CDC to stop reporting daily COVID-19 cases, moving to weekly

 The Centers for Disease Control and Prevention (CDC) will stop reporting daily COVID-19 cases later this month and switch to weekly reports after more than two years of near constant daily updates.

In an update regarding its coronavirus data and surveillance, the CDC said it was transitioning from daily to weekly reports to allow for more “flexibility” and to reduce the burden on state and local governments. The change in case reporting will take place on Oct. 20.

“Data processing cutoffs for jurisdictions will be every Wednesday at 10AM ET for line level case and death data, and Wednesday at 5PM ET for aggregate case and death data,” the CDC stated.

This move to weekly reports could be similar to how the CDC covers the annual flu season. The agency typically updates its influenza data on a weekly basis, with reports containing compiled data on one site as opposed to the COVID-19 dashboard that is currently being used.

This is the latest in a series of recent developments where the federal government has pulled back on the amount of resources and scrutiny being used in the pandemic.

The Biden administration ended the requirement for international travelers coming into the U.S. to provide a negative COVID-19 test in June.

In late August, the White House said it expected to shift COVID-19 vaccine distribution to the private market early next year. The federal government also stopped offering free at-home COVID-19 tests through the mail that same month.

This decision comes as further pandemic funding has stalled in Congress. The administration had included a request for billions more in funding for both the COVID-19 pandemic and the monkeypox outbreak in the stopgap spending bill last month, but the request was ultimately dropped a few days before the deadline.

https://thehill.com/policy/healthcare/3677194-cdc-to-stop-reporting-daily-covid-19-cases-moving-to-weekly-reports/

Brookdale Senior Living is Exploring a Sale

 Brookdale Senior Living Inc., one of the biggest operators of senior-living communities in the US, is exploring options including a potential sale, according to people familiar with the matter. The stock gained as much as 29%

The Brentwood, Tennessee-based company is working with financial advisers to scope out potential buyers, said the people, who asked not to be identified because the information isn’t public. No final decision has been made and Brookdale could remain independent. 

https://www.bloomberg.com/news/articles/2022-10-07/brookdale-senior-living-is-said-to-explore-sale

House seeks to limit CMS' drug coverage authority after Aduhelm decision

 New bipartisan legislation seeks to limit regulators’ ability to restrict Medicare reimbursement of certain drugs in response to the Biden administration’s controversial Aduhelm decision. 

Reps. Vern Buchanan, R-Florida, and Nanette Barragan, D-California, introduced on Wednesday the Mandating Exclusive Review of Individual Treatments (MERIT) Act. The legislation would reform the Centers for Medicare & Medicaid Services (CMS) process for coverage determinations of new drugs. 

“The federal government should make it easier for seniors to access breakthrough treatments, not unreasonably restrict potentially life-changing drugs for our nation’s most vulnerable patients,” Buchanan said in a statement. 

Buchanan and Barragan’s bill is in response to how CMS handled Medicare coverage of Biogen’s Aduhelm, a controversial Alzheimer’s disease treatment. 

Back in April, CMS finalized a national coverage determination that targets not only Aduhelm but the entire class of treatments. CMS ruled that only Medicare patients in eligible clinical trials would get coverage for the monoclonal antibodies directed against amyloid plaques.

So far, the Food and Drug Administration has only approved Biogen’s Aduhelm in the class. However, more such drugs are in the pipeline, and their clinical efficacy has been disputed.

The legislation would require CMS to evaluate any new drugs or treatments individually instead of an entire class as in the Aduhelm decision. 

“By requiring CMS to review each drug individually, the MERIT Act will undo the actions taken by CMS that would otherwise unnecessarily limit access to drugs like Aduhelm for seniors,” according to a release on the legislation. 

Buchanan noted in a release that preliminary data have shown promising results for a drug similar to Aduhelm. 

The legislation has broad support from Alzheimer’s patient groups that vehemently fought the CMS decision. 

“This bill corrects a massive injustice by CMS against people with Alzheimer’s,” said George Vradenburg, chairman and co-founder of the group UsAgainstAlzheimer’s, in a statement. “The decision by CMS to deny coverage for the first class of disease-modifying Alzheimer’s treatments, including those still in clinical trials, was cruel and unconscionable.”

It remains unclear whether the legislation would get through Congress before the end of this session as lawmakers don’t come back until after the midterm elections next month. However, if Republicans take the House, Buchanan would be in line to lead the health subcommittee on the powerful Ways and Means Committee, which could help passage in the next session. 

CMS said in a statement it does not comment on pending legislation.

https://www.fiercehealthcare.com/payers/house-lawmakers-seek-limit-cms-drug-coverage-authority-after-aduhelm-decision

Sarepta Therapeutics Presents New Data from its Gene Therapy and RNA Platforms

 Sarepta Therapeutics, Inc.  (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will share new data from across its genetic medicine portfolio at the 27^th International Hybrid Annual Congress of the World Muscle Society 2022 Congress (WMS 2022), taking place Oct. 11-15, 2022, in Halifax, Nova Scotia, Canada.

Data includes a late-breaking real-world evidence presentation on eteplirsen in treated patients with Duchenne amenable to exon 51 skipping, in addition to research from the Company’s gene therapy platform including preclinical data supporting the functionality of the SRP-9001 (delandistrogene moxeparvovec) Sarepta’s investigational gene therapy for the treatment of Duchenne.

https://www.biospace.com/article/releases/sarepta-therapeutics-presents-new-data-from-its-gene-therapy-and-rna-platforms-at-world-muscle-society-2022/

BridgeBio: New Data on Novel Approaches to RAS-driven Cancers

 The conference will take place at the National Cancer Institute at Frederick, Maryland from October 17-19, 2022

- Presentation to include details from next-generation G12C dual inhibitor clinical candidate and characterization of advanced leads from thePI3Kα:RAS breaker program

- BridgeBio will host an investor call on October 17, 2022 at 1:30 pm ET to discuss the data and next steps for its two lead RAS programs

- RAS is the most common oncogenic driver with approximately 30% of all human cancers being driven by RAS mutations, including large proportions of lung, colorectal and pancreatic tumors. PIK3CA is the second most common oncogene in human tumors, being present in more than 30% of breast and endometrial carcinomas.

Webcast Information
BridgeBio will host an investor call and simultaneous webcast to discuss preclinical data from both lead RAS programs and the selection of the KRAS G12C dual inhibitor development candidate on October 17, 2022 at 1:30 pm ET. To access this call via phone, participants will need to register using the following link where they will be provided a phone number and access code: (https://register.vevent.com/register/BIbd4d7a752dcc4ade970571556d4060e5). The webcast and presentation slides can be viewed during the time of the call via a link on the event calendar page of BridgeBio’s website at https://investor.bridgebio.com/. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days following the event. 

https://www.biospace.com/article/releases/bridgebio-pharma-to-present-new-data-on-its-novel-approaches-to-ras-driven-cancers-at-the-fourth-ras-initiative-symposium/

96% of Humana Medicare Advantage Members in Contracts rated 4-Star or Above for 2023

 

• Humana received a 5 out of 5-star rating for HMO plans in Louisiana, Tennessee and Kentucky, covering approximately 356,000 members
• Humana received a 4.5-star rating for Medicare Advantage contracts offered in 46 states and Puerto Rico, covering more than 3 million members, nearly double last year’s members in plans with this rating
• 4.9 million, or approximately 96%, of Humana Medicare Advantage members are currently enrolled across in plans rated 4 stars and above for 2023
• 99% of Humana’s Group Medicare Advantage members in rated contracts will be in 4-star plans or higher for 2023

https://www.biospace.com/article/releases/96-percent-of-humana-s-medicare-advantage-members-are-in-contracts-rated-4-star-or-above-for-2023-66-percent-are-in-contracts-rated-4-5-star-or-higher/

Alnylam: FDA OKs application for liver disease treatment

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved a label expansion for OXLUMO® (lumasiran), an RNAi therapeutic administered via subcutaneous injection, now indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate (UOx) and plasma oxalate (POx) levels in pediatric and adult patients. The approval is based on positive efficacy and safety results of the ILLUMINATE-C Phase 3 study of OXLUMO in patients with severe renal impairment, including those on hemodialysis.

PH1 is an ultra-rare genetic disease characterized by oxalate overproduction in the liver. The excess production of oxalate results in the deposition of calcium oxalate crystals in the kidneys and urinary tract and can lead to the formation of painful and recurrent kidney stones and nephrocalcinosis, which can progress to kidney failure. PH1 can also lead to oxalate deposition in multiple organs beyond the kidney, a condition known as systemic oxalosis.

https://finance.yahoo.com/news/alnylam-announces-fda-approval-supplemental-003000004.html