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Life Sciences
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May 20, 2025
Creditors Win Fight Against Insider Releases In Azzur Ch. 11
A Delaware bankruptcy judge on Tuesday sustained an objection to insider releases in the Chapter 11 liquidation plan of Azzur Group, finding the pharmaceutical services company had not justified the releases for prepetition conduct of current and former officers, directors, and equity holders.
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May 20, 2025
Biotech Stockholders Challenge Director Pay Levels In Del.
Investors in biotech company Intellia Therapeutics Inc. stock opened a derivative suit in Delaware's Court of Chancery on Tuesday seeking recovery of allegedly excessive compensation paid to non-employee directors for multiple years without an approval vote by stockholders.
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May 20, 2025
Sales Exec Admits Role In $70M Brain Scan Kickback Scheme
A former operations and regional sales manager for a mobile medical diagnostic company has agreed to plead guilty to taking part in a $70.6 million conspiracy to pay kickbacks to doctors who ordered unnecessary brain scans, Massachusetts federal prosecutors announced Tuesday.
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May 19, 2025
Former Kite Pharma Exec Alleges Gender Bias, Retaliation
Gilead Sciences and its subsidiary Kite Pharma have been hit with a suit in California state court by a former company executive alleging she was underpaid compared to her male counterparts and fired while out on medical leave after she raised concerns about equal pay.
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May 19, 2025
SEC's 'Shadow Trading' Win Should Be Tossed, 9th Circ. Told
An ex-Medivation Inc. executive found liable in the U.S. Securities and Exchange Commission's first-ever "shadow trading" case has asked the Ninth Circuit to overturn the verdict, arguing that his company's policies should have kept the matter from going to a jury in the first place.
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May 19, 2025
Ex-CTA Worker Can Take Vaccine Bias Claim To Trial
An ex-Chicago Transit Authority employee fired after refusing COVID-19 vaccination can take his religious discrimination claim to a jury this summer after an Illinois federal judge grilled the agency Monday on its assertion that the plaintiff didn't seek an exemption for sincerely held religious beliefs and rejected its argument that he was "cherry-picking" Catholic doctrine.
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May 19, 2025
Feds Get Early Win In Drugmakers' Suit Over 340B Rebates
A D.C. federal judge awarded an early win to the U.S. Department of Health and Human Services on Friday on claims it illegally blocked drugmakers' efforts to implement rebates instead of discounts in a decades-old drug pricing program, finding the agency has the authority to pre-approve the price reduction models.
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May 19, 2025
Bluebird Beats Patent Case Over Blood Disease Therapies
A Delaware federal judge has tossed a lawsuit against Bluebird Bio alleging two of its multimillion-dollar gene therapy treatments for blood disorders infringed patents held by San Rocco Therapeutics LLC, after the dispute had been narrowed by a previous claim construction ruling.
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May 19, 2025
Biotech Services Company Files Ch. 11 With $60M In Debt
Contracted biotechnology research company AmplifyBio filed for Chapter 11 protection late Friday in Ohio bankruptcy court listing about $60 million in debt, saying it intends to sell its assets after failing to realize sufficient revenue to support its capital-intensive operations.
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May 19, 2025
Wachtell-Led Regeneron To Buy 23andMe, Gaining User Data
Regeneron Pharmaceuticals said Monday it emerged as the winning bidder for 23andMe, agreeing to pay $256 million to scoop the once high-flying consumer genomics firm out of bankruptcy while pledging to uphold strict privacy standards.
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May 19, 2025
Covington Corporate M&A Atty Moves To Clifford Chance
Clifford Chance LLP has hired a Covington & Burling LLP partner for its U.S. corporate mergers and acquisitions practice to strengthen its capabilities in the healthcare and life sciences sector, the firm said Monday.
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May 19, 2025
USPTO Seeks Input On Guidelines For Fighting Online Fakes
The U.S. Patent and Trademark Office published a notice in the Federal Register on Monday requesting comments from intellectual property rights holders, online marketplaces and others on draft guidelines to combat the illicit trade and sale of counterfeit goods on the internet.
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May 16, 2025
IPO Pipeline Restarts As Tariff-Related Volatility Eases
Initial public offerings are showing life again after a tariff-induced slumber, buoyed by strong debuts and a growing pipeline as more venture-backed technology startups are lining up public listings before Memorial Day and into June.
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May 16, 2025
J&J Unit Hit With $147M Verdict In Catheter Antitrust Suit
A California federal jury found Friday that Johnson & Johnson's medical technology unit Biosense Webster violated federal and state antitrust laws by withholding clinical support to hospitals using third-party reprocessed catheters, awarding plaintiff Innovative Health more than $147 million in damages.
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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.
Expert Analysis
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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.
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A Look At FDA's Plans To Establish New OTC Drug Category
The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.
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The Fed. Circ. In 2024: 5 Major Rulings To Know
In 2024, the Federal Circuit provided a number of important clarifications to distinct areas of patent law – including design patent obviousness, expert testimony admissions and patent term adjustments – all of which are poised to have an influence going forward, say attorneys at Knobbe Martens.
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Rethinking Litigation Risk And What It Really Means To Win
Attorneys have a tendency to overestimate litigation risk before summary judgment and underestimate risk after it, but an eight-stage litigation framework can clarify risk at different points and help litigators reassess what true success looks like in any particular case, says Joshua Libling at Arcadia Finance.
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How DOGE's Bite Can Live Up To Its Bark
All signs suggest that the Department of Government Efficiency will be an important part of the new Trump administration, with ample tools at its disposal to effectuate change, particularly with an attentive Republican-controlled Congress, say attorneys at K&L Gates.
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US-China Deal Considerations Amid Cross-Border Uncertainty
With China seemingly set to respond to the incoming U.S. administration's call for strategic decoupling and tariffs, companies on both sides of the Pacific should explore deals and internal changes to mitigate risks and overcome hurdles to their strategic plans, say attorneys at Covington.
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Considering The Status Of The US Doctrine Of Patent Misuse
A recent Ninth Circuit decision and a U.K. Court of Appeal decision demonstrate the impact that the U.S. Supreme Court's 2015 decision in Kimble v. Marvel Entertainment has had on the principle that post-patent-expiration royalty payments amount to patent misuse, not only in the U.S. but in English courts as well, say attorneys at Covington.
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Series
Playing Rugby Makes Me A Better Lawyer
My experience playing rugby, including a near-fatal accident, has influenced my legal practice on a professional, organizational and personal level by showing me the importance of maintaining empathy, fostering team empowerment and embracing the art of preparation, says James Gillenwater at Greenberg Traurig.
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Looking Back At 2024's Noteworthy State AG Litigation
State attorneys general across the U.S. took bold steps in 2024 to address unlawful activities by corporations in several areas, including privacy and data security, financial transparency, children's internet safety, and other overall consumer protection claims, say attorneys at Troutman Pepper.
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Opinion
No, Litigation Funders Are Not 'Fleeing' The District Of Del.
A recent study claimed that litigation funders have “fled” Delaware federal court due to a standing order requiring disclosure of third-party financing, but responsible funders have no problem litigating in this jurisdiction, and many other factors could explain the decline in filings, say Will Freeman and Sarah Tsou at Omni Bridgeway.