Topic:

Regulatory

Latest Headlines

Latest Headlines

Purdue preps potential Zohydro killer for FDA review after positive PhIII

As the commercial release of Zogenix's hydrocodone bitartrate pain drug Zohydro spawns headlines from coast-to-coast warning of a potential epidemic of abuse similar to what was seen with OxyContin, the rival Purdue Pharma says it has successfully wrapped a Phase III trial of its abuse-resistant competitor. And the data sets the stage for an FDA filing later this year as Zogenix labors at its own early-stage efforts at making a pain pill that's harder to abuse.

Geron shares blasted as FDA slams the brakes on imetelstat studies

Geron is back in the tank. The biotech's shares were in meltdown mode Wednesday morning, plunging about 60% in premarket trading after the company announced that the FDA put its one and only drug imetelstat on a full clinical hold after detecting a risk of long-term liver damage following prolonged exposure to the treatment.

Storm-tossed Chimerix rushes into a pilot study, with dying child as its 1st patient

On Tuesday morning, Chimerix CEO Ken Moch was at the center of a media storm, maintaining that there was no way the biotech could responsibly provide its experimental antiviral to a dying child named Josh Hardy, a drug the boy's parents vowed was all that could save the child's life. By Tuesday night, though, Moch had found a way to give the treatment to the 7-year-old after all, as part of the clinical development program for the drug.

AngioDynamics gains expanded FDA clearance for its bypass device at a crucial time

AngioDynamics said it won expanded FDA clearance for one of its key vascular access devices, a development that could help it boost the market reach for a product it bills as a healthcare cost-cutter.

Pharma wins battle against proposed Medicare reimbursement changes

Following a huge outcry from drugmakers, insurance companies, and patient advocates, the Obama administration said Monday it had abandoned proposed changes to the Medicare Part D drug benefit.

Ranbaxy issues a recall, but so do Pfizer, Baxter, Gilead and Mylan

India's Ranbaxy Laboratories has issued another recall for its generic Lipitor, but a series of product recalls in recent weeks have come from plants around the world and companies as varied as Pfizer, Mylan and Gilead Sciences.

Mainstay Medical's implantable neuromodulation device scores Australian approval for clinical trials

Mainstay Medical won approval from Ethics Committees in Australia to begin a clinical trial of its implantable neuromodulation device.

FDA informatics chief: NGS is an immediate priority for the agency

This week FDA officially introduced its push to open up its data to the public and particularly app developers. The unveiling went over the goals of openFDA, but also detailed some other areas in which the agency is investing. FDA is pushing hard into NGS and cloud-based genomics.

AstraZeneca says Nexium pills with Ranbaxy ingredient are safe to use

While most drugs from India are generics, sometimes Indian products are used by Big Pharma for their top brands, like AstraZeneca's Nexium.

EU suggests new warning for same sleeping pill that landed a Kennedy before a jury

Sleep drugs have been the root of plenty of safety worries over the years, especially when it comes to driving while under their influence. Now, just a week after the wrap of one of the highest-profile cases to revolve around Ambien generic zolpidem--Kerry Kennedy's--the European Medicines Agency's Pharmacovigilance Risk Assessment Committee is recommending updates to its product information to underscore the drug's associated risks.