Topic:

Regulatory

Latest Headlines

Latest Headlines

Alexion wins EMA nods for not one but two drugs

Rare-disease specialist Alexion Pharmaceuticals won a double header from the EMA today when the agency recommended approval of two of its drugs, including Kanuma, the enzyme replacement med it picked up in its $8.4 billion buyout of Synageva.

Alexion gets EU green light for a pair of rare disease drugs

European regulators are recommending approval for two rare disease treatments from Alexion, a victory for the biotech as it works to expand its stable of commercialized drugs.

Nurse pleads guilty to taking Insys kickbacks as Subsys marketing probe continues

In an apparent sign that federal prosecutors are zeroing in on the pain-drug maker Insys Therapeutics, a Connecticut nurse and top prescriber has pleaded guilty to accepting $83,000 worth of kickbacks from the company.

Novartis scores recommendation from EMA for myeloma drug Farydak

After scoring FDA approval earlier this year, Novartis' multiple myeloma med Farydak (panobinostat) is picking up steam across the pond, snagging the European Medicines Agency's (EMA) recommendation for patients with advanced forms of the disease.

Japan approves Bayer sales of Eylea for diabetes-related visual impairment

Japan's Pharmaceuticals and Medical Devices Agency approved Bayer's Eylea for the treatment of diabetes-related visual impairment, the company said in a release June 26.

Australia's Ley hits back at drug firms on access to new medicines, reimbursement policies

A growing tussle between industry and Australia's Liberal-led coalition over efforts to trim drug reimbursement costs widened this week as Health Minister Sussan Ley hit back at Medicines Australia over the approval times for newer treatments and related costs.

Pharmacy groups plead with FDA for more time to get on board with track-and-trace

The Drug Supply Chain Security Act, passed by Congress in 2013, lays out a timetable for companies to be able to comply with the so-called track-and-trace rules that would allow the FDA to more easily locate recalled products and to protect against counterfeits.

FDA panel slated to weigh Bayer Essure safety after more than 5,000 complaints

The U.S. Food and Drug Administration has further formalized its ongoing review of the controversial Essure permanent birth control implant from Bayer.

Pharmacies want more time to comply with track-and-trace rules

This year the FDA gave drugmakers, wholesalers and logistics companies an extra four months to get on board with new regulations requiring them to be able to track lots of prescription drug products all along the chain of custody. Now pharmacy groups are asking if they could catch a similar break.

CDC panel disappoints Pfizer, GSK with limited backing for meningitis B shots

The CDC's Advisory Committee for Immunization Practices gave the go-ahead for wider use of meningitis B vaccines, but stopped short of a universal recommendation, not the result many--including GlaxoSmithKline and Pfizer--were hoping to see.