About Covid-19
CDC Backs Boosters for High-Risk Kids Aged 5-11, Shorter Time Between Shots: “The U.S. Centers for Disease Control and Prevention on Tuesday backed the emergency use approval of Pfizer's booster shot for high-risk kids between the ages of 5 and 11, along with shortening the time period between a second dose and a booster shot from six months to five months.
Both approvals came from the U.S. Food and Drug Administration on Monday…”
CDC recommend Pfizer-BioNTech booster for 12-to-17-year-olds: “The Centers for Disease Control and Prevention recommended Wednesday that children 12- to 17-years-old should get a Pfizer-BioNTech coronavirus vaccine booster, expanding protection to adolescents and teens as surging infections threaten to disrupt schools and workplaces across the country.”
A variant found in France is not a concern, the W.H.O. says.: “The World Health Organization says that it is monitoring a coronavirus variant detected in a small number of patients in France, but that, for now, there is little reason to worry about its spread.
The B.1.640.2 variant was first identified in October and uploaded to Gisaid, a database for disease variants, on Nov. 4. Only about 20 samples have been sequenced so far, experts said this week, and only one since early December.
Abdi Mahmud, a Covid incident manager with the W.H.O., told reporters in Geneva on Tuesday that the variant had been on the agency’s radar since November, but added that it did not appear to have spread widely over the past two months.”
Omicron estimated to be 95.4% of coronavirus variants in U.S. - CDC: “The Omicron variant was estimated to be 95.4% of the coronavirus strains circulating in the United States as of Jan. 1, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.”
Biden’s coronavirus testing push will need to face the ghost of websites past: “The swift spread of the omicron variant has laid bare the dearth of coronavirus tests nationwide, prompting President Biden last month to announce plans to make 500 million rapid tests available in part through a new federal website where citizens can sign up to receive them.
If history is any indication, though, the portal’s launch could face some of the same technological stumbling blocks that have plagued similar projects in the past.”
Israeli study reports fivefold jump in antibodies with 4th Pfizer vaccine shot: “A fourth shot of the Pfizer-BioNTech coronavirus vaccine generated a fivefold boost in antibodies a week after the jab, according to preliminary results of a study made public by the Israeli government Tuesday…
‘The fourth shot acted just like the first and second shots,’ said Sheba spokesperson Steve Walz. ‘A few people had low fevers, a few had sore arms but nothing more than that.’”
Existing vaccines effective against severe Omicron, study suggests: “Cellular immunity elicited by the BioNTech/Pfizer and Johnson & Johnson Covid-19 vaccines is effective against the Omicron coronavirus variant, according to a study, suggesting vaccines will protect against severe disease even if the antibody responses against the strain are not as strong or durable. The findings, contained in a new Harvard medical school study, add to evidence that the current vaccines hold up against severe Covid outcomes, and could help health authorities to decide whether to switch to Omicron-targeted jabs.”
COVID-19 Oral Vaccine and Antibody Booster: B. subtilis Spores, Biotechnology Breakthrough by DreamTec: “In its recently published peer-reviewed paper in an international medical journal Vaccines, which demonstratesBacillus subtilis (B. subtilis) spores, expressing a SARS-CoV-2 spike protein receptor binding domain (sRBD) on their surface can then produce neutralizing antibodies. DreamTec conducted a pilot study for a new COVID-19 oral vaccine which is able to elicit an immune response in both mice and human volunteers without adverse effects…”
Dr. Reddy’s to Price Generic Pill of Merck’s COVID-19 Antiviral at 50 Cents: “Generics giant Dr. Reddy’s Laboratories has reportedly priced its generic version of Merck’s COVID-19 oral antiviral, molnupiravir, at approximately 50 cents a pill.
Shortly before the new year, Dr. Reddy’s won Emergency Use Authorization from the Drugs Controller General of India allowing the company to produce its generic, which will be sold under the brand name Molflu in India. The drug will reportedly be made available to Indian pharmacies starting next week.”
COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly: From the Office of HHS OIG: “Medicare Part B spent $1.5 billion on COVID-19 tests in 2020, while at the same time, spending on non-COVID-19 tests declined by $1.2 billion. The result was a net spending increase of 4 percent, but the decrease in utilization of non-COVID-19 tests raises questions about the potential impacts on beneficiary health.”
U.S. reports over 1 million new daily Covid cases as omicron surges: “The U.S. has reported a record single-day number of daily Covid cases, with more than 1 million new infections.
A total of 1,082,549 new coronavirus cases were reported Monday, according to data compiled by Johns Hopkins University, as the highly infectious omicron variant continues to spread throughout the country and beyond.
The U.S. also has the highest seven-day average of daily new cases in any country tracked by Johns Hopkins.”
Walmart, Kroger Raise Prices of Covid-19 Test Kits: “Walmart Inc. and Kroger Co. are raising their prices for BinaxNOW at-home rapid tests, after the expiration of a deal with the White House to sell the test kits at cost for $14…
The deal with the White House expired in December, and Walmart said this week that it is raising the kits’ price to $19.98 a box. Kroger now sells them for $23.99. The BinaxNOW tests aren’t currently available on Amazon.”
Walmart to offer COVID-19 antiviral prescriptions: “Walmart said Pfizer’s Paxlovid and Merck’s Molnupiravir, both oral medicines, will be available at some Walmart and Sam’s Club pharmacies this week as supplies allow….
Since Paxlovid and Molnupiravir are prescribed to people with COVID-19, the drugs will be available at Walmart and Sam’s Club only via curbside pickup or drive-through pharmacy windows, according to Walmart.”
About health insurance
Centene closes $2.2B acquisition of Magellan Health: “Centene has completed its $2.2 billion acquisition of managed care organization Magellan Health, moving the insurer further into the behavioral health space, the company said Tuesday.
Centene and Magellan cleared all regulatory hurdles, both at the state and federal level, a condition of closing the deal. Magellan will operate independently under the Centene umbrella and will continue to be led by CEO Ken Fasola…
Magellan will add 5.5 million members and boost Centene's established presence in specialty healthcare and pharmacy management.”
About pharma
Delaware Judge Denies Sarepta Protection Under Hatch-Waxman “Safe Harbor”: On January 4, 2022, Judge Andrews from the United States District Court for the District of Delaware denied Sarepta Therapeutics, Inc.’s (“Sarepta”) Rule 12(b)(6) motion to dismiss a complaint for infringement of U.S. Patent No. 10,526,617 filed by Regenxbio, Inc. (‘Regenx’) and the University of Pennsylvania (‘UPenn’).
The ‘617 patent claims a ‘cultured host cell containing a recombinant nucleic acid molecule encoding the capsid protein.’ Regenx and UPenn alleged that Sarepta manufactured and used cells covered by the ‘617 patent in order to make certain gene therapy products including Sarepta’s ‘SRP-9001…
In denying Sarepta’s motion, Judge Andrews agreed with Regenx and relied on Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008), a case which found that the Safe Harbor did not apply to use of a patented optical spray analyzer that was used in connection with regulatory submissions for aerosol drug delivery systems but was itself not subject to regulatory approval. Citing several district court rulings following Proveris, Judge Andrews held that “a patented product that is not subject to FDA premarket approval is not a ‘patented invention’ under §271(e)(1)” and is therefore not covered by the Safe Harbor.”
The text of the decision quotes from the Hatch-Waxman Act:
“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”
DC Circ. Revives Terror-Funding Case Against AstraZeneca: “The D. C. Circuit on Tuesday revived a lawsuit accusing AstraZeneca, Pfizer and several other pharmaceutical companies of helping to finance terror acts — through lucrative medical goods contracts with Iraq's health ministry — that have injured or killed hundreds of U. S. service members and civilians in the country between 2005 and 2011. A three-judge panel overturned and remanded a D. C. federal court's July 2020 dismissal order, which found that service members and other victims of the Hezbollah-linked militia group Jaysh al-Mahdi failed to state claims for either direct or secondary "aiding-and-abetting" liability under the Anti-Terrorism Act, or ATA.”
About hospitals and health systems
Hospitals Still Not Fully Complying With Federal Price-Disclosure Rules: “No hospitals have been penalized as of late December, according to the Centers for Medicare and Medicaid Services, which is responsible for enforcing the rules. The maximum penalty this year for violators is $109,500 per hospital, and the penalty increases to as much as $2 million in January.
The agency has issued approximately 335 warnings for violations and is giving hospitals information and technical help to increase compliance as of early December, a CMS spokeswoman said. Regulators also requested that 98 hospitals submit plans for how and when they would comply.”