- Brazilian court strips Gilead of its patent for Hepatitis C drug Sovaldi (pharmaceutical-technology.com)
A judge from the 21st Federalist Court of Brasilia has ruled to invalidate US biopharma company Gilead’s exclusivity patent for Sovaldi (sofosbuvir)...Hepatitis C is a major public health issue in Brazil; it has been estimated by Brazilian academics that 1.5 million people in the country were chronically infected with the virus in 2014...A centre-left, environmentalist presidential candidate for the upcoming election, Marina Silva, filed a popular action analysis complaint to the court arguing that Gilead’s patent for Sovaldi should be overturned in order to reduce costs for patients...The patent was granted in 2015 by the National Institute of Industrial Property...Silva and her running mate Eduardo Jorge claim the INPI made the decision without the consent of the National Agency of Sanitary Surveillance, meaning Brazil’s national interest was not adequately recognised in the decision...
- This Week in Managed Care: September 28, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- AbbVie’s not the only one facing kickbacks scrutiny. Add Biogen, Sanofi, Gilead and more (fiercepharma.com)
At first glance, it seems like a logical idea: pharma companies teaching doctors' staff how to handle patients using their drugs and helping staffers with reimbursement questions. But a slew of companies are discovering that it's not so simple...In fact, it might just be against the law...Biogen, Sanofi and Gilead Sciences are under investigation by federal and state authorities for offering reimbursement services and clinical education programs, the companies have disclosed in securities filings. Additionally, Bayer, Amgen and Eli Lilly face whistleblower lawsuits over the issue...In Sanofi’s case, the U.S. Attorney’s Office...sent the company a civil investigative deman...“requesting documents and information relating to Sanofi US’s certified diabetes educator program during the period from 2007 to the present.”...Gilead....received a voluntary request from the U.S. Attorney’s Office...seeking information “related to our reimbursement support offerings, clinical education programs and interactions with specialty pharmacies for Sovaldi and Harvoni...
- DOJ wants Aetna, CVS Health to divest Part D plans before merger approval (healthcarefinancenews.com)
CVS Health and Aetna need to divest some of their Medicare Part D assets before the Department of Justice will grant approval for their proposed $69 billion mega-merger...The DOJ is expected to conclude its review of the deal once the companies have satisfied the antitrust concern...Aetna has a 9 percent market share among Part D plans while CVS Health has a 24 percent market share, with overlap in some markets...California Insurance Commissioner Dave Jones asked the DOJ to block the merger over Part D concerns, saying that reducing competition for the drug prescription plans would likely result in higher premiums.CVS has 6.1 million Part D members; UnitedHealth, 5.36 million; Humana 4.9 million; Express Scripts 2.5 million; and Aetna 2.2 million...The merger...would add a pharmacy benefit manager to one of the nation's largest health insurance companies...Approval for the vertical integration between payer and PBM has shown more success than the horizontal mergers proposed between Aetna, Humana and Anthem, Cigna. The DOJ blocked both mega bids on the basis of antitrust concerns.
- Scientists behind game-changing cancer immunotherapies win Nobel medicine prize (reuters.com)2018 Nobel Prize in Medicine Awarded to 2 Cancer Immunotherapy Researchers (nytimes.com)
American James Allison and Japanese Tasuku Honjo won the 2018 Nobel Prize for Physiology or Medicine on Monday for game-changing discoveries about how to harness and manipulate the immune system to fight cancer...The seminal discoveries by the two Laureates constitute a landmark in our fight against cancer...Allison...worked on a protein known as CTLA-4 and realized that if this could be blocked, a brake would be released, unleashing immune cells to attack tumors...Honjo...separately discovered a second protein called PD-1 and found that it too acted as an immune system brake, but with a different mechanism...The discoveries led to the creation of a multibillion-dollar market for new cancer medicines. In particular, drugs targeting PD-1 blockade have proved a big commercial hit, offering new options for patients with melanoma, lung and bladder cancers...
- September 28: Pharmacy Week in Review: Bills Receive Congressional Approval to Prohibit Gag Clauses (pharmacytimes.com)
Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Health Management Associates to pay $260 million to settle criminal charges for allegedly defrauding Medicare, Medicaid (cnbc.com)Health Management Associates Pays $260 Million To Settle Whistleblower Lawsuits (marketwatch.com)
Health Management Associates agreed to pay more than $260 million and entered a deferred prosecution agreement to settle criminal charges for allegedly paying physicians kickbacks and defrauding Medicare, Medicaid and other federal programs...HMA, which was acquired by the for-profit hospital Community Health Systems in 2014, allegedly paid physicians in exchange for patient referrals and submitted inflated claims for emergency department facility fees to federal health insurance programs...HMA pressured emergency room physicians, including through threats of termination, to increase the number of inpatient admissions from emergency departments — even when those admissions were medically unnecessary...
- New REMS for Immediate-Release Opioids in Outpatient Settings – Training for Pharmacists and Nurses, Not Just Prescribers (ptcommunity.com)
The FDA has approved a final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) that includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS, for the first time...
- ….applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics…
- ….training be made available to health care providers who are involved in the management of patients with pain (e.g., nurses and pharmacists), and not only to prescribers.
- ...education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain.
- ...new product labeling containing information about the health care provider education available through the new REMS.
- ,,,the agency has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint). This includes updated educational content.
- Novartis, axing 19% of its workforce, faces big challenges with thinned ranks (fiercepharma.com)
....CEO Vas Narasimhan’s plan to reduce Novartis’ overall workforce by at least 19%, from 124,000 today to under 100,000 by 2022, he told reporters...Most of those cuts will come from manufacturing and the company’s 2019 spinoff of its Alcon eye unit. But a restructuring of business services will result in an additional 700 jobs lost, the company said...Novartis plans to move some management operations from its Basel headquarters to the five service centers in India, Malaysia, Mexico, the Czech Republic and Ireland...The primary drivers for this intention are the benefits that standardization, simplification and a sound global services location strategy bring over time...Novartis stands out for the sheer size and scope of its downsizing plan—and for the challenges the company will still have to address with a rapidly shrinking workforce. Novartis is grappling with marketing and manufacturing issues surrounding Kymriah, for example, and it called off planned price hikes in the face of increasing scorn from Washington on Big Pharma pricing practices. Novartis is also facing pricing pressure on key products, including psoriasis drug Cosentyx and its stable of generic drugs produced by its Sandoz division, which is facing a sales decline in the U.S. even as its volume continues to grow.
- Pharma’s slow embrace of continuous manufacturing (biopharmadive.com)
Widespread in other industries, continuous manufacturing features what's essentially an end-to-end assembly line, through which raw materials are steadily fed and constructed into final products...It's seen as faster and more flexible than the tried-and-true system of batching that forms the foundation of pharma manufacturing. The Food and Drug Administration is eagerly encouraging its use ...on a whole, the industry remains wedded to batch production. The reasons for why are many, but foremost is a reluctance to overhaul finely tuned manufacturing networks or to introduce new risks into drug development...Doing something different like continuous was going outside the box...Using an uninterrupted production process eliminates, or significantly reduces, the "hold times" in between steps that are typical in batch manufacturing. For J&J, production of Prezista used to take about two weeks from start to finish using batch methods...through continuous manufacturing, production takes only three days...since the raw ingredients don't need to transition in and out of production for quality testing, continuous manufacturing systems can run over a longer period of time, potentially upping output...For all of the advantages of continuous manufacturing over batch production, drugmakers must weigh switching over against retooling carefully crafted production networks.