Rise and shine, another busy day is on the way. And a fine one it is. Once again, a bright, shiny sun is enveloping the oh-so-quiet Pharmalot campus, where the short person has decamped for the local schoolhouse, Mrs. Pharmalot is pursuing her latest mission, and the official mascots are happily snoozing at our feet. As for us, we are staying wide awake thanks to a cup of stimulation. As for you, here are some tidbits to keep you going. Hope you have a great day …
The Food and Drug Administration has relaxed labeling requirements for the Mifeprex abortion drug, the New York Times tells us. In most states, this will reduce the number of doctor visits women need to make and extend the time in which they can receive the drug, from 49 days to 70 days from the last menstrual period. The decision is a victory for abortion rights advocates, but is unlikely to go over well in conservative states.
Valeant Pharmaceuticals is offering its lenders a one-time fee and extra interest on loans in exchange for waiving a default, Bloomberg News reports. The default may occur because the drug maker delayed an earnings filing and loosened some restrictions on its debt load. The company is asking its lenders to extend a deadline for filing its annual 2015 financial statement to May 31 from March 30.
The US Federal Trade Commission is seeking more information on the pending merger between Pfizer and Allergan, the Wall Street Journal writes. The deal, which would create the world’s biggest drugmaker, would move the company to Ireland as part of a tax inversion. The drug makers say they expected the request as “part of the regulatory process” and still expect the deal to close in the second half of this year.
Indian drug makers may face legal action for selling cancer medicines at higher than the maximum retail price, the Economic Times says. Meanwhile, India’s Central Drugs Standard Control Organization issued a memo vowing to reduce the backlog of pending clinical trial applications within three weeks, according to TwoFour Insight. The directive to speed reviews applies to any pending global clinical trials, new drug approvals, and medical devices.
Nurx, which describes itself as Uber for birth control, will soon start delivering the Truvada for PrEP, a daily pill that is prescribed to thwart HIV infection, the Guardian says. Patients in California will be able to obtain a prescription for PrEP, which stands for pre-exposure prophylaxis, by using a mobile app without having to see a doctor. The information is viewed remotely by a doctor instead.
The Turkish health ministry launched an investigation into allegations that a drug maker secured $85 million in business advantages through bribes, just days after Novartis acknowledged a probe is under way, Reuters says.
The FDA said it would allow the use of an experimental test from Roche to screen donated blood for the Zika virus, STAT reports.
The FDA also cleared a Jazz Pharmaceuticals drug for treating a rare kind of liver disease, making it the first treatment to win US approval for the condition, Reuters says.
The FDA, meanwhile, will not approve an Opko Health kidney drug until contract manufacturer Catalent fixes problems at its softgel plant in Florida, InPharma Technologist writes.
The European Medicines Agency has started its review of Bristol-Myers Squibb’s Opdivo in Hodgkin’s lymphoma, which could be the first such indication for a checkpoint inhibitor, PMLive tells us.
A class action lawsuit over a Johnson & Johnson metal hip implant affecting more than 1,700 Australians was settled for $250 million, according to SBS.
The UK’s National Institute for Health and Care Excellence issued new draft guidelines designed to help streamline the treatment of multimorbidities, according to Pharma Times.