- Roche pulls out of ‘superbug’ antibiotic project (reuters.com)
Swiss drugmaker Roche Holding has dropped out of a high-profile project to develop an antibiotic for treating "superbug" infections…"Roche has decided to discontinue its involvement in the clinical development of the investigational antibiotic RG7929/POL7080 for the treatment of patients with severe Pseudomonas aeruginosa infections and will return the asset to Polyphor,"…Roche spokesman said that antimicrobial resistance remained a major threat to public health and Roche would continues to focus on this unmet medical need as part of its infectious disease research and development strategy.
- Norway mulls using heroin to prevent deadly overdoses (washingtonpost.com)
Bergen is the last stop on a global drug route that gives it one of the worst heroin problems in Europe…Now with a change in local government here and in the capital, Oslo, there is an appetite to use radical policies to curb the alarming number of Norwegians who die from heroin overdoses each year. Alongside traditional replacement therapies, such as methadone, the new left-wing local leaders want to use a medical form of injectable heroin [diamorphine] to treat the most at-risk users…The official goal is to wean them off the drug entirely, but even the most ardent supporters admit the most achievable target is to bring them within a safer environment, while helping to tackle the crime associated with heavy drug use…Norway has the worst heroin mortality rate in Western Europe...
- Ex-hospital CFO, physicians guilty in $580M kickback scheme (beckershospitalreview.com)Five Individuals, Including Two Doctors, Charged in Kickback Schemes Involving nearly $600 Million in Fraudulent Claims by Southern California Hospitals (justice.gov)
…ex-CFO (James Canedo ) of the now-defunct Pacific Hospital in Long Beach, Calif., was among those who recently reached a plea agreement with prosecutors for his involvement in a fraud scheme that generated $580 million in false billings…The 15-year-long fraud scheme involved…submitting bills to workers' compensation insurers and the U.S. Department of Labor for spinal surgeries. The surgeries were performed on patients who had been referred by dozens of physicians, chiropractors and others who were paid illegal kickbacks…More than $580 million in bills were fraudulently submitted by Pacific Hospital during the last eight years of the scheme alone. [California Pharmacy Management and its successor, Industrial Pharmacy Management, were also important players in the scheme. Both companies set up and managed what were essentially mini-pharmacies within doctors’ offices.]
- Southampton Town Councilman Pleads Guilty to Conspiring to Illegally Distribute Oxycodone (dea.gov)
Bradley Bender, Southampton Town Councilman, pleaded guilty today to conspiring to illegally distribute oxycodone…Bender received phony prescriptions for oxycodone from a Riverhead physician assistant, Michael Troyan, filled those prescriptions, and illegally exchanged the oxycodone pills for cash and steroids with another co-conspirator. The oxycodone pills were then re-sold to drug abusers…“Councilman Bender’s actions in this oxycodone distribution conspiracy victimized the very community he was entrusted to represent…guilty plea should serve as a reminder that no one is above the law, including those entrusted with passing our laws.”
- Beijing aims to refill medicine chest with ‘Made in China’ drugs (reuters.com)
China, already a global powerhouse in high-tech areas…is turning its industrial might to the challenge of making more of its own drugs for a vast and aging population… China is the world's second biggest drugs market behind the United States…Increasing local competition is part of a structural upheaval in China's hospital-dominated prescription drug market. Selling drugs to patients at a hefty mark-up - especially off-patent Western "branded generics" - often accounts for 40-50 percent of Chinese hospitals' revenues. But the authorities are now pushing a policy of zero mark-ups, initially in smaller county hospitals...Pivotal to the transformation of the market is the China Food and Drug Administration…The watchdog has promised to speed up approval of innovative new drugs, which can take 5-7 years…It's probably been taking everyone a little by surprise…As we hit the next decade in the 2020s, I'd be very surprised if there wasn't at least a top 20, if not top 10, global pharma player that was headquartered in China.
- FDA to Announce Next Steps in Essure Review (raps.org)Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study (bmj.com)
Food and Drug Administration says it plans to make an announcement on the birth control device Essure in February 2016, after the agency completes a "high priority" review of the device's safety…The agency is also considering a recent MDEpiNet study…found women who received Essure had a "more than 10-fold higher risk of undergoing reoperation," when compared to women who had laparoscopic sterilization…Essure is a permanent birth control device…marketed by Bayer…Essure was first approved...in 2002 under FDA's premarket approval process…In recent years Essure has been surrounded by controversy as patients and activists have claimed the device has caused serious and debilitating side effects… Others have claimed the device is not as effective as it claims…in November, Representative Mike Fitzpatrick introduced a bill titled the E-Free Act directing FDA to pull Essure's PMA within 60 days of the bill's passage. So far the bill has four co-sponsors, including Reps. Marsha Blackburn, Christopher Smith and Lou Barletta.
- Arizona health insurance co-op to close shop Dec. 31 (cnsnews.com)
Executives with Arizona's nonprofit health insurance co-op said Tuesday that they have failed to come up with additional financial backing and the insurer plans to shut down all operations Dec. 31…The announcement by Meritus Health Partners means 59,000 Arizonans it now covers need to find a new insurer by Dec. 15…The decision comes nearly a month after the state Department of Insurance suspended its right to sell new policies or renew current ones and placed it under formal supervision… The nonprofit was one of 23 co-ops created under the Affordable Care Act to provide competition to for-profit insurers, but many have struggled and more than half have now failed or will close by the end of the year.
- Merrill Lynch 4 Top Pharmaceutical Dividend Stocks To Own For 2016 (247wallst.com)4 Biopharma and Pharmaceutical Stocks With Game-Changing Catalysts Coming (247wallst.com)
Despite the howling from political candidates trying to make the top drug-makers their whipping boy in populist campaign efforts, the need and demand for pharmaceuticals will only continue. This is especially the case when you consider that we now live in a world with an aging population that is going to be popping more and more doctor-prescribed pills…While pricing and cost concerns won’t go away completely until the election cycle winds down, now may be an ideal time to add the top yielding stocks to portfolios for 2016…The companies we found have long histories of paying and raising their dividends, and make good sense for conservative growth and income portfolios.
- Abbott Lab
- Eli Lilly
- Merck & Co.
- Pfizer
- Senators Call on FDA to Allow Certain Canadian Drug Imports (raps.org)
Food and Drug Administration should allow the importation of pharmaceutical products from Canada if they meet certain stipulations, Sens. Chuck Grassley and John McCain wrote in a letter to Health and Human Services Secretary Sylvia Burwell… senators call on FDA to “immediately” certify the importation of prescription drugs
- if they are off patent and are no longer marketed by the drug developer,
- if there are “significant and unexplained” price increases,
- if no direct competitor product is currently marketed and the introduction of a new drug will benefit US consumers, or
- if the drug is “produced in another country by the name brand manufacturer that initially developed the drug or by a well-known generic manufacturer that commonly sells pharmaceutical products in the United States.”
Drugs could also be imported from countries outside of Canada “with similar regulatory regimes related to drug approvals,”…As far as how FDA could go about allowing such imports, the senators point to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 that allows FDA to permit pharmacists and wholesale retailers to import drugs from Canada.
- Resources for Implementing New Collaborative Services with Primary Care Providers (pharmacytimes.com)
Bryan Ziegler, PharmD, executive director of Kennedy Pharmacy Innovation Center, provides some resources for community pharmacists to use when implementing new collaborative services with primary care providers.










