The U.S. government filed a lawsuit in Manhattan federal court yesterday against Swiss company Novartis AG (NVS). The U.S. is demanding up to $3.35 billion in damages and civil fines over alleged violations of the federal False Claims Act. The case alleges that Novartis filed improper reimbursement claims for Exjade, which is used to treat […]

There’s a growing refrain among those who pay for healthcare services that they want new products to deliver more value. When it comes to prescription drugs, this is usually interpreted to mean medicines that provide more benefit, at lower costs per increment of clinical advantage. Drugs that deliver more bang for the buck. But pharmaceutical […]

On his first day as chief executive of Ligand Pharmaceuticals in January 2007, John Higgins was shown into a conference room in the biotech firm’s 135,000-square-foot San Diego headquarters. Inside was a table so mammoth, Higgins recalls, “you could practically land a corporate jet on it.” The new CEO immediately instructed the head of facilities […]

In what may slow the growth of premiums for Americans purchasing coverage on public exchanges under the Affordable Care Act, a new report shows 2015 enrollees using fewer prescriptions than those who signed up for coverage in 2014. Express Scripts (ESRX), one of the nation’s largest managers of prescription drugs, said the number of new […]

SACRAMENTO, Calif., June 30, 2015 /PRNewswire/ — A new analysis and infographic released today estimate California’s exposure to high-priced Hepatitis C medications could range from hundreds of millions of dollars, even if only 5 percent of Californians infected with Hepatitis C receive treatment through state programs. The analysis, which looks at the costly impact of […]

June 30, 2015By Alex Keown and Riley McDermid, BioSpace.com Breaking News Staff BOSTON – Vertex Pharmaceuticals (VRTX) is anxiously waiting for regulatory approval of its newest cystic fibrosis medication Orkambi, a treatment which is widely expected to have a broad impact on the cystic fibrosis market – and a treatment widely expected to sharply boost […]

The Food and Drug Administration was sued by two advocacy groups seeking to force the faster disclosure of clinical trial data that helped Gilead Sciences Inc win approval for two blockbuster hepatitis C drugs. In their June 25 lawsuit, Yale University’s Global Health Justice Partnership and the Treatment Action Group, an AIDS non-profit, said doctors […]

New drugs from Novartis and Alexion won a green light from European regulators on Friday, delivering a boost to both drugmakers and offering new treatment options for cancer and rare diseases. Experts from the European Medicines Agency (EMA) said they had recommended approval of Novartis’s Farydak for multiple myeloma, an aggressive blood cancer, and Odomzo […]

This week saw the climax (or, for those who like to demonize the global pharmaceutical industry, perhaps the anti-climax) of a year-long saga linking an increased risk of melanoma with drugs such as sildenafil (better known as Viagra) used to treat erectile dysfunction. The story began in 2014 when a team of Boston scientists observed […]

TARRYTOWN, N.Y., June 26, 2015 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Bayer HealthCare’s Japanese subsidiary, Bayer Yakuhin, Ltd., received approval for EYLEA® (aflibercept) Injection by the Ministry of Health, Labour and Welfare (MHLW) in Japan for the treatment of patients with macular edema secondary to retinal vein occlusion (RVO). This new indication […]