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Friday, December 12, 2025

Pax­ton Sues EPIC for Gate­keep­ing Data, Restrict­ing Parental Access to Children’s Med­ Records

 Attorney General Ken Paxton filed a lawsuit against Epic Systems Corporation (“Epic”) for their unlawful monopolization of the electronic health records industry and for engaging in deceptive practices that restrict parental access to their minor children’s medical records.

Epic’s database software houses more than 325 million patient records, representing 90% of all U.S. citizens. The corporation uses a wide range of exclusionary tactics to prevent potential competition from its partners, customers, and even its own employees. Epic also interferes with hospitals’ ability to use its own patient data as part of its scheme to block software competitors. As a result, Texas patients experience diminished quality of health care due to their preferred physicians receiving incomplete or out-of-date patient health records. These anticompetitive practices further harm Texas hospitals and Texas patients by raising costs and blocking innovative technologies. 

Additionally, Epic exploits its control over patient medical records, data it does not own, to automatically hide children’s medication lists, treatment notes, and provider messages from parents when their child turns a mere twelve years old. These deceptive practices undermine the fundamental right of parents to direct their children’s healthcare and clearly violate Tex. Health & Safety Code § 183.006, which grants parents complete and unrestricted access to their children’s medical records. 

“We will not allow woke corporations to undermine the sacred rights of parents to protect and oversee their kids’ medical well-being,” said Attorney General Paxton. “This lawsuit aims to ensure that Texans can readily obtain access to these records and benefit from the lower costs and innovation that come from a truly competitive electronic health records market.”

This suit is a part of Attorney General Paxton’s broader effort to stop electronic health record vendors from unlawfully restricting parental access to minors’ medical records. Earlier this year, the Office of the Attorney General secured a settlement with Austin Diagnostic Clinic (“ADC”) that required full restoration of parental proxy access for children aged 12 to 17. The Attorney General has also issued civil investigative demands to other electronic health record (“EHR”) software providers to ensure those companies follow Texas law and respect parental rights in the medical setting. 

To read the lawsuit, click here.

https://www.texasattorneygeneral.gov/news/releases/attorney-general-ken-paxton-sues-major-medical-record-database-gatekeeping-data-and-restricting

'Top FDA brass said to have pushed for a faster review of Lilly’s weight loss pill'

 Top officials at the U.S. FDA have internally urged its reviewers to speed up the evaluation of Eli Lilly’s (LLY) marketing application for its weight loss pill orforglipron after the Indiana-based drugmaker pushed for a faster review timeline, Reuters reported on Friday.

According to internal documents, the FDA Commissioner's Office has sought to shorten the time reviewers spend assessing if marketing applications for drugs such as orforglipron, selected for a new Priority Voucher program, have enough information from 60 days to one week.

However, internal pushback has prompted the Commissioner's Office to indicate that it may cut those review timelines to 2 or 3 weeks, depending on a marketing application's complexity.

If implemented, an FDA decision on orforglipron’s filing could be expected by as early as March 28, well ahead of a May 20 action date set by the reviewers, according to the documents.

With Novo Nordisk’s (NVO) oral version of its weight-loss therapy Wegovy currently under FDA review with a decision expected this month, a potential approval of LLY’s pill could spark a new battle between the companies in the market for oral obesity drugs.

In June, the FDA unveiled the FDA Commissioner’s National Priority Review voucher program to shorten the review timelines for certain drugs from the standard 10–12-month period to 1–2 months from the filing of a marketing application.

So far, 15 drugs, including orforglipron and a higher-dose version of Novo Nordisk’s (NVO) weight-loss therapy Wegovy, have been selected for the program, which the FDA said was launched to benefit companies serving U.S. national priorities.

https://www.msn.com/en-us/health/other/top-fda-brass-said-to-have-pushed-for-a-faster-review-of-lilly-s-weight-loss-pill/ar-AA1SdBRq

BioCryst wins FDA approval for Orladeyo oral pellets

 BioCryst Pharma (BCRX) announced on Friday that the U.S. Food and Drug Administration (FDA) approved an oral pellet formulation of its best-selling therapy, Orladeyo, as a once-daily preventive option for children with hereditary angioedema, a genetic condition characterized by swelling.

Specifically, the FDA has greenlighted the company’s New Drug Application (NDA) for Orladeyo oral pellets as a prophylactic therapy for patients aged two to 12 years with HAE, according to BioCryst (BCRX).

Orladeyo becomes the first targeted oral prophylactic therapy available for HAE patients aged 2 and above, with the approval, the company said, adding that the oral pellet formulation marked a convenient mode of drug administration for children.

In December 2020, the FDA cleared a capsule version of the drug for prophylaxis of HAE patients 12 years and older, and so far, patients under 12 have had to rely on intravenous or subcutaneously delivered targeted HAE therapies.

https://www.msn.com/en-us/health/other/biocryst-wins-fda-approval-for-orladeyo-oral-pellets/ar-AA1SdEzK

Astrana Health initiated as Buy at Needham on valuation

 Needham has initiated coverage on Astrana Health (ASTH) with a Buy rating and a $28 price target. Analyst Matthew Shea highlights a valuation gap between the health tech firm and hospital operators, noting Astrana's trading level of ~6x 2026 EBITDA as a relative floor. Shea emphasizes that Astrana's integration of hospital operations into its value-based care network through acquisitions like Prospect Health, alongside its promising growth and margin potential, warrants a valuation at least on par with hospital operators.

https://www.gurufocus.com/news/3251885/astrana-health-asth-initiated-with-buy-rating-and-28-target-by-needham

J&J's Akeega granted expanded indication in prostate cancer

Johnson & Johnson's Akeega (niraparib/abiraterone acetate) has received regulatory approvals and is seeking expanded use in prostate cancer, already approved for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) and now under review for earlier-stage, hormone-sensitive prostate cancer (mHSPC) with HRR gene alterations, aiming to delay progression in high-risk patients with this specific genetic profile. The drug, a dual-action tablet combining a PARP inhibitor (niraparib) and an androgen blocker (abiraterone), showed significant benefit in Phase 3 trials for both mCRPC and mHSPC populations with these mutations.

STAAR Surgical falls as proxy adviser recommends against revised Alcon deal

 STAAR Surgical (STAA) dropped 5% after proxy adviser Glass Lewis recommended holders reject the revised $30.75 a share offer from Alcon (ALC).

“We do not believe there exists persuasive cause for investors to endorse the revised Alcon arrangement," Glass Lewis wrote in its report, according to a statement from Broadwood Partners, STAAR's biggest shareholder, who has been opposed to the sale. 

he latest recommendation comes after Alcon (ALC) on Tuesday  raised its offer to $30.75 from the original deal price of $28. Shareholders are scheduled to vote on the transaction on Dec. 19. 

“In reaffirming its opposition to this misbegotten transaction, Glass Lewis correctly concluded that the revised price is not compelling and that the STAAR Board lacks credibility," Neal C. Brasher, Broadwood founder and president, said in the statement. 

Broadwood, which has a 30% stake in STAAR (STAA), and holder Yunqi Capital both earlier this week said they still plan to vote against the Alcon  deal even with the revised bid.

“We stand by the comprehensive sales process overseen by a Board committed to maximizing value for STAAR stockholder," STAAR said in a statement to Seeking Alpha.  "Since the initial announcement of the Alcon merger agreement, Broadwood has distorted the truth and worked at every turn to derail the transaction to serve its own interests. STAAR believes its stockholders will be harmed if this transaction is not approved and that the value of STAAR will be significantly less. STAAR stockholders have a choice: $30.75 in cash from Alcon or allow Broadwood to obtain even greater influence without paying any premium to other stockholders.”

https://www.msn.com/en-us/money/companies/staar-surgical-falls-as-proxy-adviser-recommends-against-revised-alcon-deal/ar-AA1SeC1L

Bristol Myers Squibb upgraded at Guggenheim on 2026 pipeline catalysts

 Guggenheim upgrades Bristol Myers Squibb to buy, citing promising drug pipeline and potential 21% upside

https://seekingalpha.com/news/4531147-bristol-myers-squibb-upgraded-guggenheim-2026-pipeline-catalysts