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.
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 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'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%.
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.