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Life Sciences
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August 04, 2025
GTCR Says Buyer In Place For Potential FTC Divestiture Deal
Private equity firm GTCR BC Holdings told an Illinois federal court it has a signed agreement with a buyer for a deal that should fix the concerns raised by the Federal Trade Commission over its planned $627 million purchase of a medical device coatings company.
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August 04, 2025
Feds Get 2nd Crack At Regeneron FCA Case After Key Ruling
The government may pursue an alternate theory of its False Claims Act kickback case against Regeneron Pharmaceuticals Inc. and try again for a pretrial win after a First Circuit ruling created a "critical shift" in the law, a Massachusetts federal judge said Monday.
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August 04, 2025
Chemical Group Says Fluoride Judge Got It Wrong
The American Chemistry Council told the Ninth Circuit that a California federal judge who ruled that current limits on fluoride in drinking water aren't protective enough misinterpreted the Toxic Substances Control Act and urged reversal of his decision.
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August 04, 2025
Investors Say Novo Nordisk Misled Them Over Drug Demand
Novo Nordisk was hit with a proposed securities class action in New Jersey federal court alleging the company misled investors over its revenue outlook for 2025 by allegedly overstating the likelihood patients would switch to its branded diabetes and weight loss drugs.
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August 04, 2025
Moderna Seeks To Be Cleared In $5B COVID Vax Patent Case
Moderna has urged a Delaware federal judge to clear it in a rival mRNA vaccine developer's $5 billion patent suit over the company's COVID-19 vaccines, saying it is shielded because it made them for the federal government.
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August 04, 2025
Rising Star: Keker's Bailey Heaps
Bailey Heaps of Keker Van Nest & Peters LLP helped two chemistry professors defeat a lawsuit centering on the commercialization of a scientific breakthrough and won an $80 million verdict in a dispute over a milestone payment, earning him a spot among the life sciences law practitioners under age 40 honored by Law360 as Rising Stars.
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August 04, 2025
Barnes & Thornburg Adds Leader Of FDA Practices At 2 Firms
Barnes & Thornburg LLP has hired the former leader of both Husch Blackwell LLP and Michael Best & Friedrich LLP's U.S. Food and Drug Administration-focused practices who brings a perspective to its Washington, D.C., office that includes working at the agency for more than a decade.
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August 04, 2025
Healthcare Investor Clinches $1.86B For 5th Credit Fund
Healthcare investment firm OrbiMed, advised by Gunderson Dettmer Stough Villeneuve Franklin & Hachigian LLP, on Monday announced that it wrapped its latest fund after securing $1.86 billion of investment commitments, which will be used to partner with healthcare companies across various sectors.
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August 04, 2025
Ex-FDA Chief Of Staff Joins Hogan Lovells' Pharma Team
The former chief of staff at the U.S. Food and Drug Administration, who most recently was a senior policy adviser there in the commissioner's office, has joined Hogan Lovells' Washington, D.C., team as a partner, the firm announced Monday.
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August 01, 2025
Meta Illegally Recorded Flo Users' Data, Calif. Jury Finds
A California federal jury Friday found Meta Platforms Inc. liable for violating the state's wiretap law by using a data analytics tool to retrieve sensitive health data from users of the popular menstrual tracking app Flo, in what plaintiffs' counsel called "one of the first times" a major tech company has been held accountable for such practices.Â
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August 01, 2025
Wheeling & Appealing: Midyear Highlights For Every Circuit
In this special edition of Wheeling & Appealing, we're spotlighting key decisions and developments in every circuit court during the first half of 2025, while also previewing August's most intriguing oral arguments, including a remarkably "fierce" showdown between Edible Arrangements and 1-800-Flowers with millions of dollars in attorney fees on the line.
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August 01, 2025
IP Owners Largely Win In Stewart's Newest Discretion Orders
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart dismissed most of the 50 petitions for inter partes review addressed in her latest decisions over discretionary denials at the Patent Trial and Appeal Board.
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August 01, 2025
USPTO Tightens Rules On Patent Challengers' Arguments
Patent challengers at the Patent Trial and Appeal Board will no longer be able to skirt a requirement that they must identify where all the elements of the patent are found in prior art patents or printed publications, according to a notice from the U.S. Patent and Trademark Office.
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August 01, 2025
AGs Sue Trump Over 'Onslaught Of Pressure' On Trans Care
The Trump administration has improperly "weaponized" federal laws against drug misbranding, false claims and female genital mutilation as part of a pressure campaign to undermine state protections for gender-affirming care, a coalition of state attorneys general argued in a new suit Friday.
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August 01, 2025
En Banc 9th Circ. Backs LA Schools In Vax Mandate Fight
A majority en banc Ninth Circuit has affirmed a lower court's decision upholding Los Angeles Unified School District's COVID-19 vaccine mandate for employees, while two partially dissenting judges disagreed with the majority's conclusion that the policy passes constitutional muster.
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August 01, 2025
States Urge High Court To Keep NIH Grant Funds Flowing
A coalition of 16 states pressed the U.S. Supreme Court on Friday to reject the Trump administration's push to resume the mass termination of scientific research grants, saying a district judge had authority to pause the cuts.
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August 01, 2025
Monthly Merger Review Snapshot
The U.S. Department of Justice abandoned its challenge of a corporate travel management deal, while lawmakers are calling for scrutiny of the agency's recent decision to settle a different case, and the Federal Trade Commission agreed to nix the requirements placed on a pair of oil and gas deals.
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August 01, 2025
OptumRx Moves To DQ Motley Rice In Utah Opioid Case
Pharmacy benefit manager OptumRx has moved to disqualify Motley Rice LLC from representing the state of Utah in an opioid crisis lawsuit, claiming the firm clearly violated ethical rules by investigating OptumRx on behalf of government entities, then suing OptumRx in a private capacity.
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August 01, 2025
J&J Unit's Catheter Rival Scores Injunction After $442M Win
A California federal judge will block Johnson & Johnson's Biosense Webster from refusing clinical support for its Carto cardio mapping systems from hospitals that use competitors' cardiac catheters, requiring the company to institute nondiscriminatory pricing for its services at hospitals regardless of which products they use.
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July 31, 2025
Hospitals Want To Duck Pharmacy Career Match Program Suit
A professional pharmacy organization and a group of teaching hospitals teed up motions to dismiss Wednesday against proposed class action allegations that they conspired to restrict wages and benefits by funneling new pharmacists through a job-matching program, telling a Maryland federal judge that there's no sign of an agreement.
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July 31, 2025
Biotech Co. Beats Investor Suit Over Antifungal Drug Recall
Biotechnology company Scynexis Inc. has won dismissal, for now, of a proposed investor class action alleging that it triggered a 34% share decline by knowingly misleading investors about manufacturing compliance issues that led to a drug recall, with the court finding the allegations the company should have known and disclosed issues only show "fraud by hindsight."
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July 31, 2025
Robotic Surgery Co.'s Antitrust Appeal Backed At 9th Circ.
Surgical Instrument Service Co. Inc. has received backing at the Ninth Circuit from a trade association and others groups as it looks to revive its case accusing Intuitive Surgical Inc. of blocking third parties from refurbishing components for its popular da Vinci surgery robot.
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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.
Expert Analysis
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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.
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Series
Law School's Missed Lessons: Communicating With Clients
Law school curricula often overlook client communication procedures, and those who actively teach this crucial facet of the practice can create exceptional client satisfaction and success, says Patrick Hanson at Wiggam Law.
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3 Judicial Approaches To Applying Loper Bright, 1 Year Later
In the year since the U.S. Supreme Court overturned Chevron deference in its Loper Bright Enterprises v. Raimondo decision, a few patterns have emerged in lower courts’ application of the precedent to determine whether agency actions are lawful, say attorneys at Husch Blackwell.
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Prepping For SEC's Changing Life Sciences Enforcement
By proactively addressing several risk areas, companies in the life sciences sector can position themselves to minimize potential exposure under the U.S. Securities and Exchange Commission's return to back-to-basics enforcement focused on insider trading and fraud, say attorneys at Morgan Lewis.
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Series
Adapting To Private Practice: From US Rep. To Boutique Firm
My transition from serving as a member of Congress to becoming a partner at a boutique firm has been remarkably smooth, in part because I never stopped exercising my legal muscles, maintained relationships with my former colleagues and set the right tone at the outset, says Mondaire Jones at Friedman Kaplan.
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How Providers Can Brace For Drug Pricing Policy Changes
Though it's uncertain which provisions of the Trump administration's executive order aimed at addressing prescription drug costs will eventually be implemented, stakeholders can reduce potential negative outcomes by understanding pathways that could be used to effectuate the order's directives, say attorneys at McDermott.
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Discretionary Denial Rulings May Spur Calls For PTAB Reform
The U.S. Patent and Trademark Office's recent decision in iRhythm Technologies v. Welch Allyn, denying inter partes review based on the patent owner's settled expectations that the patent would not be challenged, could motivate patent holders to seek Patent Trial and Appeal Board reform to preserve patent quality without burdening owners, say attorneys at Dechert.