- CRISPR Patent Outcome Won’t Slow Innovation (technologyreview.com)
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…
- Report: London Drugs could be first to market with medical marijuana (tricitynews.com)
A B.C. (British Columbia)-based pharmacy chain is itching to be the first in Canada to sell medical marijuana...London Drugs vice-president John Tse says that the pharmacy has already begun training to pharmacists to dispense marijuana as soon as regulations are in place. The federal government is expected to introduce legislation on both medical and recreational marijuana in the spring...London Drugs is only interested in the medical side – foresees a longer wait time than that before it comes to pharmacy shelves...After the legislation comes out there’s still the regulation…. and then there’s provincial governments and each of our colleges of pharmacists need to write regulations to operationalize it...We’ll be as fast as the laws allow… but it could happen overnight, we’re that ready…London Drugs will purchase marijuana only from federally licensed cannibis producers and that the pharmacy chain will only purchase if conditions are right...It’s not overly difficult to grow but what are the growing conditions like? Is there mold or pesticides… chemical compounds can be varied by different strains...They’ve already begun discussions with pot producers to lay the groundwork of setting up a supply chain...
- Following EpiPen controversy, federal watchdog to review Medicaid rebates (statnews.com)
A government watchdog agency is conducting three new reviews of the Medicaid Drug Rebate Program to determine the extent to which drug companies are properly paying required givebacks to the health care program...Under the Medicaid Drug Rebate Program, companies must accurately report — and pay — a rebate on drugs paid for by the agency...The ruckus erupted because Mylan reported EpiPen as a generic product for nearly a decade. This is an important distinction, because classifications are used to determine the size of rebates...are lower for generics — 13 percent versus 23 percent for a brand-name product...The more we learn about the misclassifications, the more we know this program is in dire need of proper oversight...It’s unclear whether CMS took any action between 2009 and now to get the EpiPen classification back on track after being told about the misclassification...
- Pharmacy Week in Review: December 9, 2016 (pharmacytimes.com)
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.
- Naloxone now available without a prescription at all CVS Pharmacy locations in Nevada (drugstorenews.com)
Naloxone is now available without a prescription at all CVS Pharmacy locations in Nevada...(CVS) stated it established a standing order with physicians in the Sliver State that allows CVS Pharmacy to expand access to the medication across the state...Naloxone is a safe and effective antidote to opioid overdoses and by expanding access to this medication in our Nevada pharmacies by the use of a physician's standing order for patients without a prescription…We are dedicated to helping the communities we serve address and prevent drug abuse and we are expanding access to naloxone to give more people a chance to get the help they need for recovery...CVS Health now dispenses naloxone in 37 states.
- ‘Bribes,’ ‘kickbacks,’ and ‘fantastic’ nights get ex-Insys CEO, execs indicted for conspiracy (fiercepharma.com)
Prosecutors have worked their way to the top of Insys Therapeutics. After arresting a series of lower-level workers, the Justice Department...hauled in former CEO Michael Babich…Federal authorities alleged that Babich and five other former Insys executives and managers “led a nationwide conspiracy” to bribe doctors to boost scripts for the company’s powerful and addictive painkiller Subsys...indictment...detailed a scheme that Babich and the others allegedly set up with 10 healthcare practitioners in Alabama, Michigan, Texas, Arkansas and elsewhere. The Insys execs pushed sales staff to offer hundreds of thousands of dollars in “bribes and kickbacks” to doctors to increase their Subsys scripts...According to the DOJ, Babich faces charges of conspiracy to commit racketeering, conspiracy to commit wire and mail fraud and conspiracy to violate the Anti-Kickback Law...
- This Week in Managed Care: December 9, 2016 (ajmc.com)
Sara Belanger, with The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network.
- U.S. Files First Charges in Generic Drug Price-Fixing Probe (bloomberg.com)Two former pharma execs first to be charged in generic price-fixing probe (statnews.com)
The Justice Department accused two executives of colluding with other generic pharmaceutical companies to fix prices, the first criminal charges stemming from a sweeping two-year investigation...Jeffrey Glazer, a former chief executive officer of Heritage Pharmaceuticals Inc., and Jason Malek, an ex-president...Each were charged in a criminal information with two counts of conspiring with other drug makers to fix the prices of an antibiotic and a drug used to treat diabetes (doxycycline and glyburide) . An information is often used as part of a plea agreement with prosecutors...Glazer and Malek accomplished this brazen theft by creating at least five dummy corporations, which they used to siphon off Heritage’s profits through numerous racketeering schemes," Heritage alleges. "Through one particularly audacious scheme...secretly arranged deeply discounted sales of Heritage products to their dummy corporations or through complicit third parties willing to act as straw buyers in return for bribes...Glazer and Malek then illicitly pocketed the profit that resulted when Heritage customers paid the market price for the drugs...The U.S. antitrust investigation spans more than a dozen companies and about two dozen drugs...
- Supreme Court urged to weigh in on six-month biosimilar delays (fiercepharma.com)
Novartis’ Sandoz unit has been marketing Zarxio, its biosimilar version of Amgen’s blockbuster drug Neupogen, for more than a year, but the drug is still tangled in a patent fight that boils down to one central question: Should biosimilar makers have to give six months' notice to the original drugmaker after they receive FDA approval for their copycat version? The answer will affect not only Novartis and Amgen, but any company seeking to make a biosimilar product…The U.S. Solicitor General...asked the Supreme Court to interpret the 2009 law that originally laid out the proper procedure for seeking FDA approval for biosimilar drugs.
- ISMP Names Top Medication Safety Issues of 2016 (pharmacytimes.com)
It’s crucial for pharmacists to be aware of medications associated with high risk for error and harm to patients, and to look for best ways to implement practices for improving safety and patient care...The Institute for Safe Medication Practices...Compiled data gathered from hospital medication error reports, risk assessments, consumer reports, and FDA collaboration...to name the top medication classes involved in adverse events...the top 5 high-alert medication classes based on data from 2016. Opioids, antithrombotics, and insulins topped the list, followed by antipsychotics and antibiotics...data pegged wrong dosage as the top reason for adverse events in most cases, except in the use of antibiotics, for which wrong drug was the top reason...