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Life Sciences
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May 16, 2025
Biotech Co. Hit With Investor Suits Over Cancer Drug Launch
Cancer treatment company Iovance Biotherapeutics has been hit with two proposed shareholder class actions accusing the company of misleading the public about the success of its commercial rollout of an FDA-approved skin cancer treatment.
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May 16, 2025
Parents Sue Colgate Over Alleged Dangers Of Fluoride Rinse
A proposed class of buyers of oral rinses is suing Colgate-Palmolive Co., alleging it misleadingly advertises its Hello Kids Fluoride Rinse as safe despite the U.S. Food and Drug Administration considering it too dangerous for children under 6 years old.
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May 16, 2025
Bank Balks At Nostrum Ch. 11 Sale Over Drug Disposal Issue
Waterford Bank NA has objected to New Jersey drugmaker Nostrum Laboratories Inc.'s plan to sell an Ohio property, saying the bank doesn't want to be left to pay for the disposal of large quantities of controlled substances left at the site, an issue the parties are now negotiating ahead of a hearing next week.
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May 16, 2025
Illumina Accuses Ex-Workers' Co. Of Infringing Gene Tech IP
Biotechnology giant Illumina Inc. filed a lawsuit Thursday against Element Biosciences in Delaware federal court, accusing the company founded by former Illumina employees of infringing five patents related to automated gene sequencing technology.
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May 16, 2025
Feds Want Ex-McKinsey Exec To Serve Time For Obstruction
Prosecutors urged a Virginia federal judge Thursday to sentence a disbarred, former senior McKinsey & Co. partner to one year in prison for obstructing an investigation into the consulting giant's work with opioid-manufacturer Purdue Pharma, while defense counsel pushed for probation so that he can return to his home in Thailand.
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May 16, 2025
Ex-Womble Bond Atty Heads To Chicago With Shook Hardy
Shook Hardy & Bacon LLP has expanded its Chicago office with the recent addition of an attorney with nearly 40 years of experience representing clients in mass tort matters and commercial disputes.
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May 16, 2025
23 States Win Order Halting Billions In HHS Public Health Cuts
A Rhode Island federal judge on Friday barred the Trump administration from cutting off billions of dollars in funding to state public health programs, determining the abrupt grant terminations likely violated congressional authority over spending.
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May 16, 2025
Cooley, Goodwin Build BioMarin's $270M Inozyme Buy
Biotechnology company BioMarin Pharmaceutical Inc., advised by Cooley LLP, on Friday announced plans to buy clinical-stage biopharmaceutical company Inozyme Pharma Inc., led by Goodwin Procter LLP, in a $270 million all-cash deal.
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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.Â
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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.
Expert Analysis
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Navigating The Potential End Of GLP-1 Drug Shortages
The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.
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High Court Could Further Limit Deference With TCPA Fax Case
The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.
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5 Ways To Create Effective Mock Assignments For Associates
In order to effectively develop associates’ critical thinking skills, firms should design mock assignments that contain a few key ingredients, from messy fact patterns to actionable feedback, says Abdi Shayesteh at AltaClaro.
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Calif. Cannabis Decision Deepens Commerce Clause Divide
In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.
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Opinion
IVF Suits Highlight Need For Better Legal Frameworks
The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.
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Recent Suits Show Antitrust Agencies' Focus On HSR Review
The U.S. Department of Justice's suit this month against KKR for inaccurate and incomplete premerger filings, along with other recent cases, highlights the agency's increasing scrutiny of Hart-Scott-Rodino Act compliance for private equity firms, say attorneys at Willkie.
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The 7th Circ.'s Top 10 Civil Opinions Of 2024
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2024, and explain how they may affect issues related to mass arbitration, consumer fraud, class certification and more.
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Royal Canin Ruling Won't Transform Removal Jurisdiction
The U.S. Supreme Court's ruling in Royal Canin USA v. Wullschleger means that federal district courts must now remand whenever an amended complaint excises grounds for federal jurisdiction — but given existing litigation strategy and case law trends, this may ultimately preserve, rather than alter, the status quo, say attorneys at Norton Rose.
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Lessons From The Pharma Industry On Patent Cliffs
In the next five years, patents for drugs that have generated billions in global sales are set to expire, and companies that view this imminent patent cliff as an opportunity for strategic renewal rather than a challenge will be best positioned to maintain market leadership, says Keegan Caldwell at Caldwell Law.
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Mentorship Resolutions For The New Year
Attorneys tend to focus on personal achievements or career milestones when they set yearly goals, but one important area often gets overlooked in this process — mentoring relationships, which are some of the most effective tools for professional growth, say Kelly Galligan at Rutan & Tucker and Andra Greene at Phillips ADR.
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What Nearshoring Growth In Americas Means For Patents
With the new U.S. administration potentially focused on implementing draconian trade restrictions, nearshoring in the Americas is expected to grow, and patent prosecution attorneys will be kept on their toes as the patent landscape from country to country continues to evolve, says Ernest Huang at Procopio.
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Takeaways From FDA's Updated Confirmatory Trial Guidance
The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.
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The Most Important Schedule I Drug Regulatory Shifts Of 2024
In 2024, psychedelics and cannabis emerged as focal points in medical research, marking a pivotal year in their legal and regulatory journey, but these developments presented both opportunities and challenges within this evolving field, say Kimberly Chew at Husch Blackwell and Stephen Kim at Avicanna.
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Series
Coaching Little League Makes Me A Better Lawyer
While coaching poorly played Little League Baseball early in the morning doesn't sound like a good time, I love it — and the experience has taught me valuable lessons about imperfection, compassion and acceptance that have helped me grow as a person and as a lawyer, says Alex Barnett at DiCello Levitt.
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5 Litigation Funding Trends To Note In 2025
Lawyers and their clients must be prepared to navigate an evolving litigation funding market in 2025, made more complicated by a new administration and the increasing overall cost of litigation, says Jeffery Lula at GLS Capital.