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The decision has major implications for the pharmaceutical industry because it will dictate how long brand-name makers of biologic drugs can keep near-copies, called biosimilars, off the market. Even the six months at issue in the case can mean hundreds of millions of dollars in sales...Health insurers expect biosimilars to be cheaper than original brands, like generics, saving consumers billions of dollars each year...Novartis said in a statement that the ruling "will help expedite patient access to life-enhancing treatments."...Amgen spokeswoman Kelley Davenport said the company was disappointed but "will continue to seek to enforce our intellectual property against those parties that infringe upon our rights."...The companies disagreed on how to apply that law's requirement that a biosimilar drug maker give the brand-name manufacturer 180 days notice before launching its copycat version...In July 2015, the appeals court ruled that the 180-day notice must be given after FDA approval, a ruling the Supreme Court reversed...Writing for the court, Justice Clarence Thomas said that the decision was not based on policy arguments, but rather, the "plain language" of the biosimilar law itself...

The state of Ohio...sued five major drug manufacturers, accusing them of misrepresenting the risks of prescription opioid painkillers that have fueled a sky-rocketing drug addiction epidemic...The suit, filed by Attorney General Mike DeWine, comes as a growing number of state and local governments are suing drugmakers and distributors, seeking to hold them accountable for a deadly and costly opioid crisis...The five companies Ohio sued were Purdue Pharma LP, Johnson & Johnson's Janssen Pharmaceuticals Inc unit, a unit of Endo International Plc, Teva Pharmaceutical Industries Ltd's Cephalon unit and Allergan Plc...The suit...seeks to halt deceptive practices, a declaration the companies acted illegally and unspecified damages to the state and consumers...

He has a private jet, a pedigree of winning billion-dollar settlements, and the (sometimes grudging) respect of his adversaries. Now, he wants to become pharma’s latest headache...Class-action attorney Steve Berman is coming after a drug industry he says is "gouging" the American consumer. And his suits have the potential to crack the lid on the black box of drug pricing, shedding light on a secretive process that has sparked an escalating blame game between drug makers and the many middlemen in the US health care system...Berman sees the drug pricing system as a Rube Goldberg machine for extracting money from patients: Pharma sets a high price for a given medication, and then promises a big, undisclosed rebate to the pharmacy benefit managers who control which drugs get covered by insurers. As prices go up, so too do the secret rebates. Berman’s conclusion: The big guys get richer, and the patients pay the price...So he’s suing...

CRISPR that favored the Broad Institute…Jennifer Doudna of the University of California...and Emmanuelle Charpentier of the University of Vienna were first to apply for patent in 2012 after discovering how the primitive bacterial system...could be used to edit genomes in simple pieces of DNA…A team at the Broad Institute led by...Feng Zhang applied for a separate patent six months later, but paid for a fast-track review process, which landed them the first CRISPR patent in 2014. The Broad's patents were for showing that the CRISPR system could be used to edit more advanced, eukaryotic cells, including animal and human cells...In its...decision, an appeals board...determined that the Broad's CRISPR patents "did not interfere" with those awarded to the UC because they were sufficiently different, allowing them to stand...In the appeal...UC is seeking a reversal of the decision, which ended before actually determining who invented the use of CRISPR in eukaryotic cells. Major commercial applications of CRISPR are expected to be in eukaryotic cells...geneticist George Church said he expects the disputes will end in cross-licensing...I'm not that interested in the details of who pays who what. We're all going to do very well, including the patients. That was evident from the very beginning…

The National Association of Chain Drug Stores this week shared with the House Ways and Means Committee the important role pharmacy plays in the nation’s healthcare system in an effort to encourage passage of legislation giving pharmacists provider status under Medicare Part B...The Pharmacy and Medically Underserved Areas Enhancement Act has been introduced in both the House and Senate, and NACDS’ statement looked to drum up support by outlining the work pharmacists do for patients, particularly in medically underserved areas..."We urge you to increase access to much-needed services for underserved Medicare beneficiaries by supporting H.R. 592/S. 109, the Pharmacy and Medically Underserved Areas Enhancement Act, which will allow Medicare Part B to utilize pharmacists to their full capability by providing those underserved beneficiaries with services, subject to state scope of practice laws, not currently reaching them," NACDS said...

A jury...convicted Binh "Ben" Chung, a Las Vegas doctor accused of drugging and raping patients, of sexual assault and kidnapping charges...Prosecutors claimed Chung, 43, had videotaped sex acts with three unconscious women and a teenage girl who also had been drugged...Chung told jurors that he had an ongoing consensual affair with one of the women, and that she was awake in the videos jurors watched, playing a role in his "Sleeping Beauty" fantasy...He said he had somnophilia, a fetish for having sex with someone who is unconscious. He also testified that the teenager prosecutors said he molested in another video was actually the woman with whom he claimed he had an affair...Jurors deliberated the case for more than eight hours, including roughly four hours Friday, before convicting Chung of 11 of the 14 counts, including use of a minor in the production of pornography, kidnapping, battery with intent to commit sexual assault, and four counts of sexual assault...

GlaxoSmithKline must pay $3 million to a woman who sued the drug company over the death of her husband, a lawyer who committed suicide after taking a generic version of the antidepressant Paxil…The jury's award followed a trial in federal court...over the death of Stewart Dolin...who jumped in front of an oncoming commuter train in 2010 after taking a generic equivalent of GSK's Paxil...GSK maintains that because it did not manufacture or market the medicine ingested by Mr. Dolin, it should not be liable," GSK said. "Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit...Dolin's lawyers had requested $39 million. They alleged GSK had evidence paroxetine increases the risk of suicide by older users by as much as 670 percent, yet failed to include that on the warning label...

Kaléo Pharma's price hikes on the lifesaving overdose med Evzio haven’t only angered lawmakers. A leading pharmacy benefit manager, Express Scripts, is going after the tiny drugmaker for unpaid rebates triggered by the exponential price increases...Express Scripts sued...claiming Kaléo owes it $14.5 million in unpaid rebates. The company’s coverage contract with Kaléo includes two types of rebates, a "formulary rebate" designed to secure coverage and a "price protection rebate" to limit exposure to dramatic price hikes….Kaléo faced Congressional heat earlier this year, when more than 30 senators wrote to the drugmaker seeking information about the drastic price hikes. According to the lawsuit, Kaléo took Evzio’s price from $718 per unit in September 2014 to $4,687 by November 2015...The senators wrote that they were "deeply concerned" about the price hikes that came amid an opioid-abuse epidemic...

Buried deep in its first quarter earnings filing with the Securities and Exchange Commission, Eli Lilly & Co. disclosed it is being investigated for insulin pricing practices by the attorneys general of New Mexico and Washington. The Washington AG is looking at Lilly's relationship with pharmacy benefit managers...Insulin competitor Novo Nordisk has also said it is under investigation by the two AGs for pricing and trade practices for its insulin products, going back as far as 2005...Things are getting complicated at the moment for the big three in insulin. As well as the investigations by the attorneys general, last month, Sanofi, Novo Nordisk and Lilly, along with the pharmacy benefit managers CVS, Express Scripts and UnitedHealth's OptumRx, were slapped with a complaint and demand for a jury trial from the Type 1 Diabetes Defense Foundation.

A North Carolina law firm is one of the primary drivers of a class action lawsuit that alleges that prescription dog and cat food is a marketing scheme devised by pet food companies to pump up their profits...At the heart of it, the world’s largest pet food manufacturers are requiring that certain pet foods be sold by prescription even though there is no legal requirement for that prescription…requiring a prescription from a veterinarian misleads consumers, providing cover that enables pet food companies to charge excessive prices...Prescription pet food contains no drug or other ingredient not also common in non-prescription pet food...Defendants in the civil lawsuit...include the companies behind four brands of prescription pet foods that dominate the market: Hill’s Prescription Diet, Purina Pro Plan Veterinary Diets, Royal Canin Veterinary Diet and Iams Veterinary Formula...the lawsuit argues, the companies “control the sale of prescription pet food from manufacture to veterinarian to retail, which has allowed their deception and price-fixing conspiracy to be implemented and perpetuated with minimal risk of detection or defection.”...prescription pet foods “have not been evaluated by the FDA for safety, efficacy, or nutritional adequacy.”...Prescription pet food accounts for about 5 percent of the $24 billion in pet food sold in the U.S. each year...or more than $1 billion a year...Pet food...“is the only food on the planet that’s allowed to make a health claim” by the FDA...