Topic:

Regulatory

Latest Headlines

Latest Headlines

Sanofi, Protein Sciences win flu jab nods in older adults

A couple of flu vaccine makers have new patient populations to target, thanks to a pair of recent FDA approvals in older adults.

Government report says medical device tax will not deter innovation

The Republican takeover of the Senate means the chances of a repeal of the medical device tax are improved, but the Congressional Research Service just gave supporters of the tax ammunition. This week it released to the public a report claiming the medical device tax will only result in a 0.2% decrease in device industry jobs and output.

Government watchdog promises to monitor device cybersecurity, reimbursement in FY 2015

The watchdog agency of the Department of Health and Human Services promised to crackdown on defective medical devices and  cybersecurity  in hospitals in its recently released agenda for fiscal year 2015. 

GlaxoSmithKline heads to the FDA with its next big respiratory bet

GlaxoSmithKline is racing to be the first on the market with a new approach to treating severe asthma, filing U.S. and European applications for the injectable mepolizumab as it jockeys with Teva and AstraZeneca.

FDA clears catheter for targeted drug delivery in peripheral vasculature

The FDA recently gave 510(k) clearance to a two-balloon catheter for the targeted delivery of diagnostic and therapeutic agents to the visceral vascular system. This subset of the peripheral vasculature consists of the arteries that supply blood to the intestines, spleen and liver.

Can Rockwell Medical win FDA approval for its dialysis drug?

FDA reviewers have little doubt that Rockwell Medical's iron-replacement treatment for dialysis patients met its goals in late-stage trials, but the company, seeking agency approval, may have trouble convincing regulators that its Phase III results can translate into real-world benefits.

Novartis gears up for FDA scrutiny with a new blood cancer drug

Novartis believes its new oncology treatment can make a major difference for patients with multiple myeloma, a blood cancer with a particularly grim prognosis. But first it'll have to convince a group of independent experts that the drug's ability to extend survival by a few months outweighs a significant increase in safety risks.

Covidien gets FDA nod for directional artherectomy system for peripheral artery disease

Covidien won FDA 510(k) clearance for its directional atherectomy devices for peripheral artery disease, a notch in the company's belt as it anticipates the close of its pending $43 billion deal with Medtronic.

FDA warning cites Hikma plant for repeatedly failing to investigate issues

Hikma recently acknowledged that it had received a warning letter from the FDA for a plant in Portugal. What the drugmaker did not disclose is that some of the warnings were repeats, noted in three previous inspections of the facility dating back a decade.

Forest recalls another 90,000-plus bottles of Bystolic

Forest Laboratories, now a unit of Actavis, has expanded on a recall of one of its key drugs, adding another lot of more than 94,000 cartons of the blood pressure meds to the nationwide retrieval. It is the second recall in three months.