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Life Sciences
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June 20, 2025
Fed. Circ. Revives MSN Challenge To Bausch IBS Drug Patent
The Federal Circuit has instructed the Patent Trial and Appeal Board to take another crack at evaluating the validity of a drug patent owned by Bausch Health Ireland Ltd., holding that the PTAB's initial decision lacked the detail needed to determine whether it was right or wrong.
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June 20, 2025
DEA Judge Backs Federal Ban On 2 Research Chemicals
A U.S. Drug Enforcement Administration judge determined Friday that two unrestricted psychoactive research chemicals belong in Schedule I, the most stringent tier of prohibited substances under the federal Controlled Substances Act.
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June 20, 2025
2nd Purdue Plan Heading For Creditor Vote, Nov. Hearing
A New York bankruptcy judge Friday set OxyContin maker Purdue Pharma's second try at a bankruptcy plan on course for a November confirmation hearing, clearing the plan disclosure statement to be sent out for a creditor vote.
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June 20, 2025
Investor Can't Get Emergency Injunction In Sinovac Battle
A New York federal judge will not grant an investor an emergency injunction to preserve the status quo as it pursues arbitration in Hong Kong or Beijing stemming from a bitter, yearslong battle for control of Chinese vaccine maker Sinovac, saying the investors have not demonstrated a likelihood of "irreparable harm."
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June 20, 2025
PE Firm Demands FDA Docs For Defense In Deal Challenge
Private equity firm GTCR BC Holdings LLC is seeking a court order for the U.S. Food and Drug Administration to produce over a decade's worth of medical device approval applications, arguing the documents are necessary in its defense against a merger challenge by the federal government.
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June 20, 2025
NJ Court Greenlights Beasley Allen Attys In Talc Litigation
A New Jersey state judge will allow two Beasley Allen Law Firm attorneys to represent a California couple in their suit accusing Johnson & Johnson of selling carcinogenic talc-based baby powder and appear pro hac vice despite the company's vehement opposition.
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June 20, 2025
Nose Spray Co. Sues FTC Over Substantiation Requirement
Nasal spray maker Xlear Inc. is suing the Federal Trade Commission in Utah federal court, seeking a declaration that the agency is going beyond its statutory mandate by requiring scientific substantiation in marketing claims, even if the claims are not false and misleading.
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June 20, 2025
Taxation With Representation: Latham, Paul Weiss, Covington
In this week's Taxation With Representation, Nippon Steel closes its purchase of U.S. Steel, Hunter Point Capital buys a minority stake in Equitix, Eaton acquires Ultra PCS Ltd. from the Cobham Ultra Group, and Eli Lilly and Co. acquires Verve Therapeutics.
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June 20, 2025
Psychedelic Therapy Reform Gets Boost From Conservatives
Former Texas Gov. Rick Perry told attendees at a psychedelics conference this week that he was committed to loosening federal restrictions on a prohibited psychoactive substance that has shown promise in treating mental health conditions like opioid addiction.
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June 20, 2025
Justices Let E-Cig Retailers Join Challenge To FDA Prohibition
The U.S. Supreme Court ruled Friday that e-cigarette retailers can challenge the U.S. Food and Drug Administration's denial of product marketing applications, finding manufacturers aren't the only entities that can be adversely affected by the agency's decisions.
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June 20, 2025
High Court Says FCC Orders Not Above District Court Review
The U.S. Supreme Court on Friday ruled that district courts should be allowed to question the slate of regulations that the Federal Communications Commission has issued under the Telephone Consumer Protection Act, further constricting the power of federal agencies to interpret laws.
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June 18, 2025
Texas Judge Vacates Biden-Era HHS Abortion Privacy Rule
A Texas federal judge on Thursday agreed to vacate a U.S. Department of Health and Human Services rule finalized during the Biden administration that aimed to protect the privacy of patients seeking abortions and gender-affirming care, ruling that the HHS didn't have the authority to "fashion special protections" in areas of "great political significance."
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June 18, 2025
J&J Hit With $8M Verdict In Multi-Exposure Talc Case
A jury awarded $8 million on Wednesday to a Massachusetts woman who said Johnson & Johnson's talcum powder caused her mesothelioma, rejecting the company's claims that family members' work around asbestos absolved it of blame.
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June 18, 2025
Anavex Gets Suit Over Rett Syndrome Clinical Trials Nixed
A New York federal judge tossed an Anavex investor's proposed class action alleging she suffered losses from its misleading statements regarding methodologies used in neurological treatment clinical trials, ruling that stock prices rose from the day the statements were made after Anavex made corrective disclosures in a pre-market earnings call.
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June 18, 2025
Sotera Investors Urge 6th Circ. To Reopen Toxic Gas Suit
Sotera Health investors are seeking to revive a lawsuit accusing the company of concealing the carcinogenic nature of a gas used at its sterilization plants, telling the Sixth Circuit that the company knew that its "outrageous and cynical" behavior would cost it hundreds of millions of dollars.
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June 18, 2025
Spectrum Pharma Investors Get First OK For $16M Deal
A Nevada federal judge has given the first green light to a nearly $16 million settlement between a pharmaceutical company and a class of investors who claimed the company and its executives overstated the status of two of its developed drugs and withheld negative data and trial results, leading to a stock drop when the truth was revealed.
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June 18, 2025
Psychedelics And The Law In Focus At Colo. Conference
Colorado Gov. Jared Polis announced a pardon for all state-level convictions for psilocybin and psilocin possession at a psychedelics conference this week, in recognition that these substances are now legal in the state and in another indication that their relationship with the law is in flux.
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June 18, 2025
High Court Concurrences Signal Hard Battle For Trans Rights
U.S. Supreme Court Justice Amy Coney Barrett joined the court's two most conservative members Wednesday to suggest laws that differentiate based on transgender status should be subject to the lowest level of judicial review, providing guidance to lower courts that will likely make it harder for litigants to vindicate trans rights.
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June 18, 2025
23andMe Seeks To Ease Concerns Over Sale To Founder
Several states indicated Wednesday they may no longer oppose the $305 million sale of 23andMe to a nonprofit led by Anne Wojcicki, a co-founder of the company, after the debtor structured the transaction as an equity transfer.
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June 18, 2025
Dealmakers Eye More Crypto-Targeted SPAC Mergers
More special purpose acquisition companies plan to seize upon the revival of cryptocurrencies under a second Trump administration and take cryptocurrency-related ventures public in the coming months, an attorney told a gathering of dealmakers on Wednesday.
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June 18, 2025
Ex-Drug Exec Must Testify, But Keeps 5th Amendment Rights
Sandoz, Teva, Actavis and Taro can again subpoena the deposition testimony of a former Actavis and Teva executive, but a Pennsylvania federal judge is still allowing the witness to invoke his Fifth Amendment rights against self-incrimination, even though the Justice Department dropped the criminal charges against him.
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June 18, 2025
Ga. Court Backs Dismissal Of Hemp Farm's Drug Raid Suit
A Georgia appellate panel has said that state law enforcement cannot be held liable for allegedly damaging tens of thousands of dollars worth of product at a hemp farm, ruling that the Georgia Department of Public Safety was wholly shielded by sovereign immunity.
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June 18, 2025
FDA Dodges Suit Over Ozempic, Wegovy Listing
The U.S. Food and Drug Administration was able to escape allegations that it catered to Big Pharma by nixing cheaper versions of the miracle weight loss drug Ozempic, after a Texas federal judge tossed a lawsuit from two compounding pharmacies.
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June 18, 2025
DC Judge Restores Some Canceled COVID Grants For Now
A D.C. federal judge has ordered the U.S. Department of Health and Human Services to restore at least some canceled public health grants to four local governments, ruling the Trump administration likely exceeded its constitutional power when it terminated the grants in March.
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June 18, 2025
Dorsey & Whitney Adds Patent Partner From Perkins Coie
Dorsey & Whitney LLP has grown its intellectual property offerings in Washington state with the addition of an experienced patent attorney from Perkins Coie LLP.
Expert Analysis
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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.
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How Attys Can Use A Therapy Model To Help Triggered Clients
Attorneys can lean on key principles from a psychotherapeutic paradigm known as the "Internal Family Systems" model to help manage triggered clients and get settlement negotiations back on track, says Jennifer Gibbs at Zelle.
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3 Steps For In-House Counsel To Assess Litigation Claims
Before a potential economic downturn, in-house attorneys should investigate whether their company is sitting on hidden litigation claims that could unlock large recoveries to help the business withstand tough times, says Will Burgess at Hilgers Graben.
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J&J's Failed 3rd Try Casts Doubt On Use Of 'Texas Two-Step'
A Texas bankruptcy court recently rejected Johnson & Johnson's third attempt to use Chapter 11 to resolve liabilities from allegations of injuries from using talcum powder, suggesting that the U.S. Supreme Court's limitations on nondebtor releases, from 2024's Purdue Pharma ruling, may prove difficult to evade, say attorneys at Cadwalader.
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Series
Teaching College Students Makes Me A Better Lawyer
Serving as an adjunct college professor has taught me the importance of building rapport, communicating effectively, and persuading individuals to critically analyze the difference between what they think and what they know — principles that have helped to improve my practice of law, says Sheria Clarke at Nelson Mullins.
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Why Attys Should Get Familiar With Quantum Computing
Quantum computing is projected to pose significant updates to current practices in cryptography, making the issue relevant to policymakers and the legal profession generally, particularly when it comes to data storage, privacy regulations and pharmaceutical industry market changes, say professors at the University of San Francisco.
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Series
Adapting To Private Practice: From DOJ Enviro To Mid-Law
Practitioners leaving a longtime government role for private practice — as when I departed the U.S. Department of Justice’s environmental enforcement division — should prioritize finding a firm that shares their principles, values their experience and will invest in their transition, says John Cruden at Beveridge & Diamond.
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Legal Ethics Considerations For Law Firm Pro Bono Deals
If a law firm enters into a pro bono deal with the Trump administration in exchange for avoiding or removing an executive order, it has an ethical obligation to create a written settlement agreement with specific terms, which would mitigate some potential conflict of interest problems, says Andrew Altschul at Buchanan Angeli.
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Reproductive Health Under Trump So Far, And What's Next
Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.
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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.