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Life Sciences
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May 15, 2025
Novo's Real Target In Doc Bid Is $800M Arbitration, Co. Says
A Singaporean pharmaceutical company is urging a North Carolina federal court to nix its order permitting Novo Nordisk AS to seek information bolstering its fraud claims stemming from an $800 million hypertension drug deal, saying the Danish drugmaker is improperly looking to prop up an ongoing arbitration instead.
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May 15, 2025
UMich Protesters Say Lives 'Upended' By Campus Bans
An attorney for protesters challenging their bans from the University of Michigan campus told a federal judge Thursday that the trespass orders have "upended" their lives because the vast campus intertwines with the city of Ann Arbor and urged the court to find the bans violated their due process.
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May 15, 2025
Bausch, Mylan Settle Patent Suit Over Generic IBS Drugs
The makers of gastrointestinal drug Trulance have resolved their patent lawsuit, which sought to block several Mylan generic drugs from competing with the drug, in a confidential settlement agreement, according to a West Virginia federal court filing.
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May 15, 2025
Harvard Researcher Held By ICE To Be Returned To Mass.
A Harvard Medical School researcher and Russian national taken into custody by immigration officers who found frog embryos in her luggage three months ago will be returned to Massachusetts to face a smuggling charge, a Louisiana federal judge ordered on Thursday.
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May 15, 2025
Amarin Tells Justices Hikma Has Gotten Far Ahead Of Itself
Amarin Pharma urged the U.S. Supreme Court on Thursday to turn away a generic-drug maker's bid to get an induced infringement suit thrown out, saying the pleadings-stage case is "in its infancy" and that the company is looking for a "safe-harbor from having to litigate at all."
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May 15, 2025
Curaleaf And Ex-VP In Settlement Talks, Court Told
Curaleaf has tentatively agreed to drop a lawsuit against a former executive it accused of stealing confidential records to share with a rival cannabis firm, according to a notice filed in Florida federal court.
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May 15, 2025
Davis Wright Adds Longtime Knobbe Martens IP Duo In Seattle
Davis Wright Tremaine LLP has brought in two intellectual property partners credited with helping Knobbe Martens open its Seattle office.
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May 15, 2025
Regeneron Wins $271.2M In Amgen Antitrust Suit
A federal jury in Delaware put Amgen Inc. on the hook Thursday for at least $271.2 million in punitive damages arising from an alleged scheme that undercut Regeneron's price for its Praluent anti-cholesterol drug by bundling Amgen's competing, higher-priced Repatha with rebates for two expensive, blockbuster medications.
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May 14, 2025
Actinium Faces Derivative Suit Over FDA Application Claims
Officers and directors of biopharmaceutical company Actinium Pharmaceuticals Inc. face a shareholder derivative action accusing them of breaching their fiduciary duties after the company's lead product candidate failed to secure a certain approval from the U.S. Food and Drug Administration.
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May 14, 2025
J&J Unit's Catheter Policy Stopped Free-Riding, Jury Told
A Johnson & Johnson unit sales director took the stand Wednesday in Innovative Health's antitrust case against its medical technology unit Biosense Webster, defending Biosense's policy cutting off clinical cardiac mapping support to hospitals using third-party reprocessed catheters and explaining that the policy prevented competitors from free-riding on its investments in clinical support training.
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May 14, 2025
RJ Reynolds Can Keep Trial Win In Engle Case, Court Says
A Florida appeals court on Wednesday affirmed a verdict in favor of R.J. Reynolds in an Engle progeny suit over a longtime smoker's death, saying counsel's failure to use all their juror challenges invalidates an argument that a juror was unfairly selected.
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May 14, 2025
Integra Brass Face Investor Suit Over FDA Compliance Lapses
Executives and directors of medical device company Integra Lifesciences Inc. were hit with a derivative suit alleging they misled investors about the company's compliance with regulatory standards for over five years, causing share declines when information regarding Integra's violations emerged.
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May 14, 2025
Regeneron-Amgen Trial Goes To Jury With An Extra Day
Federal jurors started deliberating on a Regeneron Pharmaceuticals Inc. antitrust suit late Wednesday accusing Amgen Inc. of tripping up Regeneron's anti-cholesterol drug insurance eligibility by illegally bundling Amgen's competing version with rebates for two unrelated drugs, with potential triple damages in the balance.
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May 14, 2025
Sage Therapeutics Brass Sued Over Drug Candidate Claims
The top brass of Sage Therapeutics Inc. have been hit with a shareholder derivative suit in New York federal court alleging they misled investors about the safety, efficacy, durability and commercial prospects of three of the company's drug candidates and overstated their likelihood to be approved by the U.S. Food and Drug Administration.
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May 14, 2025
2nd Circ. Has Tough Questions On Nixing Medical Imaging Award
The Second Circuit appeared divided on Wednesday on whether parties to a medical imaging joint venture could agree to designate New York courts to decide whether to vacate an arbitral award issued in Switzerland under their contract without violating an underlying treaty.
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May 14, 2025
10th Circ. Chilly To Biotech's SEC Asset Freeze Challenge
A panel of Tenth Circuit judges seemed skeptical Wednesday that a lower court had abused its discretion in granting a freeze of a biotech firm's assets in a suit brought by the U.S. Securities and Exchange Commission accusing the company and its founders of misappropriating roughly $9 million.
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May 14, 2025
Harvard Researcher Charged With Smuggling Amid ICE Case
Federal prosecutors on Wednesday unsealed criminal smuggling charges against a Russian national and Harvard Medical School researcher who has been challenging her monthslong detention by U.S. Immigration and Customs Enforcement after she returned to the U.S. from Europe carrying frog embryos.
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May 14, 2025
Alnylam Halts Patent Row Over Pfizer, BioNTech COVID-19 Vax
Alnylam Pharmaceuticals has decided to end a district court patent case over the COVID-19 vaccine made by Pfizer and BioNTech, asking a Delaware federal judge Tuesday to rule that the companies do not infringe its mRNA patents, while potentially setting the stage for an appeal.
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May 14, 2025
Novo Nordisk, Septerna Ink Up To $2.2B Obesity Drug Deal
Denmark's Novo Nordisk said Wednesday it has signed a drug development deal worth up to $2.2 billion with U.S.-based Septerna, part of its continued push to expand treatments for obesity, Type 2 diabetes and related diseases.
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May 14, 2025
D'Oh! Kimberly-Clark Can't Keep Wage Suit In Federal Court
A Pennsylvania federal judge invoked "The Simpsons" as he granted a Kimberly-Clark employee's request to ship his unpaid overtime proposed class action back to state court, saying the paper goods company is trying to "embiggen" the amount in controversy beyond what's feasible.
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May 14, 2025
Eckert Seamans Enters NYC With 11 Hawkins Parnell Attys
Eckert Seamans Cherin & Mellott LLC said Wednesday that it has launched an office in New York City with the addition of an 11-attorney team from Hawkins Parnell & Young LLP, while scaling back its New Jersey presence.
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May 14, 2025
Biotech Firm Verax Tells Court Eviction Could End Company
Biotech company Verax Biomedical Inc. has said it faces the prospect of going out of business unless a Massachusetts judge agrees to block its landlord from proceeding with an eviction, at least through the end of its current lease.
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May 14, 2025
RFK Jr. Defends HHS Cuts, Pledges To 'Spend Smarter'
In his first appearance on Capitol Hill since his confirmation, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday characterized a massive reorganization and reductions in workforce as practical moves to optimize the sprawling agency.
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May 14, 2025
Biogen Sues Ex-Collaborator Over Rights To Drug Tech
Biogen said its partner on a since-shelved Alzheimer's drug is trying to claim rights to an unrelated novel therapeutic that the Massachusetts company recently shared with the Swiss partner under a confidentiality agreement, according to a lawsuit filed Tuesday.
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May 13, 2025
Asterisk Doesn't Save CVS In Sanitizer Row, 9th Circ. Told
An attorney for a man suing CVS Pharmacy urged the Ninth Circuit on Tuesday to revive his claims alleging the company misled consumers with a promise its hand sanitizer kills 99.99% of germs, arguing the asterisk on the front label does not clear the company of wrongdoing despite a recent ruling from the circuit that gives significance to that type of asterisk.
Expert Analysis
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Assessing PE Risk After Mass. False Claims Act Amendments
A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.
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What Trump Actions Mean For Federal Research Funding
New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.
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How Courts Can Filter Nonmeritorious Claims In Mass Torts
Nonmeritorious claims have been a key obstacle to settlement in many recent high-profile mass torts, but courts may be able to use tools they already have to solve this problem, says Samir Parikh at Wake Forest University.
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Series
Racing Corvettes Makes Me A Better Lawyer
The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.
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Opinion
Attorneys Must Act Now To Protect Judicial Independence
Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch’s authority, says attorney Bhavleen Sabharwal.
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Rethinking 'No Comment' For Clients Facing Public Crises
“No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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As Failure-To-Warn Preemption Wanes, Justices May Weigh In
Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products — so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.
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How Design Thinking Can Help Lawyers Find Purpose In Work
Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits — but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.
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The Fate Of Biden-Era Clinical Study Guidance Under Trump
Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.
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Trending At The PTAB: Insights From 2024 Fed. Circ. Statistics
Looking at stats from the Federal Circuit's decisions in 219 Patent Trial and Appeal Board appeals last year sheds light on potential trends and strategy considerations that could improve appeals' chances of success, say attorneys at Finnegan.
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Opinion
Weight Drug Suits Highlight Need For Legal Work On Safety
The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.
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10 Issues To Watch In Aerospace And Defense Contracting
This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.
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Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis
In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.
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Compliance Pointers For DOJ's Sweeping Data Security Rule
A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.
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Series
Competitive Weightlifting Makes Me A Better Lawyer
The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.