Category:

Pharmacists in Connecticut have been dispensing medical cannabis for more than a year now. The state’s medical cannabis law requires that a board-certified pharmacist be onsite to dispense the product at a medical cannabis dispensary, of which there are currently six in Connecticut...Minnesota pharmacists began dispensing medical cannabis under the state’s 2014 cannabis legislation, and now New York’s law, also passed in 2014, includes language requiring pharmacists to dispense..."There are now three states that have a solid health care model [with a pharmacist to dispense]," said Joseph Friedman, BSPharm, founder of a medical cannabis dispensary in Illinois. Friedman is a vocal supporter of pharmacists’ role in the growing industry. No mandate under Illinois’ medical cannabis law requires pharmacists to dispense, however...Under federal law, cannabis is a Schedule I drug, but Connecticut’s law reclassifies it as a Schedule II drug. Because of this change, medical cannabis goes through the same process as other controlled substances in Connecticut, meaning it’s tracked through the Connecticut Prescription Monitoring and Reporting System, a statewide database updated weekly with patients’ prescription data...University of Minnesota College of Pharmacy is also looking into incorporating education courses about medical cannabis into the pharmacy curriculum...Including New York, 23 states and the District of Columbia currently have laws that legalize and regulate cannabis for medicinal purposes. It’s uncertain, at this point, if and how pharmacists will be part of other states’ dispensing operations...

The title of this recent article really says it all: "Characterisation of trials where marketing purposes have been influential in study design: a descriptive study." The authors’ entering hypothesis essentially is that many of Big Pharma’s clinical trials are designed solely for marketing purposes with the trial designs themselves governed by people whose sole concern is drug sales and not the health of patients...Currently, there are few documented examples of marketing trials. Nonetheless, there are reasons why marketing trials should be of concern to patients and physicians. Notably, the research objectives–to promote the use of a medical product–may not be clear to investigators and communicated to participants. The features that suggest a trial may be considered as marketing are, however, currently unclear.

• Vested interests, recruitment of investigators who are frequent prescribers of competing products;
• disproportionally high payments given to investigators;
• sponsorship by the company’s sales and marketing division;
• minimal requirements for data leading to poor data quality
• recruitment of a large number of centres

Zika virus infection, the scary new disease for which there is no vaccine or treatment, is “spreading explosively” from Africa and Southeast Asia...The United States and 20 other countries...have reported cases of the virus since Brazil reported the first cases of local transmission last May. Delivered by varieties of mosquitoes...it has boosted interest in mosquito-borne diseases...What’s needed is...modern genetic engineering techniques to more effectively prevent mosquitoes from delivering the viruses and parasites that cause disease….The FDA has long delayed the approval of a November 2011 application for a field trial to test a new biological control agent for the mosquito species Aedes aegypti. Although that field trial is concerned specifically with dengue fever, A. aegypti...also transmits Zika...Oxitec has created a new way to control Aedes aegypti. Male mosquitoes are bred in the laboratory with a specific genetic mutation that, in the absence of a certain chemical, causes their offspring to die before reaching maturity...This safe and effective control technique has been approved in Brazil and open field trials of these mosquitoes have been conducted in Brazil, the Cayman Islands, Panama and Malaysia...Eight months have passed since FDA promised last May to publish for public comment a routine environmental assessment of the Oxitec field trial in Florida. Only after FDA reviews the comments will FDA consider whether to grant approval. This delay is unnecessary and unconscionable.

Massachusetts Attorney General...opening a new front in the push to boost access to life-saving drugs, has warned the country’s biggest biotech company that it faces possible legal action unless it lowers the price of two popular hepatitis C medicines...In a letter to Gilead Sciences Inc., made public Wednesday, the attorney general wrote that the high price of the company’s Sovaldi drug, which costs $84,000 for a full 12-week course of treatment, and its Harvoni regimen, at $94,500, "may constitute an unfair trade practice in violation of Massachusetts law" because they are too expensive for many patients...While other state attorneys general have sued drug makers seeking larger Medicaid rebates or discounts, her office is believed to be the first to consider using a state consumer protection law to charge a company with overpricing its products...

A federal appeals court ruled Monday that four patents related to Purdue Pharma's painkiller OxyContin are invalid, potentially bringing Teva Pharmaceutical Industries Ltd and others a step closer to introducing generic versions of the drug...Purdue had sued Teva, Amneal Pharmaceuticals, Epic Pharma and a U.S. arm of Mylan NV after they sought approval from the Food and Drug Administration to make generic OxyContin...Despite the court's ruling, Purdue has several other patents protecting OxyContin, and we do not anticipate generic manufacturers selling the product in the near future...Three of the patents Purdue sought to enforce in its lawsuits are related to an improved formulation of oxycodone, the active ingredient in OxyContin...The other patent describes technology designed to prevent abuse of the drug by making it difficult to crush and causing it to form a gel when dissolved in water so that it cannot be injected...Purdue appealed all four cases to the Federal Circuit...

PBM giant Express Scripts has long been a leader in the fight to tamp down drug prices, and now, it's using its formulary power to freeze out a diabetes drug from controversial Valeant...The company will exclude the Canadian drugmaker's Glumetza--an extended-release, brand-name version of generic med metformin--as soon as copycats become available on Feb. 1...Valeant hiked the price of Glumetza by more than 800% in 2015, Express Scripts says; as of July 31, the drug's list price stood at $10,020 for 90 tablets, up from $896 in January 2013..."By excluding Glumetza from these formularies, Express Scripts clients are ensuring that their patients be dispensed the more affordable generic formulation of metformin,"...noting that "branded Glumetza will not be allowed to process" under any circumstances.

...pharmacy benefit managers expect the launch of Merck & Co Inc's new hepatitis C pill to improve their leverage in price negotiations with drugmakers...The Food and Drug Administration...approved Merck's Zepatier (elbasvir and grazoprevir) for treatment of patients infected with the most common form of the liver-destroying virus, genotype 1, as well as the less common genotype 4...The list price for the new drug is $54,600 for a 12-week regimen - compared with $94,500 for Gilead Sciences Inc's Harvoni. A multi-pill regimen, Viekira Pak, from AbbVie Inc has a list price near $83,000..."We look forward to working with Merck," Express Scripts said..."Having multiple, clinically effective options allows us to again leverage competition and make medicine more affordable for our clients while ensuring appropriate patient access."..."Given Merck's interest in participating in such a large market, we model and fully expect increased price competition and we also view Merck's list price as a rational way to stay out of the drug pricing spotlight,"...

Drugmaker Abbott Laboratories said it would acquire Alere for $5.8 billion in a deal that would expand its diagnostics business and make it a leader in point-of-care testing...Point-of-care tests help increase the speed of treatment by bringing test results to doctors in a matter of minutes as they can be conducted in the physician's office, an ambulance or even at home...Alere, which has annual sales of $2.5 billion, makes tests for infections such as HIV, tuberculosis, malaria and dengue...Abbott, which had annual sales of $20.4 billion in 2015, said its total diagnostics sales would exceed $7 billion after the close of the deal...Alere's net debt, currently $2.6 billion, will be assumed or refinanced by Abbott.

Walgreens Boots Alliance this year moved its annual shareholder's meeting...to...Manhattan, approving three proposals made by the board, reviewing the company's recent events and looking ahead to the future...all of which executives said would help deliver a banner year for Walgreens in 2016.

1. Rite Aid acquisition - The addition of rite aid to our network offers the potential for significant cost savings and purchasing efficiencies in addition to opportunities in terms of important market penetration...
2. Valeant Pharmaceuticals partnership - ...offer its branded dermatology and ophthalmology products at a reduced cost to the consumer...This partnership...is a demonstration of how partnerships can create value while reducing costs for the system as a whole...
3. Boots’ beauty proposition - transforming Walgreens into must-visit destination centers for WBA's owned beauty brands...as part of the company's initiative "Beauty 2000"...

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.