Roche's real-time polymerase chain reaction tests for the detection of influenza A and B can now be used in settings such as the emergency room, pharmacies and physicians' offices, thanks to a CLIA waiver exempting it from a set of regulations on large diagnostic laboratories carried out by the federal Centers for Medicare & Medicaid Services.
A special panel of Japan's Ministry of Health, Labour and Welfare (MHLW) received around 50 formal applications and has cleared screening for the "sakigake" fast-track drug and device review process before the Pharmaceuticals and Medical Devices Agency, according to a ministry spokesman.
Lower costs for newer medicines through subsidies are going begging in Australia as drug companies increasingly look to avoid putting products through regulation paces needed to qualify, a report in news.com.au said, citing a PwC (PricewaterhouseCoopers) survey of 23 drug companies.
Bayer is facing disheartening news for its controversial birth control device Essure prior to an FDA panel meeting to discuss the product's safety, as new analysis by the agency shows a spike in reports from women who had bad reactions to the device.
Japanese drugmaker Otsuka won FDA approval for a two-drug therapy for colorectal cancer, planning to market the combination as a treatment for advanced forms of the disease.
St. Jude Medical has received a CE mark for its latest neuromodulation technology--the Infinity Deep Brain Stimulation System to treat movement disorders. It expects to get sign-off from the FDA and to launch the system in the U.S. before year's end. The franchise is the latest addition to St. Jude's neuromodulation business, which last quarter grew faster than the company's other groups in cardiac rhythm management, atrial fibrillation and cardiovascular.
On Monday, Hillary Clinton spooked biotech investors with a tweet promising to crack down on high drug prices. Shares plummeted. On Tuesday, she'll publicly unveil her pricing proposals in an Iowa speech, but until then, her campaign has offered some quick hints.
New court documents in the first trial over claims that Johnson & Johnson promoted its blockbuster painkiller, Tylenol, without disclosing potentially dangerous side effects show that J&J's McNeil Consumer Healthcare unit planned to lobby government officials to prevent the FDA from implementing safety restrictions, ProPublica reports.
India's Pune-based Serum Institute is seeking in-country fast-track approval for a biologic drug candidate to treat all four strains of dengue, the Times of India reported, with the news coming amid speculation over an equity offering by the company and a massive virus outbreak in India.
The only inhaler that administers a slow-moving mist to help respiratory patients inhale the medication is now FDA-approved for the long-term maintenance treatment of asthma, in addition to its previous indication to treat COPD.