulk drugs from its manufacturing facilities both at Toansa and Dewas, in order to reassess quality controls at the plants.
Also posted in Emerging Markets, FDA, Global, Regulatory | Tagged , , , | Leave a comment

Drug Shortages Continue to Plague Health Care System

Despite notable successes in preventing and mitigating short supplies of important medicines, the drug shortage crisis still disrupts medical treatment and gives drug manufacturers a bad name. The Food and Drug Administration is doing a better job of identifying potential shortage situations and implementing relief strategies, but many supply problems continue to limit treatment options […]
Also posted in FDA, Legal, Manufacturing, Supply Chain | Tagged , , , , , , | Leave a comment

Love Potion #9: The Hypoactive Sexual Desire Disorder Pipeline

New products in development for women distressed by a lack of sexual desire and satisfying sexual experiences are causing a stir, but not for the reasons one might expect. Do women have less of a right than men to combat sexual disorders with pills? That’s the question eight national and international women’s advocacy groups asked […]
Also posted in FDA, healthcare, leadership, Market Access, Patient Communication, R&D, Regulatory, Strategy | Tagged , , , , , , , , , | 1 Comment

FDA Gets More Funding, IPAB Gets Less

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out. In this period of ever-tighter government outlays, the Food and Drug Administration did fairly well in gaining additional funds, along with user fee revenues that had been put on […]
Also posted in FDA, healthcare, Legal, Regulatory | Tagged , , , , , , , , | Leave a comment

J.P. Morgan: Pharma's Agenda for 2014

Presenters at the 32nd annual J.P. Morgan Healthcare Conference talked up value-based pricing, emerging market strategies, complex generics and new technology, from bedside devices and genetic sequencers to first-in-class mechanisms of action. Company executives honed in on their chosen therapeutic areas and made the case for aggressive spending in R&D to bring the next generation […]
Also posted in Biotech, Corporate Responsibility, Deals, Emerging Markets, Europe, Events, FDA, Gene therapy, Global, IP, leadership, Legal, Manufacturing, Market Access, Orphan Drugs, People, pricing, R&D, Regulatory, Sales, Strategy, Technology | Tagged , , , , , , , , , , , , , , , , , | Leave a comment
  • Categories

  • Meta