Topic:

Regulatory

Latest Headlines

Latest Headlines

DOJ cracks down on devicemakers in 2014 with $100M+ in fines

In a show of force, the Department of Justice just announced two fines against providers for healthcare fraud under the False Claims Act totaling more than $10 million. The news coincided with release of an annual report on healthcare fraud, which claims that the feds recovered $3.3 billion in fiscal year 2014.

FDA removes the brakes on Pfizer and Lilly's pain drug

A once-halted pain candidate from partners Pfizer and Eli Lilly now has the green light to resume late-stage testing, as the FDA has lifted a clincal hold tied to some serious safety concerns for the whole class of drugs.

Amgen link strong as Astellas files with PMDA on Evolocumab, and new indication for Kiklin

Japan's Astellas Pharma has filed with Japan's Pharmaceutical and Medical Devices Agency for approval of PCSK9 inhibitor evolocumab for high cholesterol under the Amgen Astellas BioPharma joint venture.

India's Stempeutics gets EMA advanced therapy designation for Stempeucel

Cipla-backed Stempeutics, an India advanced clinical stage biotech company based in Bangalore, said the European Medicines Agency has granted Advanced Therapy Medicinal Product classification for its novel stem cell drug Stempeucel.

India's top court issues injunction on Glenmark from selling copy of Merck's Januvia

India's highest court has granted an injunction against Glenmark Pharmaceuticals, blocking it from producing and marketing a generic of Merck's Januvia (sitagliptin) for treating diabetes. A patent-infringement suit was not affected by the decision.

India plans pharma manufacturing clusters to ease costs

India's health ministry said the government plans to spend $27.3 million to establish ten clusters around the country for drug makers to share common production facilities and reduce their costs by 25%.

TB cases outside of lungs rise in India

India physicians report an uptick in the number of tuberculosis cases occurring not in the lungs, but elsewhere in the body even as they criticize the government for failing to see that patients have access to the drugs they need to treat the disease.

FDA under pressure to establish staff social media policy

Having faced years of criticism for its failure to publish guidelines on how the industry can use social media, the FDA is now being chastised by the advocacy group Union of Concerned Scientists over its lack of a policy for its staff.

FDA hustles on opioid guidance to avoid budget meddling

The FDA is rushing to complete guidance on abuse-deterrent opioids before the end of June because if it doesn't, Congress has promised to take away $20 million in money for salaries and expenses in the FDA Commissioner's Office and give it instead to its criminal investigations unit to fight drug diversion.

India tells drugmakers to pass along excise tax cut

India's National Pharmaceutical Pricing Authority has ordered all drugmakers to pass along to the consumer the recent reduction in the excise duty on imported medicines.