- Banner Health facilities victim to cyberattack (reviewjournal.com)
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...
- FDA warns Chinese drug maker over lying (statnews.com)
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...
- Pharmacy Week in Review: August 5, 2016 (pharmacytimes.com)
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.
- Express Scripts bars new launches from Lilly, Merck and shuts out Novo for 2017 (fiercepharma.com)
For the third year in a row, Express Scripts unveiled a new national formulary excluding dozens of drugs. And for the third year in a row, a short list of winners and losers comprises some of Big Pharma’s biggest launches...The list of excluded meds--85 for 2017--covers many of the same brand names as before. For instance, Novo Nordisk’s blockbuster GLP-1 diabetes drug Victoza and two of its top-selling insulins remain barred, as Express Scripts favors Eli Lilly’s diabetes range--and most likely, Lilly’s discounts. AbbVie’s hepatitis C cocktails Viekira Pak and Technivie remain the chosen therapies in that field, with Gilead Sciences' first-to-market meds Harvoni and Sovaldi out in the cold...Express Scripts and its biggest pharmacy benefits rival, CVS Health, started the exclusionary formulary trend a few years ago by kicking off a handful of meds that they saw as too costly and easily replaced...Express Scripts continued its tradition of punishing drugmakers that have pushed through big price hikes, used co-pay discount cards to hawk me-too meds, and employed other strategies the PBM considers no-nos.
- Pharmacy Business Transition Strategies – Being Prepared (pharmacypodcast.com)
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)
- Putting the cost of medicines in context (catalyst.phrma.org)
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...
- Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels (raps.org)
Drug, biologic and biosimilar companies’ comments on Food and Drug Administration draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label...FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product…
- Amgen says it...believes a biosimilar label should include a summary of the clinical data, including immunogenicity data, used to demonstrate biosimilarity or interchangeability…
- Pfizer said...biosimilars should not be labeled "as though they were small molecule generic drugs" and that it "recommends that biosimilar labeling include a statement reflecting whether interchangeability has been assessed."
- Merck & Co...says "that a single blanket approach applicable to all biosimilar products is not appropriate, and may cause unnecessary confusion among stakeholders."...recommends that rather than using such blanket statements, FDA take a risk-based approach for each biosimilar…
- Boehringer Ingelheim says that it "does not agree that a biosimilar label needs to include a ‘biosimilarity statement,’...Such information is not ‘essential scientific information needed by health care practitioners for the safe and effective use of a drug.’
- Sandoz...says... "It is self-evident that the very act of highlighting the indications that are extrapolated is being proposed by some groups in order to raise doubts as to the safety and efficacy of the biosimilar for those indications, and perhaps to also imply inferiority of biosimilars across the board.
- This Week in Managed Care: August 6, 2016 (ajmc.com)
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 FDA just greenlit releasing mutant Zika-killing mosquitoes in Florida (fusion.net)Spraying Begins in Miami to Combat the Zika Virus (nytimes.com)Zika in the United States, explained in 9 maps (vox.com)
...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...
- Drug lobby plans counterattack on prices (politico.com)
It is just one part of a larger effort by the K Street powerhouse to seize control of the public narrative over drug prices...Washington’s powerful drug lobby is gearing up to spend hundreds of millions of dollars on a post-election ad war pushing back against politicians from both parties who have savaged its members over drug prices...The massive campaign by the Pharmaceutical Research and Manufacturers of America — expected to start positive by highlighting drugs that save or prolong lives — will dwarf the $20 million that health insurers spent on the iconic "Harry and Louise" campaign credited with sinking Hillary Clinton's health reform plan in the early 1990s.