It was attention-grabbing when California sued a handful of drugmakers, accusing them of lying about the safety of their high-powered painkillers and blaming them for an epidemic of prescription drug overdoses and a resurgence in heroin use. But from a legal standpoint, a California judge has ruled, there is not much there to stand on.
Hep C drugs like Gilead Sciences' Sovaldi and AbbVie's Viekira Pak can cure hepatitis C, preventing people from getting liver disease. But in some states like Illinois, a person on Medicaid can't get Sovaldi unless they already have advanced liver disease. Even then, other restrictions can block them from access to the pricey meds. This kind of rationing is to save money, not lives, and is discriminatory White House medical advisors have told the administration. Experts have urged a reluctant administration to lay down some consistent guidelines for Medicaid on use of the new drugs.
Bristol-Myers Squibb and Sanofi scored a victory in a False Claims Act marketing case over its blood-thinner, Plavix, as a federal judge in New Jersey tossed out some allegations from a former Sanofi sales rep that the company made misleading statements about the med to gain more Medicare and Medicare coverage.
Last quarter, Gilead reported a slowdown for its quick-launching hep C treatments--and that's a trend that's still ongoing, according to a pair of RBC Capital Markets analysts.
With approvals in the U.S and Europe expected soon, it looked like Takeda would have time to get its new multiple myeloma treatment into the market before patents fell off of blockbuster Velcade in 2022. But CEO Christophe Weber may need to plot a new strategy after a federal judge overturned a key patent, putting the Japanese drugmaker's drug vulnerable to generics 5 years early.
While data on the heart and stroke risks of testosterone enhancers have been mixed, the FDA has held firm on its position that "Low T" drugs should be used only for medical conditions not as a lifestyle drugs. Now the FDA says drugmakers need to provide new data on the heart and stroke risks of using them to boost testosterone in aging men. But, to save everybody a lot of time, effort and cost, it would be great if the drugmakers would do the clinical trial work together.
Eli Lilly has been making its fair share of courtroom appearances lately, battling claims over withdrawal symptoms linked to its blockbuster antidepressant in the U.S. and defending a patent for a lung cancer drug in Europe. In its latest legal saga, the drugmaker is going head-to-head with a woman who claims that Lilly stole her idea for a tool that helps patients' remember to take their meds.
Amgen is paying up to resolve claims that it broke the rules while marketing anemia drug Aranesp and anti-inflammatory blockbuster Enbrel. The company has settled with 48 states for $71 million, marking the latest state-level crackdown on alleged marketing violations in the pharma industry.
Merck & Co. has encountered a few roadblocks in recent years with its diabetes drug, Januvia as safety concerns took a bite out of sales. The company has worked hard to reverse this trend, and recently unveiled data on heart safety could do its part. But now Merck could be facing another threat, and not from a regulator or competing drugmaker--but a devicemaker.
Boehringer Ingelheim's COPD treatment, Spiolto Respimat, is up against a raft of competitors--especially in the E.U., where it recently won its first approvals. Now, though, it's touting new data from a quality of life study that it hopes will give it a leg up.