- U.S. Army can’t add a pricing safeguard to Sanofi’s Zika vaccine license, official says (fiercepharma.com)
Despite pushback from intellectual property activists...and high-profile politicians, a U.S. Army official dismissed concerns about a pending license transfer for a Zika vaccine candidate to pharma giant Sanofi...Responding to criticism of the proposed deal, the U.S. Army’s director of medical technology transfer at the Medical Research and Materiel Command, Barry Datlof, wrote...that the deal will comply with U.S. laws and will "be in the best interest of the U.S. government and the public…Originally developed by Army scientists, the immunization went into phase 1 testing with National Institutes of Health support. Sanofi joined the effort to prepare for phase 2 trials and to create a clinical development and regulatory strategy...KEI (Knowledge Ecology International )...started protesting the proposed license soon after the U.S. government disclosed the plan...Highlighting the extensive government funding for the program—$43 million so far, with the potential for more—KEI asked for pricing safeguards and argued that the license transfer would "not be legal" because it isn’t necessary to motivate Sanofi to develop the vaccine...Datlof said it’s not feasible for the Army to "define, implement and enforce 'affordable prices' or to set price controls for a potential vaccine that will require great investment and face high risk of failure."...the Army still plans to issue the license...
- Audit offers bevy of regulations for Nevada medical marijuana program (reviewjournal.com)
Tweaking the system...Nevada’s legislative audit division issued nine recommendations for the state’s medical marijuana program:
- Better verification of authenticity of physicians who recommend marijuana
- More monitoring of physicians who write those recommendations
- Ensure patients reason’s for growing at home are legitimate
- Eliminate the background check for medical marijuana card applicants
- Develop controls so dispensaries do not sell to patients with expired cards
- Better safeguard sensitive information
- Develop a cleaner and more organized record keeping system
- Some vets can go to CVS ‘MinuteClinics’ for minor illnesses (hosted.ap.org)
Some ailing veterans can now use their federal health care benefits at CVS "MinuteClinics" to treat minor illnesses and injuries, under a pilot program announced...by the Department of Veterans Affairs...The new program, currently limited to the Phoenix area, comes three years after the VA faced allegations of chronically long wait times at its centers, including its Phoenix facility, which treats about 120,000 veterans...The Phoenix pilot program is a test-run by VA Secretary David Shulkin who is working on a nationwide plan to reduce veterans' wait times...Veterans would not be bound by current restrictions under the VA's Choice program, which limits outside care to those who have been waiting more than 30 days for an appointment or have to drive more than 40 miles to a facility. Instead, Phoenix VA nurses staffing the...medical center's help line will be able to refer veterans to MinuteClinics for government-paid care when "clinically appropriate."..."We believe in the MinuteClinic model of care and are excited to offer our health care services as one potential solution for the Phoenix VA Health Care System and its patients," said Tobias Barker, chief medical officer of CVS MinuteClinic...
- WFI System Meets European Requirements (pharmtech.com)
Bosch’s new system for the production of water for injection, which is used in solutions for injection and infusion, uses membrane processing and ultrafiltration. Previously, it was only possible to produce WFI for the European market using distillation...the revised European Pharmacopeia monograph allows, for the first time, WFI to be obtained using other comparable processes...Pharmatec designed a WFI production unit using membrane processes that meets the requirements...from the European Medicines Agency...The generation unit employs cold membrane processing methods (i.e., reverse osmosis and electrodeionization), with an additional ultrafiltration step...Monitoring all the processes in the production chain is essential to guaranteeing the microbial quality of the water, which is why we fitted the unit with various sensors and measuring devices to monitor the water quality throughout the process and to check the individual steps...
- Nation’s first public needle vending machine for drug users debuts in Las Vegas (reviewjournal.com)
Las Vegas health officials are turning a familiar piece of equipment — the vending machine — into a first-in-the-nation experiment to automate the dispensing of clean needles for intravenous drug users...The program is a joint effort between the Southern Nevada Health District, the Nevada AIDS Research and Education Society and Trac-B Exchange, which developed the machine. The idea is that making clean needles and other gear available will reduce the spread of bloodborne infections among drug users who would otherwise share the injection rigs…materials for the program were funded by private donations...Having access to clean syringes is a harm-reduction approach that’s going to allow people to protect themselves against getting communicable diseases such as HIV and hepatitis C...The machines...will distribute cardboard boxes containing clean syringes and disposal containers for used needles. They will also offer kits for wound cleaning and safe sex. Users will have to register first to receive a swipe card and unique identification number that they can use to receive up to two kits per week...Machines will be available by the end of May at Trac-B Exchange, 6114 W. Charleston Blvd.; Aid For AIDS Nevada, 1120 Almond Tree Lane; and the Community Counseling Center, 714 E. Sahara Ave.
- This Week in Managed Care: April 21, 2017 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Nation’s First ‘Budtender’ Certified In Sacramento (sanfrancisco.cbslocal.com)
A Sacramento woman was recently certified as California’s and the nation’s first cannabis pharmacy technician or "budtender."...Shayna Schonouer isn’t just an expert on all things cannabis-related when it comes to using marijuana products to treat a medical condition. She is now the only person in the nation to hold the state-sanctioned title of "budtender."...Schonouer has just wrapped-up a two-year program making her the first graduate apprentice in the field of pharmacy cannabis technician..."She’s not a doctor, she’s not a pharmacist — but she has in this industry enough expertise to help people make informed decisions on their choices to self-medicate," explained Don Merrill, who works for the state’s Department of Industrial Relations and helps run the program...She will now work with pharmacists who offer cannabis products to patients coping with cancer or any chronic condition...It will also be her job to make sure the cannabis products coming in to shops and pharmacies are properly tested...
- GSK must pay $3 million in generic Paxil suicide lawsuit: U.S. jury (finance.yahoo.com)
GlaxoSmithKline must pay $3 million to a woman who sued the drug company over the death of her husband, a lawyer who committed suicide after taking a generic version of the antidepressant Paxil…The jury's award followed a trial in federal court...over the death of Stewart Dolin...who jumped in front of an oncoming commuter train in 2010 after taking a generic equivalent of GSK's Paxil...GSK maintains that because it did not manufacture or market the medicine ingested by Mr. Dolin, it should not be liable," GSK said. "Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit...Dolin's lawyers had requested $39 million. They alleged GSK had evidence paroxetine increases the risk of suicide by older users by as much as 670 percent, yet failed to include that on the warning label...
- Pharmacy Week in Review: April 21, 2017 (pharmacytimes.com)
Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Is prescription pet food better for your pet – or for the companies that make it? (sacbee.com)
A North Carolina law firm is one of the primary drivers of a class action lawsuit that alleges that prescription dog and cat food is a marketing scheme devised by pet food companies to pump up their profits...At the heart of it, the world’s largest pet food manufacturers are requiring that certain pet foods be sold by prescription even though there is no legal requirement for that prescription…requiring a prescription from a veterinarian misleads consumers, providing cover that enables pet food companies to charge excessive prices...Prescription pet food contains no drug or other ingredient not also common in non-prescription pet food...Defendants in the civil lawsuit...include the companies behind four brands of prescription pet foods that dominate the market: Hill’s Prescription Diet, Purina Pro Plan Veterinary Diets, Royal Canin Veterinary Diet and Iams Veterinary Formula...the lawsuit argues, the companies “control the sale of prescription pet food from manufacture to veterinarian to retail, which has allowed their deception and price-fixing conspiracy to be implemented and perpetuated with minimal risk of detection or defection.”...prescription pet foods “have not been evaluated by the FDA for safety, efficacy, or nutritional adequacy.”...Prescription pet food accounts for about 5 percent of the $24 billion in pet food sold in the U.S. each year...or more than $1 billion a year...Pet food...“is the only food on the planet that’s allowed to make a health claim” by the FDA...










