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The British healthcare cost evaluation agency has recommended coverage of Astellas Pharma’s prostate cancer drug Xtandi and Bristol-Myers Squibb’s melanoma treatment Yervoy, noting that the therapies provide sufficient gains in overall survival of patients who were treated for the cancers. Read More
Canadian trade officials are pushing back against Eli Lilly’s $500 million damages claim against the government in an international trade dispute, claiming the brand manufacturer demonstrates a fundamental lack of understanding for Canada’s patent laws and treaty obligations. Read More
A federal court has granted Mylan’s request for a temporary restraining order to halt all sales of competitor Apotex’s generic version of Paxil CR, the latest step in Mylan’s claim to generic exclusivity on GlaxoSmithKline’s blockbuster antidepressant. Read More
Brand manufacturers who use risk evaluation and mitigation strategies (REMS) to delay generic competition by denying product samples to would-be ANDA filers are costing pharmaceutical payers billions of dollars each year, according to a new study commissioned by GPhA. Read More
The FDA released its fourth warning letter in two days against a compounding pharmacy, this time chiding a large compounder for a mixture of quality violations at its four facilities. Read More
The FDA is set to release a slew of product-specific guidances to help generic manufacturers demonstrate the bioequivalence between their proposed generic and the reference product. Read More
HHS has issued a new variation of its recently invalidated rule requiring drugmakers to offer discounts on orphan drugs sold to hospitals that serve the poor when the products are meant for non-rare conditions. Read More
Indian regulators are seeking information from six manufacturers of generic cancer drugs in preparation for setting price caps on the products, a move that one industry observer says was expected. Read More
The FDA cited a trio of compounders for a wide swath of quality violations, igniting renewed criticism that the agency is “unjustified” in using a new law to enforce old violations. Read More
After initially rejecting FDA’s authority, a Texas compounding pharmacy acceded to the agency’s request to cease production and recall all of its sterile products due to quality concerns. Read More