- ASHP and ACPE Update Pharmacy Technician Accreditation Standards (ashp.org)
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.
- Biotech firm settles insider trading lawsuit for $20M (statnews.com)
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.
- Sanofi wins first dengue vaccine market approval in Mexico (reuters.com)Mexico Approves Sanofi’s Dengue Vaccine but Pricing Questions Remain (may req sub) (wsj.com)
Sanofi's dengue vaccine is to make its market debut in Mexico, the French drugmaker said…adding that it expects to have filed for market approval in some 20 countries by year-end…the preventive treatment, called Dengvaxia, for all four dengue virus serotypes, but only for patients aged 9 to 45 who live in areas where the disease is endemic…This means the world's first dengue vaccine has no approval yet for use on young children, a population considered to be most at risk, or for use by tourists…Dengue fever is a mosquito-borne disease caused by four virus serotypes as categorized by the World Health Organisation...the disease is seen as a threat to about half of the world's population. Some 400 million people are believed to be infected annually...
- India a potential center for orphan drug development and demand (fiercepharmaasia.com)
India may be sitting on a pharmaceutical gold mine. It has more than 7 times the number of people affected by rare diseases than the United States, a less expensive workforce for making drugs and an often-criticized price-control system that, by definition, does not affect orphan drugs…One India-based company sees a profitable outcome for its orphan drug, a sign the nation could become a major source of the often-overlooked treatments as other drugmakers watch to see if the optimism is justified and lasts… India offers the advantage of cheaper drug development, orphan drugs often have already produced or at least studied relatives, and many of them…are curative, thus reducing the burden on healthcare systems. And, it has a lot more potential patients.
- Ibuprofen gels not a patch on new delivery tech say UK developers (in-pharmatechnologist.com)
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.
- China economy not the main culprit in pharma slowdown, FT says (fiercepharmaasia.com)
If drugmakers foreign and domestic are counting on a return to reaping big benefits once China bounces back from its recent economic decline, they may wish to take another look. The economy may not be the problem; it is in the design of the nation's huge healthcare system…That is the conclusion of a lengthy look at the healthcare situation, including pharmaceuticals, in China by London's Financial Times…China has been engaged in a huge expansion of its healthcare system for the past several years, aimed primarily at getting care to all parts of the vast country, primarily its rural parts… while demand was increasing for pharmaceuticals, medical devices and other healthcare items, China needed to rein in the costs of the system and operate it more efficiently…China especially saw a need to get more bang from its $150 billion spent on pharmaceuticals at the same time a new government focused on ending corruption, which in healthcare centered on a hospital system that relied on drug sales for adequate income…“the whole health system is unbalanced,"…
- Medication Therapy Management: Helping to Improve Health, Control Costs (morningconsult.com)S.776 - Medication Therapy Management Empowerment Act of 2015 (congress.gov)
Chronic conditions, such as arthritis, can be debilitating…One way to help patients…manage their condition is to follow their medication regimens…pharmacists are uniquely positioned to help these patients understand why taking their medications as prescribed is fundamental to their health…Poor medication adherence – not taking medications as prescribed – costs the…healthcare system $290 billion annually in emergency room visits and catastrophic care. There is a solution…Medication therapy management is a…service offered by pharmacists…that helps ensure medications are taken appropriately to help improve health, reduce the risk of adverse events, and help control healthcare costs…Pending bipartisan legislation in the U.S. Senate – S. 776, the Medication Therapy Management Empowerment Act of 2015 – would improve access to MTM services for senior citizens enrolled in the Medicare program. Medicare Part D patients with specific chronic conditions would benefit from the education and training of pharmacists… to help ensure that medications are taken appropriately…CMS has also recently announced a pilot initiative to enable Medicare Part D plans the opportunity to utilize new and innovative approaches to MTM, which can lead to improved patient access to MTM services and greater medication adherence.
- Reefer Gladness? DEA OKs Catalent to supply marijuana from Missouri plant (in-pharmatechnologist.com)
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,”
- Sanofi, Shantha to supply polio vaccines for India’s universal immunization scheme (fiercevaccines.com)
India will join more than 110 countries that have introduced the injectable inactivated polio vaccine to their calendars. Sanofi and its Indian affiliate, Shantha Biotechnics, will supply polio vaccines to the Indian government via UNICEF. The vaccines will be used in India's universal immunization program…Sanofi Pasteur has already supplied the government with its Imovax Polio vaccine, and Shantha will soon follow suit with its ShanIPV. While oral polio vaccines have previously been included in the nation's universal immunization program, the WHO recommends replacing it with the injected inactivated vaccine…While India is officially polio-free, it borders Pakistan and Afghanistan, which still report polio cases…With the introduction of IPV in their immunization schedule, India moves the world much closer to being polio-free…
- Pozen and Tribute, spooked by tax rule changes, kill plans to put merged company in Ireland (fiercepharma.com)
The U.S. Treasury's latest stab at deflecting tax inversions deals has persuaded at least one player to give up plans for a move to Ireland, but not from looking outside the U.S. for some tax relief. Pozen, which was headed to Ireland as part of its merger plans with Tribute Pharmaceuticals, will set up shop instead in Tribute's home turf of Canada…The two drugmakers said recently they charted the change of course "after reviewing the recent guidance from the Treasury's Notice 2015-79 issued on November 19, 2015 and its potential impact on the proposed transaction."…Pozen and Tribute recommitted to their merger but said that they will go to Canada instead…The new company, which will be renamed Aralez Pharmaceuticals, has a $350 million commitment from a syndicate led by private equity firm Deerfield Investments.










