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Life Sciences
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June 26, 2025
Kirkland Stops Repping Novartis After Regeneron Sought DQ
A New York federal judge accepted the withdrawal Thursday of the entire Kirkland & Ellis LLP team that recently joined Novartis Pharma's legal team battling antitrust allegations over the eye medication Eylea, just a week after plaintiff Regeneron Pharmaceuticals sought their disqualification over an "unthinkable" conflict of interest by the lawyers, whose firm previously represented Regeneron.
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June 26, 2025
Hims & Hers Face Investor Suits Over Wegovy Collab
Telehealth company Hims & Hers Health Inc. has been hit with investors' proposed class actions accusing it of exploiting its partnership with Novo Nordisk, the distributor of weight loss drug Wegovy, to sell "knockoff" drugs, causing Hims shares to fall 35% when Novo Nordisk announced earlier this week the collaboration had been terminated.
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June 26, 2025
Biotech Co. Must Face Investor Suit Over Misleading Claims
Biotech company CytoDyn and its former executives and directors cannot escape a suit accusing them of misleading shareholders about the likelihood that the U.S. Food and Drug Administration would approve its drug the company claimed had the potential to treat HIV and COVID-19.
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June 26, 2025
6th Circ. Backs Mich. Newborn Blood Testing Program
A Sixth Circuit panel reversed a win for a group of parents challenging a Michigan newborn health screening program, finding that the way blood samples are stored and used in the program does not violate the parents' right to make medical decisions for their children.
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June 26, 2025
Kimberly-Clark Inks $4.15M Deal In Gown Fraud Suit
Kimberly-Clark Corp. has agreed to pay $4.15 million to settle a suit brought by a doctor on behalf of the federal government alleging it violated the False Claims Act by falsely claiming its surgical gowns protected against contagious diseases.
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June 26, 2025
Judge Casts Doubt On Plea Deals In Blood Test Defect Case
A set of plea agreements between Massachusetts federal prosecutors and former Magellan Diagnostics executives has been thrown into uncertainty amid a dispute over whether the executives admitted to fraud related to defective blood tests or merely an intent to mislead, a question a judge said Thursday might be "a very expensive rabbit hole."
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June 26, 2025
Judge Tosses Biogen MS Drug Antitrust Suit, For Now
An Illinois federal court tossed a proposed class action accusing Biogen of reducing competition for its multiple sclerosis drug Tecfidera through payments to pharmacy benefit managers, after finding that only some drug pricing lists would have been affected.
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June 26, 2025
Ex-FDA Regulator Joins ArentFox Schiff's Pharma Practice
ArentFox Schiff LLP has hired a career U.S. Food and Drug Administration compliance professional, whose oversight focused on ensuring pharmaceutical industry participants' compliance with drug supply chain rules and other governing regulations, as counsel in the firm's food, drug, medical device and cosmetic practice in Washington.
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June 25, 2025
Stewart, APJ Leader Discretionarily Deny 33 More Petitions
The acting U.S. Patent and Trademark Office director rejected 21 petitions for Patent Trial and Appeal Board reviews on Wednesday, and the board's acting deputy chief judge denied another 12 where the acting director recused herself for the first time.
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June 25, 2025
TCPA Litigants Brace For 'Seismic Shift' After Deference Blow
The U.S. Supreme Court's backing of broad judicial review for the crush of regulatory orders interpreting the Telephone Consumer Protection Act is poised to turn the litigation landscape on its head, as key statutory determinations that have long been viewed as settled matters are suddenly ripe for scrutiny.Â
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June 25, 2025
SEC Wins Jury Verdict In $10M Blood Bank Fraud Suit
A California federal jury has found the former CEO of a blood bank business liable for securities fraud, agreeing with the U.S. Securities and Exchange Commission that the executive defrauded retirees out of more than $10 million by promising them returns he knew he could not deliver.
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June 25, 2025
Cigna Says Bristol-Myers Delayed Cancer Drug Generic
Cigna has launched an antitrust suit in New York federal court accusing Bristol-Myers Squibb Co. and its Celgene subsidiary of fraudulently obtaining patents, filing sham litigation and paying off generic-drug makers to maintain a monopoly on their blockbuster blood-cancer drug Pomalyst.
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June 25, 2025
Anti-Aging Biotech Startup Minovia Inks $180M SPAC Merger
Minovia Therapeutics Ltd., an Israeli startup developing treatments for age-related decline, plans to go public in the U.S. at a $180 million valuation by merging with special purpose acquisition company Launch One Acquisition Corp., both parties announced Wednesday.
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June 25, 2025
Fed. Circ. Won't Revive Inventor's Patent Suit Against Google
The Federal Circuit on Wednesday denied a bid to revive a patent infringement case from a man who says Google's products use aspects of his threat-detection technology.
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June 25, 2025
Aetna, CVS Slam Lab's Revised Suit Seeking $20.6M Payment
Aetna and its owner, CVS Health Corp., say a medical laboratory's revamped lawsuit alleging that $20.6 million in invoices remain unpaid fares no better than an earlier version that led a Connecticut federal judge to show the lab the courthouse door earlier this year.
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June 25, 2025
Hospital Slams Novo Nordisk's Insulin Pen Suit Sanctions Bid
Connecticut's Griffin Hospital says Novo Nordisk's attempt to score sanctions in a lawsuit about insulin pen contamination should be rejected because no law requires the healthcare facility to lay out its adversary's possible defenses when pleading its claims.
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June 25, 2025
CVS PBM Hit With $95M Judgment For Overbilling Medicare
A Pennsylvania federal judge on Wednesday ruled that CVS's pharmacy benefits manager owes the government $95 million for overbilling Medicare Part D-sponsored drugs, leaving the door open for the amount to be tripled later.
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June 25, 2025
K&L Gates Adds Powers Pyles Pharma Litigator To DC Team
K&L Gates LLP said Wednesday it has brought on a pharmaceutical attorney from Powers Pyles Sutter & Verville PC who worked for nearly a decade as a pharmacist and has handled pharmacy law matters for more than 15 years.
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June 25, 2025
EisnerAmper Adds International Tax Pro To Minneapolis Office
EisnerAmper has expanded its international tax services group with a new partner who helps individual and corporate clients navigate legislation, regulatory risks and compliance obligations.
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June 24, 2025
Minn. Water Co. Prevails In Retained Limit Coverage Row
A water purification company that's faced a bevy of product liability lawsuits over a disinfectant product needs to pay only one $5 million retained limit before a Chubb unit's coverage obligations under umbrella policies potentially kick in for one of the underlying cases, a Minnesota federal court ruled.
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June 24, 2025
Health Data Co. Must Face Revised Investor Fraud Suit
A Connecticut federal judge won't toss an amended class action claiming a healthcare technology company misled investors about a data platform it claimed to operate that didn't actually exist, ruling that statements about the platform's capabilities are not inactionable, forward-looking statements.
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June 24, 2025
Abbott Hit With Genetic Privacy Suit Over Hiring Practices
Abbott Laboratories was sued Tuesday in Illinois federal court by a former worker alleging the company's onboarding materials asked for his family's medical history in violation of a state law aimed at protecting residents' genetic information.
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June 24, 2025
Calif. AG Asks 9th Circ. To Undo Limits On Pay-For-Delay Ban
California enforcers on Monday asked the Ninth Circuit to overturn a district court's decision that a state law restricting "reverse payment" settlements between brand-name and generic-drug makers cannot be used to regulate deals that were struck outside the Golden State.
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June 24, 2025
Pollution Exclusion Applies Without Exception, AIG Unit Says
An AIG unit urged the Illinois Supreme Court to find that a permit or regulation allowing a company to discharge toxins into the environment has no bearing on the application of a pollution exclusion, saying "pollution is pollution" regardless of government authorization.
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June 24, 2025
Ex-J&J Atty's Race Bias Suit Lacks Facts, Company Argues
Johnson & Johnson Services Inc. told a New Jersey federal court this week that a former in-house data privacy attorney suing the pharmaceuticals giant for discrimination failed to plead any facts supporting her allegation that the company passed her over for a job in favor of a less qualified candidate.
Expert Analysis
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Patent Drafting Pointers From Fed. Circ. COVID Test Ruling
The Federal Circuit's recent decision in DNA Genotek v. Spectrum Solutions provides several best practice pointers for drafting and prosecuting patent applications, highlighting how nuances in wording can potentially limit the scope of claims or otherwise affect claim constructions, says Irah Donner at Manatt.
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Opinion
Congress Must Reform The PTAB To Protect Small Innovators
Lawmakers must reintroduce the Promoting and Respecting Economically Vital American Innovation Leadership Act or similar legislation to prevent larger companies from leveraging the Patent Trial and Appeal Board to target smaller patent holders, says Schwegman Lundberg's Russell Slifer, former deputy director of the U.S. Patent and Trademark Office.
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Series
Baseball Fantasy Camp Makes Me A Better Lawyer
With six baseball fantasy experiences under my belt, I've learned time and again that I didn't make the wrong career choice, but I've also learned that baseball lessons are life lessons, and I'm a better lawyer for my time at St. Louis Cardinals fantasy camp, says Scott Felder at Wiley.
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Series
Adapting To Private Practice: From Fed. Prosecutor To BigLaw
Making the jump from government to private practice is no small feat, but, based on my experience transitioning to a business-driven environment after 15 years as an assistant U.S. attorney, it can be incredibly rewarding and help you become a more versatile lawyer, says Michael Beckwith at Dickinson Wright.
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What To Expect For Stem Cell Regulation Under Trump Admin
The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.
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Firms Still Have Lateral Market Advantage, But Risks Persist
Partner and associate mobility data from the fourth quarter of 2024 shows that we’re in a new, stable era of lateral hiring where firms have the edge, but leaders should proceed cautiously, looking beyond expected revenue and compensation analyses for potential risks, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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10 Practical Takeaways From FDA's Biopharma AI Guidance
Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.
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Opinion
We Must Allow Judges To Use Their Independent Judgment
As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.
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Series
Performing Stand-Up Comedy Makes Me A Better Lawyer
Whether I’m delivering a punchline on stage or a closing argument in court, balancing stand-up comedy performances and my legal career has demonstrated that the keys to success in both endeavors include reading the room, landing the right timing and making an impact, says attorney Rebecca Palmer.
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Unpacking The Illicit E-Cigarette Crackdown By State AGs
A bipartisan coalition of attorneys general for nine states and the District of Columbia announced a coordinated effort to curb illicit electronic cigarette sales, illustrating the rising prominence of state attorneys general using consumer protection laws to address issues of national scope, especially when federal efforts prove ineffective, say attorneys at Troutman.
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Lawmakers Shouldn't Overlook Rare Disease Therapies' Value
As the ORPHAN Cures Act is pending in Congress, policymakers assessing the value of certain drugs for price regulation should consider data beyond what is collected in clinical trials, say Alice Chen at the University of Southern California, and Molly Frean and Yao Lu at Analysis Group.
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Series
Adapting To Private Practice: From SEC To BigLaw
As I adjusted to the multifaceted workflow of a BigLaw firm after leaving the U.S. Securities and Exchange Commission, working side by side with new colleagues on complex matters proved the fastest way to build a deep rapport and demonstrate my value, says Jennifer Lee at Jenner & Block.
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China High Court Ruling Could Encourage Antitrust Litigation
Practitioners defending U.S. companies in China should take note of a Chinese Supreme Court ruling that plaintiffs can file suits based on either where the alleged action, or where the result of such action, occurred — which will promote civil litigation by minimizing procedural battles over forum selection, says Yang Yang at Leaqual Law Firm.
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Making The Case For Rest In The Legal Profession
For too long, a culture of overwork has plagued the legal profession, but research shows that attorneys need rest to perform optimally and sustainably, so legal organizations and individuals must implement strategies that allow for restoration, says Marissa Alert at MDA Wellness, Carol Ross-Burnett at CRB Global, and Denise Robinson at The Still Center.
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How Amended Rule 702 Affects Testimony In Patent Litigation
In 2023, Federal Rule of Evidence 702 was amended to address the apparent failure of some courts to prevent unreliable expert evidence from reaching a jury, but a statistical analysis of Daubert decisions in 2022 and 2024 shows that courts remain divided about how to apply consistent evidence standards, say attorneys at Perkins Coie.