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Life Sciences
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July 31, 2025
18 GOP Sens. Urge Trump To Fill IP Negotiator Post
Eighteen Republican U.S. senators urged President Donald Trump to appoint someone to the vacant role of chief innovation and intellectual property negotiator of the U.S. Trade Representative in order to work to remove what they called "market-distorting price controls" in the pharmaceutical industry.
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July 31, 2025
HHS Plans To Test Rebates In 340B Drug Pricing Program
The Trump administration on Thursday announced plans for a pilot project that would allow certain drugmakers to abandon upfront discounts in the 340B program and instead require hospitals to apply for rebates, testing an idea that would fundamentally reshape the long-running program.
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July 31, 2025
Honeywell Ex-GC Claims Age Bias Led To Firing At 55
A Honeywell International Inc. former vice president and general counsel accused the Charlotte-based conglomerate of age discrimination, telling a North Carolina federal court that she was fired for turning 55.
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July 31, 2025
ITC Ends Dermatology Needle Import Ban After Settlement
The International Trade Commission has lifted a ban on certain imports of skin treatment devices that infringed patents owned by a South Korean dermatologist's needle business after it settled with a rival.
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July 31, 2025
J&J Fired Sales Worker Who Reported Pay Issue, Suit Says
Johnson & Johnson wrongly credited a former executive sales representative's sales to another worker, leading to lost earned commissions, and then fired him once he complained, the former employee said in a suit in Texas federal court.
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July 30, 2025
3rd Circ. Won't Upend Investors' Class Cert. In J&J Talc Suit
A split Third Circuit on Wednesday upheld a New Jersey federal judge's class certification order in a Johnson & Johnson investor action alleging the company artificially inflated its stock price by failing to disclose cancer risks associated with its talcum powder products, finding the lower court did not err in concluding that common issues predominate in the suit.
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July 30, 2025
Flo Likely To Get Health Privacy Claim Tossed In Meta Case
The California federal judge overseeing a trial on allegations that Flo Health and Meta Platforms Inc. violated the privacy of millions of women who used Flo's period tracker app said Wednesday he'd likely toss the California Confidentiality of Medical Information Act claim, saying the lack of evidence is an "unsurmountable" problem.
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July 30, 2025
Illumina To Pay $9.8M To Resolve Cybersecurity Qui Tam Case
Biotechnology company Illumina Inc. has agreed to pay $9.8 million in a settlement with the U.S. Department of Justice to put to rest a first-of-its-kind False Claims Act suit alleging the company violated cybersecurity regulations for medical devices, according to an announcement Wednesday.
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July 30, 2025
No Philly Clause Is Valid In Med Mal Case, Pa. Panel Says
A Pennsylvania appellate panel said Wednesday that a contract a patient signed before surgery mandating that any legal actions must be heard in Bucks County is valid and enforceable, affirming a trial court's transfer of the medical malpractice suit from plaintiff-friendly Philadelphia County.
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July 30, 2025
CVS Can't Arbitrate RICO Suit Over Alleged 'No Generic' Policy
CVS effectively forfeited its arbitration rights in proposed class action litigation accusing it of conspiring to block Medicare beneficiaries from accessing generic versions of prescription drugs, a Pennsylvania federal judge ruled in denying the company's bid to enforce an arbitration agreement.
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July 30, 2025
FDA's Vaccine Chief Is Out After Loyalty To Trump Questioned
Dr. Vinay Prasad's tenure as the top vaccine regulator at the U.S. Food and Drug Administration ended abruptly this week following intense criticism from conservative activists who questioned his loyalty to President Donald Trump.
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July 30, 2025
Mich. PBM Opioid Suit Belongs In State Court, Judge Told
Counsel for the State of Michigan argued Wednesday that a lawsuit accusing pharmacy benefit managers Express Scripts and OptumRx of fueling the opioid crisis is not subject to federal officer removal and should be sent back to state court.
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July 30, 2025
ImmunityBio Investors Nab Initial OK On Derivative Suit Deal
A California federal judge has granted initial approval to a deal ending derivative claims that ImmunityBio executives failed to disclose manufacturing deficiencies that doomed the company's lead cancer drug application.
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July 30, 2025
GTCR Denied Rival's Old Sales Prospects Data In FTC Case
An Illinois federal judge refused Tuesday to force a rival medical device coatings company to cough up old sales projections data so private equity firm GTCR BC Holdings can defend against a Federal Trade Commission challenge to its $627 million purchase of Surmodics.
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July 30, 2025
DHS Sinks Docs' Free Speech Suit Over COVID Policies
A Texas federal judge on Wednesday dismissed free speech claims brought against the U.S. Department of Homeland Security and three specialty medical boards by a doctor group claiming the government and boards punished them for disapproving of COVID-19 vaccines and mandates.Â
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July 30, 2025
Fla. AG Allowed To Drop Sandoz Generics Price-Fixing Claims
After several months of wrangling over the terms of a $10 million generic drug price-fixing settlement, a Connecticut federal judge on Wednesday granted Florida's request to permanently drop its claims against Sandoz, finding that it would be an abuse of discretion to hold up the resolution any longer.
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July 30, 2025
Pharma Tech Co. Diaceutics Hires Former Sandoz Atty As GC
Pharmaceutical technology company Diaceutics PLC has hired a lawyer with in-house experience at Sandoz and Novartis as its general counsel.
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July 30, 2025
WilmerHale Taps Life Science Pro To Chair Transactions Dept.
WilmerHale announced Wednesday that the former Latham & Watkins LLP attorney it hired last year to co-chair its life sciences practice is taking over as the chair of its transactional department.
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July 29, 2025
Fed. Circ. Backs Rejection Of Man's HPV Vaccine Claims
A man who claimed vaccines he received as a teen, including one meant to guard against HPV, caused him to develop inflammatory bowel disease will receive no payments under the National Vaccine Injury Compensation Program, the Federal Circuit ruled on Tuesday, affirming a determination that his theory that vaccines caused his illness is unsupported.
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July 29, 2025
Trump Says High Court Rulings Undermine Wash. Halt On EOs
Recent decisions by the U.S. Supreme Court undermine a Washington federal judge's finding that portions of two executive orders concerning gender-affirming care and transgender identity likely violate the Constitution, the Trump administration argued in recent filings.
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July 29, 2025
Teva, Amneal End Case Over Listing Inhaler IP In Orange Book
A New Jersey federal judge on Tuesday closed litigation between Teva and Amneal, which had led to the Federal Circuit's major decision that patents for Teva's inhalers don't belong in the U.S. Food and Drug Administration's Orange Book.Â
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July 29, 2025
Reported Plan For Value-Based Patent Fees Unnerves Experts
A proposal reportedly under consideration by the Trump administration to charge patent owners a new fee based on the value of their patents has spurred numerous questions and concerns among experts, who say the idea appears nearly unworkable and could hinder innovation.
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July 29, 2025
Ocugen Beats Investor Suit Over Financial Controls
Biopharmaceutical company Ocugen Inc. on Tuesday won permanent dismissal from an investor's class action accusing it of concealing weak financial controls that led to it refiling accounting statements for several periods, with a Pennsylvania federal judge determining that Ocugen's stock price recovered from the announcement it had erred in its reports.
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July 29, 2025
J&J Owes $43M For 30-Year Talc User's Mesothelioma
A Massachusetts state court jury ordered Johnson & Johnson Tuesday to pay more than $42.6 million to a former talc user with mesothelioma and his wife, following a trial in which the man's lawyer told jurors the alleged cancer-causing effects of the company's baby powder were its "dirty little secret."
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July 29, 2025
RFK Jr. Slams Vaccine Injury Program: 3 Things To Know
U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. is taking aim at the national program that compensates people for vaccine injuries, calling it a "heartless" system that he intends to fix.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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Fed. Circ. In June: Transitional Phrases In Patent Claims
The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.
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Series
Playing Soccer Makes Me A Better Lawyer
Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.
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Strategies For Cos. Navigating US-Indian Pharma Partnerships
Recent policy adjustments implemented by the U.S. government present both new opportunities and heightened regulatory scrutiny for the Indian life sciences industry, amplifying the importance of collaboration between the Indian and U.S. pharmaceutical sectors, say Bryant Godfrey at Foley Hoag and Jashaswi Ghosh at Holon Law Partners.
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DOJ-HHS Collab Crystallizes Focus On Health Enforcement
The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.
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Series
Law School's Missed Lessons: Learning From Failure
While law school often focuses on the importance of precision, correctness and perfection, mistakes are inevitable in real-world practice — but failure is not the opposite of progress, and real talent comes from the ability to recover, rethink and reshape, says Brooke Pauley at Tucker Ellis.
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23andMe Fine Signals ICO's New GDPR Enforcement Focus
Many of the cybersecurity failures identified by the Information Commissioner’s Office in its investigation of 23andMe, recently resulting in a £2.3 million fine, were basic lapses, but the ICO's focus on several new U.K. General Data Protection Regulation considerations will likely carry into the future, say lawyers at Womble Bond.
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Eye Drop Ruling Clarifies Importance Of Patent Phrasing
The Federal Circuit's recent ruling in Eye Therapies v. Slayback, rejecting the Patent Trial and Appeal Board's interpretation of "consisting essentially of," highlights the importance of using clear and consistent terms throughout a patent's filing history to shield it against future challenges, says Liliana Di Nola-Baron at Panitch Schwarze.
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How The Healthline Privacy Settlement Redefines Ad Tech Use
The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.
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How Sweeping Budget Bill Shakes Up Health Industry
With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.
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Series
Adapting To Private Practice: From ATF Director To BigLaw
As a two-time boomerang partner, returning to BigLaw after stints as a U.S. attorney and the director of the Bureau of Alcohol, Tobacco, Firearms and Explosives, people ask me how I know when to move on, but there’s no single answer — just clearly set your priorities, says Steven Dettelbach at BakerHostetler.
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A Look At Key 5th Circ. White Collar Rulings So Far This Year
In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.
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High Court Cert Spotlights Varying Tests For Federal Removal
A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.
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How To Increase 3rd-Party Preissuance Patent Submissions
Attorneys Marian Underweiser and Marc Ehrlich, who helped draft the America Invents Act, discuss changes that the U.S. Patent and Trademark Office could potentially implement to facilitate its hopes for increased participation in front-end patent challenges.
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Trump Air Emissions Carveouts Cloud The Regulatory Picture
President Donald Trump's new proclamations temporarily exempting key U.S. industries from air toxics standards, issued under a narrow, rarely-used provision of the Clean Air Act, will likely lead to legal challenges and tighter standards in some states, contributing to further regulatory uncertainty, say attorneys at GableGotwals.