- CVS To Invest Tax Cut In Worker Wages And Reducing Aetna Deal’s Debt (forbes.com)
CVS Health...said...it plans to use more than $1 billion in benefits from a new corporate tax cut to boost wages and benefits for workers and reduce debt from its purchase of Aetna...The drugstore chain is gaining $1.2 billion in overall annual tax savings from the Tax Cuts and Jobs Act passed last year....CVS plans to use $425 million annually to increase the starting wage for hourly employees to $11 an hour , freeze employee health premiums for a year and create a new parental leave program...CVS' annualized tax benefit will also be directed toward “data analytics, care management solutions and store service offering pilots to improve health outcomes and lower costs for patients, as well as on debt reduction related to its planned acquisition of Aetna...
- ‘Ostracized and criticized’ Indian CRO hits US FDA with $50m lawsuit (in-pharmatechnologist.com)
Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns...In April 2016, the US Food and Drug Administration issued Semler Research Center an ‘Untitled Letter’ stating evidence it had found of data manipulation in a number of bioanalytical studies during an inspection of its facility in Bangalore, India...The Agency then sent a notice to drug sponsors that bioavailability/bioequivalence studies conducted by the contract research organisation would need to be repeated...Semler filed a lawsuit against the FDA, the United States Department Of Health And Human Services and the United States Of America – along with various individuals – for total damages of approximately $50m...The firm claims the FDA’s actions were in violation of the Fifth Amendment, interfered with economic advantages and intentionally inflicted financial distress on the company.
- Long-Dreaded Amazon Threat to Drug Middlemen Draws Closer (bloomberg.com)
The industry awoke to the news Tuesday that Amazon.com Inc. was joining with Berkshire Hathaway Inc. and JPMorgan Chase & Co. to form a new health-care business, in an attempt by three of the world’s best-known companies to contain the spiraling cost of keeping their U.S. workers healthy...Other groups of big employers have tried to improve worker health care in the past, but none have dethroned the pharmacy-benefit managers who drug companies and some lawmakers claim aren’t transparent about the pricing deals they strike on behalf of health plans, and about how much money they keep for themselves...“They could completely cut out the middlemen here,” said Pratap Khedkar...at...ZS Associates. By doing so, Amazon, Berkshire and JPMorgan could gain more control over their spending and save money pharmacy-benefit managers currently consume...
- FDA asks drugmakers to limit amount of opioid drug in packaging (reuters.com)
...Food and Drug Administration is asking manufacturers of a common opioid medicine to change the way the drug is packaged, as part of efforts to deter its abuse amid an opioid epidemic...The FDA said...it sent letters to manufacturers of diarrhea medicine loperamide, asking them to ensure that packages contain only a limited amount of the drug that is appropriate for use for short-term diarrhea...The agency wants to eliminate the large bottles in which loperamide is often sold because the abuse of the drug requires such large quantities.
- Pharma’s latest defense against pricing criticism: Drugs lower health-care costs (cnbc.com)
When the topic of drug prices comes up, as it so often does in this post-Martin Shkreli world, pharma is always prepared with a rebuttal...Pharma CEOs are now touting that the use of medicines lowers other health-care spending...Studies have shown some truth to the claim, but critics say the support doesn't go that far...most often, pharmaceuticals have the effect of improving or maintaining an individual's health...for example, taking antibiotics to prevent a more severe infection or adhering to medication to manage a chronic condition like diabetes or high blood pressure...In either of those circumstances, taking the medication may also avert hospital admissions and thus reduce the use of medical services...
- Fair Pharma? Intermountain’s New Generic Drug Company (catalyst.nejm.org)
Leemore Dafny, PhD, interviews Marc Harrison, MD, President and Chief Executive Officer of Intermountain Healthcare.
Dafny: We’re here to talk about this new initiative that you are spearheading to create a new generic manufacturing company for pharmaceuticals, and I want to start by saying that we’ve seen a lot of vertical integration in health care, typically different health care providers merging, or providers and health plans. But integration of providers into pharmaceutical manufacturing — setting aside a little compounding — is pretty unprecedented. So I just want to start our conversation by asking, why are you doing it?
Harrison: Well, I guess I’d say necessity is the mother of invention, right? This is not an ambition that Intermountain, nor I suspect the other systems, have had, but as organizations that really try and put our patients at the center of everything we do, some of the issues we’re having around shortages and then secondarily around pricing — they’ve changed the way we’ve thought about things, and so I guess the very few folks in the generic drug industry who are creating these issues, we owe them some thanks because it’s caused us to think creatively.
- Online forums give investors an early warning of shady scientific findings (statnews.com)
Scientists around the globe nowadays regularly take to the internet to scrutinize research after it’s been published — including to run their own analyses of the data and spot mistakes or fraud...And as interest in this so-called post-publication peer review has swelled, one lawyer argues, biotech and pharma companies would do well to take note. If companies and their investors aren’t reading these sites, they may be the last to know when industry-funded research is called into question...The most prominent forum for these discussions is PubPeer, where anyone can create an anonymous account and comment on published research papers. Many of the posts on PubPeer point out instances of plagiarism and duplicated or manipulated images — all of which represent retractable offenses and serious scientific misconduct. But posters often note erroneous data, flawed methodology, or even just sloppy thinking that somehow escaped the scrutiny of peer reviewers before the article was published.
- Justice Department requests more information on CVS-Aetna merger (cnbc.com)
Trump administration regulators are not ready to sign off on CVS Health's $69 billion deal to acquire Aetna...The Department of Justice asked the firms to provide more information on Thursday, just as the 30 day waiting period under Hart Scott Rodino Act expired...So far, the Trump administration has shown it's not receptive to vertical integration deals...The DOJ's second notice request extends the waiting period on the CVS-Aetna deal for another 30 days. In the meantime, the firms have scheduled shareholder votes to approve the deal for March 20th.
- The ‘smart pill’ market could be worth $3B by 2025 – meet the key players (drugdeliverybusiness.com)
The “smart pill” market is expected to nearly quadruple in value to $3 billion by 2025...Driving this growth is an increasing demand for minimally-invasive procedures, as well as better patient monitoring capabilities...
- Medtronic‘s SmartPill...capsule measures pressure, acidity, temperature and transit time as it passes through a person’s gastrointestinal tract...
- CapsoVision...has created...CapsoCam Plus small bowel capsule endoscope system...is designed to give a 360-degree panoramic lateral image of the small bowel to help clinicians spot small bowel abnormalities...
- Olympus Corp...Endocapsule EC-10 system is designed to help doctors visualize the small bowel…and features a 160-degree wide-angle field of view...
- Proteus Digital Health...a pill that can monitor patient compliance...The system helps patients track the ingestion of their medication by sending a message from the pill’s sensor to a wearable patch, which then transmits the data to a mobile app.
- EtectRx...ID-Cap system includes a capsule embedded with a sensor that sends a signal to a battery-powered reader worn around the user’s neck once the pill reaches the stomach...then sends that data to a smartphone via Bluetooth to reach the patient and, ultimately, the physician.
- Report: Medicare Part B Payment Hikes Could Offset 340B Cuts for Many Hospitals (ptcommunity.com)
...some dispute...findings on the controversial cuts...Increased reimbursements under Medicare Part B overall could offset potential losses for hospitals under changes to the 340B discount program, according to a new analysis...consulting firm Avalere Health analyzed hospital-level data from the Centers for Medicare and Medicaid Services on reimbursements in 2017 and 2018 and found that 85% of hospitals would receive higher Part B payouts that would minimize the reductions from cuts to 340B discounts...CMS finalized changes to 340B in November, changing its payment rate to 22.5% less than the list price for medication. Previously, it had paid up to 6% more than the list price under the program, and the cuts could equal $1.6 billion in lost payments...Rural hospitals would especially benefit from CMS’ increased Part B payouts, according to Avalere, as those facilities will net an average increase of 2.7%. Urban hospitals will see a 1.4% net increase...The 340B program wasn’t always controversial, but in recent years lawmakers and pharmaceutical companies have expressed concern that too many hospitals have enrolled, taking advantage of the program’s discounts. A study...suggests that hospitals have snapped up physician practices in areas like oncology to boost their 340B discounts but don’t often invest those savings in improving care for low-income patients.