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Life Sciences
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February 14, 2025
FTC's Ferguson, PBMs Agree: Nix Leader Removal Safeguards
Federal Trade Commission Chairman Andrew N. Ferguson offered his own support Friday for enabling the president to readily fire independent agency commissioners at the FTC and beyond, a day after pharmacy benefit managers cited the new U.S. Department of Justice policy in their own battle with the FTC.
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February 14, 2025
Digital Health Co. Beats Some Claims In SPAC Investor Suit
A New Jersey federal judge has dismissed, with leave to amend, claims in an investor suit against a blank check company that took digital health equipment venture Butterfly Network Inc. public, finding that some of the shares the plaintiffs purchased are not traceable to the registration statement at issue in the suit.
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February 14, 2025
Fed. Circ. Risks Relying On 'Science Fiction,' Justices Told
The Federal Circuit's presumption that prior art is always enabled can lead it to "sacrifice true innovations based on earlier science fiction," the owner of invalidated food wrapping patents told the U.S. Supreme Court on Thursday.
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February 14, 2025
Trump Admin To Cut Thousands Of Federal Health Employees
The Trump administration has started to cut thousands of federal healthcare employees, following through on its promises to shrink government and enact mass changes to agencies that oversee the health of millions of Americans.
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February 14, 2025
New Delisting Rules Shorten Leash For Distressed Companies
Distressed companies should take heed of new stock exchange rules that are likely to accelerate delistings for stocks that trade below minimum requirements, particularly targeting businesses that rely on reverse stock splits to inflate their share prices, attorneys say.
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February 14, 2025
CVS Wins Arbitration In Medicare Fee Antitrust Suit
An Arizona federal judge ordered four independent pharmacies to arbitrate their claims accusing CVS of exploiting a Medicare loophole to charge them exorbitant fees, saying several unconscionable provisions in an underlying arbitration clause could be severed.
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February 14, 2025
Fed. Circ. Rejects COVID Test Suit In Gilstrap-Authored Ruling
A California federal judge properly found that Spectrum Solutions LLC didn't infringe a COVID-19 test maker's patent directed to preserving biological samples, the Federal Circuit said Friday in an opinion written by a top patent judge visiting the court.
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February 14, 2025
Some Discovery On Hold In Abbott Infant Formula Case
An Illinois federal judge on Friday granted in part a request by Abbott Laboratories to pause a shareholder derivative suit over how it managed the 2022 infant formula crisis, allowing written discovery to go on while staying depositions until May.
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February 14, 2025
Fed. Circ. Ruling Shows Even Small Cos. Can Win At ITC
A small biotech company's recent patent win, where the Federal Circuit held that even its limited domestic investments qualified it to sue at the U.S. International Trade Commission, makes clear that the ITC's powerful import bans aren't just available to major businesses, attorneys say.
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February 14, 2025
8 Things Attys Should Know About Conn.'s $55B Budget
Connecticut Gov. Ned Lamont's two-year budget for the years 2026 and 2027 includes drug price limits, an expansion of the state's unfair trade practices act, key changes to hospital ownership laws and slots for 13 new judges.
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February 14, 2025
Judge Upholds Pay-For-Delay Ban Law, But Only In Calif.
A California federal judge has upheld part of a new state law that the Association for Accessible Medicines alleged unlawfully restricted "reverse payment" settlements between makers of brand-name and generic drugs, finding that the law's attempt to regulate deals outside of California runs afoul of the Constitution, but is otherwise valid.
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February 14, 2025
Camston Wrather Files For Ch. 7 With Over $100M In Debt
California-based sustainable resource recovery company Camston Wrather LLC has filed for Chapter 7 bankruptcy listing liabilities between $100 million and $500 million along with up to $50 million in assets, citing insufficient funding to continue operations.
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February 14, 2025
Tariffs On Drugs And Chips May Not Bring Makers Stateside
The White House's planned tariffs on semiconductors, computer chips and pharmaceuticals are likely to raise prices for consumers and businesses, but won't necessarily lead to the president's stated goal of growing domestic manufacturing, attorneys and others told Law360.
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February 14, 2025
2nd Judge Blocks Trump Trans Health Order, Chides DOJ Atty
A Washington federal judge on Friday put a second temporary block on President Donald Trump's executive order targeting funding for gender-affirming care for people younger than 19, at a Seattle hearing where the judge said she was extremely frustrated with a federal government attorney's inability to answer questions about the order's discriminatory impact on transgender youth.
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February 13, 2025
Mallinckrodt Fails To Halt Airgas' Generic Nitric Oxide Drug
A Delaware federal judge has rejected Mallinckrodt Pharmaceuticals' attempt to block French industrial gas company Airgas Healthcare from selling a generic version of its inhaled nitric oxide treatment, saying Mallinckrodt didn't show enough evidence that Airgas infringed its patents or that it would suffer irreparable harm.
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February 13, 2025
DC Judge Affirms Approval Of Teva's Generic Sleep Drug
A D.C. federal judge upheld the U.S. Food and Drug Administration's approval of Teva's generic version of Vanda's sleep-walking treatment tasimelteon, ruling Thursday that omitting Braille on the labeling is permissible as it would be "aberrant" to allow safe variations in a drug's substance but not for labeling.
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February 13, 2025
Long-Term Zantac Use Raised Cancer Risks, Jury Hears
Chronic ranitidine ingestion was a factor in the development of prostate cancer in two men who are retrying their claims over the active ingredient in Boehringer Ingelheim's over-the-counter Zantac medication, the University of South Carolina's chief urologist testified in Illinois on Thursday.
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February 13, 2025
Maryland Judge Blocks Trump's Orders On Trans Healthcare
A Maryland federal judge on Thursday temporarily blocked the Trump administration from restricting gender-affirming care for people under the age of 19 and required the administration to keep in place federal funding for healthcare providers that provide transgender care.
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February 13, 2025
Merck Investor Sues Over Gardasil China Market Projections
Pharmaceutical giant Merck & Co. Inc. has been hit with a proposed shareholder class action alleging it overstated global demand for its human papillomavirus vaccine Gardasil, damaging investors when it revealed earlier this month it would not meet its revenue projections for the vaccine and paused shipments to China.
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February 13, 2025
9th Circ. Upholds DEA Denial Of Psilocybin Petition
The Ninth Circuit on Thursday affirmed the U.S. Drug Enforcement Administration's rejection of a Seattle physician's request to treat terminally ill patients with psilocybin.
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February 13, 2025
Musk's $97B OpenAI Bid Dubbed A 'Stunt' Amid Other Rumors
After a Wall Street Journal report on Monday revealed that a consortium of investors led by Elon Musk was offering $97.4 billion to buy the nonprofit that controls OpenAI, rumors began to swirl regarding the true intentions behind the billionaire's bid.
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February 13, 2025
Robert F. Kennedy Jr. Confirmed, Sworn In As HHS Secretary
Robert F. Kennedy Jr. is officially the nation's top healthcare official.
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February 13, 2025
Paul Hastings, Cooley Lead Obesity-Focused Aardvark's IPO
Obesity-focused Aardvark Therapeutics Inc. began trading Thursday after pricing a $94 million initial public offering at the bottom of its range, represented by Paul Hastings LLP and underwriters' counsel Cooley LLP, joining a string of biotechnology firms to go public recently.
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February 13, 2025
Greenberg Traurig Adds Goodwin Life Sciences Pro In Texas
Greenberg Traurig LLP has expanded its life sciences and technology practice with a shareholder in Austin, Texas, who has extensive expertise in handling cross-border deals and came aboard from Goodwin Procter LLP.
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February 12, 2025
Judge Finds No Infringement In Alcon's Eye Drop Patent Suit
Alcon Inc. has failed to persuade a Delaware federal court to block the release of a generic glaucoma treatment that would compete with a brand of eye drops the company sells.
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, Law360 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 Law360 in an expansive interview.
Expert Analysis
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Opinion
Confusing Injury-In-Fact Rules Hinder Federal Practice
A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.
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2 Anti-Kickback Developments Hold Lessons For Biopharma
The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.
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In-House Counsel Pointers For Preserving Atty-Client Privilege
Several recent rulings illustrate the challenges in-house counsel can face when attempting to preserve attorney-client privilege, but a few best practices can help safeguard communications and effectively assert the privilege in an increasingly scrutinized corporate environment, says Daniel Garrie at Law & Forensics.
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How SDNY US Atty Nom May Shape Enforcement Priorities
President Donald Trump’s nominee for U.S. attorney in the Southern District of New York, former U.S. Securities and Exchange Commission Chair Jay Clayton, will likely shift the office’s enforcement priorities, from refining whistleblower policies to deemphasizing novel prosecutorial theories, say attorneys at Cohen & Gresser.
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Improving Comms Between Trial Attys And Tech Witnesses
In major litigation involving complex technology, attorneys should employ certain strategies to collaborate with companies' technical personnel more effectively to enhance both the attorney's understanding of the subject matter and the expert's ability to provide effective testimony in court, say attorneys at Buchalter.
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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.