About Covid-19
White House tells businesses to proceed with vaccine mandate despite court-ordered pause: “The White House on Monday said businesses should move forward with President Joe Biden’s vaccine and testing requirements for private businesses, despite a federal appeals court ordering a temporary halt to the rules.”
How protein-based COVID vaccines could change the pandemic: “Unlike the relatively new technologies that the mRNA and viral-vector COVID-19 shots are based on, protein vaccines have been used for decades to protect people from hepatitis, shingles and other viral infections. To elicit a protective immune response, these shots deliver proteins, along with immunity-stimulating adjuvants, directly to a person’s cells, rather than a fragment of genetic code that the cells must read to synthesize the proteins themselves.
Although protein vaccines are not yet in widespread use for COVID-19, late-stage clinical-trial data so far look promising, demonstrating strong protection with fewer side effects than other COVID-19 shots typically cause.”
Rite Aid to make vaccine sign-up site accessible after DOJ intervenes: “The DOJ said in a release Monday that the site’s calendar didn’t show screen reader users any available appointment times, and those who use the tab key instead of a mouse couldn’t complete the required consent form.
The agreement also alleged the site included some text and links with low color contrast, introducing difficulties for individuals with low vision.”
Qiagen Gets CE Mark for COVID-19, Influenza A and B, RSV Test: “Qiagen has received the CE mark for its QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test, which runs on the company’s QIAstat-Dx system.
The test is intended to quickly identify whether patients have common seasonal respiratory infections or COVID-19…”
OVID-19 Misinformation is Ubiquitous: 78% of the Public Believes or is Unsure About At Least One False Statement, and Nearly a Third Believe At Least Four of Eight False Statements Tested: A fascinating article about misconceptions. One very interesting finding is beliefs by news source:
”People’s trusted news sources are correlated with their belief in COVID-19 misinformation. At least a third of those who trust information from CNN, MSNBC, network news, NPR, and local television news do not believe any of the eight false statements, while small shares (between 11% and 16%) believe or are unsure about at least four of the eight false statements.
Larger shares of those who trust COVID-19 information from leading conservative news sources believe misinformation, with nearly 4 in 10 of those who trust Fox News (36%) and One America News (37%), and nearly half (46%) of those who trust Newsmax, saying they believe or are unsure about at least half of the eight false statements.”
Pfizer-BioNTech expected to seek authorization for coronavirus booster for people 18 and older: “The request, which may be filed as soon as this week, is likely to win the backing of the Food and Drug Administration, said the individuals, who spoke on the condition of anonymity because they were not authorized to discuss the issue. That would essentially fulfill the Biden administration’s booster-for-all-adults goal, announced last August amid concerns about waning vaccine protection.”
About pharma
Purdue Agrees Not To Finalize Ch. 11 Plan Until Appeals Done: “A New York bankruptcy judge said Tuesday that a stay of the implementation of Purdue Pharma's Chapter 11 plan pending appeals was unnecessary after Purdue agreed not to take the plan's final steps until after the first round of appeals are decided.”
Drugmakers get mixed bag in lawsuit rulings over 340B contract pharmacy moves: “A federal judge found drug companies cannot unilaterally restrict sales of products discounted under the 340B program to contract pharmacies.
But a separate ruling found that manufacturers don’t have to provide discounts.
The opinions, released late Friday, are the latest in a legal fight between six drugmakers and the Biden administration over whether they must offer discounted products to contract pharmacies. Federal judges issued separate rulings in lawsuits filed by Novo Nordisk, Sanofi, Novartis and United Therapeutics.
The lawsuits were filed in response to Health Resources and Services Administration’s (HRSA's) decision in May to warn the six drugmakers—Eli Lilly, Sanofi, United Therapeutics, Novartis, AstraZeneca and Novo Nordisk—to walk back the restrictions imposed in summer 2020.”
Merck Announces Receipt of Antitrust Clearance in Germany and Austria Relating to Tender Offer to Acquire Acceleron Pharma Inc.: The SEC still needs to give final clearance.
Oklahoma Court Overturns $465M Opioid Ruling Against J&J: “The Oklahoma Supreme Court on Tuesday overturned a $465 million opioid ruling against drugmaker Johnson & Johnson, finding that a lower court wrongly interpreted the state's public nuisance law.
The court ruled in a 5-1 decision that the district court in 2019 was wrong to find that New Jersey-based J&J violated the state’s public nuisance statute. It also rejected the state’s appeal to increase the damage award.”
Unsealed Emails Show How J&J Shaped Report on Talc's Links to Cancer: “Unsealed emails reveal the role baby-powder maker Johnson & Johnson played in a report that an industry group submitted to U.S. regulators deciding whether to keep warnings off talc-based products linked to cancer.
The emails -- unsealed in the state of Mississippi’s lawsuit against J&J over its refusal to add a safety warning -- show J&J and its talc supplier chose the scientists hired by their trade association, the Personal Care Products Council, to write the 2009 report assessing talc-based powders’ health risks. They also show the researchers changed the final version of their report at the companies’ behest.
The U.S. Food and Drug Administration said it relied in part on the report in its decision to forgo a warning for the product.”
About hospitals and health systems
10 Years of Hospital Readmissions Penalties: “Over the lifetime of the program, 2,920 hospitals have been penalized at least once. That’s 93% of the 3,139 general acute hospitals subject to HRRP [Hospital Readmission Reduction Program] evaluation, and 55% of all hospitals. Moreover, 1,288 have been punished in all 10 years. Only 219 eligible hospitals have avoided any payment reductions since the program’s start in 2013, though more than 2,000 hospitals are automatically exempt from penalties because they have specialized functions: those that focus on children, psychiatric patients, veterans, rehabilitation and long-term care or those that serve as the only hospital in an area.”
Tenet and USPI to Acquire SurgCenter Development and Establish Long-Term Development Partnership:
“Tenet Healthcare Corporation (NYSE: THC), and its subsidiary United Surgical Partners International (USPI), today announced that they have entered into a definitive agreement with the principals of SurgCenter Development (SCD) to acquire SCD. Under the terms of the agreement, Tenet/USPI will acquire SCD’s ownership interests in 92 ambulatory surgery centers (ASCs) and other related ambulatory support services (collectively, the Portfolio).
USPI and SCD’s principals will also enter into a five-year partnership and development agreement designed to provide seamless continuity and support for SCD’s facilities and physician partners over the coming years. Going forward, USPI also has the exclusive option to partner with SCD on de novo development projects over the life of the agreement…
Tenet/USPI will acquire SCD’s ownership interests in 92 ASCs and related ambulatory support services for approximately $1.2 billion.”
25 attorneys general urge court to block New Jersey hospital merger: This action highlights the national attention hospital mergers are receiving.
“California Attorney General Rob Bonta and Pennsylvania Attorney General Josh Shapiro are leading the multistate coalition that is urging an appeals court to keep intact the Aug. 4 decision by the U.S. District Court for the District of New Jersey to grant a preliminary injunction blocking the merger.
In its decision, the district court said the merger would result in anticompetitive effects like higher prices and lower-quality care. Less than a month after the court's decision, Hackensack Meridian and Englewood Health filed an appeal.
The coalition argues the appeals court should block the merger because ‘states have seen a wave of hospital consolidation, resulting in large healthcare systems with substantial market power and the ability to wield it to the detriment of insurers and patients,’ according to a news release from Mr. Bonta's office.”
In a related article on the same topic: Hospital M&A: 18 recent deals
About healthcare IT
Researchers uncover software flaws leaving medical devices vulnerable to hackers: “Researchers say they have found more than a dozen vulnerabilities in software used in medical devices and machinery used in other industries that, if exploited by a hacker, could cause critical equipment such as patient monitors to crash.
The research, shared exclusively with CNN, points to the challenges that hospitals and other facilities have had in keeping sensitive software updated as the resource-absorbing coronavirus pandemic continues. It's also an example of how federal agencies are working more closely with researchers to investigate cybersecurity flaws that could affect patient safety.
Nearly 4,000 devices made by a range of vendors in the health care, government and retail sectors are running the vulnerable software, according to cybersecurity firms Forescout Technologies and Medigate, which discovered the issue.”