Author: Peter

In a...setback for Bristol-Myers Squibb, its blockbuster Opdivo medicine failed to meet the primary endpoint in an important, late-stage study involving patients with newly diagnosed non-small cell lung cancer. The news sent Bristol-Myers stock plunging 17 percent...the top-line results from the Phase 3 trial...indicated that Opdivo failed to show progression-free survival in patients. By comparison, Merck disclosed two months ago that its own Keytruda treatment met the primary endpoint in a trial in which the drug was being tested for the same condition...Bristol-Myers has, so far, achieved...success with its immunotherapy treatments in combating various forms of cancer. The trial results are likely to undermine assumptions that the drug maker will maintain its leading role in treating lung cancer, the deadliest form of cancer...

Arizona-based health services operator Banner Health said...that it was the victim of a cyberattack potentially affecting about 3.7 million patients, physicians, health plan members and others across seven states...The organization, which operates a community hospital in Fallon and facilities in Fernley, did not confirm whether any Nevada patients’ information was compromised in the attack...Jennifer Ruble said she didn’t yet have data on the number of people affected in each of the seven states in which the health system operates...The nonprofit system is mailing letters to possibly affected individuals, has contacted law enforcement and has taken actions to block cyberattackers, according to a statement...

The next time that employees at Xiamen Origin Biotech want to lie to regulators about what they are doing, they may want to make sure that the doors to nearby rooms are closed...During an inspection last January of its facilities in the southeastern Chinese province of Fujian, an employee told a US Food and Drug Administration inspector that the company did not keep any drugs on location. But while they reviewed company operations in a conference room, the inspector happened to notice that an adjacent room was being used to warehouse relabeled medicines...The same Xiamen employee also thought nothing of telling the inspector that the company had stopped relabeling drugs in January 2015. But during the inspection, the FDA staffer reviewed a list of exported drugs that showed Xiamen had distributed them until January 2016...Pharmaceutical and ingredients manufacturers in China and India have come under intense scrutiny in recent years due to a series of disturbing events...the flow of FDA warning letters about companies based in these countries receives added attention, sometimes deservedly so. Xiamen, for instance, also lied to its customers, according to the FDA...The company falsified and omitted information on certificates of analysis...which are supposed to verify the veracity of its products...

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

A coalition of pharmacy industry organizations has asked congressional leaders to weigh proposals that would free certain biologic drugs from adherence to U.S. Pharmacopeia standards...the American Pharmacists Association and eight other groups sent a letter to the chairman and ranking members of key House and Senate committees expressing concern about proposals by the Food and Drug Administration and a provision in Section 11 of the FDA and NIH Workforce Authorities Modernization Act that would exempt certain biologics — including biosimilars — from USP public standards for quality, including the naming of biologic and biosimilar medicines...USP’s work provides a uniform quality standard, clarity for health care practitioners and confidence for patients...Pharmacists rely on USP quality standards. Removing requirements to adhere to these standards will raise additional questions and concerns about the safety of these emerging products...Our organizations share a commitment to patient safety and, as such, we believe that biologics and biosimilars should be required to have the same nonproprietary names based on existing standards and mechanisms...the pharmacy industry groups said in the letter. "Given the broad and negative implications of such potential naming proposals, as well as their controversial nature, we are requesting that FDA not finalize current guidance and proposals and that legislation not include these provisions."

Jimmy Neil talks with Dave Ellis VP – Pharmacy Transition Services at Cardinal Health...Pharmacy Transition Services is a full spectrum, consultative approach to the revolving world of pharmacy ownership for both buyers and sellers. We collaborate with pharmacy owners to develop a complete and actionable strategy, helping them to develop an exit plan that meets their financial goals, while preserving their legacy within the community...Assistance is also provided to those interested in acquiring pharmacies, but who may not understand the capital requirements or other requirements to achieve their goals. (podcast 25:54 min)

Discussions about costs are important. No patient should have to worry about whether they can afford the care they need. At the same time, it is important to look at costs across the health care system and not just the share going toward life changing medicines...new therapies are transforming care for patients fighting debilitating diseases like cancer, hepatitis C, high cholesterol and more. In the midst of all this progress, the share of spending on retail medicines remains the same as it was 50 years ago. In fact, government actuaries project the share of health care spending attributable to medicines will continue to grow in line with overall health care cost growth for at least the next decade...Our updated Prescription Medicines: Costs in Context explains how competition among brand-name medicines, high generic utilization rates and aggressive tactics by insurers and pharmacy benefit managers to negotiate lower prices all help to keep costs under control...

Pfizer Inc. said...that it acquired Bamboo Therapeutics Inc., a biotechnology firm developing gene therapies, for $150 million and potential milestone payments in a deal to expand the drug giant’s presence in the experimental field…Bamboo is developing treatments for neuromuscular conditions and central nervous system disorders. Pfizer...will take over the company’s treatments in development, which haven’t yet been tested in people, as well as Bamboo’s manufacturing facility. Bamboo’s most advanced drug, for a rare nerve-cell disorder called giant axonal neuropathy, is enrolling patients for its first human trial. It is also working on a treatment for Duchenne muscular dystrophy, a rare and deadly muscle disease.

Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.

...the Food and Drug Administration gave the okay to a field trial that would release genetically modified Zika-killing mosquitoes in the Florida Keys...the FDA released a final environmental assessment of the trial, finding that it “will not have significant impacts on the environment.” The project, led by Oxitec, a biotech company that focuses on insect control, calls for the release of thousands of genetically engineered male Aedes aegypti mosquitoes. The lab insects are bred so that over time they could kill off much of the local mosquito population by passing on a gene fatal to any offspring they have with wild females...The FDA’s okay is a major step forward toward a U.S. implementation of the technology at a time of much concern over the spread of Zika in the U.S. after cases in Florida...