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Life Sciences
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April 30, 2024
Feds Endorse Easing Marijuana Status In Big Policy Shift
Federal drug enforcers will recommend loosening restrictions on cannabis for the first time since the drug was made federally illegal decades ago, the U.S. Department of Justice announced Tuesday.
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April 30, 2024
Don't Miss It: McDermott, Paul Weiss Lead Month's Hot Deals
A lot can happen in the world of mergers and acquisitions over the course of a month. Here, Law360 recaps the deals you may have missed, including transactions helmed by McDermott and Paul Weiss.
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April 30, 2024
Medical Device Biz Hologic To Buy UK Rival For $310M
Hologic Inc. has agreed to buy Endomagnetics Ltd., a developer of breast cancer surgery technology, for approximately $310 million, as the U.S. medical company moves to expand its presence in the women's health sector.
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April 29, 2024
Pfizer Inks $25M Deal Ending Leftover Effexor Antitrust Claims
A proposed class of indirect buyers have asked a New Jersey federal judge to greenlight a $25.5 million settlement to end allegations that Pfizer unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant Effexor XR.
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April 29, 2024
Judge Rejects 2 Challenges To Medicare Drug Price Talks
A New Jersey federal judge on Monday shot down a pair of challenges to the Medicare drug price negotiations, extending a string of court victories for the Biden administration as it defends the talks as entirely voluntary.
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April 29, 2024
Sandoz Says Biopharma Biz Added 'Poison' To Market
More than $160 million separate generic-drug maker Sandoz Inc. and biopharmaceutical firm United Therapeutics Corp. in their estimates of damages suffered by Sandoz when the other company effectively blocked the sale of Sandoz's generic version of a hypertension medication, according to opening statements Monday during a bench trial in New Jersey federal court.
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April 29, 2024
Mistrial Called In $86M Stent Patent Case Against Medtronic
An $86 million case in Texas over stents sold by medical device giant Medtronic has ended in a mistrial after U.S. District Judge Alan Albright was notified that a juror didn't want to budge on a position that was at odds with the rest of the jurors.
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April 29, 2024
Boehringer Accused Of Monopolizing Inhaler Product Market
Boehringer Ingelheim Pharmaceuticals has manipulated the U.S. patent and drug approval system to unlawfully block makers of generic inhaler medications, health and welfare funds claimed in a lawsuit filed Monday in Connecticut federal court, arguing that the "availability of generics has tangible cost and life-saving effects."
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April 29, 2024
Pharma Co. Hit With Investor Suit Over Liver Drug Trials
Biopharmaceutical company Akero Therapeutics and three of its executives were hit with a proposed class action in California federal court alleging they made misleading statements about the patient population in a clinical trial for its liver disease treatment.
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April 29, 2024
HHS Delays Menthol Cigarette Ban Indefinitely
U.S. Secretary of the Department of Health and Human Services Xavier Becerra said Friday that a proposed ban on menthol cigarettes has been put on hold for now, citing the need to process considerable feedback from civil rights groups and the criminal justice movement.
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April 29, 2024
Amid Backlash, FDA Extends Control For Lab-Developed Tests
The U.S. Food and Drug Administration inked a final rule Monday that gives the agency broad authority over lab-developed tests by classifying them as medical devices, a move that has drawn ire from congressional leadership and those in the healthcare and life sciences industries.
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April 29, 2024
Catching Up With Delaware's Chancery Court
A multibillion-dollar Tesla trust proposal, a Truth Social bond, power plays over Prince's estate, and three in the ring for World Wrestling Entertainment. All of this and much more came up in Delaware Chancery Court dockets last week.
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April 29, 2024
AI Pharma Co. Sued By Investor Over Handling Of Fired CEO
Artificial intelligence-driven pharmaceutical company Exscientia PLC has been hit with a proposed class action alleging its former CEO engaged in inappropriate personal relationships with employees, and that the company's chairman knew but concealed it.
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April 29, 2024
Alcon Owes $34M In Glaucoma Patent Row, Jury Finds
A Delaware federal jury has found that Alcon and various related entities are on the hook for a $34 million judgment in a patent suit about medical devices to treat glaucoma launched by Sight Sciences.
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April 29, 2024
4th Circ. OKs Sanctions Against Law Firm In Bestwall Ch. 11
A split Fourth Circuit panel on Monday refused to overturn more than $402,000 in sanctions against a law firm and its clients as part of bankruptcy proceedings for a Georgia-Pacific unit, saying the contempt and sanctions orders can't be appealed because they aren't final judgments.
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April 29, 2024
PTAB Rejects Masimo's Concurrent Bid To Review Apple Patent
A board of administrative patent judges has declined one of the petitions challenging claims in an Apple patent involved in some of its disputes with medical technology startups Masimo and AliveCor, citing the board's skeptical view of "multiple, staggered petitions."
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April 29, 2024
Judge Rejects Class Certification Of Seizure Drug Customers
An Illinois federal judge has rejected a class certification bid in a suit against drugmaker Mallinckrodt and prescription delivery platform Express Scripts, ruling that the plaintiffs were unable to meet their predominance burden as a class.
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April 29, 2024
Connecticut Firm Seeks $500K Fee In Magnesium Class Action
A Connecticut law firm has asked a New Jersey federal judge to approve its request for $500,000 in attorney fees and expenses for its representation in a class action over a company's allegedly deceptive advertising of a magnesium supplement.
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April 29, 2024
Deciphera Stock Soars On $2.4B Deal With Japan's Ono
Deciphera Pharmaceuticals Inc. said Monday it has agreed to be purchased by Japan's Ono Pharmaceutical Co. Ltd. for $2.4 billion, which sent the Waltham, Massachusetts-based cancer drugmaker's stock soaring more than 72%.
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April 29, 2024
Justices To Weigh RICO Injury Scope In CBD Case
The U.S. Supreme Court on Monday agreed to hear a case brought by a trio of CBD companies asking the justices to establish whether a plaintiff can bring a personal injury claim under the Racketeer Influenced and Corrupt Organizations Act.
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April 29, 2024
Philips Inks $1.1B Deal To Resolve CPAP Injury Claims
The plaintiffs' attorneys leading a multidistrict litigation against Koninklijke Philips NV and some of its American subsidiaries announced Monday that they had reached a $1.1 billion settlement agreement for plaintiffs claiming that degraded foam in their breathing machines caused them personal injuries or will require long-term medical monitoring.
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April 26, 2024
Law360 Reveals Titans Of The Plaintiffs Bar
In the past year, plaintiffs have won settlements and judgments for millions and billions of dollars from companies such as Wells Fargo, Goldman Sachs, Facebook and Fox News, with many high-profile cases finally wrapping up after years of fighting. Such cases — involving over-the-top compensation packages, chemical contamination, gender discrimination and data mining — were led by attorneys whose accomplishments earned them recognition as Law360's Titans of the Plaintiffs Bar for 2024.
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April 26, 2024
Ex-McKinsey Partner Says Firm Made Him Opioids 'Scapegoat'
A former McKinsey & Co. partner lobbed defamation claims at the consulting firm, claiming Friday that it lied to the government and the public about his purported role in deleting evidence amid government investigations into the firm's work with opioid manufacturers, an alleged scheme designed to make him the "scapegoat."
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April 26, 2024
New FDA Official Talks Food Safety After Formula Outbreak
James "Jim" Jones, the first U.S. Food and Drug Administration deputy commissioner for human food, was named to the role last year in the wake of an infant formula contamination outbreak. He sat down this week with Law360 to discuss what he's learned from his first months in the position.
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April 26, 2024
Ex-USPTO Solicitor Heads To Carmichael IP
A veteran intellectual property attorney who once served as the chief legal officer at the U.S. Patent and Trademark Office has made the move to Carmichael IP PLLC.
Expert Analysis
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Perspectives
6 Practice Pointers For Pro Bono Immigration Practice
An attorney taking on their first pro bono immigration matter may find the law and procedures beguiling, but understanding key deadlines, the significance of individual immigration judges' rules and specialized aspects of the practice can help avoid common missteps, says Steven Malm at Haynes Boone.
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Series
ESG Around The World: Canada
In Canada, multiple statutes, regulations, common law and industry guidance address environmental, social and governance considerations, with debate over ESG in the business realm potentially growing on the horizon, say attorneys at Blakes.
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5 Legal Considerations For Psychedelic Therapy Sector
With multiple developments signaling the rise of psychedelic-assisted psychotherapy, it is imperative that clinicians understand unique legal nuances ranging from corporate formation to specialized insurance coverage, say Kimberly Chew and Natasha Sumner at Husch Blackwell.
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Lessons From Country Singer's Personal Service Saga
Recent reports that country singer Luke Combs won a judgment against a Florida woman who didn’t receive notice of the counterfeit suit against her should serve as a reminder for attorneys on best practices for effectuating service by electronic means, say attorneys at Jenner & Block.
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A Potential Proactive Tool For Public-Private Joint Ventures
In the current environment of heightened antitrust enforcement, the National Cooperative Research and Production Act seems tailor-made for the collaborative work among competitors encouraged by the Biden administration's infrastructure and green energy funding legislation, say Jeetander Dulani and Susan Ebner at Stinson.
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Patent Prosecution Carries Consequences For Later Litigation
The Federal Circuit's recent Mylan v. Actelon holding, along with three other 2023 decisions, underscores the continued need for patent prosecutors to make note of potential claim construction issues that may arise in subsequent litigation, says Steven Wood at Hunton.
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10 Global Antitrust Trends To Anticipate In 2024
Proactive navigation of the antitrust enforcement environment remains crucial this year as legal policy and tools evolve to meet intensifying global economic complexity, including geopolitical tensions, trade realignment, market volatility and inflation, say attorneys at Freshfields.
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Global Cartel Enforcement Looks Set To Intensify In 2024
The cartel enforcement winds may strengthen this year, with the U.S. Department of Justice, as well as regulators in other countries, placing a renewed focus on pursuing international cartels and more traditional, hard-core cartel conduct, say attorneys at Simpson Thacher.
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Series
Baking Bread Makes Me A Better Lawyer
After many years practicing law, and a few years baking bread, I have learned that there are a few keys to success in both endeavors, including the assembly of a nourishing and resilient culture, and the ability to learn from failure and exercise patience, says Rick Robinson at Reed Smith.
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Supreme Court Amgen Ruling's Major Effect On Enablement
The U.S. Supreme Court's Amgen v. Sanofi invalidity holding continues to significantly affect technologies and all aspects of the patent system by providing confidence in the Federal Circuit's approach and a clearer understanding on enforceability and the disclosure needed for compliance, say Irena Royzman and Daniel Williams at Kramer Levin.
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Federal Courts And AI Standing Orders: Safety Or Overkill?
Several district court judges have issued standing orders regulating the use of artificial intelligence in their courts, but courts should consider following ordinary notice and comment procedures before implementing sweeping mandates that could be unnecessarily burdensome and counterproductive, say attorneys at Curtis.
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7 E-Discovery Predictions For 2024 And Beyond
The legal and technical issues of e-discovery now affect virtually every lawsuit, and in the year to come, practitioners can expect practices and policies to evolve in a number of ways, from the expanded use of relevancy redactions to mandated information security provisions in protective orders, say attorneys at Littler.
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Top Considerations For Retailers Using AI To Combat Theft
The Federal Trade Commission's recent enforcement action against Rite Aid indicates a significant evolution in the landscape surrounding biometric information and artificial intelligence data collection by retailers, meaning retailers should take reasonable measures to prevent harm to customers, say attorneys at Dentons.
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2 FCPA Settlements Illuminate Self-Disclosure, Disgorgement
Two of last year’s Foreign Corrupt Practices Act settlements — with biomedical company Lifecore and mining company Corsa Coal — suggest that the government will be much more flexible in negotiating disgorgement amounts if an entity voluntarily self-discloses misconduct, say Michael Gilbert and Lucas Amodio at Sheppard Mullin.
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Opinion
Anti-Kickback Statute Does Not Require But-For Causation
A proper interpretation of the Anti-Kickback Statute clearly indicates that but-for causation is not required for False Claims Act Liability, and courts that hold otherwise will make it significantly easier for fraudsters to avoid accountability, says Kenneth Capesius at Baron & Budd.