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

  • Series

    Swimming Makes Me A Better Lawyer

    Author Photo

    Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.

  • Mid-2024 FCA Enforcement And Litigation Trends To Watch

    Author Photo

    Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

  • What 100 Federal Cases Suggest About Changes To Chevron

    Author Photo

    With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.

  • Why High Court May Have Rejected IP Obviousness Appeal

    Author Photo

    Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.

  • Microplastics At The Crossroads Of Regulation And Litigation

    Author Photo

    Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.

  • The Fed. Circ. In April: Hurdles Remain For Generics

    Author Photo

    The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.

  • Tylenol MDL Highlights Expert Admissibility Headaches

    Author Photo

    A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.

  • Don't Use The Same Template For Every Client Alert

    Author Photo

    As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.

  • Don't Fall On That Hill: Keys To Testifying Before Congress

    Author Photo

    Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.

  • Online Portal Helps Fortify Feds' Unfair Health Practices Fight

    Author Photo

    The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.

  • Series

    Walking With My Dog Makes Me A Better Lawyer

    Author Photo

    Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.

  • Think Like A Lawyer: Follow The Iron Rule Of Trial Logic

    Author Photo

    Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.

  • The Art Of Asking: Leveraging Your Contacts For Referrals

    Author Photo

    Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.

  • Trending At The PTAB: Permissible New Reply Arguments

    Author Photo

    In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.

  • Wave Of Final Rules Reflects Race Against CRA Deadline

    Author Photo

    The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.

Want to publish in Law360?


Submit an idea

Have a news tip?


Contact us here
Can't find the article you're looking for? Click here to search the Life Sciences archive.
Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!