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The FDA has granted a breakthrough therapy designation to Pfizer’s investigational bivalent rLP2086 meningococcal B vaccine, the drug giant said Thursday. Read More
House Democrats are asking Gilead Sciences to justify the cost of its pricy hepatitis C pill Sovaldi, saying many of their constituents affected by the disease may not be able to afford it. Read More
Efforts by generic drugmakers to initiate patent litigation early by sending premature Paragraph IV certification notices to innovators are prompting the FDA to crack down on the practice, though it’s not yet clear what actions the agency intends to take. Read More
Novo Nordisk has aced the first Phase III trial of its hemophilia candidate, giving the drugmaker a needed boost in a tight race with two other competitors vying to be first to market with a new therapy targeting a disease the FDA says demands industry attention. Read More
The European Medicines Agency (EMA) has launched a new pilot program intended to speed new therapies to patients via a process that authorizes products for use by targeted populations in stages. Read More
Manufacturers of stem cell and cell-based products (SCCPs) should perform stability tests during early phases of clinical trials to establish the products are sufficiently stable for the period required by the study, a draft guidance by India’s Central Drugs Standard Control Organization advises. Read More
Drugmakers seeking marketing authorization in Australia will soon be able to make complete submissions in electronic format only, allowing for cost savings and potentially swifter reviews. Read More
The surge of opposition to Zogenix’s controversial painkiller Zohydro ER shows no signs of abating, with state officials joining congressional critics in calling for a reversal of the single-entity hydrocodone product’s approval. Read More
The FDA has rejected Avedro’s NDA for its riboflavin ophthalmic solution/KXL System, saying additional data supporting the drug-device combo’s efficacy and safety are required for approval. Read More
The FDA has extended by three months the PDUFA-review date for Biogen Idec’s Plegridy, a drug candidate proposed to treat relapsing multiple sclerosis (MS), the drugmaker said Tuesday. Read More