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Life Sciences
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March 06, 2025
FDA Nominee Hedges On Job Cuts, Abortion Drug In Hearing
The nominee to lead the U.S. Food and Drug Administration, Dr. Marty Makary, repeatedly hedged about whether he would reconvene a flu vaccine committee, maintain access to the abortion drug mifepristone or control future job cuts during his confirmation hearing in front of a Senate panel on Thursday.
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March 06, 2025
Kirkland-Led Medical Device Firm Prices Upsized $202M IPO
Shares of Kestra Medical Technologies Ltd. soared in debut trading Thursday after the maker of wearable defibrillators priced an upsized $202 million initial public offering above its range, represented by Kirkland & Ellis LLP and underwriters' counsel Allen Overy Shearman Sterling LLP.
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March 06, 2025
Trump Administration Ordered To Release Funds To States
A Rhode Island judge on Thursday ordered the Trump administration to stop withholding funds from states, saying an executive order freezing federal grants, loans and other payments approved by Congress "fundamentally undermines" the separation of powers and is causing irreparable harm.
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March 05, 2025
Celltrion Can't Undo Eye Med Biosimilar Injunction On Appeal
The Federal Circuit on Wednesday affirmed a lower court's preliminary injunction barring South Korea-based Celltrion Inc. from launching a biosimilar version of Regeneron's blockbuster eye disease treatment Eylea, rejecting Celltrion's argument that it has shown a patent on the drug may be invalid.
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March 05, 2025
Teva Wants Pause Of Patent Delisting For High Court Appeal
Israeli drugmaker Teva Pharmaceuticals is hoping the Federal Circuit will keep an injunction ordering it to remove its inhaler patents from the U.S. Food and Drug Administration's Orange Book on hold while it appeals the matter to the U.S. Supreme Court.
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March 05, 2025
Pfizer Beats Claims Of Copay Aid Scheme For Good
Litigation firms accusing Pfizer of a scheme to inflate drug prices for Medicare and Medicaid plans saw their suit dismissed permanently, with a Washington, D.C., federal judge ruling they had been given "enough chances" to remedy pleading deficiencies in their claims.
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March 05, 2025
Nationwide Block Of Trump Trans Healthcare Orders Extended
A Maryland federal judge has extended a nationwide injunction that was set to expire this week prohibiting the Trump administration from enforcing executive orders banning federal funding for gender-affirming care for people under the age of 19, finding the harm inflicted by the orders is "non-speculative, concrete, and potentially catastrophic."
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March 05, 2025
Biotech Co. Maravai Hit With Investor's Internal Controls Suit
Health research tools company Maravai LifeSciences Holdings Inc. has been hit with a proposed shareholder class action alleging it failed to report that it had issues with its internal reporting controls ahead of its announcement that an inaccurate report led to the misallocation of $3.9 million.
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March 05, 2025
Senators Press Trump's NIH Nominee On Grant Cuts, Vaccines
Dr. Jay Bhattacharya vowed to support research into chronic diseases but repeatedly refused Wednesday to express an opinion on cost-cutting efforts at the National Institutes of Health, sidestepping bipartisan questions during a hearing on his nomination to run the biomedical research agency.
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March 05, 2025
Pfizer, BioNTech Get PTAB To Invalidate Moderna Vaccine IP
The Patent Trial and Appeal Board handed a massive victory to Pfizer and BioNTech on Wednesday, as it invalidated two Moderna patents covering its Spikevax COVID-19 vaccine, which the challengers stand accused of infringing.
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March 05, 2025
Trump's NIH Cost-Cutting Measure Blocked By Judge
A Massachusetts federal judge ruled Wednesday that the Trump administration cannot cap indirect costs for research grants at the National Institutes of Health, rejecting the move as a rushed cost-saving measure that violates federal law governing the expenses.
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March 05, 2025
3 Firms Build Jazz Pharmaceuticals' $935M Chimerix Buy
Jazz Pharmaceuticals on Wednesday revealed plans to acquire biopharmaceutical company Chimerix in a $935 million deal built by three law firms that will further diversify Jazz's oncology portfolio.
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March 05, 2025
Skin Care Tech Co. Files Ch. 11 With $400M Prepackaged Plan
Skin care and beauty technology company Cutera Inc. filed for Chapter 11 protection in a Texas bankruptcy court Wednesday with over $429 million in debt and a prepackaged debt-swap plan to cut that number by nearly $400 million.
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March 04, 2025
Meijer Says 1st Circ. Must Resolve Takeda Arbitration Order
Grocery store chain Meijer on Tuesday urged a Massachusetts federal judge to allow it to immediately appeal his ruling granting Takeda Pharmaceutical's bid to arbitrate the grocer's antitrust claims over a constipation drug, arguing that the case presents several issues that the First Circuit needs to address.
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March 04, 2025
Gov't Says 2 Lab Owners Billed $40M In COVID Test Scheme
Federal prosecutors opened their case Tuesday against two laboratory owners, telling jurors in Florida that they ran a more than $40 million scheme to submit medically unnecessary COVID-19 testing claims to healthcare benefit programs.
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March 04, 2025
Apple Seeks Ban Against Masimo's Original Smartwatch
Apple has urged a Delaware federal judge to issue an injunction against a healthcare technology company found last year to have infringed two of the tech giant's design patents with its W1 smartwatch and charger, calling the defense's refusal to agree to the injunction "telling."
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March 04, 2025
Fed. Circ. Affirms PTAB Decision Backing Stem Cell Patent
A biotech research outfit failed Tuesday to persuade Federal Circuit judges to rethink an administrative board ruling that rejected a challenge mounted against a stem cell patent.
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March 04, 2025
Moderna Faces MRNA Vax Patent Suits In Canada And Beyond
Pennsylvania drug developer Arbutus Biopharma and Genevant Sciences have taken their COVID-19 vaccine litigation against Moderna worldwide, suing the pharmaceutical company in courts in Canada, Japan and Switzerland, along with the Unified Patent Court, alleging infringement.
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March 04, 2025
Alcon, Lens.com Settle 7-Year Trademark Fight In NY
Alcon and Lens.com informed a New York federal judge Tuesday that they've agreed to resolve their long-running trademark dispute over claims that Lens.com was reselling some of Alcon's products without authorization.
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March 04, 2025
PBMs Ask 8th Circ. To Pause FTC's Insulin Pricing Case
Caremark Rx, Express Scripts and OptumRx have asked the Eighth Circuit to pause the Federal Trade Commission's in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices as they push their constitutional claims against the agency.
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March 04, 2025
After 'Historic Low' In 2023, Number Of ITC Cases Soar In 2024
The U.S. International Trade Commission saw a significant uptick in disputes last year, according to a Tuesday report by a firm that represents expert witnesses used in litigation.
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March 04, 2025
In Rare Move, Texas Judge Shuns Out-Of-State BigLaw Attys
Two out-of-state BakerHostetler attorneys' "frequent" work in the Lone Star State has sunk their bids to be admitted pro hac vice in a lawsuit accusing the U.S. Food and Drug Administration of catering to Big Pharma by nixing cheaper versions of the miracle weight loss drug Ozempic.
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March 04, 2025
Freezer Co. Drops Supplier Suit Over $15M Embryo Loss
Freezer maker Chart Inc. has dropped its lawsuit alleging one of its suppliers should pay part of a $15 million verdict stemming from an implosion of Chart's cryopreservation tanks in 2018, which destroyed human eggs and embryos, according to an order Monday.
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March 04, 2025
Colo. Biotech, Founders Owe SEC $14.3M Over Fraud Claims
A Colorado federal judge has ordered a biotech startup and two of its founders to pay the U.S. Securities and Exchange Commission roughly $14.3 million and barred them from serving as officers and directors of public companies after finding that they fraudulently raised over $10 million by overstating their own investments in the company.
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March 04, 2025
IRS Asks To Toss Abbott Labs' FOIA Action For Tax Records
Discovery limitations in a U.S. Tax Court case apply to documents related to an Internal Revenue Service investigation of Abbott Laboratories' transfer policies and thus mean that Abbott can't access them with a Freedom of Information Act request, the IRS told a D.C. federal court.
Expert Analysis
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Opinion
Judge Should Not Have Been Reprimanded For Alito Essay
Senior U.S. District Judge Michael Ponsor's New York Times essay critiquing Supreme Court Justice Samuel Alito for potential ethical violations absolutely cannot be construed as conduct prejudicial to the administration of the business of the courts, says Ashley London at the Thomas R. Kline School of Law of Duquesne University.
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A Look At Drug Price Negotiation Program's Ongoing Impact
More than two years after the passage of the Inflation Reduction Act and the rapid implementation of the drug price negotiation program, attorneys at Ropes & Gray discuss how the IRA has influenced licensing strategies, and how maximum fair prices under the law have economically affected certain drugs.
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Opinion
Congress Must Consider Accurate Data About Patent Thickets
If Congress revisits a controversial bill this year aimed at limiting the number of patents pharmaceutical manufacturers could assert, it must make sure to act based on accurate reports — such as a recent U.S. Patent and Trademark Office study that found no evidence of patent thicketing, says David Kappos at the Council for Innovation Promotion.
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Lights, Camera, Ethics? TV Lawyers Tend To Set Bad Example
Though fictional movies and television shows portraying lawyers are fun to watch, Hollywood’s inaccurate depictions of legal ethics can desensitize attorneys to ethics violations and lead real-life clients to believe that good lawyers take a scorched-earth approach, says Nancy Rapoport at the University of Nevada, Las Vegas.
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Will 4th Time Be A Charm For NY's 21st Century Antitrust Act?
New York's recently introduced 21st Century Antitrust Act would change the landscape of antitrust enforcement in the state and probably result in a sharp increase in claims — but first, the bill needs to gain traction after three aborted attempts, says Tyler Ross at Shinder Cantor.
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Perspectives
Accountant-Owned Law Firms Could Blur Ethical Lines
KPMG’s recent application to open a legal practice in Arizona represents the first overture by an accounting firm to take advantage of the state’s relaxed law firm ownership rules, but enforcing and supervising the practice of law by nonattorneys could prove particularly challenging, says Seth Laver at Goldberg Segalla.
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The Post-Macquarie Securities Fraud-By-Omission Landscape
While the U.S. Supreme Court's 2024 opinion in Macquarie v. Moab distinguished inactionable "pure omissions" from actionable "half-truths," the line between the two concepts in practice is still unclear, presenting challenges for lower courts parsing statements that often fall within the gray area of "misleading by omission," say attorneys at Katten.
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AI Will Soon Transform The E-Discovery Industrial Complex
Todd Itami at Covington discusses how generative artificial intelligence will reshape the current e-discovery paradigm, replacing the blunt instrument of data handling with a laser scalpel of fully integrated enterprise solutions — after first making e-discovery processes technically and legally harder.
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IP, Licensing, M&A Trends To Watch In Life Sciences This Year
2025 promises to continue an exciting trajectory for the life sciences industry, with major trends ranging from global harmonization of intellectual property to cross-border licensing activity and an increase of nontraditional financial participants in the mergers and acquisition space, say attorneys at Morgan Lewis.
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When Innovation Overwhelms The Rule Of Law
In an era where technology is rapidly evolving and artificial intelligence is seemingly everywhere, it’s worth asking if the law — both substantive precedent and procedural rules — can keep up with the light speed of innovation, says Reuben Guttman at Guttman Buschner.
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Anticipating Direction Of Cosmetics Regulation Under Trump
It is unclear how cosmetics regulation reform from the last few years will fare under President Donald Trump, but the new administration's emphasis on deregulation and Robert F. Kennedy Jr.'s views on product safety provide some insight, say attorneys at Crowell & Moring.
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Drug Pricing Policy Trends To Expect In 2025 And Beyond
Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.
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Imagine The Possibilities Of Openly Autistic Lawyering
Andi Mazingo at Lumen Law, who was diagnosed with autism about midway through her career, discusses how the legal profession can create inclusive workplaces that empower openly autistic lawyers and enhance innovation, and how neurodivergent attorneys can navigate the challenges and opportunities that come with disclosing one’s diagnosis.
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.
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Parsing 3rd Circ. Ruling On Cannabis, Employee Private Suits
The Third Circuit recently upheld a decision that individuals don't have a private right of action for alleged violations of New Jersey's Cannabis Regulatory, Enforcement Assistance and Marketplace Modernization Act, but employers should stay informed as the court encouraged the state Legislature to amend the law, say attorneys at Mandelbaum Barrett.