Topic:

Regulatory

Latest Headlines

Latest Headlines

China FDA approves first proton carbon ion therapy for Siemens device

China's FDA has disclosed its first approval of proton carbon ion therapy equipment by clearing the Siemens device at the Shanghai Heavy Ion Proton Hospital to treat cancer patients with radiation.

South Korea tells Bayer to divest oral contraceptives business

Bayer Korea has been ordered to divest its oral contraceptives business, chiefly its Mercilon (ethinylestradiol) drug, which it acquired when its Germany parent Bayer bought Merck's consumer-care business recently.

India threatens restrictions on China pharma imports

India's government has threatened to place restrictions on imports of nonessential items, including pharmaceuticals, from China if it does not ease some of its "protectionist tendencies" toward India products.

Lee Kuan Yew remembered for focused effort to build Singapore into a pharma, biotech center

Lee Kuan Yew, Singapore's first prime minister, who developed the small city-state into a vibrant manufacturing center for petrochemicals, shipping, electronics and a financial hub also leaves a legacy for the drug and biotech industry in Asia that will play out over decades.

Does the FDA overregulate devices? Experts weigh in

Opinions are all over the map when it comes to whether the FDA regulates medical devices too strictly or too loosely. Those favoring more regulation point to power morcellators and duodenoscopes. Industry and others who favor faster access note that in Europe, many advanced devices are made available years before they are commercialized in the U.S.

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.