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Life Sciences
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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.
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July 29, 2025
22 States Sue To Block Defunding Of Planned Parenthood
California and more than 20 other states on Tuesday launched their own legal challenge to budget legislation that halts federal Medicaid funding for Planned Parenthood, alleging the measure illegally targets the organization and violates its First Amendment rights.
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July 29, 2025
Jones Day Hires Former Pharma Co. Counsel In DC
Jones Day has hired a former Morgan Lewis & Bockius LLP partner, who has also worked in-house at two pharmaceutical companies and with the U.S. Drug Enforcement Administration, the firm announced Tuesday.
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July 29, 2025
Seeger Weiss Named Lead Negotiation Counsel In J&J MDL
A New Jersey federal judge overseeing long-running multidistrict federal litigation against Johnson & Johnson over its talcum powder products has appointed Christopher A. Seeger of Seeger Weiss LLP to lead a negotiation team to guide plaintiffs through settlement talks.
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July 29, 2025
Pharma Co. Blasts Adversary For Nudging Judge Assignment
A pharmaceutical solutions group has assailed its opponent's "hurry-up-court" motion nudging the appointment of a new judge after the previous judge overseeing their contract fight retired, saying its adversary "has only itself to blame" for the alleged delays that have put off a final resolution.
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July 29, 2025
NY Judge Faces Recusal Request Over Gilead Stock Holdings
A criminal defendant who admitted to taking part in a black market HIV drug scam has asked the Manhattan federal judge presiding over his case to step away after the judge disclosed brief ownership of nearly 9,000 shares of Gilead Sciences Inc., while the defendant was fighting her $2 million restitution order.
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July 29, 2025
9th Circ. Clarifies Kickback Boundaries For Referral Bonuses
A Ninth Circuit opinion affirming a California man's fraud conviction provides some clarity — and a warning — to the owners of medical testing laboratories wondering what sales tactics are allowed under a 2018 kickbacks law.
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July 29, 2025
Federal Cuts Shake Up Clinical Research Funding Landscape
As the Trump administration makes deep cuts to clinical research funding, healthcare attorneys worry that the delicate balance between federal grants and private investment is at risk. Crowell & Moring LLP partner Linda Malek talks to Law360 Healthcare Authority about the industry's concerns.
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July 28, 2025
Pharma Co. Alleges Clinical Trial Data Was Fabricated
A pharmaceutical research and development company sued New Jersey-based research organization Clinilabs LLC and several Florida clinical research firms Friday claiming they fabricated and covered up important clinical trial data for a new Alzheimer's disease treatment, wasting millions of dollars and setting the drug back at least five years.
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July 28, 2025
PBMs Can't Escape NY State Law Claims In Opioid MDL
Two UnitedHealth subsidiaries cannot escape claims that they exacerbated the opioid crisis by providing data analytics and consulting services to drugmakers, a federal judge overseeing the multidistrict litigation ruled on Monday, saying the New York state municipalities have adequately alleged RICO by claiming they were part of the same criminal conspiracy.
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July 28, 2025
NeoGenomics Wants Jury Trial In Natera DNA Test Patent Fight
NeoGenomics Laboratories Inc. told a North Carolina federal judge that a company suing it for patent infringement over DNA cancer test technology, Natera Inc., had no right to withdraw its demand for a jury trial and move forward with a bench trial.
Expert Analysis
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The State Of AI Adoption In The Patent Field
The use of generative artificial intelligence in patent-related practices has lagged behind early predictions, which may be explained by a number of core concerns that organizations must address before seriously considering adoption, say attorney Michael Drapkin and leadership coach Michael Colacchio.
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Purdue Case Could Transform Patent Obviousness Analyses
If accepted for review by the U.S. Supreme Court, Purdue Pharma v. Accord Healthcare — concerning whether Purdue's abuse-deterrent opioid formulation patents were invalid as obvious — could significantly shift how courts weigh secondary considerations in patent obviousness analyses, say attorneys at Lathrop.
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Federal Regs Order May Spell Harsher FDCA Enforcement
A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.
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Series
Law School's Missed Lessons: Practicing Self-Care
Law schools don’t teach the mental, physical and emotional health maintenance tools necessary to deal with the profession's many demands, but practicing self-care is an important key to success that can help to improve focus, manage stress and reduce burnout, says Rachel Leonard​​​​​​​ at MG+M.
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ABA Opinion Makes It A Bit Easier To Drop A 'Hot Potato'
The American Bar Association's recent ethics opinion clarifies when attorneys may terminate clients without good cause, though courts may still disqualify a lawyer who drops a client like a hot potato, so sending a closeout letter is always a best practice, say attorneys at Thompson Hine.
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IRhythm IPR Denial Raises Key PTAB Discretion Questions
By giving the passage of time a dispositive role in denying institution of five inter partes review petitions filed by iRhythm Technologies, the U.S. Patent and Trademark Office has upended the strategic considerations for filing and defending against IPRs, disclosing prior art during prosecution, and engaging in licensing negotiations, say attorneys at Dentons.
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Canadian Suit Offers Disclosure Lesson For US Cannabis Cos.
A Canadian class action asserting that Aurora Cannabis failed to warn consumers about the risk of developing cannabinoid hyperemesis syndrome may spawn copycat filings in the U.S., and is a cautionary tale for cannabis and hemp industries to prioritize risk disclosure, says Ian Stewart at Wilson Elser.
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Opinion
IPR Denial In IRhythm Should Not Set A Blanket Rule
Though the Patent Trial and Appeal Board's discretionary denial in iRhythm v. Welch Allyn last month raised concerns that mere knowledge of a patent could bar inter partes review institution, a closer look at the facts and reasoning reveals why this case's holdings should not be reflexively applied to all petitioners, says David McCombs at Haynes Boone.
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What High Court's Tenn. Trans Care Ruling Means Nationally
The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.
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How Trump's Trade Policies Are Shaping Foreign Investment
Five months into the Trump administration, investors are beginning to see the concrete effects of the president’s America First Investment Policy as it presents new opportunities for clearing transactions more quickly, while sustaining risk aversion related to Chinese trade and potentially creating different political risks, say attorneys at Covington.
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Series
My Opera And Baseball Careers Make Me A Better Lawyer
Though participating in opera and the world of professional baseball often pulls me away from the office, my avocations improve my legal career by helping me perform under scrutiny, prioritize team success, and maintain joy and perspective at work, says Adam Unger at Herrick Feinstein.
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Opinion
Subject Matter Eligibility Test Should Return To Preemption
Subject matter eligibility has posed challenges for patentees due to courts' arbitrary and confusing reasoning, but adopting a two-part preemption test could align the applicant, the U.S. Patent and Trademark Office and the courts, says Manav Das at McDonnell Boehnen.
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8 Ways Lawyers Can Protect The Rule Of Law In Their Work
Whether they are concerned with judicial independence, regulatory predictability or client confidence, lawyers can take specific meaningful actions on their own when traditional structures are too slow or too compromised to respond, says Angeli Patel at the Berkeley Center of Law and Business.
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Is SEC Moving Away From Parallel Insider Trading Cases?
The U.S. Securities and Exchange Commission's apparent lack of follow-up in four recent criminal cases of insider trading brought by the Justice Department suggests the SEC may be reconsidering the expense and effort of bringing parallel civil charges for insider trading, say attorneys at Dentons.
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Rising Enforcement Stakes For Pharma Telehealth Platforms
Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.