We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
EU drug regulators Friday recommended Endocyte’s vintafolide for approval as an ovarian cancer treatment, providing the drugmaker with a major milestone in its attempt to market its first product. Read More
An EU panel of drug reviewers Friday urged approval of Boehringer Ingelheim and Eli Lilly’s diabetes drug empagliflozin, lauding the candidate just two weeks after the FDA turned it down. Read More
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phases of clinical trials to establish the products are sufficiently stable for the period required by the study, a draft guidance by India’s Central Drugs Standard Control Organization advises.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