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Clinical trial results showed Olumiant plus conventional disease-modifying antirheumatic drugs were more effective than conventional treatments alone for severe RA. Read More
A class action lawsuit claims that Beijing-based Sinovac Biotech misled shareholders and bribed regulators at the China Food and Drug Administration to expedite its drug and clinical trial applications. Read More
New guidance from the UK’s National Institute of Health and Care Excellence links the cost-effectiveness of different bisphosphonate medications for osteoporosis with a patient’s 10-year risk of bone fractures. Read More
New Hampshire has joined the long list of states to take legal action against Purdue Pharma, maker of OxyContin (oxycodone), the company’s extended-release prescription opioid painkiller. Read More
A class action lawsuit claims that Beijing-based Sinovac Biotech misled shareholders and bribed regulators at the China Food and Drug Administration to expedite its drug and clinical trial applications. Read More
Biologics sponsors will only need to report minor postapproval manufacturing changes on an annual basis, said the FDA in a new draft guidance. Read More
Hedge fund investors are suing generics manufacturer Teva for not being forthcoming about a federal price-fixing investigation — saying the company’s false statements before the eventual reveal of a subpoena resulted in losses of billions in shareholder value. Read More
Unable to resolve persistent manufacturing problems, New Jersey-based drugmaker Pacira Pharmaceuticals is ending production of its DepoCyt chemotherapy drug and closing the California plant where it is made. Read More
The FDA is planning to modernize its recruitment and hiring practices to fill the several hundred vacancies plaguing the agency and attract more scientific talent. Read More