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Life Sciences
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May 23, 2025
Fed. Circ. Lifts Stay Against MSN In Entresto Appeal
The Federal Circuit won't make a Delaware federal judge hold off on entering a judgment that would stop MSN Pharmaceuticals from having its generic version of Novartis' blockbuster cardiovascular drug Entresto approved, saying Friday that MSN hasn't pled its case convincingly.
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May 23, 2025
Meta, App Maker Flo Can't Escape All Of Privacy Class Action
A California federal judge ruled Thursday that聽Flo Health Inc. and Meta cannot escape all the claims in a class action brought by users of a menstrual cycle app who allege their privacy was violated, denying parts of both companies' summary judgment bids.聽
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May 23, 2025
LegitScript Can't Use 'Unclean Hands' To Ax Antitrust Case
The Ninth Circuit on Friday said that pharmacy verification and monitoring service provider LegitScript could not toss an antitrust action brought by PharmacyChecker.com based on assertions that the plaintiff facilitated the illegal importation of foreign drugs, saying that the defense of unclean hands doesn't bar the lawsuit.
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May 23, 2025
Seattle Cancer Center Inks $11.5M Class Data Breach Deal
A Washington state judge has given final approval to an $11.5 million class action settlement to end litigation against Seattle-based Fred Hutchinson Cancer Center over a 2023 data breach that exposed patient information, with the judge awarding $3.8 million in attorney fees in a deal class counsel values at more than $50 million.
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May 23, 2025
Fed. Circ. Dings PTAB Decision Upholding X-Ray Patent
The Federal Circuit on Friday reversed a Patent Trial and Appeal Board ruling that claims in an X-ray patent aren't invalid as anticipated, concluding that the board's claim construction in the matter was incorrect, even though the board denied that it was construing any claims.
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May 23, 2025
Ex-McKinsey Exec Sentenced For Obstructing Purdue Probe
A Virginia federal judge has sentenced a disbarred attorney and former McKinsey & Co. partner to six months in prison聽for obstructing an investigation into the consulting giant's work with opioid manufacturer Purdue, federal prosecutors announced Friday.
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May 23, 2025
Trump Admin Must Restore 'Censored' Harvard Docs' Articles
A Massachusetts federal judge on Friday ordered the U.S. Department of Health and Human Services to restore articles penned by two Harvard Medical School researchers that contained terms like "transgender" and "LGBTQ," calling their removal a "textbook example of viewpoint discrimination."
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May 23, 2025
FTC Probing Alcon's $430M Lensar Deal
The Federal Trade Commission has requested additional information about Swiss eye care company Alcon Inc.'s planned purchase of Florida-based medical technology developer Lensar Inc. in a deal worth up to $430 million.
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May 23, 2025
Biotech Insider Traded On $3.5B Novartis Deal, Feds Say
A former board member at Chinook Therapeutics orchestrated an insider-trading scheme after learning about Novartis' plans to purchase the biotech company for $3.5 billion in 2023, according to an indictment announced Friday.
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May 23, 2025
Class Of Health Plans Certified In Avandia Marketing MDL
A Pennsylvania federal judge has certified a class of health plans in multidistrict litigation over GlaxoSmithKline's alleged deceptive marketing of the drug Avandia in which the plans claim they wouldn't have paid higher premiums for the drug if they'd known about its potential cardiovascular risks.
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May 23, 2025
My So-Called Retirement: Some IP Lawyers Just Can't Quit
When patent partner Terry Rea set out to retire, the onetime acting director of the U.S. Patent and Trademark Office had her eyes on the independence that retirement promises 鈥 flexible hours, fewer deadlines and less stress over having lots of people counting on you.
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May 23, 2025
Cooley Hires 'Next-Gen' Boston Labor & Employment Partner
A Choate Hall & Stewart LLP partner has joined Cooley LLP's labor and employment practice and global litigation department in Boston.
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May 23, 2025
Ballard Spahr Adds IP Transactions Pro From DLA Piper
Ballard Spahr LLP announced Thursday that its New York office has gained a life science and climate change-focused corporate lawyer with a background in licensing and other intellectual property transactions from DLA Piper.
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May 23, 2025
Insulet Foe Rips $30M Atty Fee Ask As 'Over-Lawyered'
A South Korean medical device maker told a Massachusetts federal judge that rival Insulet's request for $30 million in attorney fees following a $60 million trade secrets judgment should be denied, calling that amount "exorbitant" and saying Insulet "consistently over-lawyered disputes."
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May 22, 2025
Fed. Circ. Backs Pfizer Win Against Gene Therapy Patents
The Federal Circuit on Thursday sided with the Patent Trial and Appeal Board's findings that a pair of patents covering a new kind of experimental gene therapy to treat hemophilia were invalid, handing a win to patent challenger Pfizer.
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May 22, 2025
Senators Unveil DNA Privacy Bill Amid 23andMe's Ch. 11 Sale
A bipartisan group of U.S. senators on Thursday introduced a bill designed to safeguard customers' genetic information in bankruptcy cases, saying 23andMe's plan to sell users' DNA data to a pharmaceutical company during its Chapter 11 raises new concerns surrounding consumer privacy.
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May 22, 2025
Calif. Docs Bring FDA Stem Cell Regulation Fight To Top Court
Two California clinics that provide stem cell treatments are urging the U.S. Supreme Court to review a Ninth Circuit panel's finding that their treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations.
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May 22, 2025
Justices Urged To Undo Denial Of Fast Track For Gastro Drug
Vanda Pharmaceuticals Inc. is asking the U.S. Supreme Court to reverse the Food and Drug Administration's decision denying fast-track approval for its gastroparesis drug tradipitant, saying it meets the statutory standard for fast-track review as a new treatment with the "potential to address unmet medical needs."
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May 22, 2025
EpiPen Direct Buyers, Mylan Get Final OK On Antitrust Deal
Mylan Pharmaceuticals' $73.5 million settlement with a class of direct EpiPen buyers has received final approval from a Kansas federal judge, closing out claims from institutional drug resellers that Mylan worked with Pfizer to forestall an EpiPen generic from hitting the market and artificially inflating prices for the emergency injectable.
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May 22, 2025
Manufacturer Seeks Over $19M In Beryllium Release Coverage
A medical device manufacturer accused a Zurich unit of breach of contract and bad faith in Massachusetts federal court, seeking at least $19 million in damages after it said storms caused an "unprecedented dispersal" of beryllium at one of its plants in the聽United Kingdom.
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May 22, 2025
Judge Asks If DEI Is Now 'Homogeneity, Inequity And Exclusion'
A Massachusetts federal judge considering a challenge to the Trump administration's cuts to hundreds of National Institutes of Health grants pressed the U.S. Department of Justice on Thursday for its definition of diversity, equity and inclusion, at one point asking hypothetically whether the government's policy is now "homogeneity, inequity and exclusion."
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May 22, 2025
Conn. AG Targets 'Bootleg' Weight Loss Drug Sellers
Connecticut has launched a consumer protection lawsuit in state court against a Florida-based company and its owner, accusing them of peddling untested and unsafe, research-level, "bootleg" GLP-1 weight loss drugs to customers.
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May 22, 2025
Sanofi To Acquire Goodwin-Led US Biotech Biz For $470M
Drugmaker Sanofi said Thursday that it has agreed to acquire Vigil Neuroscience, a biotechnology company specializing in neurodegenerative diseases, for approximately $470 million to give it a potential new medicine for Alzheimer's disease in a deal guided by Goodwin Procter.
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May 21, 2025
FTC Urges 8th Circ. Not To Pause In-House PBM Case
The Eighth Circuit should once again say no to a request to pause the Federal Trade Commission's in-house case accusing three pharmacy benefit managers of hiking up the price of insulin to line their own pockets, the agency has told the appellate court.
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May 21, 2025
Squires Talks Fortress, PTAB Invalidations In Senate Hearing
The Trump administration's nominee for U.S. Patent and Trademark Office director had his moment before the Senate Judiciary Committee on Wednesday, where he downplayed his controversial connections to litigation finance giant Fortress Investment Group and raised concerns that too many bad patents were being issued.
Expert Analysis
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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鈥檚 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聽U.S. v. Regeneron Pharmaceuticals, requiring the government to prove聽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.
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Series
Racing Corvettes Makes Me A Better Lawyer
The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes 鈥 complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.
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Opinion
Attorneys Must Act Now To Protect Judicial Independence
Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch鈥檚 authority, says attorney Bhavleen Sabharwal.
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Rethinking 'No Comment' For Clients Facing Public Crises
鈥淣o comment鈥 is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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As Failure-To-Warn Preemption Wanes, Justices May Weigh In
Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products 鈥 so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.
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How Design Thinking Can Help Lawyers Find Purpose In Work
Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits 鈥 but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.
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The Fate Of Biden-Era Clinical Study Guidance Under Trump
Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at聽Arnold & Porter.