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Life Sciences
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April 02, 2025
NIH Sued By Researchers Over 'Ideological Purge' On Grants
The American Public Health Association and others sued the federal government in Massachusetts federal court on Wednesday over the cancellations of billions of dollars worth of National Institutes of Health research grants on such issues as gender identity, diversity, vaccine hesitancy and climate change, claiming the "ideological purge" is illegal.
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April 02, 2025
With Dems Fired, GOP Recused, FTC Pauses PBMs Case
The Federal Trade Commission has stayed its insulin price-fixing case against pharmacy benefit managers for more than three months, saying it does not have any commissioners to hear it after two Republican members recused themselves and the two Democratic commissioners were removed from their posts by President Donald Trump last month.
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April 02, 2025
PE Firm TPG Wants Endo Trust's Transfer Suit Tossed
Private equity firm TPG Capital is seeking the dismissal of a lawsuit that aims to claw back billions of dollars reaped in an allegedly unfair deal with Endo International PLC before the drugmaker went bankrupt.
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April 02, 2025
Zoll Gets Parts Of Data Breach Class Action Tossed
A Massachusetts federal judge released Zoll Medical Corp. from some claims brought by a proposed class of medical device customers whose personal data was released after two ransomware attacks, but kept alive claims of negligence, unjust enrichment and others.
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April 02, 2025
MSN Denied More Relief For 'Falling Sky' In Entresto Dispute
A Delaware federal judge on Wednesday denied MSN Pharmaceuticals Inc.'s effort to pause a judgment delaying its generic version of a blockbuster Novartis heart medication, finding the court had already granted the company's previous request for relief and wouldn't do so again "for essentially the same falling sky."
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April 02, 2025
Garmin Beats Fitness Tracker Patent Suit, For Now
A Michigan federal judge has tossed, for now, a suit accusing Garmin International Inc. of infringing a CardiacSense Ltd. fitness tracker patent after finding the claims aren't eligible for patent protection, but the judge left room for an amended complaint to be filed.
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April 02, 2025
CVS Asserts DOJ's Opioid Prescription Suit Lacks Facts
CVS Pharmacy Inc. has told a Rhode Island federal judge that most of the U.S. Department of Justice's claims that it knowingly filed invalid prescriptions for opioids should be tossed, saying the agency failed to adequately allege the company willfully put profits over safety.
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April 02, 2025
Bidi Vapor Says FDA Denial Of E-Cig Was Unlawful
Vape company Bidi Vapor LLC urged the Eleventh Circuit on Wednesday to reverse a U.S. Food and Drug Administration decision denying its application to market a disposable e-cigarette, saying the agency acted unlawfully and ignored evidence the company presented.
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April 02, 2025
Orthodontic Software Co. Hit With Data Breach Class Action
An orthodontic software company has been hit with a proposed class action in Georgia federal court over a November data breach in which the names, birth dates, medical records, insurance information, payment card data and Social Security numbers of its clients' patients were stolen by hackers.
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April 02, 2025
Justices Broaden RICO Reach To Personal Injuries
The U.S. Supreme Court on Wednesday expanded the type of civil actions that can be brought under a federal racketeering statute, asserting that claims stemming from personal injuries are redressable if they can be shown to have caused economic harm.
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April 02, 2025
Supreme Court Backs FDA Block Of Flavored Vapes
The U.S. Supreme Court on Wednesday overruled a determination that the U.S. Food and Drug Administration acted arbitrarily when it rejected an e-cigarette company's applications to market flavored vape products.
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April 01, 2025
FDA Beats Challenge To Approval Of Elanco's Cattle Gas Drug
The U.S. Food and Drug Administration has defeated an administrative challenge to its approval of Elanco Health's drug meant to reduce ammonia gas emissions from beef cattle and their waste, with a California federal judge ruling Tuesday that the agency reasonably evaluated its safety based on a wide array of studies.
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April 01, 2025
Takeda Antitrust Trial Over Actos Generics Set For July
A New York federal court refused a bid from Takeda Pharmaceuticals Co. to escape a long-running case accusing it of unlawfully delaying generic versions of its diabetes treatment Actos and scheduled a trial to start in July.
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April 01, 2025
Fla. Defends Sandoz Price-Fixing Settlement Terms
Florida defended its deal with Sandoz Inc. on Monday, saying the other states suing the generic-drug maker over price-fixing have no right to object to the settlement, which does not require court approval and does not affect the states objecting to it.
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April 01, 2025
Two More Pharmacies Hit With Eli Lilly Weight Loss Drug Suits
Eli Lilly and Co. filed another round of lawsuits Tuesday accusing compounding pharmacies of selling copycat versions of its weight loss and diabetes medications, saying in New Jersey and Delaware federal courts that two online pharmacies are deceiving consumers about their knockoff products.
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April 01, 2025
No Inequitable Conduct From Fresenius Foe, Judge Says
German medical giant Fresenius has failed to convince a Delaware federal judge that any foul play could be found in the prosecution of a patent involved in a fight over selling IV bags filled with calcium supplements, used to treat hypocalcemia.
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April 01, 2025
Ex-Biotech CEO Wrongly Sentenced To 7 Years, DC Circ. Told
A former biotech executive who pled guilty to misleading investors about a blood-based COVID-19 test urged the D.C. Circuit to order a redo of his seven-year prison sentence on Tuesday, telling an appeals panel that the trial court miscalculated the sentencing guidelines.
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April 01, 2025
IBM And J&J Beat 'Speculative' Data Breach Suit, For Now
A New York federal judge has tossed with leave to amend a proposed class action alleging IBM and Johnson & Johnson's healthcare arm failed to safeguard sensitive health information of thousands of patients before a 2023 data breach, finding the purported harm is "entirely speculative" as currently alleged.
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April 01, 2025
Talc Claimants Tell 3rd Circ. Whittaker Couldn't File Ch. 11
Talc injury claimants on Tuesday asked the Third Circuit to dismiss Whittaker Clark & Daniels' Chapter 11 case, saying a South Carolina state judge had given control of the talc supplier to a receiver six weeks before the company filed for bankruptcy.
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April 01, 2025
FDA Cuts Prompt Biotech Players To Rethink Deal Strategies
Funding cuts at the U.S. Department of Health and Human Services are sending ripples of concern through the biotech industry, as attorneys advise companies to consider a wider breadth of strategic alternatives amid fears of regulatory delays.
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March 31, 2025
Texas Judge Deems Lab-Test Rule Outside FDA Authority
A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."
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March 31, 2025
Former Stimlabs Exec Must Face Trade Secrets Claims
A former biomedical technology company executive must face claims that she absconded with thousands of internal files containing valuable product information in the days and weeks leading up to her ouster last year, a Georgia federal judge ruled.
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March 31, 2025
Ex-Blood Bank Atty Goes Back To Ballard Spahr In Phoenix
Ballard Spahr LLP has picked up a former in-house intellectual property lawyer from nonprofit blood bank Vitalant who had worked at the law firm a little over a decade ago.
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March 31, 2025
Nasdaq's Tighter IPO Rules Raise Bar For Small Companies
Nasdaq is seeking to weed out volatile stocks by tightening listing standards for small companies conducting initial public offerings or uplistings, although lawyers caution that new rules could prompt capital-hungry companies to pursue other listing strategies, including reverse mergers.
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March 31, 2025
Buyer Class Of Surgical Robots Is Certified In Antitrust Fight
A California federal judge on Monday certified a class of thousands of hospitals alleging Intuitive Surgical monopolized the market for robotic surgical tools by blocking third-party repairs and tying services to robot purchases, finding the case raises common antitrust questions that can be resolved on a classwide basis.
Expert Analysis
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What's Next For State Regulation Of Hemp Cannabinoids
Based on two recent federal court cases that indisputably fortify broad state authority to regulate intoxicating hemp cannabinoid products, 2025 will feature continued aggressive state regulation of such products as industry stakeholders wait for Congress to release its plans for the next five-year Farm Bill, say attorneys at Foley Hoag.
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Series
Collecting Rare Books Makes Me A Better Lawyer
My collection of rare books includes several written or owned by prominent lawyers from early U.S. history, and immersing myself in their stories helps me feel a deeper connection to my legal practice and its purpose, says Douglas Brown at Manatt Health.
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Opinion
New DOJ Leaders Should Curb Ill-Conceived Prosecutions
First-of-their-kind cases have seemingly led to a string of overly aggressive prosecutions in recent years, so newly sworn-in leaders of the U.S. Department of Justice should consider creating reporting channels to stop unwise prosecutions before they snowball, says Jonathan Porter at Husch Blackwell.
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Tips For Pharma-Biotech Overlap Reporting In New HSR Form
While there’s no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.
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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.