Life Sciences

  • May 10, 2024

    Pharma Cos., FDA Debate 'Same Drug' In Orphan Drug Case

    Two pharmaceutical companies and the U.S. Food and Drug Administration faced off in D.C. federal court Friday over allegations that the federal agency wrongly approved a treatment that rivals Jazz Pharma's narcolepsy drug despite Jazz's exclusivity rights under the Orphan Drug Act.

  • May 10, 2024

    Lab Exec Sentenced For Deadly Fungal Meningitis Outbreak

    The founder of a Massachusetts drug compounding center was sentenced in Michigan to 10 to 15 years in prison for his role in a fungal meningitis outbreak after he agreed to a plea deal with state prosecutors earlier this year.

  • May 10, 2024

    Pharmaceutical Cos. Can't Nix Parkinson's Drug Antitrust Suit

    A Delaware federal judge has issued a sealed order refusing to dismiss drugmakers Sage Chemical Inc. and TruPharma's antitrust suit accusing rival Supernus Pharmaceuticals and others of suppressing generic versions of the Parkinson's treatment Apokyn.

  • May 10, 2024

    Fox Rothschild Hires Ex-Seed IP Trio On The West Coast

    Fox Rothschild is bringing on more intellectual property talent on the West Coast, announcing Friday that it had added three former Seed IP attorneys to its Seattle offices.

  • May 10, 2024

    No 'Piecemeal' Fees For Infant Data Win Amid 6th Circ. Appeal

    A federal judge said Friday that he wouldn't award attorney fees to children who challenged Michigan's handling of blood samples collected in an infant health screening program until the state's Sixth Circuit appeal is resolved.

  • May 10, 2024

    Sanofi, Novavax Sign $1.2B Deal For One-Shot COVID, Flu Jab

    Sanofi and U.S. vaccine developer Novavax Inc. said on Friday that the French pharmaceutical company has bought a co-exclusive licensing agreement worth up to $1.2 billion, part of a collaboration to create a combined global COVID-19 and influenza shot.

  • May 09, 2024

    Fed. Circ. Lifts Ban On Generic Cos.' Bladder Drugs

    The Federal Circuit on Thursday rejected Astellas Pharma's latest effort to stop the launch of generic drugs that would compete with its own blockbuster overactive bladder medication and lifted a temporary ban that was put in place by the appeals court in April.

  • May 09, 2024

    Judge Clarifies Gilead Didn't Directly Infringe HIV Drug IP

    A Delaware federal judge on Thursday rejected Gilead Sciences' request to amend her judgment finding that two medications in its HIV prevention regimen, Truvada and Descovy, directly infringed the government's invalidated patents, but clarified her judgment to say that non-party patients or physicians committed the infringement.

  • May 09, 2024

    First Zantac Trial Plaintiff Says She Can't Live Normal Life

    An Illinois woman suing the former manufacturers of Zantac heartburn medication and claiming her long-term use of the drug caused her colon cancer testified Thursday that she has struggled to control her bowels since her 2015 diagnosis and has experienced multiple accidents in public places that left her humiliated and fearful to leave her home.

  • May 09, 2024

    Judge Halts DEA's Hearing On Proposed Psychedelics Ban

    An administrative law judge with the U.S. Drug Enforcement Administration has ordered the agency to cancel a June 10 hearing on its proposal to ban two psychedelic substances while a researcher's federal lawsuit challenging the agency's actions plays out in court, according to an order made public Thursday.

  • May 09, 2024

    Masimo Makes Offer To End Activist Politan's Proxy Contest

    Medical technology company Masimo Corp. revealed Thursday that it is willing to appoint one of the director nominees put forth by activist investment firm Politan Capital Management LP in exchange for the company dropping its proxy fight, though Politan signaled distaste with the proposed deal.

  • May 09, 2024

    Fed. Circ. Skeptical Allergan Illegally Extended Exclusivity

    A Federal Circuit panel seemed doubtful Thursday that a patent covering Allergan's bowel treatment drug Viberzi should have its life cut short based on the expiration date of related patents, in oral arguments over obviousness-type double patenting.

  • May 09, 2024

    Ex-Dental Device CEO Cops To $10.7M Investor Fraud

    The former CEO of a dental device company pled guilty Thursday to defrauding investors out of $10.7 million with false claims that his company received the U.S. Food and Drug Administration's approval for a device he promised would take the place of X-rays.

  • May 09, 2024

    Ex-Official Says NJ, Ethics Board Are 'Stonewalling' Discovery

    A former New Jersey health official has asked a state judge to order the state and its ethics commission to provide full discovery around his claims that he was fired in 2020 for raising concerns about the governor's chief of staff earmarking COVID-19 tests for relatives, accusing the Garden State of "stonewalling" his requests for documents and communications.

  • May 09, 2024

    Body-Sculpting Device Supplier Hit With Fraud Claims

    A Massachusetts company that sells body-sculpting equipment tricks buyers into believing their operations will be unrealistically lucrative, and harms them with restraints on pricing and coercion against transferring their devices, according to a lawsuit in Connecticut state court.

  • May 09, 2024

    11th Circ. Rejects Monsanto's Roundup Suit Redo Request

    The full Eleventh Circuit has rejected Monsanto's renewed request for review of a panel's ruling that a Georgia doctor can allege the company failed to warn about cancer risks associated with the use of Roundup weedkiller despite federal pesticide labeling requirements.

  • May 09, 2024

    Ex-Pharma Exec Asks 1st Circ. To DQ Judge In Contempt Case

    U.S. District Judge Mark Wolf cannot be impartial and must be disqualified from presiding over a criminal contempt trial against a former pharmaceutical executive accused of using an alias to flout a civil judgment, the defendant told the First Circuit in a Wednesday filing.

  • May 09, 2024

    Apnea Device Maker ProSomnus Gets OK For Ch. 11 Loan

    A Delaware bankruptcy judge Thursday gave sleep apnea device maker ProSomnus interim permission to tap into $13 million in Chapter 11 financing to fund the company through what it says will be the end of its case in August.

  • May 09, 2024

    Deals Rumor Mill: Paramount, Peloton, International Paper

    Sony and Apollo plan to break up Paramount if their $26 billion bid prevails, private equity firms are eyeing a Peloton buyout, and International Paper gets a $15 billion bid from Brazil's Suzano. Here, Law360 breaks down the notable deal rumors from the past week.

  • May 08, 2024

    Quinn Emanuel Atty Says Asset Freeze Hurt Outcome Defense

    The U.S. government's overreach in restraining millions more than it could reasonably trace back to a $1 billion fraud by Outcome Health prevented the company's former CEO from hiring Quinn Emanuel Urquhart & Sullivan LLP attorneys to defend the charges like he originally wanted, an Illinois federal judge heard Wednesday.

  • May 08, 2024

    Opioid Maker Beats Investor Suit Over FDA Warning For Good

    A California federal judge has permanently dismissed a lawsuit from investors of acute pain drug company AcelRx Pharmaceuticals Inc. accusing it of engaging in misbranding violations that put it at greater risk for regulatory scrutiny.

  • May 08, 2024

    Shockwave Medical Investor Challenges $13B Deal With J&J

    A shareholder of cardiovascular treatment company Shockwave Medical Inc. is attempting to halt the company's "unfair" $13 billion proposed transaction with Johnson & Johnson by filing a securities suit, saying the transaction will only benefit company insiders and damage public shareholders.

  • May 08, 2024

    Conn. Justices To Hear McCarter & English Damages Demand

    The Connecticut Supreme Court has accepted a certified question from a federal district court judge in McCarter & English LLP's yearslong fee feud with a former client, agreeing to decide whether the firm can recover punitive damages after years chasing Jarrow Formulas Inc. and winning a jury verdict last year.

  • May 08, 2024

    Kirkland Drives Vance Street To $775M Fund IV Closing

    Los Angeles-based private equity shop Vance Street Capital, advised by Kirkland & Ellis LLP, on Wednesday announced it held the first and final close for its fourth fund with $775 million in tow.

  • May 08, 2024

    Sleep Apnea Co. Hits Ch. 11 Over $41.5M In Debt, Cash Woes

    California-based ProSomnus, which produces devices to prevent sleep apnea, said a balance sheet heavy with more than $41.5 million in debt and difficulty in funding its continued operations forced it to file for Chapter 11 protections in Delaware.

Expert Analysis

  • Benzene Contamination Concerns: Drugmakers' Next Steps

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    After a citizen petition to the U.S. Food and Drug Administration and a flurry of class actions over benzene contamination in benzoyl peroxide acne products, affected manufacturers should consider a thoughtful approach that includes assembling internal data and possibly contacting the FDA for product-specific discussions, say attorneys at Morgan Lewis.

  • Opinion

    States Should Follow Federal Lead On Expert Evidence Rules

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    The recently amended Federal Rule of Evidence 702 will help ensure expert testimony in federal courts reflects adequate data and reliable methods properly applied to a given case, and state courts — home to the overwhelming majority of U.S. litigation — should adopt similar changes, says retired attorney Michael Harrington.

  • The Pros And Cons Of NIST's Proposed March-In Framework

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    Recent comments for and against the National Institute of Standards and Technology’s proposed guidance on march-in rights — which permit the government to seize federally funded patents — highlight how the framework may promote competition, but could also pose a risk to contractors and universities, say Nick Lee and Paul Ragusa at Baker Botts.

  • Opinion

    Federal MDL Rule Benefits From Public Comments

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    The new Federal Rule of Civil Procedure concerning multidistrict litigation that was approved this week by the Advisory Committee on Civil Rules incorporates ideas from public comments that will aid both plaintiffs and defense attorneys — and if ultimately adopted, the rule should promote efficient, merits-driven MDL case management, say Robert Johnston and Gary Feldon at Hollingsworth.

  • Practicing Law With Parkinson's Disease

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    This Parkinson’s Awareness Month, Adam Siegler at Greenberg Traurig discusses his experience working as a lawyer with Parkinson’s disease, sharing both lessons on how to cope with a diagnosis and advice for supporting colleagues who live with the disease.

  • When Trade Secret Protection And Nat'l Security Converge

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    The Trump administration's anti-espionage program focused on China is over, but federal enforcement efforts to protect trade secrets and U.S. national security continue, and companies doing business in high-risk jurisdictions need to maintain their compliance programs to avoid the risk of being caught in the crosshairs of an investigation, say attorneys at Baker McKenzie.

  • The Merger Cases That Will Matter At ABA Antitrust Meeting

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    While the American Bar Association's Antitrust Spring Meeting this week will cover all types of competition law issues in the U.S. and abroad, expect the federal agencies' recent track record in merger enforcement to be a key area of focus on the official panels and in cocktail party chatter, say attorneys at Freshfields.

  • Calif. Verdict Showcases SEC's New 'Shadow Trading' Theory

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    Last week's insider trading verdict, delivered against biopharmaceutical executive Matthew Panuwat by a California federal jury, signals open season on a new area of regulatory enforcement enabled by the U.S. Securities and Exchange Commission's shadow trading theory, say Perrie Weiner and Aaron Goodman at Baker McKenzie.

  • Series

    Playing Hockey Makes Me A Better Lawyer

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    Nearly a lifetime of playing hockey taught me the importance of avoiding burnout in all aspects of life, and the game ultimately ended up providing me with the balance I needed to maintain success in my legal career, says John Riccione at Taft.

  • For Lawyers, Pessimism Should Be A Job Skill, Not A Life Skill

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    A pessimistic mindset allows attorneys to be effective advocates for their clients, but it can come with serious costs for their personal well-being, so it’s crucial to exercise strategies that produce flexible optimism and connect lawyers with their core values, says Krista Larson at Stinson.

  • HHS Opioid Rule Generally Benefits Providers And Patients

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    The U.S. Department of Health and Human Services' newly effective rule, the first substantial change to opioid treatment programs and delivery standards in over 20 years, significantly expands access and reduces stigma around certain medications, though the rule is narrow in scope and does have some limitations, say attorneys at Alston & Bird.

  • Trump's NY Civil Fraud Trial Spotlights Long-Criticized Law

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    A New York court’s recent decision holding former President Donald Trump liable for fraud brought old criticisms of the state law used against him back into the limelight — including its strikingly broad scope and its major departures from the traditional elements of common law fraud, say Mark Kelley and Lois Ahn at MoloLamken.

  • Opinion

    Requiring Leave To File Amicus Briefs Is A Bad Idea

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    A proposal to amend the Federal Rules of Appellate Procedure that would require parties to get court permission before filing federal amicus briefs would eliminate the long-standing practice of consent filing and thereby make the process less open and democratic, says Lawrence Ebner at the Atlantic Legal Foundation and DRI Center.

  • 2 Recent Suits Show Resiliency Of Medicare Drug Price Law

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    Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.

  • 4 Ways To Motivate Junior Attorneys To Bring Their Best

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    As Gen Z and younger millennial attorneys increasingly express dissatisfaction with their work and head for the exits, the lawyers who manage them must understand and attend to their needs and priorities to boost engagement and increase retention, says Stacey Schwartz at Katten.

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