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Life Sciences
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June 23, 2025
Justices Call For SG's Take On Skinny Label Petition
The U.S. Supreme Court on Monday asked the solicitor general to weigh in on so-called skinny labels as Hikma Pharmaceuticals fights the reinstatement of litigation challenging its generic version of Amarin Pharma's blockbuster cardiovascular drug Vascepa.
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June 23, 2025
Illumina To Buy SomaLogic For Up To $425M
Biotechnology company Illumina Inc. on Monday announced plans to acquire data-driven proteomics technology company SomaLogic from its parent Standard BioTools for up to $425 million in a deal built by three law firms.
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June 20, 2025
Science Research Funding Cuts Blocked By Mass. Judge
A Massachusetts federal judge Friday prohibited the Trump administration from cutting certain National Science Foundation research funding associated with facilities and administrative costs, ruling that the policy runs afoul of multiple laws and the government hasn't adequately explained its reasoning.
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June 20, 2025
23andMe Judge Aims For Quick Decision On Sale To Founder
After a second all-day hearing, a Missouri bankruptcy judge said he would decide as quickly as he can on the proposed $305 million sale of genetic testing company 23andMe to a nonprofit led by co-founder Anne Wojcicki.
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June 20, 2025
High Court Urged To Rein In FDA Oversight Of Stem Cells
The Association of American Physicians and Surgeons asked the U.S. Supreme Court Friday to review a Ninth Circuit decision the organization argued would wrongly give the government control over a patient's own stem cells.
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June 20, 2025
Many Foreign Firms Could Face Stricter Access To US Markets
The U.S. Securities and Exchange Commission's reevaluation of the definition of a foreign private issuer could have far-reaching consequences, potentially tightening access to U.S. markets for companies based in China and beyond, lawyers say.
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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 Âé¶¹´«Ã½ 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 Âé¶¹´«Ã½ 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.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Âé¶¹´«Ã½360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Âé¶¹´«Ã½360 in an expansive interview.
Expert Analysis
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Observations On 5 Years Of Non-Notified CFIUS Inquiries
Since 2020, the Committee on Foreign Investment in the United States has identified and investigated covered cross-border transactions not formally notified to CFIUS, and a look at data from 50 non-notified matters during that time reveals the general dynamics of this enforcement function, say attorneys at Cooley.
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9th Circ. Has Muddied Waters Of Article III Pleading Standard
District courts in the Ninth Circuit continue to apply a defunct and especially forgiving pleading standard to questions of Article III standing, and the circuit court itself has only perpetuated this confusion — making it an attractive forum for disputes that have no rightful place in federal court, say attorneys at Gibson Dunn.
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An Underused Tariff Exemption For Medical Product Importers
Medical device importers may be able to reduce tariff exposure by leveraging an often-overlooked Nairobi Protocol duty exemption for products specially designed to benefit those with qualifying medical conditions, says Samuel Finkelstein at LMD Trade Âé¶¹´«Ã½.
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Series
Competing In Modern Pentathlon Makes Me A Better Âé¶¹´«Ã½yer
Opening myself up to new experiences through competing in modern Olympic pentathlon has shrunk the appearance of my daily work annoyances and helps me improve my patience, manage crises better and remember that acquiring new skills requires working through your early mistakes, says attorney Mary Zoldak.
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Prepare For Increased FDA Inspections Of Foreign Facilities
In light of the U.S. Food and Drug Administration's recently announced plans to expand use of unannounced inspections of foreign drug manufacturing factories, foreign firms should implement best practices in anticipation of an imminent increase in enforcement activity, say attorneys at McGuireWoods.
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Series
Âé¶¹´«Ã½ School's Missed Lessons: Teaching Yourself Legal Tech
New graduates often enter practice unfamiliar with even basic professional software, but budding lawyers can use on-the-job opportunities to both catch up on technological skills and explore the advanced legal and artificial intelligence tools that will open doors, says Alyssa Sones at Sheppard Mullin.
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Navigating Potential Sources Of Tariff-Related Contract Risk
As the tariff landscape continues to shift, companies must anticipate potential friction points arising out of certain common contractual provisions, prepare to defend against breach claims, and respond to changing circumstances in contractual and treaty-based relationships, say attorneys at Debevoise.
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How AI May Reshape The Future Of Adjudication
As discussed at a recent panel at Texas A&M, artificial intelligence will not erase the human element of adjudication in the next 10 to 20 years, but it will drive efficiencies that spur private arbiters to experiment, lead public courts to evolve and force attorneys to adapt, says Christopher Seck at Squire Patton.
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When Legal Advocacy Crosses The Line Into Incivility
As judges issue sanctions for courtroom incivility, and state bars advance formal discipline rules, trial lawyers must understand that the difference between zealous advocacy and unprofessionalism is not just a matter of tone; it's a marker of skill, credibility and potentially disciplinary exposure, says Nate Sabri at Perkins Coie.
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Should Patent Disputes Be Filed In The ITC Or UPC?
When companies must choose between initiating patent litigation in the U.S. International Trade Commission or the European Union's Unified Patent Court, the ITC may offer a few distinct advantages, but ultimately the decision requires consideration of case-specific factors, say attorneys at White & Case.
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Opinion
NJ Should Align With Federal Rule On Expert Testimony
The time is right to amend Rule 702 of the New Jersey Rules of Evidence to align it with the recently amended Rule 702 of the Federal Rules of Evidence and clarify the standard for admissibility of expert testimony, says Timothy Freeman at Tanenbaum Keale.
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2 NY Rulings May Stem Foreign Co. Derivative Suits
In recent decades, shareholders have challenged the internal affairs doctrine by bringing a series of derivative actions in New York state court on behalf of foreign corporations, but the New York Court of Appeals' recent rulings in Ezrasons v. Rudd and Haussmann v. Baumann should slow that trend, say attorneys at Cleary.
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Recent Reports Shed Light On Section 340B's Effectiveness
Recent analyses of the Section 340B program's effectiveness in helping patients afford drugs in Minnesota reinforce concerns about the program's lack of transparency and underscore the need for further evaluation of whether legislative reform should be enacted, say William A. Sarraille at the University of Maryland, and Andrée-Anne Fournier and Molly Frean at Analysis Group.
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Opinion
Congress Should Pass IP Reform, Starting With 3 Patent Bills
Congress is considering a trio of bipartisan bills to fix patent law problems that have cropped up over the past two decades, and it shouldn't stop there — addressing two other intellectual property issues is critical for America's economy, says retired Judge Kathleen O'Malley at the Council for Innovation Promotion.
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Class Standing Issues Still Murky After Justices Punt LabCorp
While litigants and district courts had hoped the U.S. Supreme Court's ruling in LabCorp v. Davis would provide much-needed clarity on the interplay between Article III standing and class certification, the court's failure to rule on the issue leaves disagreement, confusion and uncertainty for stakeholders, says Erica Rutner at Cozen O'Connor.