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Life Sciences
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May 21, 2025
Device Maker Who Evaded Tax Gets 2 Years In Prison
A Florida man who sold millions of dollars worth of medical devices that federal prosecutors said were unproven to work was sentenced to two years in prison for evading taxes and ordered to pay $2.3 million in restitution to the Internal Revenue Service.
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May 21, 2025
Walgreens Ducks False Ad Suit Over Mucus Relief Meds
An Illinois federal judge on Tuesday dismissed a potential class action accusing Walgreens of misleading customers by selling them over-the-counter mucus relief medicine containing benzene without warning them of that risk, saying the claims are preempted by a federal drug safety law.
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May 20, 2025
Flo Users Get Class Cert. In Google, Meta Data-Sharing Suit
A California federal judge has granted class status to users of the menstrual cycle tracking app developed by Flo Health Inc. in a suit accusing the company of unlawfully sharing their personal health information with Google and Meta, finding that the defendants' opposition to this move lacked clarity and support.
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May 20, 2025
Barclays Officials Beat Shareholder's Suit At NY High Court
New York's highest court on Tuesday rejected arguments that current and former officials of London-based Barclays PLC can be sued under New York law over a series of scandals that have rocked the bank, a decision that sparked rebuke from the court's chief judge.
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May 20, 2025
Novo Fights To Keep Info Bid In $800M Fraud Dispute Alive
Novo Nordisk is urging a North Carolina federal court not to dismiss its order permitting the Danish drugmaker to seek information bolstering its $800 million fraud claims stemming from a hypertension drug deal, saying the testimony is needed to preserve assets as it pursues arbitration of its claims.
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May 20, 2025
Cancer Drug Co. Beats Investor Suit Over FDA Rejection
Cancer drug company Checkpoint Therapeutics Inc. has permanently escaped a shareholder suit alleging it understated the likelihood the U.S. Food and Drug Administration would refuse approving Checkpoint's lead product candidate, with a New York federal judge ruling company statements were not shown to be false or made with scienter.
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May 20, 2025
Medical Organizations Sue Feds For Removing Health Data
The U.S. Department of Health and Human Services and several constituent agencies are accused of violating the Administrative Procedure Act by illegally purging websites containing critical public health information related to trans and HIV care, vaccines and the prevention of outbreaks of communicable diseases, according to a lawsuit filed Tuesday in Washington federal court.
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May 20, 2025
Medical Supply Co. Faces Ga. Suit Over Unwanted Texts
A Florida-based medical supply company has been hit with a proposed Telephone Consumer Protection Act class action in Georgia federal court by a man who says he received several promotional text messages from the company after he added himself to the National Do Not Call Registry.
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May 20, 2025
Moderna Says Order To Narrow Vax IP Case Should Stay
Moderna has said that a federal judge should ignore a rival mRNA developer's request to rethink his decision limiting issues in a patent suit over the company's COVID-19 vaccines, saying the rival is trying to make new arguments too late.
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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.
Expert Analysis
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Series
Playing Football Made Me A Better Lawyer
While my football career ended over 15 years ago, the lessons the sport taught me about grit, accountability and resilience have stayed with me and will continue to help me succeed as an attorney, says Bert McBride at Trenam.
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10 Arbitrations And A 5th Circ. Ruling Flag Arb. Clause Risks
The ongoing arbitral saga of Sullivan v. Feldman, which has engendered proceedings before 10 different arbitrators in Texas and Louisiana along with last month's Fifth Circuit opinion, showcases both the risks and limitations of arbitration clauses in retainer agreements for resolving attorney-client disputes, says Christopher Blazejewski at Sherin and Lodgen.
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Keys To Handling Digital Investigations In Pharma IP Litigation
In the high-stakes realm of pharmaceutical intellectual property litigation, efficient e-discovery and digital investigation workflows are essential to supporting strategic arguments, building defensible cases and proving that the requirements for market entry have been adequately met, says Jerry Lay at FTI Consulting.
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Series
Power To The Paralegals: The Value Of Unified State Licensing
Texas' proposal to become the latest state to license paraprofessional providers of limited legal services could help firms expand their reach and improve access to justice, but consumers, attorneys and allied legal professionals would benefit even more if similar programs across the country become more uniform, says Michael Houlberg at the University of Denver.
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What's Next For Lab Test Regulation Without FDA Authority
A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.
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10 Soft Skills Every GC Should Master
As businesses face shifting regulatory and technological uncertainty, general counsel will need to strengthen certain soft skills to succeed, from admitting when they make a mistake to maintaining a healthy dose of dispassion, says Douglas Brown at Manatt.
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6 Criteria Can Help Assess Executive Branch Actions
With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.
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An Unrestrained, Bright-Eyed View Of Legal AI's Future
Todd Itami at Covington offers a bright-eyed, laughing-all-the-way, skydive look at what the legal industry could look like after an artificial intelligence revolution, which he believes may happen much sooner and more dramatically than we expect.
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Tracking The Evolution In Litigation Finance
Despite continued innovation, litigation finance remains an immature market with borrowers recieving significantly different terms as lenders learn to value cases, which firms need a strong handle on to ensure lending terms do not overwhelm collateral value, says Robert Wilkins at Lightfoot Franklin.
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Keys To Regulatory Diligence In Life Sciences Transactions
Conducting effective regulatory due diligence for life sciences deals requires careful review of a target company's activities, and separate sets of considerations for commercial and pipeline products, says Anna Zhao at GunnerCooke.
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How Courts Weigh Section 1782 Discovery For UPC Cases
A look at cases from six different federal district courts reveals a number of discretionary factors that influence how courts consider Section 1782 discovery applications in connection with Unified Patent Court proceedings, say attorneys at Finnegan.
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Opinion
In Vape Case, Justices Must Focus On Agencies' Results
With the U.S. Supreme Court's ruling in U.S. Food and Drug Administration v. Wages and White Lion Investments having put off the question of whether agency decisions arrived at erroneously are always invalid, the court should give the results of agency actions more weight than the reasoning behind them when it revisits this case, says Jonathan Sheffield at Loyola University Chicago School of Law.
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Series
Volunteer Firefighting Makes Me A Better Lawyer
While practicing corporate law and firefighting may appear incongruous, the latter benefits my legal career by reminding me of the importance of humility, perspective and education, says Nicholas Passaro at Ford.
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E-Discovery Quarterly: The Perils Of Digital Data Protocols
Though stipulated protocols governing the treatment of electronically stored information in litigation are meant to streamline discovery, recent disputes demonstrate that certain missteps in the process can lead to significant inefficiencies, say attorneys at Sidley.
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Defense Strategies After Justices' Personal Injury RICO Ruling
In Medical Marijuana v. Horn, the U.S. Supreme Court recently held that the Racketeer Influenced and Corrupt Organizations Act can be invoked by some plaintiffs with claims arising from personal injuries — but defense counsel can use the limitations on civil RICO claims to seek early dismissal in such cases, say attorneys at Debevoise.