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Merck & Co said it agreed to enter into a settlement and license agreement with Bristol-Myers Squibb Co and Ono Pharmaceutical Co Ltd to resolve all global patent-infringement litigation related to its cancer drug, Keytruda...Merck will make an initial payment of $625 million to Bristol and Japan's Ono. The company will also pay a 6.5 percent royalty rate on Keytruda sales from January 2017 to December 2023, and a 2.5 percent rate for the subsequent three years...Bristol will get 75 percent of the royalties and Ono will get the rest.

The U.S. Supreme Court...agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them...an appeal by Novartis AG of a 2015 federal appeals court decision that prevented the...company from selling its biosimilar version of...Amgen Inc's $1-billion-a-year Neupogen until six months after the Food and Drug Administration approved it. The case could determine how quickly patients have access to biosimilar medicines at potentially cheaper prices...The dispute arose when Amgen sued Sandoz...alleging patent infringement and violations of the law governing biosimilars. The companies disagreed on how to apply the law's requirement that a biosimilar drug maker give the brand-name manufacturer 180 days notice before launching its copycat version...The justices...also agreed to resolve Amgen's appeal in the same case over whether biosimilar makers must give brand-name manufacturers a copy of their application to make a copycat drug after it is submitted to the FDA.

A drug distributor owned by Cardinal Health Inc has agreed to pay $10 million to resolve claims it failed to alert the U.S. Drug Enforcement Administration to suspiciously large orders of...painkillers by New York-area pharmacies...The settlement with Kinray LLC, a New York City-based pharmaceutical distributor, disclosed in papers filed...in federal court in Manhattan...Kinray shipped the drugs to more than 20 New York pharmacy locations in amounts that were many times greater than the distributor's average sales of controlled substances to all of its customers...Kinray ignored numerous "red flags" and did not report any suspicious orders to the DEA...latest agreement stemmed from a 2012 settlement with the DEA in which its facility in Lakeland, Florida, was suspended from selling painkillers and other drugs for two years...The 2012 deal only resolved administrative aspects of the case, not potential fines Cardinal Health faced in Florida or elsewhere...(Cardinal Health)...has set aside $44 million to cover those potential liabilities.

The legal battle over who invented the powerful gene-editing tool isn’t likely to dim hopes for better crops and powerful new medical treatments...a panel of judges at the Patent and Trademark Office...heard arguments as to who should own the rights to the century’s biggest biotechnology invention to date, a precise gene-editing system called CRISPR-Cas9 that has the potential to treat serious human genetic disorders and create designer crops that resist drought and pathogens...Embroiled in the dispute are the Broad Institute of MIT and Harvard...and the University of California...Groups at the two universities are fighting for ownership of CRISPR gene editing in eukaryotic cells (those of humans, plants, and animals), which represents the most lucrative uses of the technology...At stake are billions of dollars tied up in numerous commercial agreements with biomedical and agricultural companies. The outcome of the so-called patent interference could render some of those contracts invalid...But the patent judges’ decision...is not likely to put any CRISPR companies out of business or even slow the lightning pace of research and development in commercial laboratories…

A former Lincoln County commissioner was sentenced Friday to one-to-four years in prison for defrauding insurance companies...Adam Katschke...previously pleaded guilty to felony insurance and Medicaid fraud in the case...Katschke, the head pharmacist and owner of Meadow Valley Pharmacy in Caliente, defrauded insurance companies...by billing for large amounts of pharmaceutical prescriptions that were rarely provided as billed to the patients or prescribed by a physician...The sentencing...ordered Katschke to pay $1.5 million in restitution...The defendant stole a million and a half dollars from taxpayers through Medicaid, a program designed to provide care for those in need, not line the pockets of fraudsters…

A federal judge...ruled that Mumia Abu-Jamal should be provided new medications by the state to treat his hepatitis C infection...U.S. District Judge...ordered that Abu-Jamal, who is serving life in prison for the 1981 killing of Philadelphia Police Officer Daniel Faulkner, must be seen by a doctor within 14 days to determine if there is a medical reason he should not get the expensive drugs...If...is medically cleared, the state must provide him with recently developed direct-acting antiviral medication, also known as DDA (DAA, Direct-Acting Antivirals)... Department of Corrections...has argued in court filings that Abu-Jamal has not met the criteria for treatment...The state has about 7,000 inmates with hepatitis C, and treating them - at a cost of $84,000 to $90,000 per person - would cost $600 million... DOC will no doubt appeal this ruling...

Mylan launched its 1st generic EpiPen emergency allergy treatment 1 day after attorney generals from 20 states filed a civil complaint against Mylan, Teva Pharmaceuticals, and 4 other generic drug makers. The complaint alleges that the companies co-conspired in informal gatherings, calls and text messages to fix the price for glyburide...and doxycycline hyclate...The generic EpiPen will sell for $300 per two-pack, which is a 50% discount compared to the price of the brand name device...Mylan CEO Heather Bresch said in a statement...“Unfortunately, families will continue to face sticker shock for medications and may be forced to make difficult choices until the pharmaceutical pricing system is reformed to address the increasing shift of costs directly to consumers.”...The 4 other companies targeted by the complaint are Heritage Pharmaceuticals, Aurobindo Pharma, Citron Pharma and Mayne Pharma...

A Henderson man has pleaded guilty to fraudulently distributing more than $100 million worth of prescription drugs that came from the black market...Randy Crowell, 56, entered the plea last week in federal court...on one count of conspiracy to commit health care fraud. The case stretches from Utah, where Crowell’s wholesale distribution company was based, to street corners of Manhattan and the Bronx, where people sold their prescriptions to low-level collectors for $40 a bottle or more...Crowell gained about $16 million in profits…Crowell ran the scheme...as the operator and owner of a licensed wholesale distributor of prescription medications...During that time, he and co-conspirators funneled prescription medications from the black market to pharmacies nationwide...He exposed people with life-threatening illnesses to medicines they had no idea had been diverted from the normal stream of commerce, all the while defrauding health care companies and government benefit programs…

Community pharmacist sentenced for dispensing the wrong medicine spoke of ‘cramped working’ conditions and problem of similar packaging...An “overworked” community pharmacist, who pleaded guilty to dispensing the wrong drug to a patient who later died, has been sentenced to four months imprisonment suspended for two years...Martin White of Belfast Road, Muckamore in Northern Ireland, mistakenly dispensed propranolol instead of prednisolone, having told investigators that the two packages were “side by side on the shelf and have similar branding”...White admitted at an earlier hearing...to an offence under section 64 of the Medicines Act 1968, that he had “supplied a medicinal product in pursuance of a prescription given by a practitioner, which was not of the nature or quality specified”, to the prejudice of Ethna Walsh...(her) death has had a devastating effect on her family and said the damage and injury caused by the pharmacist could not be higher...The pharmacist’s degree of culpability was the result of “poor professional performance, but not professional misconduct”...adding that there was “no evidence of intentional negligence”...given the cumulated effect of White’s guilty plea, previous good character, loss of reputation and career and permanent financial loss, (Judge Gordon Kerr) said he did not feel an immediate custodial sentence was necessary...

Merck & Co...was awarded $2.54 billion in royalties by a federal jury in a patent lawsuit against Gilead Sciences Inc over Gilead's blockbuster hepatitis C drugs Sovaldi and Harvoni...The jury in Delaware reached the verdict following a nearly two-week trial, finding that a patent acquired by Merck in 2014 on hepatitis C treatments was valid...Harvoni and Sovaldi have drawn attention for their breakthrough success in curing hepatitis C in more than 90 percent of patients, and for their high cost...Harvoni's list price is $1,125 per pill and $94,500 for a 12-week regimen. Foster City, California-based Gilead, one of the world's largest biotechnology companies, made nearly $20 billion on the two drugs in 2015.