Expert Analysis

Takeaways From FDA's Updated Confirmatory Trial Guidance

The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's ... (more story)

A Look At FDA's Plans To Establish New OTC Drug Category

The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs... (more story)

2024 Was A Significant Year For HIPAA Compliance

The Office of Civil Rights' high level of Health Insurance Portability and Accountability Act activity in 2024 and... (more story)

Deals & Corporate Governance More

Biotech Co. Defends Antitrust Counterclaims Against Rival

Biotech company Zymo Research Corp. is defending its claims that German diagnostic competitor Qiagen GmbH's infringement suit is nothing more than an attempt to discredit a competitor, saying Zymo offered to p... (more story)

Ex-J&J Exec Accused Of File Theft Has Died, Court Told

A former competitive strategy director for Johnson & Johnson accused of stealing confidential files when he left the company to work for Pfizer has died, according to a court filing.

10th Circ. Affirms Toss Of Surgical Assistants' Antitrust Suit

The Tenth Circuit on Tuesday refused to revive an antitrust lawsuit against a national surgical certification board accused of monopolizing a surgical assistants and technicians accreditation and certification... (more story)

Fla. Court Proposes $19M In Damages In Spinal Products Suit

A Florida federal judge has recommended that the principal of spine medical equipment companies pay $19.3 million in damages after allegedly breaching an agreement and forming a direct competitor to a business... (more story)

Vanda Loses Takings Clause Arguments In Trade Secret Fight

A Court of Federal Claims judge has held that specifications on how fast Vanda Pharmaceuticals' drugs dissolve do not count as property interest under the Fifth Amendment, handing a loss to the pharmaceutical ... (more story)

Cooley-Led Insulin Device Maker Preps $113M IPO

Insulin delivery system maker Beta Bionics on Wednesday announced the terms for its initial public offering, planning to raise $113 million.

Digital Health & Technology More

Patient Can't Sue Over Clinic's 'Data Incident,' Ill. Justices Say

A medical clinic patient who received a letter stating a "data incident" may have compromised her personal information but appeared not to have led to the information's misuse does not have standing to pursue ... (more story)

IVF Patients Want CooperSurgical Embryo Loss Suits Joined

Four product liability lawsuits targeting the maker of recalled culture media for in vitro fertilization should be consolidated and sent to the Connecticut Superior Court's complex litigation docket, the parti... (more story)

Pharma Co. Says Ex-CEO's Alleged Misconduct Is Not Fraud

Artificial intelligence-driven pharmaceutical company Exscientia PLC has asked a New Jersey federal court to toss a suit alleging it is responsible for share price declines following the termination of its CEO... (more story)

Law360 Names Practice Groups Of The Year

Law360 would like to congratulate the winners of its Practice Groups of the Year awards for 2024, which honor the attorney teams behind litigation wins and significant transaction work that resonated throughou... (more story)

Law360 Names Firms Of The Year

Eight law firms have earned spots as Law360's Firms of the Year, with 54 Practice Group of the Year awards among them, steering some of the largest deals of 2024 and securing high-profile litigation wins, incl... (more story)

NC Biz Court Bulletin: Judge Bids Adieu, TikTok Wants Out

The North Carolina Business Court's former chief judge hung up his robes for the last time as the court entered the new year with a ruling that shapes the fate of beset real estate company MV Realty's consumer... (more story)

Policy & Compliance More

Trump Revives Federal Anti-Abortion Policies

President Donald Trump issued two executive orders Friday targeting abortion inside and outside the United States, reinstating a ban on federal funding for certain international family planning groups and revo... (more story)

Anti-Abortion Group Seeks High Court Review Of NJ Probe

An anti-abortion pregnancy center operator wants the U.S. Supreme Court to revive its federal court challenge to a subpoena from the New Jersey attorney general that seeks information about its donors, urging ... (more story)

J&J Escapes Part Of Worker's Drug Benefits Suit, For Now

A suit alleging Johnson & Johnson overcharged employees through a prescription drug benefits program was partially tossed Friday, with a New Jersey federal judge ruling the suing worker failed to show the cour... (more story)

Feds Drop HIPAA Charges Against Houston Surgeon

The federal government has dropped criminal charges against a Texas surgeon accused of improperly accessing patient information and sharing information about the hospital's gender-affirming care practices with the press.

Employer Groups Back Tossing Pension Annuity Suit In NY

Three employer trade groups are backing Bristol-Myers Squibb and investment manager State Street as they fight claims brought by retirees of the pharmaceutical giant that the companies violated federal benefit... (more story)

5th Circ. Upholds Tossing Medicare Rate Policy Challenge

A Fifth Circuit panel said it agrees with a Texas federal judge that a lawsuit brought by four anesthesia practices claiming a Centers for Medicare and Medicaid Services policy will cost them $4 million in red... (more story)