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A medical charity that lost a crucial stamp of approval from the U.S. government because it had worked too closely with its drug-company donors said it will decide in January whether it can continue to help patients pay for their prescriptions...the Caring Voice Coalition, one of the biggest patient-assistance charities in the U.S., said it is delaying offering patients financial help for 2018 until it decides what to do...“We are very concerned that we may not be able to remain as a long-term viable resource for individuals with chronic illness,”...the Office of Inspector General of the Department of Health and Human Services rescinded its favorable advisory opinion of the Caring Voice Coalition, in part because the charity had provided drugmakers with data that could help them see if their contributions were helping their own customers. That could potentially give drug companies greater power to raise prices, the HHS said. It was the first time the HHS has rescinded a favorable advisory opinion for a patient-assistance charity.

Translational Software recently became the latest in a growing number of health IT vendors creating systems to advance precision medicine with its debut of its PGx pediatric platform. Another precision medicine player stepped into the market...with a product designed to be integrated smack dab in the middle of a physician’s clinical workflow. 2bPrecise, a cloud-based precision medicine platform vendor and an Allscripts company, launched a pharmacogenomics (PGx) system to bring crucial data to the clinical workflow...2bPrecise Pgx...makes pharmacogenetic information accessible so physicians can make better informed treatment decisions based on a patient’s unique genetic makeup...The 2bPrecise PGx system plugs into an EHR’s native workflow and can integrate content from Translational Software (a genomic data-based clinical decision support system) and other knowledge sources to enable precision medicine-based decision making at the point of care. 2bPrecise’s PGx system is part of its larger precision medicine platform, built to capture and store genomic data from a range of sources, enabling the harmonization of clinical knowledge and genomic research to extract patient-specific insights.

Any health system trying to tackle population health management in any meaningful way has to grapple with the challenge of patients who don't adhere to their care plans – especially those who, for whatever reason, don't take their medicines in the way they were prescribed..."Medication nonadherence is a massive public health problem,"..."We estimate that almost $300 billion a year is spent in caring for health conditions that are attributable to nonadherence – that amount of money could be saved if patients were fully adherent to their medications,"..."11 percent of all hospitalizations and other staggeringly high numbers" – can be directly attributed to patients failing to take their meds on time, in the right dosage or at all...So what's the answer to better health? Innovating on more and more medicines, or getting better at ensure (ensuring) they're put to work on the people who need them most?...Population-level studies have shown that medication adherence is only about 50 to 60 percent...If we know each nonadherent patient had a different reason for that – maybe it's cost, or maybe it's competing priorities, or confusion and uncertainty, or fear of potential side effects – the question becomes: how to ascertain that?..."That's where predictive analytics is really coming into play,"...Predictive strategies can also "help identify who's most likely to benefit from certain types of intervention – that's really where the future of predictive analytics lies,"..."We can identify timing. And we might be able to begin to identify barriers people have and what might be reasons they're not adherent using big data...

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.

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

Walgreens Boots Alliance said Wednesday it would expand its global retail pharmacy operations by taking a 40% stake in Sinopharm Holding Guoda Drugstores Co. Ltd., a subsidiary of China National Accord Medicines Corporation...Sinopharm GuoDa “operates and franchises retail pharmacies across China,” a market that Walgreens CEO Stefano Pessina has said he wants to tap as the companies looks to faster growing and emerging markets to extend its reach...“It is China’s leading pharmacy chain,”,,,Alliance Boots has had a joint venture in China known as Guangzhou Pharmaceuticals, which is a drug wholesaler in China. The joint venture operates pharmacies under a local brand...

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...

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.

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'.

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.