Almost 10,000 GE and Siemens MRI machines are being recalled, FDA's database shows. The agency classified the recalls in its second-most severe category, meaning the affected machines "may cause temporary or medically reversible adverse health consequences."
The FDA says it won't recommend new limits on Eli Lilly schizophrenia med Zyprexa Relprevv after almost a year of investigating the deaths of two patients 3 to 4 days after they received injections.
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.
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'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, 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.
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.
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.
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.
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.