Expert Analysis

Informal Announcements Are Reshaping FDA Regulations

The U.S. Food and Drug Administration's recent shift toward using press releases, podcasts and other informal chan... (more story)

OhioHealth Suit Signals Higher Antitrust Heat On Hospitals

The recent antitrust lawsuit against OhioHealth by the U.S. Justice Department and Ohio attorney general shows tha... (more story)

A Shift In Fed. Circ.'s Approach To Patent Summary Judgment

The Federal Circuit's recent decision in Range of Motion v. Armaid may come to be seen as a seminal opinion for po... (more story)

Deals & Corporate Governance More

Anesthesia Parent Can't Duck Antitrust Suit, But Affiliate Can

The parent company of U.S. Anesthesia Partners Inc. remains in the crosshairs of a private antitrust suit accusing it of trying to monopolize Texas anesthesia services, while a federal judge dismissed for now ... (more story)

Biogen Paying $5.6B For Apellis As 4 Firms Advise

Biogen Inc. said Tuesday that it has agreed to acquire Apellis Pharmaceuticals Inc. in a cash transaction valued at about $5.6 billion, with four law firms steering the transaction focused on key therapies for... (more story)

Co.'s Dual Citizenship Doesn't Kill Jurisdiction, 4th Circ. Told

A medical supply company urged the Fourth Circuit on Wednesday to revive its suit against a U.K. company over COVID-19 test kits, arguing the Chinese citizenship of one of its members doesn't destroy a North C... (more story)

Covington, Freshfields Advise On $6.7B Merck Oncology Deal

Merck & Co. said Wednesday it will acquire clinical-stage oncology company Terns Pharmaceuticals Inc. for $53 per share in cash, giving the deal an equity value of $6.7 billion.

Sarepta Urges Full Fed. Circ. To Wipe Out Gene Therapy IP

Sarepta Therapeutics Inc. wants the full Federal Circuit to rethink a decision reviving a University of Pennsylvania gene therapy patent, saying a panel got its analysis of patent eligibility wrong.

ITC Says Hydrafacial Patent Infringed, But Won't Ban Imports

The U.S. International Trade Commission has found that an aesthetics medical device company infringed a Hydrafacial LLC skin treatment patent, but stopped short of enforcing a ban on imports.

Digital Health & Technology More

Telemedicine Biz Can't Escape Investor Suit Over User Losses

A New York federal judge on Tuesday ruled Teladoc Health Inc. cannot escape an investor suit over its declining user base and increased advertising budget, saying the departure of its former chief executive in... (more story)

TriZetto's $70M Trade Secret Verdict Upheld, Total Award Cut

A New York federal judge has upheld a $70 million compensatory damages verdict for the TriZetto Group in a long-running trade secret fight against Syntel Inc., while also cutting punitive damages to about $140... (more story)

Del. Judge Upholds $34M Verdict In Glaucoma Patent Feud

A Delaware federal judge has affirmed a $34 million verdict against Alcon and related entities for infringing patents covering medical devices to treat glaucoma, disagreeing that Sight Sciences Inc. had failed... (more story)

Del. Blackbaud Ruling Signals A New Era For Cyberinsurance

The recent Delaware Supreme Court ruling in Travelers v. Blackbaud shows that cyberinsurance is moving into a second maturity phase, in which insurers will increasingly attempt to recover their payments from v... (more story)

Eli Lilly Keeps Most Of Weight Loss Drug Copy Suit Alive

A California federal judge has refused to throw out a lawsuit accusing a pair of telehealth companies of making copies of Eli Lilly's obesity and type 2 diabetes drugs but agreed to trim the case.

Biopharma's Brass Hid Anxiety Drug Trial Risks, Investor Says

Vistagen Therapeutics' current and former top brass have been hit with a derivative shareholder suit in California federal court alleging they overstated its clinical trial for a novel, anti-anxiety drug while... (more story)

Policy & Compliance More

Novo Nordisk Unit Says Ex-Exec's Poor Work Dooms Bias Suit

By the time she was fired, a finance director of Novo Nordisk unit NNE Inc. had been falling short of company expectations while the pharmaceutical giant was preparing to get a multibillion-dollar drug facilit... (more story)

11th Circ. Backs Order To Fix Fla. System For Disabled Kids

The Eleventh Circuit upheld an injunction finding Florida's institutionalization of children with complex medical conditions violated the Americans with Disabilities Act, ruling in a split opinion that a lower... (more story)

DOL, HHS Must Face Unions' Claims In DOGE Data Suit

The U.S. Departments of Labor and Health and Human Services must continue facing claims that they illegally gave Elon Musk's Department of Government Efficiency access to employee records, as a D.C. federal ju... (more story)

Harvard Researcher Can Get Docs On Prosecution Motives

A Massachusetts federal judge ruled Wednesday that a Harvard Medical School researcher and Russian national charged with smuggling frog embryo specimens can see emails and other documents regarding the governm... (more story)

NJ Hospital Workers Win Collective Cert. In OT, Break Suit

A New Jersey healthcare network must face overtime claims on a collective basis, a federal judge ruled, saying a former employee adequately backed up allegations that the network had companywide policies under... (more story)

Sentara Health Strikes $1.5M Deal In Stable Value Fund Suit

Virginia-based healthcare system Sentara Health will pay $1.5 million to settle a class action claiming it failed to remove an underperforming investment fund from its employee retirement plan, according to fe... (more story)