- Boehringer Ingelheim inks outcomes-based contract with pharmacy benefit manager for diabetes drug (drugdeliverybusiness.com)
Boehringer Ingelheim has inked an outcomes-based contract with pharmacy benefit manager Prime Therapeutics for its oral Type II diabetes drug, Jardiance...The medication is designed to cut the risk of cardiovascular death in adult patients with Type II diabetes and established heart disease...As part of Prime’s CareCentered Contracting program, the outcomes-based deal will focus on the total cost of care for Blue Cross and Blue Shield members taking Jardiance compared to the total cost of care for patients using other diabetes drugs...this outcomes-based contract...represents an important step towards improving outcomes by lowering the total cost of care of people with diabetes...Diabetes and cardiovascular disease put a significant financial burden on the healthcare system, and we are confident Jardiance may improve outcomes by reducing the overall healthcare costs of people with Type II diabetes and cardiovascular disease...
- US FDA to take risk-based approach to biomanufacturing inspections (in-pharmatechnologist.com)
A risk-based approach to inspection regulations could result in increased audits of more complex manufacturing sites, the FDA says...The final rule...revises time of inspection requirements and removes the duties of inspector requirements, both contained in section 600 of the Code of Federal Regulations (entitled ‘Biological Products: General’)...It will affect how often the Food and Drug Administration is inspecting certain facilities and implement a risk-based schedule replacing...the biennial inspection requirement for drug and biological product establishments required in the Federal Food Drug and Cosmetic Act and aligning the requirements with 2012’s Food and Drug Administration Safety and Innovation Act ...“This change clarifies the FDA’s flexibility under FDASIA to inspect facilities either more or less frequently, according to the potential risk the establishment’s operations present, without diminishing public health protections,”...According to Commissioner Scott Gottlieb, the ruling is part of efforts to modernise the FDA’s regulations, remove inefficient policies and reduce costs.
- Arizona governor signs opioid crackdown legislation (reuters.com)
Republican Governor Doug Ducey...signed into law legislation intended to crack down on opioid abuse, calling it vital to combat an epidemic felt statewide and across the nation...The legislation includes new regulations that will limit initial opioid prescriptions to five days and set a maximum of 30 days for certain patients receiving highly addictive painkillers...Other measures call for $10 million to be spent treating opioid abusers who are underinsured and ineligible for Medicaid. A controversial provision holds harmless those reporting potential overdoses...Despite the unanimous final vote, some lawmakers raised concerns about the unintended consequences of the state becoming more involved in doctor-patient issues, fearing it may hurt individuals needing opioids...
- 340B Program Fails to Meet Its Promise, Study Finds (ptcommunity.com)
Under-served patients haven’t benefited...The 340B Drug Pricing Program, a 25-year-old discount plan aimed at boosting resources for hospitals treating low-income patients, has not delivered on its promise to enhance care for the needy, according to research from Harvard Medical School and the NYU School of Medicine...The federal program was designed to provide discounted drugs to hospitals that treat many low-income patients under the premise that generating surplus revenue would give these hospitals the financial resources to improve care for their most vulnerable. However, eligible hospitals have not used the financial windfalls from the program in ways that have clearly benefited under-served patients, according to results of the study published January 24 in The New England Journal of Medicine...Researchers say their findings paint a picture of good intentions handicapped by poor policy design and lack of oversight.
- Accused of stealing Teva secrets, Apotex CEO exits abruptly even as founder’s death ruled homicide (fiercepharma.com)
The turmoil at Canada’s largest homegrown pharma company, generics maker Apotex, continues with the resignation of CEO Jeremy Desai even as the company deals with the fallout from the murders of the company’s founder...The resignation of Desai comes six months after Teva filed a lawsuit against him and Apotex claiming that for two years Desai received copies of Teva trade secrets from his girlfriend, Barinder Sandhu, who before her 2016 departure was Teva’s chief of regulatory affairs for its American generics business...Separately, Toronto police...announced that they were investigating the strangulation deaths of 75-year-old Apotex founder Barry Sherman and his 70-year-old wife, Honey, as a targeted double murder...The Canadian billionaire was known to be litigious and was involved in a number of legal battles...
- Amazon, Berkshire, and JP Morgan to partner on health care (cnbc.com)Amazon, Berkshire Hathaway and JPMorgan Team Up to Try to Disrupt Health Care (nytimes.com)Amazon's moves in health care over the last year are finally starting to make sense (cnbc.com)
CNBC's Becky Quick reports Amazon, Berkshire Hathaway and J.P. Morgan Chase announcing they will partner on U.S. employee health care.
- Allscripts sued over ransomware attack, accused of ‘wanton’ disregard (healthcareitnews.com)Allscripts clients back online, but issues plague some cloud-based providers (healthcareitnews.com)
Just one week after some of Allscripts’ services were shut down by ransomware, the EHR giant is facing a lawsuit for allegedly failing to secure its systems and data from cyberattacks...Allscripts went down on Jan. 18, after two of its data centers...fell victim to SamSam ransomware...Florida-based Surfside Non-Surgical Orthopedics is suing Allscripts on behalf of all clients impacted, as the system outage resulted in canceled appointments, care disruptions and "significant business interruption and disruption and lost revenues.”...The provider was unable to access its patient records or electronically prescribe medications, and as a result of the outage, Surfside has “expended significant time and effort resolving these issues resulting from the breach.”...Surfside alleges that Allscripts was aware of “deficiencies in its products and services [that] could result in privacy and security vulnerability or compromises and failed to take adequate measures to protect against any such event.”
- FDA Releases 2018 Compounding Policy Priorities Plan (iacprx.org)
The Food & Drug Administration has released a 2018 Compounding Policy Priorities Plan...FDA also issued a final guidance on mixing, diluting, or repackaging biological products, which describes the conditions under which the agency does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. According to FDA, "These policies are intended to minimize public health risks, while preserving access to these products for patients who have a medical need for them."
- Canadian medical billionaire and his wife were murdered in ‘targeted’ hit, police say (scmp.com)Billionaires Barry and Honey Sherman were murdered, Canada police say (theguardian.com)
Canadian pharmaceuticals billionaire Barry Sherman and his wife Honey, who were found hanged at their indoor swimming pool, were murdered...Detective Sergeant Susan Gomes said investigators came to the conclusion after six weeks of investigation, but declined to discuss possible motives or suspects...“We have sufficient evidence to describe this as a double homicide investigation and that both Honey and Barry Sherman were in fact targeted,”…Sherman, the founder of generic drug maker Apotex, and his wife were found dead in their mansion on December 15...Sherman was a fiercely competitive businessman, once musing that a rival might want to kill him...The 75-year-old tycoon was known for litigiousness and aggressive businesses practises as he developed Apotex, which has a global workforce of about 11,000. He conceded he made enemies in Prescription Games, a 2001 book about the industry.
- Big pharma paying top dollar for biotech assets: Pro (cnbc.com)
"At some point this has to end," John Rountree, partner at Novasecta Limited, says of consolidation in the pharmaceuticals sector.