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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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Series
Volunteering At Schools Makes Me A Better Lawyer
Speaking to elementary school students about the importance of college and other opportunities after high school — especially students who may not see those paths reflected in their daily lives — not only taught me the importance of giving back, but also helped to sharpen several skills essential to a successful legal practice, says Guillermo Escobedo at Constangy.
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5 Open Questions About FDA's AI-Assisted Review Plans
The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence program for scientific reviewers and plans for agencywide deployment to speed up reviews of premarket applications, but there is considerable uncertainty surrounding the tools' ability to protect trade secrets, avoid bias and more, say attorneys at King & Spalding.
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Prospects And Challenges For Expert Evidence At The UPC
Expert testimony on economic or damages-related issues will likely play a larger part in Unified Patent Court proceedings in the near future, potentially presenting unique challenges for experts, counsel and judges alike, say analysts at Charles River.
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Attacks On Judicial Independence Tend To Manifest In 3 Ways
Attacks on judicial independence now run the gamut from gross (bald-faced interference) to systemic (structural changes) to insidious (efforts to undermine public trust), so lawyers, judges and the public must recognize the fateful moment in which we live and defend the rule of law every day, says Jim Moliterno at Washington and Lee University.
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Series
Law School's Missed Lessons: Appreciating Civil Procedure
If you’re like me, law school’s often complex and theoretical approach to teaching civil procedure may have contributed to an early struggle with the topic, but when seen from a practical perspective, new lawyers may find they enjoy mastering these rules, says Chloe Villagomez at Foster Garvey.
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Calif. Bar Exam Fiasco Shows Why Attys Must Disclose AI Use
The recent revelation that a handful of questions from the controversial California bar exam administered in February were drafted using generative artificial intelligence demonstrates the continued importance of disclosure for attorneys who use AI tools, say attorneys at Troutman.
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In 2nd Place, Va. 'Rocket Docket' Remains Old Reliable
The U.S. District Court for the Eastern District of Virginia was again one of the fastest civil trial courts in the nation last year, and an interview with the court’s newest judge provides insights into why it continues to soar, says Robert Tata at Hunton.
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Parsing A Lack Of Antitrust Info-Sharing Enforcement Clarity
Information sharing among competing firms has recently faced dramatic changes in antitrust agency guidance, while courts grapple with the permissible scope of pricing algorithms, leaving companies in limbo, but potential Trump administration changes could offer some reprieve, say attorneys at Axinn.
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What FCA Liability Looks Like In The Cybersecurity Realm
Two recent settlements highlight how whistleblowers and the U.S. Department of Justice have been utilizing the False Claims Act to allege fraud predicated on violations of cybersecurity standards — timely lessons given new bipartisan legislation introducing potential FCA liability for artificial intelligence use, say attorneys Rachel Rose and Julie Bracker.
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Foreign Sovereign Entities Should Heed 9th Circ. IP Ruling
After the Ninth Circuit recently held that four Chinese state-controlled companies were not immune from criminal indictment for alleged economic espionage, foreign sovereign-controlled entities should assess whether their operations and affiliation with their parent states qualify for sovereign immunity under the common law, say attorneys at Cleary.
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How Attorneys Can Become Change Agents For Racial Equity
As the administration targets diversity, equity and inclusion efforts and law firms consider pulling back from their programs, lawyers who care about racial equity and justice can employ four strategies to create microspaces of justice, which can then be parlayed into drivers of transformational change, says Susan Sturm at Columbia Law School.
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CMS Guidance May Complicate Drug Pricing, Trigger Lawsuits
Recent draft guidance from the Centers for Medicare & Medicaid Services proposes to expand the scope of what counts as the same qualifying single-source drug, which would significantly alter the timeline for modified drugs facing price controls and would likely draw legal challenges from innovator drug companies, say attorneys at Debevoise.
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Strategies For Litigating In The Unified Patent Court
Since opening its gates two years ago, the European Unified Patent Court has transformed the patent litigation landscape and global litigation strategies, but parties seeking to take advantage of the court's robust processes must be prepared for the front-loaded character of UPC proceedings, say attorneys at McDermott.
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Series
Running Marathons Makes Me A Better Lawyer
After almost five years of running marathons, I’ve learned that both the race itself and the training process sharpen skills that directly translate to the practice of law, including discipline, dedication, endurance, problem-solving and mental toughness, says Lauren Meadows at Swift Currie.
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Series
Law School's Missed Lessons: Supporting A Trial Team
While students often practice as lead trial attorneys in law school, such an opportunity likely won’t arise until a few years into practice, so junior associates should focus on honing skills that are essential to supporting a trial team, including organization, adaptability and humility, says Lucy Zelina at Tucker Ellis.