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Life Sciences
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April 30, 2025
Kratom Cos. Get False Ad, Addiction Suit Tossed
A California federal judge has dismissed a proposed class action alleging Thang Botanicals and FTLS Holdings LLC mislead consumers about addictive qualities of their kratom products after the plaintiffs failed to file an amended complaint on time.
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April 30, 2025
Novartis Buying Regulus In Up To $1.7B Kidney Drug Deal
Covington & Burling LLP-advised Novartis AG said Wednesday it has agreed to acquire Latham & Watkins LLP-guided Regulus Therapeutics Inc. for up to $1.7 billion in a deal that strengthens the Swiss pharmaceutical giant's kidney disease portfolio with a promising RNA-based therapy.
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April 29, 2025
Gilead Will Pay $202M In DOJ Deal Over Drug Kickbacks
Gilead agreed to pay $202 million to the federal government and some states to resolve claims it made improper payments to high-volume prescribers of its HIV drugs, New York federal prosecutors announced Tuesday.
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April 29, 2025
Omnicare Hit With $136M Jury Verdict For Bilking Feds
A New York federal jury on Tuesday returned a verdict finding that CVS Health Corp. subsidiary Omnicare illegally billed the federal government to the tune of $135.6 million, one of the largest jury verdicts in a False Claims Act case, according to a statement from the U.S. Department of Justice.
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April 29, 2025
Justices Wary Of Issuing 'Advisory' Ruling In Class Cert. Row
The U.S. Supreme Court's latest attempt to address a pressing question about class certification standards may be doomed by a procedural hiccup, with a majority of justices expressing concern Tuesday that they didn't have the authority to wade into a dispute over approval of a class that contains uninjured members.
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April 29, 2025
DC Judge Worries About 340B Rebate Program Without 'Teeth'
The D.C. federal judge tasked with deciding dueling summary judgments in litigation accusing the government of blocking drugmakers' efforts to reshape the way they do rebates seemed skeptical of endorsing a vision of the program that could have "potentially devastating consequences."
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April 29, 2025
23andMe Agrees To Privacy Ombudsman In Ch. 11
A Missouri bankruptcy judge on Tuesday signed off on a consumer privacy watchdog for 23andMe's Chapter 11 after the genetic testing group and 30 states agreed that a statutorily authorized ombudsman would be the best way to vet a Chapter 11 sale that includes 15 million users' DNA information.
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April 29, 2025
Full Fed. Circ. Urged To Undo 'Onerous' Jepson Claim Ruling
Xencor has urged the full Federal Circuit to review a decision rejecting its application for an antibody patent that used the so-called Jepson claim format, saying the case set an "onerous requirement" that is nearly impossible to meet and "eliminates any incentive" to use the format.
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April 29, 2025
Fed. Circ. Backs TM Denial Of Dark Green Gloves As Generic
The Federal Circuit on Tuesday adopted a test for determining if trademarks are generic when considering claims on distinctive colors, affirming a trademark board precedent used to reject an Indonesian medical supply company's efforts to claim a trademark for dark green surgical gloves.
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April 29, 2025
GenBioPro Can Defend FDA Approval In Mifepristone Suit
A Texas federal judge has allowed drugmaker GenBioPro to join a legal fight over access to the abortion drug mifepristone, finding that the company has a distinct interest in defending federal approval of the generic version of the medication.
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April 29, 2025
Mexico Put On Latest USTR Priority IP Watch List
The Office of the U.S. Trade Representative on Tuesday issued its annual global intellectual property report that has placed close trading partner Mexico on its list of countries to keep the closest eye on.
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April 29, 2025
Cooley Life Sciences Ace Rejoins Latham In Bay Area
Latham & Watkins LLP has welcomed back an intellectual property attorney who spent the past nine years at Cooley LLP to bolster its healthcare and life sciences practice, including advising clients about licensing and transactional matters.
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April 29, 2025
Opioid MDL Judge Won't Recuse Over Ex Parte Allegations
An Ohio federal judge will not step aside from multidistrict opioid litigation after the plaintiffs' attorney, who had alleged the judge "regularly communicates" with other lawyers involved in the litigation, testified that there was no such communication after all, the judge ruled Tuesday.
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April 29, 2025
High Court Backs HHS In Hospital Pay Formula Dispute
The U.S. Supreme Court on Tuesday sided with federal health officials in a challenge over a formula used to calculate billions of dollars in annual payments to hospitals treating indigent patients, saying that those entitled to Supplemental Security Income should be collecting cash payments before they're counted in the formula.
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April 28, 2025
Chinese Cos. Lose Immunity Fight In 9th Circ. IP Case
The Ninth Circuit on Monday shot down arguments from related Chinese steel companies that they shouldn't have to face espionage charges that they stole DuPont trade secrets for creating titanium dioxide, saying they aren't protected by foreign sovereign immunity.
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April 28, 2025
Veolia Settles Flint Water Crisis Claims For $53M
A Michigan federal judge entered final judgment Monday in litigation brought by the state of Michigan and about 26,000 individuals against Veolia North America alleging it prolonged the water crisis in Flint, Michigan, after a $53 million settlement was approved earlier this month.
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April 28, 2025
Gov't Reverses Position On Surgery For Trans Prisoners
The Trump administration is rejecting the federal government's previous stance that prison officials are constitutionally required to provide gender confirmation surgery to incarcerated people with gender dysphoria who request the treatment, noting the shift in recent statements to a Georgia federal court.
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April 28, 2025
Ziploc 'Microwave Safe' Bags Shed Microplastics, Buyer Says
S.C. Johnson & Son Inc. falsely markets Ziploc bags and containers as "microwave safe" and suitable for use in freezers despite knowing they are made from materials that shed microplastics into food when the products are used as directed, according to a proposed class action filed in California federal court.
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April 28, 2025
Walgreens Opposes Merging 'Non-Drowsy' Labeling Suits
Walgreens is pushing back on a bid to consolidate two Illinois federal lawsuits alleging the "non-drowsy" label on some of the retailer's cough suppressant medications is misleading, saying the two cases involve different allegations and are at different stages, and arguing that consolidation would cause a delay in the litigation.
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April 28, 2025
Sanofi Challenges Jurisdiction In Conn. Zantac Lawsuits
Sanofi-Aventis U.S. LLC on Monday sought to exit nine combined Connecticut lawsuits claiming the heartburn drug ranitidine degraded into a compound that causes cancer, saying it is beyond the state's long-arm statute and that due process guarantees prevent it from being sued in Connecticut.
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April 28, 2025
Ala. Medical Pot Commission Sued Over Patient Registry
A group of Alabama medical cannabis patients sued the state's Medical Cannabis Commission over the lack of a patient registry despite what they said were numerous laws obligating it to create one.
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April 28, 2025
Sullivan & Cromwell-Led Merck To Buy SpringWorks For $3.9B
Merck KGaA said Monday it has agreed to acquire U.S. biotech company SpringWorks Therapeutics for $3.9 billion, as the German science and technology group aims to grow its cancer drug business and its global presence.
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April 25, 2025
HHS Says Cuts Target Excess After Judge Seeks More Info
The U.S. Department of Health and Human Services told a Rhode Island federal judge that a group of states has no basis to challenge the cancellation of billions in grants supporting public health programs because they already received the funds appropriated to them by Congress.
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April 25, 2025
SPAC Deals Are Buzzing Again Despite Tariff Turmoil
Amid heavy volatility that has largely frozen traditional initial public offerings, deal teams are launching more special purpose acquisition companies, an alternative market to typical IPOs that so far has shown few ill effects from tariff-related uncertainty.
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April 25, 2025
Local Gov'ts, Union Sue Over COVID Grant Cancellations
Four local governments have joined with a government employees union to challenge the federal government's termination of $11 billion in grants stemming from the COVID-19 pandemic, seeking an injunction restoring the funds and a declaration that the decision to mass-terminate the grants was unlawful.
Expert Analysis
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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.
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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.