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Life Sciences
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May 16, 2025
Trump Admin Settles Vaccine Contract Info Suit For $10K
The Trump administration has reached a $10,000 settlement with a consumer advocacy group over allegedly withholding information about the government's billion-dollar contracts with companies that developed and manufactured the COVID-19 vaccine, including Pfizer and Moderna.
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May 15, 2025
J&J Unit's Economist Rips Rival's $147M Antitrust Damage Bid
Biosense Webster's economic expert took the stand Thursday in California federal court to criticize Innovative Health's claim it suffered $147 million in damages from Biosense's policy withholding clinical support to hospitals using third-party reprocessed catheters, arguing Innovative lost nothing and saved on clinical support costs it otherwise would've incurred.
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May 15, 2025
7th Circ. Weighs AbbVie Whistleblower's Drug Marketing Suit
A Seventh Circuit judge questioned whether a former AbbVie employee has plausibly alleged whistleblower retaliation in a false claims case and whether the drugmaker was holding his complaint to too high a standard Thursday as he explored whether a lower court's dismissal ruling should stand.
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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.
Expert Analysis
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NIH Cuts To Indirect Costs May Stifle IP Generation
Although currently blocked by a preliminary injunction, the National Institutes of Health's new policy to cut down on indirect cost funding creates challenges for university research projects, and may hamper the development of intellectual property — which is considered an indirect cost — for years to come, say attorneys at Snell & Wilmer.
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Recent Cases Clarify FCA Kickback Pleading Standards
Two recently resolved cases involving pharmaceutical manufacturers may make it more difficult for False Claims Act defendants facing kickback scheme allegations to get claims dismissed for lack of evidence, say Li Yu at Bernstein Litowitz, Ellen London at London & Noar, and Gregg Shapiro at Gregg Shapiro Law.
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Opinion
Antitrust Analysis In Iowa Pathologist Case Misses The Mark
An Iowa federal court erred in its recent decision in Goldfinch Laboratory v. Iowa Pathology Associates by focusing exclusively on market impacts and sidestepping key questions that should be central to antitrust standing analysis, says Daniel Graulich at Baker McKenzie.
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Opinion
State FCAs Should Cover Local Fund Misuse, State Tax Fraud
New Jersey and other states with similar False Claims Acts should amend them to cover misappropriated municipal funding, and state and local tax fraud, which would encourage more whistleblowers to come forward and increase their recoveries, says Kenneth Levine at Stone & Magnanini.
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7 Tips For Associates To Thrive In Hybrid Work Environments
Excerpt from Practical Guidance
As the vast majority of law firms have embraced some type of hybrid work policy, associates should consider a few strategies to get the most out of both their in-person and remote workdays, says James Argionis at Cozen O’Connor.
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Series
Playing Beach Volleyball Makes Me A Better Lawyer
My commitment to beach volleyball has become integral to my performance as an attorney, with the sport continually reminding me that teamwork, perseverance, professionalism and stress management are essential to both undertakings, says Amy Drushal at Trenam.
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What To Expect From 'Make America Healthy Again' Actions
The Make America Healthy Again Commission recently established by President Donald Trump and chaired by Robert F. Kennedy Jr. will potentially bring energy and attention to important public health topics, and stakeholders should be aware of pathways for sharing their input and proactively informing proceedings, says Nicholas Manetto at Faegre Drinker.
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How Law Firms Can Counteract The Loneliness Epidemic
The legal industry is facing an urgent epidemic of loneliness, affecting lawyer well-being, productivity, retention and profitability, and law firm leaders should take concrete steps to encourage the development of genuine workplace connections, says Michelle Gomez at Littler and Gwen Mellor Romans at Herald Talent.
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What's At Stake In High Court's Class Member Standing Case
The U.S. Supreme Court’s eventual decision in Labcorp v. Davis could significantly alter how parties prosecute and defend class actions in federal court, particularly if the court determines some proof of member standing is required before a class may be certified, say attorneys at Reed Smith.
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How Citizen Petitions Have Affected Drug Competition
In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.
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5 Keys To Building Stronger Attorney-Client Relationships
Attorneys are often focused on being seen as the expert, but bonding with clients and prospects by sharing a few key personal details provides the basis for a caring, trusted and profoundly deeper business relationship, says Deb Feder at Feder Development.
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Drug Kickback Ruling Will Make FCA Liability Harder To Prove
The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.
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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.