Life Sciences

  • August 15, 2024

    CMS Posts Final Costs For 1st Set Of Drugs After Negotiations

    The federal government released on Thursday the final prices of the first 10 drugs negotiated by Medicare under the Inflation Reduction Act, in a long-anticipated move set to shape the future of drug price negotiations.

  • August 15, 2024

    Price-Fixing Claims Against Par Pharma Tossed After Ch. 11

    A Connecticut federal judge on Thursday tossed Par Pharmaceutical Cos. Inc. from two price-fixing lawsuits after the defendant and its parent, Endo International PLC, recently filed the Chapter 11 reorganization plans that they said shielded them from the cases.

  • August 15, 2024

    NC Small Biz Challenges VA Bid Process For Prostate Drug

    A service-disabled veteran-owned small business in North Carolina is challenging the U.S. Department of Veterans Affairs' bid process for prostate medication, saying the terms unfairly favor foreign manufacturers despite purporting to prioritize American-made products.

  • August 15, 2024

    Pharma Co. TM Dispute Doesn't Belong In Florida, Judge Says

    A trademark lawsuit between two drug companies with similar names does not belong in a Florida federal court, a judge in West Palm Beach has ruled.

  • August 15, 2024

    Okla. Says 10th Circ. PBM Ruling Defies High Court Precedent

    Oklahoma urged the U.S. Supreme Court to review a Tenth Circuit decision nullifying certain parts of a state law regulating pharmacy benefit managers, arguing the appeals court's ruling openly conflicts with sister circuits and previous high court rulings while pushing federal benefits law beyond its limits.

  • August 15, 2024

    Paul Hastings Adds M&A, Shareholder Activism Lawyer

    Paul Hastings LLP announced Thursday that it has boosted the firm's mergers and acquisitions and shareholder activism platform with a longtime Goodwin Procter LLP partner.

  • August 14, 2024

    Costco Wants PFAS Kirkland Brand Baby Wipes Suit Tossed

    Costco hit back at a proposed class action over its fragrance-free "natural" baby wipes filed earlier this summer in California federal court, saying that the suit is trying to scare parents by alleging the wipes are tainted with so-called forever chemicals.

  • August 14, 2024

    J&J Vision Unit Sues Ex-Marketing Exec Over Move To Rival

    Johnson & Johnson's vision unit sued a former marketing director on Tuesday, saying her move to a direct competitor is an "imminent threat of immediate, irreparable harm" and asking a New Jersey federal court to enforce her noncompete agreement and other post-employment obligations.

  • August 14, 2024

    NC Judge OKs $15.2M Deal For Medical Device Investors

    A North Carolina federal judge has given the first green light to a $15.25 million settlement that will resolve a securities class action claiming that Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices.

  • August 14, 2024

    Grassley Asks HHS For Clarity On Cannabis Position

    Sen. Chuck Grassley has asked federal health officials to clarify their position on marijuana, arguing that a recent U.S. Department of Health and Human Services report is at odds with its recommendation to loosen restrictions on the drug.

  • August 14, 2024

    Novartis' $45B Biz Can Survive If Generic Debuts, Judge Says

    A D.C. federal judge told Novartis to stop acting like it would be destroyed financially by having a generic version of its best-selling drug Entresto enter the market, saying the drugmaker will be fine if it loses $3 billion in U.S. sales out of its $45 billion global revenue.

  • August 14, 2024

    AstraZeneca Freed From $107.5M Verdict In Pfizer Patent Case

    A federal judge on Wednesday overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents owned by a Pfizer unit, concluding that both patents are invalid for failing to provide sufficient information about the invention.

  • August 14, 2024

    HHS Calls For More Research, Planning To Combat Heat Risks

    Citing a sharp increase in deaths from extreme heat, the Biden administration unveiled a national strategy Wednesday that calls for better communicating the health risks of hot weather to the public and taking other steps to protect people from life-threatening heat waves.

  • August 14, 2024

    Samsung Biotech Unit Hit With Patent Suit Over Bone Drugs

    The pharmaceutical giant Amgen Inc. is fighting a bid by a South Korean rival to sell biosimilar versions of its highly popular bone drugs Prolia and Xgeva, telling a New Jersey federal court that the proposed medications will infringe 34 patents.

  • August 14, 2024

    Calbiotech Beats Ex-Worker's 401(k) Retaliation Suit

    A former Calbiotech Inc. employee must return a $12,500 payment he received after being terminated, a California federal judge ruled, finding he breached his severance agreement by filing a lawsuit claiming he was let go for asking about the life sciences company's 401(k) plan documents.

  • August 14, 2024

    Suit Claims Giant Uses Banned, Toxic Oil In Orange Soda

    A proposed class of soda drinkers is suing The Giant Co. LLC in Pennsylvania federal court, alleging that it makes and sells orange soda made with a kind of vegetable oil that federal regulators banned for its negative effects on the thyroid gland.

  • August 14, 2024

    Zantac Judge Won't Step Aside Over Wife's Reed Smith Role

    A Pennsylvania state judge overseeing the Zantac mass tort litigation against GlaxoSmithKline denied a motion to recuse himself Wednesday after expressing skepticism about the plaintiffs' contention that he could be unconsciously partial because his wife works for a firm defending the drugmaker in other jurisdictions.

  • August 13, 2024

    SEC Drops Insider Trading Suit Against Ex-Mylan Exec

    The U.S. Securities and Exchange Commission on Tuesday dismissed a Pennsylvania federal suit accusing the former chief information officer of Mylan NV of insider trading due to what his attorneys describe as compelling evidence showing his innocence, seven months after the Department of Justice dropped a parallel criminal case. 

  • August 13, 2024

    Entresto Release Delayed As Novartis Goes To Fed. Circ.

    A Delaware federal judge said Monday that Novartis is unlikely to prove that it's entitled to an injunction that would block MSN Pharmaceuticals from launching a generic version of its top-selling drug Entresto, but stayed the generic release briefly so Novartis could appeal to the Federal Circuit.

  • August 13, 2024

    Mother Can't Revive Suit Against GE For Child's Brain Damage

    A Pennsylvania appeals panel won't reinstate a mother's suit against General Electric Co. and subsidiary Datex-Ohmeda Inc. alleging that a faulty anesthesia machine caused her child permanent brain damage, finding the trial court rightly found that the state doesn't have jurisdiction over the claims.

  • August 13, 2024

    Spinal Implant Patents Verdict Must Stand, Pa. Judge Says

    A Pennsylvania federal judge declined to order a new trial Tuesday in a patent infringement suit brought against medical device maker Globus Medical Inc., ruling that the jury verdict in the company's favor had sufficient evidentiary support and that the jurors did not seem confused by the law at issue.

  • August 13, 2024

    NY, NJ And Conn. Score $4.5M Penalty Over Enzo Data Breach

    Molecular diagnostics company Enzo Biochem Inc. has agreed to pay a $4.5 million penalty after an investigation found that the company failed to implement recommended security protocols ahead of a data breach that affected millions of patients, New York's attorney general announced Tuesday.

  • August 13, 2024

    Janssen Wants New FCA Trial As Relators Seek $1.85B Win

    Janssen has urged a New Jersey federal judge to toss a jury's $150 million False Claims Act verdict that found the pharmaceutical company illegally profited from the off-label marketing of popular HIV medications, while whistleblowers have asked the court for a whopping $1.85 billion judgment consisting of trebled damages and statutory penalties.

  • August 13, 2024

    Fed. Circ. Restores J&J, Allergan's Viberzi IP After Del. Loss

    The Federal Circuit fully revived claims of patents covering Allergan's bowel treatment drug Viberzi on Tuesday, overruling a Delaware federal judge who said the claims don't meet obviousness-type double patenting or written description requirements.

  • August 13, 2024

    Former Sprinter Eyes Plea Deal In 2020 Olympics Doping Case

    A onetime world-class sprinter from the Atlanta area is in talks to resolve charges that he illegally provided banned performance-enhancement drugs while training other athletes ahead of the 2020 Tokyo Olympic Games, a Manhattan federal judge heard Tuesday.

Expert Analysis

  • How To Clean Up Your Generative AI-Produced Legal Drafts

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    As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.

  • Calif. Ruling Heightens Medical Product Maker Liability

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    The California Supreme Court's decision in Himes v. Somatics last month articulates a new causation standard for medical product manufacturer liability that may lead to stronger product disclosures nationwide and greater friction between manufacturers and physicians, say attorneys at Cooley.

  • Constitutional Protections For Cannabis Companies Are Hazy

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    Cannabis businesses are subject to federal enforcement and tax, but often without the benefit of constitutional protections — and the entanglement of state and federal law and conflicting judicial opinions are creating confusion in the space, says Amber Lengacher at Purple Circle.

  • USPTO Disclaimer Rule Would Complicate Patent Prosecution

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    The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.

  • Series

    Boxing Makes Me A Better Lawyer

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    Boxing has influenced my legal work by enabling me to confidently hone the skills I've learned from the sport, like the ability to remain calm under pressure, evaluate an opponent's weaknesses and recognize when to seize an important opportunity, says Kirsten Soto at Clyde & Co.

  • Purdue Ch. 11 Ruling Reinforces Importance Of D&O Coverage

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    The U.S. Supreme Court's recent decision in Harrington v. Purdue Pharma, holding that a Chapter 11 reorganization cannot discharge claims against a nondebtor without affected claimants' consent, will open new litigation pathways surrounding corporate insolvency and increase the importance of robust directors and officers insurance, says Evan Bolla at Harris St. Laurent.

  • Opinion

    Industry Self-Regulation Will Shine Post-Chevron

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    The U.S. Supreme Court's Loper decision will shape the contours of industry self-regulation in the years to come, providing opportunities for this often-misunderstood practice, says Eric Reicin at BBB National Programs.

  • 3 Ways Agencies Will Keep Making Law After Chevron

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    The U.S. Supreme Court clearly thinks it has done something big in overturning the Chevron precedent that had given deference to agencies' statutory interpretations, but regulated parties have to consider how agencies retain significant power to shape the law and its meaning, say attorneys at K&L Gates.

  • Roundup

    After Chevron

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    In the month since the U.S. Supreme Court overturned the Chevron deference standard, this Expert Analysis series has featured attorneys discussing the potential impact across 26 different rulemaking and litigation areas.

  • Series

    After Chevron: Expect Few Changes In ITC Rulemaking

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    The U.S. Supreme Court's opinion overruling the Chevron doctrine will have less impact on the U.S. International Trade Commission than other agencies administering trade statutes, given that the commission exercises its congressionally granted authority in a manner that allows for consistent decision making at both agency and judicial levels, say attorneys at Polsinelli.

  • 6 PTAB Events To Know From The Last 6 Months

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    The first half of 2024 brought a flurry of Patent Trial and Appeal Board developments that should be considered in post-grant strategies, including proposed rules on discretionary denial and director review, and the first decisions of the Delegated Rehearing Panel, say attorneys at Fish & Richardson.

  • Opinion

    Atty Well-Being Efforts Ignore Root Causes Of The Problem

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    The legal industry is engaged in a critical conversation about lawyers' mental health, but current attorney well-being programs primarily focus on helping lawyers cope with the stress of excessive workloads, instead of examining whether this work culture is even fundamentally compatible with lawyer well-being, says Jonathan Baum at Avenir Guild.

  • Parsing Justices' Toss Of Purdue's Controversial Ch. 11 Plan

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    The U.S. Supreme Court's recent nixing of OxyContin manufacturer Purdue Pharma's Chapter 11 proposal prevents the Sackler family from settling thousands of civil opioid lawsuits without the consent of all of the plaintiffs, and holds profound implications for bankruptcy cases, say attorneys at MoloLamken.

  • How Cannabis Rescheduling May Affect Current Operators

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    The U.S. Drug Enforcement Agency's proposal to reschedule marijuana to Schedule III provides relief in the form of federal policy from the stigma and burdens of Schedule I, but commercial cannabis operations will remain unchanged until the federal-state cannabis policy gap is remedied by Congress, say Meital Manzuri and Alexis Lazzeri at Manzuri Law.

  • Series

    Skiing And Surfing Make Me A Better Lawyer

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    The skills I’ve learned while riding waves in the ocean and slopes in the mountains have translated to my legal career — developing strong mentor relationships, remaining calm in difficult situations, and being prepared and able to move to a backup plan when needed, says Brian Claassen at Knobbe Martens.

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