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The state of California has filed a civil suit against units of drugmakers Teva and Allergan, for allegedly obstructing generic competition to Lidoderm transdermal patches...The suit...alleges a "pay-for-delay" deal between the companies and Endo Pharmaceuticals, which already had its Lidoderm product on the market and had made $825 million off of it in 2011...Allergan signed an agreement with Endo Pharmaceuticals, promising that the company would not face any generic competition for Lidoderm from units of Allergan from May 2012 through September 2013 and in turn that Allergan would not face any competition from Endo until May 2014...anticompetitive agreements...lead consumers, payors and the State to pay, directly or indirectly, monopoly prices for Lidoderm medications and deny them the lower prices that generic competition provides...  

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Teva is eager to start moving in the right direction after a particularly rocky 2016. Problem is, it’s still paying for pay-for-delay decisions made by its products’ previous owners...the generics giant last week agreed to a $225 million settlement with a group that picked up Bayer antibiotic Cipro...Also...the FTC refiled charges against Watson and former parent Actavis, claiming they illegally blocked a lower-cost generic version of Endo’s Lidoderm after entering into a pay-for-delay pact with Endo...All things considered, “the cumulative sum of fines is getting noticeable”—especially for “cash-strapped” Teva...The Israeli company earlier this month walked down its previously outlined 2017 guidance by more than $1 billion after new 2016 launches didn’t hit their marks. And some analysts think Teva’s new revenue forecast—a range of $23.8 billion to $24.5 billion--may still be too high...

Donald Trump has a chance to rally his core supporters as well as left-wing Democrats, wrapping himself in the populist flag to take on the politically powerful drug industry...He is vowing to keep a campaign pledge to push legislation allowing Medicare to negotiate prescription drug prices, a practice currently prohibited by law. Proponents say this would reduce drug prices and Medicare costs for the federal government. Medicare pays for about 29 percent of prescription drugs in the U.S. and would have considerable leverage...If Trump goes all out on this issue, it will be near impossible for….Democrats to side with the industry over a Republican president whom they accuse of representing the interests of the rich.

Pharma companies sat out the Super Bowl this year after last year’s intense scrutiny—and criticism—of three ads that aired. But their DTC devices did make one appearance...The Twentieth Century Fox movie trailer for "A Cure for Wellness" parodied a pharma ad, mashing up formulaic imagery from happy couples on the beach to a Tai Chi class in the park. But as the 30-second ad played out, it became apparent that the familiar litany of voiceover side effects was part of a much more sinister twist. (The horror movie is about a man who goes to a "wellness spa" in the Swiss Alps in search of his boss and finds that it is anything but.)...While the past couple of years have seen at least one pharma ad in the Super Bowl, increasing pressure from politicians and consumers about pricing issues may have companies laying low. That pressure, along with last year’s backlash, was likely enough to convince pharma to stay home this year, although the $5 million per 30-second spot price tag may have also been a factor.

Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

As Sanofi and Regeneron scramble to keep their PCSK9 cholesterol drug Praluent on the market, Amgen’s rival drug Repatha already appears to be chipping away at its market share...For the week of January 20, Repatha’s prescription total hit 3,231, ahead of Praluent’s 2,859...The Praluent partners are of course embroiled in a patent fight against Amgen, which claims that Sanofi and Regeneron knowingly stepped on its patents in developing Praluent. A district court jury sided with Amgen, and the judge in the case granted Amgen’s request for an injunction that would push Praluent off the market...Sanofi and Regeneron hope that the threat is short-lived; they’re trying to persuade the U.S. Circuit Court of Appeals in Washington, D.C., to put off the injunction while their patent appeal is heard. In their request for a stay, the two companies argued that they have a good chance of winning their appeal and that pulling Praluent in the meantime would do great damage to Regeneron.

An Israeli government committee gave an initial nod...for the export of medical marijuana in what could be a windfall...Israel is widely regarded as one of the world leaders in medical marijuana research, even though the local market is small. Only 23,000 people have Health Ministry permits to purchase medical cannabis from nine licensed suppliers, creating a market of $15 million to $20 million at most...Saul Kaye, CEO of iCAN, a private cannabis research hub in Israel, said there are about 50 Israeli medical marijuana companies active in many aspects of the industry, from agriculture to delivery devices, such as inhalers...Last month, Israel moved toward decriminalizing small-scale personal use of marijuana and authorities are supportive of research...

• After an unusually slow year for new drug approvals—the FDA greenlighted just 22 meds in 2016—it remains to be seen whether drugmakers can do much better in 2017. One thing’s for sure, though: No matter what total the industry tallies up this year, the crop will bring some would-be blockbusters and market disrupters.

  At the top of the list...is Ocrevus (ocrelizumab), the Roche multiple sclerosis drug that’s promising to shake things up in more ways than one...

  Sanofi and Regeneron hot-shot Dupixent (dupilumab) could make a big splash in severe atopic dermatitis, assuming payers don’t get in the companies’ way.

  Ditto for Biogen's Spinraza, which in December became the first FDA-approved product to treat spinal muscular atrophy—but whose high sticker could raise eyebrows at a time when U.S. President Donald Trump is threatening pricing action.

  Tesaro and Neurocrine are looking for their first-ever FDA approvals, in breast cancer pill niraparib and tardive dyskinesia therapy Ingrezza, respectively.

  ...Kite Pharma is aiming to get the first-ever CAR-T cancer drug to market, with a candidate, KTE-C19, that the oncology community will be watching closely as the next big thing in immunotherapies.

  Novartis’ ribociclib...which aims to challenge Pfizer’s Ibrance in the CDK 4/6 breast cancer space.

  ...semaglutide, Novo Nordisk's weekly GLP-1 drug, a would-be successor to the company's blockbuster Victoza…

It’s an edict that comes out every autumn in many hospitals: If health care workers don’t get a flu shot, they will face consequences. Some make vaccinations a condition of employment. Others require unvaccinated staff to wear surgical masks near patients for weeks during flu season...But a new study is calling into question the scientific evidence underpinning these increasingly common hospital policies — and could fuel challenges to the contentious orders...The study...concludes that the research used to justify mandatory flu shots for health sector workers is flawed, and that the policies cannot plausibly produce the benefits that had widely been assumed...the bottom line of our paper is to say there is no valid scientific evidence, even now, underpinning enforced health care worker immunizations...trying to mandate that health care workers take the flu vaccine is well-intentioned, but is taking away resources and the focus on what our main priority needs to be, which is getting a better influenza vaccine...