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Life Sciences
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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 — 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 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.
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May 21, 2025
9th Circ. Judge Asks If Apple's Watch Updates 'Ice Out' Rivals
Two Ninth Circuit judges appeared skeptical Wednesday of Apple Inc.'s arguments against reviving an antitrust suit brought by medical monitoring startup AliveCor Inc. after Apple blocked third-party access to medical data on the Apple Watch, with one judge asking rhetorically whether a "marginal" improvement by Apple could actually be a way to "ice out" competition.
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May 21, 2025
Judge Mulls National Scope Of Bid To Restore COVID Grants
A Washington, D.C., federal judge Wednesday mulled whether it would be appropriate to issue a nationwide injunction blocking the termination of $11 billion public health grants set aside under COVID-era laws in a lawsuit brought by four local governments and a public sector union.
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May 21, 2025
AbbVie Gets Victory In Allergan Shareholder Suit Upheld
An Illinois state appellate panel said Wednesday that a trial court properly dismissed a shareholder class action against biopharmaceutical company AbbVie Inc. that accused the drugmaker of issuing unregistered shares to investors after acquiring Irish pharmaceutical company Allergan.
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May 21, 2025
GOP FTC Renews Calls For Orange Book Patent Delistings
The now-Republican controlled Federal Trade Commission again called on Teva, Novartis, Mylan and other drugmakers to remove patents from a key federal database that partially insulates their drugs from generic competition, arguing Wednesday the patents cover "devices," not drugs, and thus don't warrant such protection.
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May 21, 2025
Kronos Bio Shareholder Says Sale Unfairly Benefits Execs
Kronos Bio is facing a new shareholder suit claiming its plan to be acquired by another biopharmaceutical company will unfairly entitle Kronos executives to "lucrative" benefits unavailable to public shareholders.
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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.
Expert Analysis
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Maintaining Legal Compliance For GenAI In Life Sciences
As companies continue to implement generative artificial intelligence to enhance all phases of drug discovery, they must remain mindful of legal, regulatory and practical considerations as best practices in this space emerge and evolve, say attorneys at Sullivan & Cromwell.
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Trending At The PTAB: The Influence Of Litigation Arguments
Recent decisions from the Patent Trial and Appeal Board shed light on the varying extent to which the board considers patent owners' district court arguments, particularly with respect to the meaning of claim terms, say attorneys at Finnegan.
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Series
Teaching Business Law Makes Me A Better Lawyer
Teaching business law to college students has rekindled my sense of purpose as a lawyer — I am more mindful of the importance of the rule of law and the benefits of our common law system, which helps me maintain a clearer perspective on work, says David Feldman at Feldman Legal Advisors.
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Deregulation Memo Presents Risks, Opportunities For Cos.
A recent Trump administration memo providing direction to agencies tasked with rescinding regulations under an earlier executive order — without undergoing the typical notice-and-review process — will likely create much uncertainty for businesses, though they may be able to engage with agencies to shape the regulatory agenda, say attorneys at Blank Rome.
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Series
Law School's Missed Lessons: Mastering Discovery
The discovery process and the rules that govern it are often absent from law school curricula, but developing a solid grasp of the particulars can give any new attorney a leg up in their practice, says Jordan Davies at Knowles Gallant.
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Maneuvering The Weeds Of Cannabis Vertical Integration
The conversation around vertical integration has taken on new urgency as the cannabis market expands, despite federal reform remaining a distant dream, so the best strategy for cannabis operators is to approach vertical integration on a state-by-state basis, say attorneys at Sweetspot Brands.
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Opinion
The IRS Shouldn't Go To War Over Harvard's Tax Exemption
If the Internal Revenue Service revokes Harvard's tax-exempt status for violating established public policy — a position unsupported by currently available information — the precedent set by surviving the inevitable court challenge could undercut the autonomy and distinctiveness of the charitable sector, says Johnny Rex Buckles at Houston Law Center.
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Series
Playing Guitar Makes Me A Better Lawyer
Being a lawyer not only requires logic and hard work, but also belief, emotion, situational awareness and lots of natural energy — playing guitar enhances all of these qualities, increasing my capacity to do my best work, says Kosta Stojilkovic at Wilkinson Stekloff.
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Crisis Management Lessons From The Parenting Playbook
The parenting skills we use to help our kids through challenges — like rehearsing for stressful situations, modeling confidence and taking time to reset our emotions — can also teach us the fundamentals of leading clients through a corporate crisis, say Deborah Solmor at the Wisconsin Alumni Research Foundation and Cara Peterman at Alston & Bird.
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Justices' Labcorp Questions Explore Class Cert. Tensions
At the recent oral argument before the U.S. Supreme Court in Laboratory Corporation of America Holdings v. Davis, the justices' questioning highlighted a fundamental tension between constitutional standing requirements, the procedural framework of Rule 23, and the practical challenges of managing large, diverse classes in complex litigation, say attorneys at Winston & Strawn.
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4 Legislative Proposals Reflect Growing Scrutiny Of Pharma IP
Bipartisan legislative momentum in Congress, including a recent package of bills targeting exclusivity strategies that delay generic and biosimilar competition, signals growing scrutiny of life sciences intellectual property strategies, so biologics companies and investors must pay attention to new strategic, compliance and litigation risks, says Olga Berson at Thompson Coburn.
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Series
Adapting To Private Practice: From NY Fed To BigLaw
While the move to private practice brings a learning curve, it also brings chances to learn new skills and grow your network, requiring a clear understanding of how your skills can complement and contribute to a firm's existing practice, and where you can add new value, says Meghann Donahue at Covington.
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7 Considerations For Conducting Drug Clinical Trials Abroad
With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.
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Top 3 Litigation Finance Deal-Killers, And How To Avoid Them
Like all transactions, litigation finance deals can sometimes collapse, but understanding the most common reasons for failure, including a lack of trust or a misunderstanding of deal terms, can help both parties avoid problems, say Rebecca Berrebi at Avenue 33 and Boris Ziser at Schulte Roth.
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5th Circ. Ruling Is Latest Signal Of Shaky Qui Tam Landscape
In his recent concurring opinion in U.S. v. Peripheral Vascular Associates, a Fifth Circuit judge joined a growing list of jurists suggesting that the False Claims Act's whistleblower provisions are unconstitutional, underscoring that acceptance of qui tam relators can no longer be taken for granted, say attorneys at Miller & Chevalier.