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

  • A Post-Mortem Analysis Of Stroock's Demise

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    After the dissolution of 147-year-old firm Stroock late last year shook up the legal world, a post-mortem analysis of the data reveals a long list of warning signs preceding the firm’s collapse — and provides some insight into how other firms might avoid the same disastrous fate, says Craig Savitzky at Leopard Solutions.

  • What's On The Horizon In Attorney General Enforcement

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    A look at recent attorney general actions, especially in the areas of antitrust and artificial intelligence, can help inform businesses on what they should expect in terms of enforcement trends as 10 attorney general races play out in 2024, say attorneys at Cozen O'Connor.

  • Preparing For DOJ's Data Analytics Push In FCPA Cases

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    After the U.S. Department of Justice’s recent announcement that it will leverage data analytics in Foreign Corrupt Practice Act investigations and prosecutions, companies will need to develop a compliance strategy that likewise implements data analytics to get ahead of enforcement risks, say attorneys at Cozen O'Connor.

  • Reducing The Risk Of PFAS False Advertising Class Actions

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    A wave of class actions continues to pummel products that allegedly contain per- or polyfluoroalkyl substances, with plaintiffs challenging advertising that they say misleads consumers by implying an absence of PFAS — but there are steps companies can take to minimize risk, say attorneys at Keller and Heckman.

  • Series

    Coaching High School Wrestling Makes Me A Better Lawyer

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    Coaching my son’s high school wrestling team has been great fun, but it’s also demonstrated how a legal career can benefit from certain experiences, such as embracing the unknown, studying the rules and engaging with new people, says Richard Davis at Maynard Nexsen.

  • Opinion

    New Rule 702 Helps Judges Keep Bad Science Out Of Court

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    A court's recent decision to exclude dubious testimony from the plaintiffs' experts in multidistrict litigation over acetaminophen highlights the responsibility that judges have to keep questionable scientific evidence out of courtrooms, particularly under recent amendments to Federal Rule of Evidence 702, says Sherman Joyce at the American Tort Reform Association.

  • SG's Office Is Case Study To Help Close Legal Gender Gap

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    As women continue to be underrepresented in the upper echelons of the legal profession, law firms could learn from the example set by the Office of the Solicitor General, where culture and workplace policies have helped foster greater gender equality, say attorneys at Ocean Tomo.

  • Opinion

    Patent Waiver For COVID Meds Would Harm US Biopharma

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    If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.

  • Skirting Anti-Kickback Causation Standard Amid Circuit Split

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    Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.

  • 10 Lessons From A Deep Dive Into IP Damages

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    Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.

  • What Shareholder Approval Rule Changes Mean For Cos.

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    The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.

  • Reimagining Law Firm Culture To Break The Cycle Of Burnout

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    While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • Expediting Psychedelics Approvals In The EU, UK, Australia

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    Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.

  • Series

    ESG Around The World: Brazil

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    Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.

  • Opinion

    Gilead Ruling Signals That Innovating Can Lead To Liability

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    A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.

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