- ‘One whiff and you’re stiff’: The Irish village where smoke from the local Viagra factory puts a spring in their step welcomes news the little blue pill will now be available over the counter (dailymail.co.uk)
Locals in a tiny Irish village where Viagra has been manufactured for 20 years are laughing off potentially stiff competition from Britain...Men in need of the drug will soon be able to purchase the little blue over the counter, following a public consultation by the UK Medicines and Healthcare products Regulatory Agency...But villagers from Ringaskiddy, Cork - where Pfizer manufacture a key ingredient used in Viagra - have met the news with amusement...Barmaid Debbie O'Grady told The Sunday Times: 'One whiff and you're stiff. We've been getting the love fumes for years now for free', she told The Daily Telegraph, referring to smoke emanating from one of the factory's chimneys...Ms O'Grady's mother, Sadie, even said that living in Ringaskiddy is a blessing for some men who suffered 'with problems in that department', adding that there is 'something in the air'.
- Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity (biopharminternational.com)
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars...On Dec. 4, 2017, a final round of comments from industry stakeholders who raised questions over FDA’s draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” about how to conduct analytical evaluation of similarity in biosimilars, was published...Several biopharma majors were among the commenters, including Amgen, Boehringer Ingelheim, Genentech, a Roche company, Novartis, Pfizer, Sanofi, and Shire. Other industry stakeholders include the Association for Accessible Medicines, the Biosimilars Forum, and the Biotechnology Innovation Organization...FDA introduced the draft guidance in September 2017, which specifically describes the type of information that sponsors of proposed biosimilar products should obtain regarding the structural/physicochemical and functional attributes of the reference product. In addition, the guidance describes how that information can be used in the development of an analytical similarity assessment plan for the proposed biosimilar, as well as recommends the statistical approaches for evaluating analytical similarity.
- This Week in Managed Care: December 1, 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
- UN: About 11 percent of drugs in poor countries are fake (ktvn.com)
About 11 percent of medicines in developing countries are counterfeit and likely responsible for the deaths of tens of thousands of children from diseases like malaria and pneumonia every year, the World Health Organization said...It's the first attempt by the U.N. health agency to assess the problem. Experts reviewed 100 studies involving more than 48,000 medicines. Drugs for treating malaria and bacterial infections accounted for nearly 65 percent of fake medicines... Between 72,000 and 169,000 children may be dying from pneumonia every year after receiving bad drugs. Counterfeit medications might be responsible for an additional 116,000 deaths from malaria mostly in sub-Saharan Africa...Counterfeit drugs include products that have not been approved by regulators, fail to meet quality standards or deliberately misrepresent an ingredient...In 2013, WHO set up a voluntary global monitoring system for substandard and fake drugs and has received reports of about 1,500 problematic medicines including drugs that claim to treat heart problems, diabetes, fertility problems, mental health issues and cancer. WHO also reported problems of fake vaccines for diseases including yellow fever and meningitis...
- Will Pharma Meet the Drug Tracking Deadline? (biopharminternational.com)
Manufacturers and trading partners struggle to meet drug tracking requirements...As FDA and industry near the halfway mark in the 10-year process for establishing a national electronic drug tracking system by 2023, there’s considerable concern among pharma companies, wholesaler/distributors, and pharmacists about meeting the deadline. The process for establishing the rules and infrastructure for the track-and-trace system envisioned in the Drug Supply Chain Security Act, part of the Drug Quality and Security Act of 2013, is proving to be complex and challenging for all parties...FDA recently delayed requiring drug manufacturers to imprint unique product identifiers on individual packages by November of 2017, saying it would not enforce that policy until Nov. 27, 2018. While major pharma companies are meeting the earlier time-frame for serializing and identifying drug packages, many generic-drug makers and contract manufacturers reported confusion over who is responsible for devising the identifiers and for confirming compliance with requirements. And while manufacturers applauded gaining an additional year to fully identify individual drug packages, pharmacists and other supply chain partners raised concerns that the delay would make it even more difficult for them to comply with reporting requirements for 2018 and 2019...
- CVS to Buy Aetna for $69 Billion in a Deal That May Reshape the Health Industry (nytimes.com)CVS-Aetna deal will change the way many big employers buy employee health-care benefits (cnbc.com)The CVS/Aetna Deal in 5 Quotes Now that an official proposal has been announced, how are industry leaders responding? (drugtopics.modernmedicine.com)
CVS Health said on Sunday that it had agreed to buy Aetna for about $69 billion in a deal that would combine the drugstore giant with one of the biggest health insurers in the United States and has the potential to reshape the nation’s health care industry...The transaction, one of the largest of the year, reflects the increasingly blurred lines between the traditionally separate spheres of a rapidly changing industry. It represents an effort to make both companies more appealing to consumers as health care that was once delivered in a doctor’s office more often reaches consumers over the phone, at a retail clinic or via an app...A combined CVS-Aetna could position itself as a formidable figure in this changing landscape. Together, the companies touch most of the basic health services that people regularly use, providing an opportunity to benefit consumers. CVS operates a chain of pharmacies and retail clinics that could be used by Aetna to provide care directly to patients, while the merged company could be better able to offer employers one-stop shopping for health insurance for their workers.
- Pharmacy Week in Review: December 1, 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.
- EMA Updates Brexit Guidance (biopharminternational.com)
The agency and the European Commission published updated guidance to answer questions about Brexit...On Dec. 1, 2017, the European Medicines Agency and the European Commission published updated guidance for pharmaceutical companies regarding the United Kingdom’s withdrawal from the European Union. The new guidance answers additional questions about marketing applications and authorizations...New in this update is more information on batch release sites located in the UK, which must be located in the EU; the effect on herbal medicinal products; and applications for orphan drug designation. The guidance also discusses the local representatives in the UK mentioned in product information, global marketing, and the sunset clause.
- OTC Viagra: Pfizer snags nod for nonprescription sales of the little blue pill for men in the U.K. (fiercepharma.com)
Pfizer has won a first approval for OTC Viagra. Viagra Connect, the Pfizer OTC name for its blockbuster erectile dysfunction drug, has been approved for sale in the U.K...The Medicine and Healthcare products Regulatory Agency announced...that it will reclassify the 50 mg dose from prescription only to a pharmacy medicine in the U.K. Viagra Connect is expected to be available for sale in the spring of 2018. Anyone seeking to buy the drug will be required to have a discussion with a pharmacist, who will determine whether the drug is appropriate for their use...It will continue to sell branded versions of other doses of the drug in the U.K...In regard to its U.S. OTC ambitions, Pfizer said, in a statement to FiercePharma, “While we do not have information to share on specific Rx to OTC switch programs in the United States, generally we consider prescription drugs—both within the Pfizer portfolio and outside it—for potential switch to non-prescription status. Our objective is to provide consumers with significantly greater access to medicines with well-established efficacy and safety profiles without a prescription.”
- Dark web drug market growing rapidly in Europe: report (reuters.com)Drugs and the darknet: perspectives for enforcement, research and policy (emcdda.europa.eu)
The illegal drug trade on the dark web is growing rapidly, despite authorities shutting down major market sites like AlphaBay, as crime gangs diversify and seek new clients online, a report by two European Union agencies warned...The report, which is the first of its kind to analyze the drug trade in Europe on the dark web, showed that online markets are becoming increasingly sophisticated and offering growing numbers of illegal products to buyers...Users are largely anonymous and untraceable and mainly pay with cryptocurrencies like bitcoin...Two thirds of dark web transactions involve drugs, the report by Europol and EMCDDA (The European Monitoring Centre for Drugs and Drug Addiction) found. The biggest European markets are Germany, Britain and the Netherlands. From 2011-2015, drugs worth more than 170 million euros were sold over the dark web worldwide, including nearly 80 million euros worth in Europe...the dark web is an increasingly attractive market because buyers and sellers are anonymous and there is a perception that drugs bought there are good quality...