Author: Peter

Cindy Whitehead, CEO of Sprout Pharmaceuticals, the maker of the recently approved “female Viagra” drug Addyi (flibanserin), is leaving her post only months after Valeant bought the company…Whitehead was instrumental in bringing Addyi to market. She fought through two Food and Drug Administration rejections of the drug in 2010 and 2013, pushing forward until it was finally approved in August. That effort included purchasing the drug rights herself and forming Sprout after Boehringer Ingelheim dropped it following the first rejection by the FDA…Valeant quickly bought the privately-held company for $1 billion in August after Addyi’s final FDA approval. Though, blockbuster sales have so far eluded the drug. From its launch on Oct. 17 until Nov. 6, only 227 prescriptions were written for the drug…For comparison, Viagra notched more than half a million prescriptions in its first month…Now, Valeant…is opting to switch up Sprout’s leadership…“Having built a team to take Addyi to market, we mutually agreed that it was the right time to transition to new leadership for the next phase of global commercialization.”

Novartis announced today that it has reached a delivery milestone of 300 million pediatric antimalarial treatments supplied without profit since 2009, helping to reduce the disease burden for children in more than 30 malaria-endemic countries. Coartem® Dispersible is the first artemisinin-combination therapy developed by Novartis in collaboration with Medicines for Malaria Venture specifically to meet the needs of children. Never before have so many pediatric treatments been distributed in such a short timeframe to children suffering from malaria…"This milestone underscores our long-standing commitment to the fight against malaria and to the children who are most at risk from the disease…"We are proud of the part we have played in helping to reduce childhood deaths from malaria. And we continue to provide medicine at no profit to people who need it, contributing to the goal of a world free from the disease."

As part of National Influenza Vaccination Week, December 6-12, 2015, established by the Centers for Disease Control and Prevention, government and health officials will join community partners to raise awareness about the benefits of flu vaccination and honor local flu vaccination heroes during a press conference and awards ceremony. Flu vaccination heroes to be honored include:

• Nevada State Assemblyman, James Oscarson, for his efforts to provide access to flu vaccinations for the citizens of rural communities in district 36.
• Joyce Goedeke, Vice President of Marketing/Public Relations for Southern Hills Hospital & Medical Center, for her leadership on the Immunize Nevada flu taskforce and for hosting a flu clinic at the Southern Hills Annual Balloon Festival.
• Melissa Shake, Pharmacy Manager and Immunizations Trainer for Walgreens, for her leadership on the Immunize Nevada flu taskforce and dedication to community flu protection by coordinating free flu vaccinations across southern Nevada through Walgreens’ national flu vaccine voucher program.
• Tavia Campbell, Chief Operating Officer and Co-Founder for Walls 360, Inc., for her sponsorship and donation for the 2015-2016 Immunize Nevada flu campaign.

WHEN: Friday, December 11th, 10 to 11 a.m.
WHERE: East Las Vegas Community and Senior Center, 250 N. Eastern Ave., Las Vegas

More than a year after denying allegations it surreptitiously attempted to boost its stock price, Galena Biopharma has agreed to pay $20 million to settle a shareholder lawsuit that accused the drug maker of a misleading marketing campaign and insider trading…The settlement resolves an unusual episode that raised questions about the extent to which some biotech companies may have been aggressively promoting their prospects during a bull market in biopharma stocks. However, we should note that Galena and its executives and directors did not admit any wrongdoing…Galena said it “believes the claims are without merit, but is settling the lawsuits to avoid potentially lengthy, costly, distracting, and time-consuming litigation.” Of the $20 million payment, $16.7 million will be paid by the company’s insurers and $3.3 million will be paid by Galena — $2.3 million in cash and $1 million in stock. This represents less than 1 percent of its outstanding shares.

CNBC's Meg Tirrell reports on the hearing on drug pricing focusing on older drugs.

The Delhi company, which is not to be confused with US inhaled insulin developer MannKind Corporation, will spend INR2bn ($30m) on new manufacturing facilities in India… One of the new plants – which will make finished dosage forms for the Indian market – will be constructed at an as yet unchosen site in Sikkim, a mountainous State in the North West of the country that borders Nepal and Tibet…Sikkim is popular with drugmakers despite the logistical challenges associated with running facilities in the Himalayas…Under State law, manufacturers that set up in the region before April 2017 will not have to pay taxes on revenues generated by products made there for 10 consecutive years…ManKind’s plant is scheduled to be operational next March. The firm will join Cipla, Sun Pharma, Zydus Cadila, Alembic, IPCA, Alkem Lab, Intas Pharma, Torrent Pharma and Unichem which all have manufacturing operations in the State.

UK researchers have developed an ibuprofen patch they claim offers better dosage control than gel formulations of the pain drug…The patch – which was developed by researchers at the University of Warwick and spinout company Medherant – consists of a transparent layer that is stuck to the skin with an adhesive polymer into which…in this case ibuprofen - is incorporated… the approach enables precise dosage control because the patches have “a defined size with a set amount of drug.”…the technology has wider application…“We know that a lot of other APIs can be incorporated in our patches”…Medherant is interested in partnering with the pharmaceutical industry.

Days before Pfizer Inc. was to set the price for a new breast-cancer drug called Ibrance (palbociclib), it got a surprise: A competitor raised the monthly cost of a rival treatment by nearly a thousand dollars… After carefully calibrating the price to be close to rivals and to keep doctors and insurers happy, Pfizer was left wondering if its list price of $9,850 a month for the pills was too low…Three years of market research—a stretch that started almost as soon as the new treatment showed promise in the laboratory—was suddenly in doubt. After carefully calibrating the price to be close to rivals and to keep doctors and insurers happy, Pfizer was left wondering if its list price of $9,850 a month for the pills was too low…Yet Pfizer knew setting a price too high for Ibrance might backfire…Pfizer’s multistep pricing process shows drugmakers don’t just pick a lofty figure out of the air. At the same time, its process yielded a price that bore little relation to the drug industry’s oft-cited justification for its prices, the cost of research and development…the price that emerged was largely based on a complex analysis of the need for a new drug with this one’s particular set of benefits and risks, potential competing drugs, the sentiments of cancer doctors and a shrewd assessment of how health plans were likely to treat the product.

On the recommendation of the Pharmacy Technician Accreditation Commission, ASHP (the American Society of Health-System Pharmacists) and the Accreditation Council for Pharmacy Education boards of directors have updated the Accreditation Standards for Pharmacy Technician Education and Training Programs. The update expands the flexibility of training programs to meet requirements regarding the number and types of student experiential activities that must be performed, requiring at least one and encouraging two different contemporary pharmacy practice experiences. Accredited pharmacy technician education and training programs include didactic education in sterile and nonsterile compounding; accredited programs, however, may now determine whether they provide hands-on training in sterile compounding, nonsterile compounding, or both.

Catalent has registered a facility in Missouri with the DEA to import cannabis extracts in dosage form for clinical trial studies…The contract development and manufacturing organisation  applied for its Kansas City...site to be registered as an importer of controlled substances in August, and last week the Drug Enforcement Administration approved the request…“[Catalent Pharma Solutions] is granted registration as an importer of marihuana, a basic class of controlled substance listed in schedule I,”…“The company plans to import finished pharmaceutical products containing cannabis extracts in dosage form for clinical trial studies.”..One of Catalent’s customers is GW Pharmaceuticals which has a marijuana-based compound, Epidiolex (cannabidiol), in Phase III trials for the treatment of Lennox-Gastaut syndrome…The company ships finished product to a storage facility run by Catalant in the US and investigators draw material from that facility,”