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Subsidiaries of generics maker Hetero Drugs can move forward with generic versions of kidney drug PhosLo despite an ongoing lawsuit brought by patent owner Roxane Laboratories. Read More
New Jersey-based Mutual Pharmaceutical and two other generic firms are suing brand manufacturer Reckitt Benckisser for breach of contract, alleging that RB reneged on a license agreement to provide generic supplies of its cold and flu medicine Mucinex for sale. Read More
Indian generics firm Dr. Reddy’s has filed the first patent challenge against Teva’s blockbuster multiple sclerosis drug Copaxone’s 40 mg, introducing a new chapter into the Israeli drugmaker’s efforts to protect its multibillion dollar product. Read More
A UK cost-effectiveness agency has recommended not covering Roche’s breast cancer drug Kadcyla because the treatment is too expensive, noting that a discount offered by the Swiss drugmaker wasn’t enough. Read More
Indian regulators have issued a uniform set of procedures that state drug authorities should follow when inspecting plants for good manufacturing practices and issuing certificates of pharmaceutical product (COPP) that clear drugs for export. Read More
The FDA has expanded its list of priority generics applications to include ANDAs filed under government purchasing programs and applications from filers who claim “extraordinary hardship,” such as catastrophic incidents or abrupt supply disruption. Read More
Drugmakers Hoffman-La Roche and Hyperion Therapeutics are taking part in Health Canada’s new orphan drugs pilot project to better understand how patient input may be gathered and incorporated into the drug submission review process. Read More
Pfizer will pay $35 million divided among 41 states and the District of Columbia to settle allegations it improperly marketed its immunosuppressant Rapamune for unapproved uses, a year after making a $490.9 million deal with the federal government for similar allegations. Read More
Generics manufacturers seeking product approvals in the European Union can opt to share the resulting application reviews with regulatory bodies outside the bloc under a pilot program designed to coordinate drug approvals across international borders. Read More
The FDA has approved The Medicines Company’s intravenous skin disease treatment Orbactiv, the third such product cleared this year under a pathway that provides manufacturers incentives to develop new antibiotics for serious or life-threatening infections. Read More
British regulators are seeking industry input to create a “white list” of prescription drugs that should be exempt from an EU requirement to verify the authenticity of products, as well as a “black list” of nonprescription drugs that must bear the verification. Read More
Cubist Pharmaceuticals recalled 101 lots of its antibiotic Cubicin because of a long-standing supplier issue that could have resulted in glass particles in vials. Read More