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Japanese regulators have approved Otsuka Pharmaceutical’s Samsca to treat autosomal dominant polycystic kidney disease, or ADPKD — an expanded indication that the FDA rejected last year. 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
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is proposing three rules changes to reduce the amount of information included in physician advertising. Read More
The Arkansas Supreme Court reversed a $1.2 billion verdict against Johnson & Johnson concerning its marketing practices for the antipsychotic Risperdal, giving the pharma giant another crucial legal victory. Read More
The exodus of U.S. drugmakers to Ireland continues as Horizon Pharma Wednesday bought Vidara Therapeutics and pledged to move the combined company to Ireland to take advantage of the country’s low corporate tax rate. Read More
Japanese drugmakers Astellas Pharma and Daiichi Sankyo are planning to form the first-ever large-scale compound library, through which they plan to share 400,000 compounds. Read More
PhRMA has asked the Office of the U.S. Trade Representative to put the EU on notice for its plan to publish clinical trial data that currently is treated confidentially. Read More
The UK’s Medicines and Healthcare products Regulatory Agency recorded a nearly 20 percent increase in complaints about drug advertisements in 2013 — the majority coming from companies complaining about their competitors. Read More
Shire Pharmaceuticals is recalling three lots of Gaucher disease drug Vpriv after finding stainless steel and barium sulfate particles in a small number of vials. Read More
The UK’s healthcare costs watchdog has once more rejected Celgene’s blockbuster cancer drug Revlimid for a new indication. This time, the National Institute for Health and Care Excellence (NICE) says the drug failed to show clear efficacy and cost-effectiveness as a second-line treatment for multiple myeloma. Read More