- EMA Recommends First CART-T Cell Therapies (biopharminternational.com)
...the European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite Pharma’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cells therapies for blood cancer, for approval in the European Union...Kymriah and Yescarta are the first CAR T-cell treatments to be recommended by the agency. In August 2017, Kymriah became the first CAR-T therapy approved by FDA in the United States, with Yescarta becoming the second in October 2017...Both drugs are also the first treatments supported through EMA’s Priority Medicines scheme to receive positive opinions from the Committee for Medicinal Products for Human Use...
- British Doctors Lack Transparency Where Big Pharma Pays (bloomberg.com)
Half of British doctors who received payments from the pharmaceutical industry last year remained anonymous -- prompting a call for greater transparency from drugmaker AstraZeneca Plc...About 128 million pounds ($169 million) flowed to medical professionals or organizations in consulting fees, travel expenses, donations and other items, the Association of the British Pharmaceutical Industry said...Disclosing which doctors got them is tricky due to data-privacy laws...Gaps in reporting have drawn increased scrutiny across Europe. Countries such as France and Portugal have moved to shed more light on pharma companies’ financial ties to doctors, which have been shown to sway prescribing habits. Health-care advocates are pushing for a system like that in the U.S., where legislation requires companies to fully divulge the relationships with medical practitioners...Pharma groups say there’s no need for more regulation. Doctors provide crucial insights on new medicines, often while collaborating with companies on clinical research, and they should be paid for their time, according to the European Federation of Pharmaceutical Industries and Associations...“There are numerous inefficiencies in the way that America does health care, but there’s one thing which I think America historically and consistently is pretty good at -- that’s transparency,”...“Clear rules are the only things that change behavior.”
- Nevada announces plans to use controversial sedative midazolam in execution next week (thenevadaindependent.com)
Nevada plans to execute death row inmate Scott Dozier next week using the powerful painkiller fentanyl as well the sedative midazolam — a drug that critics have blamed for executions in other states in which prisoners were seen struggling for breath before they died...The Nevada Department of Corrections offered up formal notice...that it would be putting Dozier to death next Wednesday at 8 p.m. at Ely State Prison. They also released the new lethal injection drug protocol, which comes as the state’s supply of a drug formerly in the combination — diazepam — expired...Attorneys for Dozier didn’t immediately return requests for comment on Tuesday about whether they would take any steps to challenge the protocol, or whether Dozier approves of the method...
- Amazon Buys PillPack: Six Pharmacy and Drug Channel Implications (drugchannels.net)Why Amazon’s Push Into Prescription Drugs Isn’t a Guaranteed Success (nytimes.com)Amazon could start selling discounted meds to cash payers as soon as the PillPack deal closes (cnbc.com)
Amazon has entered the pharmacy business with its acquisition of PillPack, a small mail pharmacy. Consider this move to be the end of the beginning for the pharmacy industry's evolution...The stock prices of pharmacies and pharmacy benefit managers predictably plunged...This is a small first step that will let Amazon begin growing a pharmacy dispensing business...We are still a long, long way from a fundamental restructuring of the complex U.S. drug channel. The incumbents still have opportunities to defend their position, capture value from internet technologies, and streamline distribution...
OBSERVATIONS- Amazon has made a small, partly defensive move into pharmacy dispensing.
- Amazon now has a turnkey platform for disrupting the cash-pay prescription business.
- Amazon can reinvent consumer perceptions of non-store pharmacy dispensing.
- PBMs face the prospect of disruption to their long-favored network strategies.
- Amazon still lacks a specialty pharmacy solution—and may not want one.
- The deal is good news for vertical integration.
- Nevada State Board of Pharmacy – July 2018 Newsletter (bop.nv.gov)
- Return of Dispensed Drugs to a Pharmacy
National Pharmacy Compliance News
- DEA Launches New Tool to Help Distributors Make Informed Decisions About Customers
- PTCB Launches Certified Compounded Sterile Preparation Technician Program
- DEA Enables Mid-level Practitioners to Prescribe and Dispense Buprenorphine
- New CDC Training Offers CPE on Antibiotic Stewardship
- Walmart to Provide Free Solution to Dispose of Medications With Schedule II Prescriptions
- ASHP Research and Education Foundation Predicts Trends to Affect Pharmacy in 2018
- USP Encourages Pharmacists to Help Patients Find Quality Dietary Supplements
- New CPE Monitor Subscription Plan Helps Pharmacists Track Compliance Via Mobile App
Nevada State Board of Pharmacy News
- Controlled Substance Prescription DEA Number Requirement
- Malaria eradication: tackling counterfeit and substandard drugs (pharmaceutical-technology.com)
Although malaria is beginning to be eradicated, it remains a global health issue and this is partially due to the existence of counterfeit and substandard drugs in the regions where malaria remains most prevalent: South East Asia and Africa...malaria still exists in many countries worldwide, and is an especially serious problem in Africa. Part of the explanation for the persistence of malaria in developing countries is the prevalence of substandard and counterfeit drugs being used to treat the disease...The WHO estimates one in ten medical products circulating in low and middle-income countries are substandard or falsified, with antibiotics and antimalarials being the most commonly reported...Taking low-quality or fake medicines can delay clinical recovery and increase mortality rates in patients. They can also promote resistance to the drug by introducing small, insufficient proportions of the active ingredients into the body...The GSMS (Global Surveillance and Monitory System ) published data from its first four years of operations in June 2017. 920 suspected products have been reported from 83 countries, and the most common were fake antimalarials, with 286 products reported from 26 countries.
- Merck and Novartis gender bias suits draw renewed attention, and New York is taking action (fiercepharma.com)
As the #MeToo movement puts workplace sexual harassment at the front, Merck & Co. and Novartis, two of the largest pharma companies, find themselves entangled in a different kind of gender problem: alleged pregnancy discrimination...Merck for years has been embroiled in a lawsuit that accused it of discriminating against female sales reps in promotions and pay...The Merck suit...brought...by Kelli Smith, a former...saleswoman, alleged that Merck discriminated against female sales reps and against pregnant women in its decision on promotions and pay...Smith was demoted in March 2011, after she returned from maternity leave, and was put in the lowest-paid sales rep tier...Merck isn’t the only pharma company that has been under fire with gender-bias complaints. Novartis in 2010 agreed to pay $175 million to settle a similar suit. Christine Macarelli, a former...saleswoman, said in that case that her supervisor told her “women who find themselves in my position—single, unmarried—should consider an abortion,”...Now both Merck and Novartis are under scrutiny from the New York state government’s Division of Human Rights. The agency just sent the companies letters requesting information about the discrimination claims. Because New York has a law requiring employers to accommodate pregnant workers, the state could seek damages though administrative complaints, according to the NYT...
- This Week in Managed Care: July 6, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- July 6 Pharmacy Week in Review: FDA Approves Drug Treatment for Schizophrenia, Device for Patients With Severe Emphysema (pharmacytimes.com)
Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Top Democrat demands PhRMA, BIO do more on gender issues after party with topless dancers (statnews.com)
A top Democratic senator is asking PhRMA and BIO, the major pharma and biotech industry trade groups, to detail what they are doing to address sexual harassment at their members’ companies, particularly after an industry event earlier this month featured topless dancers...In two letters...Sen. Patty Murray (Washington State)...cited “problematic public reports of gender discrimination and objectification.”...In both letters, Murray took particular aim at the Party at BIO Not Associated with BIO, an industry event that is not directly affiliated with BIO but that took place near its convention in Boston this month. The event featured topless dancers on mini stages, some of whom had company logos painted on their bodies...Murray called it an event with a “highly concerning history of objectifying women and using culturally inappropriate themes.”...“The bottom line is that objectifying women and exploiting cultural traditions for the purposes of entertaining fellow industry members is a deeply troubling indication of the way the industry leaders still devalue diversity and inclusion,” she wrote.