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Manufacturers of new biologics could receive up to eight years of exclusivity in twelve counties under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Obama inked with 11 other countries back in October, were publicly released Nov. 6. Read More
The biopharmaceutical industry isn’t hiding its displeasure with a decision from the Centers for Medicare & Medicaid Services to treat all biosimilars based on the originator product as identical for billing and reimbursement purposes. Read More
President Barack Obama signed off on a budget bill Nov. 2 that will require generics makers to pay inflation-based rebates if prices rise too quickly, based on the inflation-adjusted baseline average manufacturer price. Read More
Democratic presidential candidate Hillary Clinton joined the growing chorus of lawmakers and others outraged over Turing Pharmaceuticals’ price hike on Daraprim, pressing the FDA and FTC on Oct. 19 to broaden access to less expensive drugs. Read More
In an effort to ease a major generics approval backlog, the FDA is advising generic drugmakers and regulators on how best to streamline ANDAs of varying strengths into a single application. Read More
Swiss-based Helsinn Healthcare has settled patent litigation with Dr. Reddy’s Laboratories, allowing the Indian genericsmaker to sell a generic version of the anti-nausea injection Aloxi starting in 2018. Read More
The FDA is requiring Concordia Pharmaceuticals to conduct drug interaction studies with its potassium-lowering drug Kayexalate, after the agency’s review of just-approved Veltassa showed that the drug bound to about half of the oral medications tested. Read More
Sun Pharmaceuticals has quietly dropped an appeal of a lawsuit challenging the FDA’s authority to revoke the tentative approval of two generics made by its Ranbaxy subsidiary. Read More