Life Sciences

  • May 30, 2025

    Crowdfunding, Reg A Deals Grow Slowly As SEC Weighs Ideas

    Equity crowdfunding and expanded Regulation A offerings have grown slowly since going live over the past decade, according to new data, leaving open questions on whether regulators will ease rules to bolster these alternatives to traditional capital raising.

  • May 30, 2025

    TopCo Settles Suit Over Cough Syrup Billed As 'Non-Drowsy'

    The parties in a lawsuit alleging Tussin cough syrup's "non-drowsy" label is deceptive because the syrup makes users sleepy told an Illinois federal judge that they've reached a binding settlement that would end the case.

  • May 30, 2025

    ITC Issues Import Block On Ascletis Liver Disease Drugs

    The U.S. International Trade Commission has issued an order blocking a Hong Kong-listed drug developer from importing treatments for a type of liver disease for the next seven years.

  • May 30, 2025

    Generic-Drug Makers Near Exit From Depo-Provera MDL

    Attorneys for the plaintiffs in a multidistrict litigation claiming Pfizer Inc. failed to adequately warn patients and doctors about the risk of brain tumors associated with the hormonal contraceptive Depo-Provera told a Florida federal judge that they are close to dismissing claims against three manufacturers of generic versions of the drug.

  • May 30, 2025

    DLA Piper Adds Healthcare Regulatory Atty In DC Office

    DLA Piper strengthened its healthcare regulatory resources in Washington, D.C., with the recent addition of an attorney who previously served as acting general counsel for the U.S. Department of Health and Human Services.

  • May 30, 2025

    Former Pfizer Atty, Motley Rice Adviser Joins DiCello Levitt

    A former Pfizer vice president and assistant general counsel, who last June entered into a consulting agreement with Motley Rice LLC, is joining DiCello Levitt as a partner as part of the firm's Washington, D.C., public client practice group, the firm recently announced.

  • May 29, 2025

    AstraZeneca Inks $51.4M Settlement In Pay-For-Delay Case

    AstraZeneca Pharmaceuticals LP and Handa Pharmaceuticals LLC have agreed to shell out a combined $51.4 million to put to rest allegations AstraZeneca paid off generic-drug makers, including Handa, to protect its brand antipsychotic drug Seroquel XR, according to a filing Thursday in Delaware federal court.

  • May 29, 2025

    CMS Seeks Hospital Responses On Gender Dysphoria Care

    The Centers for Medicare & Medicaid Services is asking hospitals to produce information on gender dysphoria care provided to children and adolescents, noting in an oversight letter that the U.S. government has "serious concerns" surrounding hormone therapy and other gender-affirming medical interventions.

  • May 29, 2025

    Monsanto-Funded Researcher Influenced Panel, Jury Hears

    A Missouri jury hearing the latest trial over cancer claims related to Monsanto's glyphosate pesticides heard Thursday that a Monsanto-funded researcher was able to change the course of a prestigious international panel weighing the chemical's carcinogenicity.

  • May 29, 2025

    Express Scripts Says Arkansas Can't Ban PBM Pharmacies

    Pharmacy benefits manager Express Scripts sued the state of Arkansas in federal court Thursday, alleging that the state's recently enacted law banning PBMs from owning pharmacies in the state violated the U.S. Constitution and ran afoul of federal law governing military employee benefits.

  • May 29, 2025

    Delaware Justices Asked To Review Corporate Law Rework

    A biopharmaceutical company stockholder has sought direct certification of a derivative suit to Delaware's Supreme Court, asking for state constitutional review of legislation approved in March that limits avenues for challenges to some corporate acts.

  • May 29, 2025

    Judge Favors Vanda But Seeks Deal Over Drug Approval

    A D.C. federal judge on Thursday seemed ready to rule for Vanda Pharmaceuticals Inc. in its challenge to the U.S. Food and Drug Administration's timelines for approving new drugs but asked both sides to first try negotiating remedies to resolve the dispute.

  • May 29, 2025

    Ex-USPTO Solicitor Says He's Against Squires Nomination

    A former solicitor for the U.S. Patent and Trademark Office has come out against the nomination of John A. Squires to be the next director of the agency, saying in a letter Thursday that he's concerned about the nominee's desire to make existing patents stronger.

  • May 29, 2025

    Drugstores Say Texas Flouted Rules To Update Pharmacy Regs

    The National Association of Chain Drug Stores Inc. told the Texas Supreme Court that updates to statewide policy governing how pharmacies report drug prices flouted Texas rulemaking procedures, telling the state's high court that even if the updates were "good policy" they weren't lawful.

  • May 29, 2025

    Ex-United Therapeutics Exec Can't Dodge IP Suit

    A former United Therapeutics Corp. executive lost his bid to toss his former employer's suit alleging he used stolen intellectual property to develop a lung disease drug for a competitor, with the North Carolina Business Court ruling that it was too soon to determine if the complaint was untimely.

  • May 29, 2025

    Cochlear Implant Rivals Call Truce Ahead Of UPC Ruling

    Two cochlear implant heavyweights have quietly settled their global patent dispute, with both parties agreeing to dismiss a U.S. appeal on Thursday, bringing an abrupt end to the transatlantic clash.

  • May 28, 2025

    16 States Sue Trump Admin Over Cuts To Science Grants

    A coalition of 16 state attorneys general have sued the Trump administration in New York federal court on Wednesday to stop it from cutting millions of dollars in grant funds from the National Science Foundation for scientific research and programs aimed at enhancing diversity, equity and inclusion in STEM fields and environmental justice.

  • May 28, 2025

    5 Federal Circuit Clashes To Watch In June

    The Federal Circuit will hear cases in June that include an attempt to revive and expand a discarded $64 million trade secrets judgment against Goodyear, and a dispute between drugmakers Acorda and Alkermes that asks when licensees who pay royalties on expired patents can get a refund in arbitration.

  • May 28, 2025

    Regeneron Urges Judge In FCA Kickback Suit To Set Trial Date

    Regeneron Pharmaceuticals Inc. on Wednesday pressed a Massachusetts federal judge to ready a long-running False Claims Act suit for a jury and reject the government's second bid for a pretrial win under a different legal theory following a First Circuit setback.

  • May 28, 2025

    Fla. Judge Told Pharma Co. Rival Also Stole Trade Secrets

    A Florida federal judge on Wednesday denied an India-based pharmaceutical company's bid to reject a competitor's defense against a lawsuit alleging trade secrets theft by claiming its accuser is responsible for the same conduct, expressing doubt whether she can rule on such an issue.

  • May 28, 2025

    Fed. Circ. Lets Stewart Revise Longhorn Sanctions Order

    The Federal Circuit on Wednesday granted a bid by the acting head of the U.S. Patent and Trademark Office to allow her to revise the Patent Trial and Appeal Board's decision to cancel 183 of Longhorn Vaccines & Diagnostics' patent claims as a punishment for "egregious abuse of the PTAB process."

  • May 28, 2025

    3rd Circ. Pauses J&J Unit Appeal In Talc Study Libel Case

    The Third Circuit on Wednesday granted a bid by Johnson & Johnson's talc liability unit to stay briefing in its appeal seeking to revive a libel case over a scientific article linking talcum power to mesothelioma.

  • May 28, 2025

    Drugmaker LIVation Fights Novo Nordisk's Trademark Claims

    A Connecticut company, accused by Novo Nordisk Inc. of breaking trademark and unfair trade practices laws by comparing its compounded drugs to Ozempic, says it has taken down online posts the pharma giant challenged in April, claiming Novo Nordisk can no longer prove ongoing harm.

  • May 28, 2025

    Class Suit Against AI Drugmaker Back On After Mediation Fails

    After the parties failed to settle through mediation, a Connecticut federal judge has unpaused the latest iteration of a proposed class action accusing artificial intelligence-driven drugmaker BioXcel Therapeutics Inc. of false and misleading statements about U.S. Food and Drug Administration compliance issues surrounding a dementia drug.

  • May 28, 2025

    Indian Pharma Co. Hit With Patent Suit Over Fennec's Cancer Drug

    An Indian multinational pharmaceutical company is infringing a patent for a drug to treat hearing loss in pediatric cancer patients undergoing chemotherapy, a North Carolina biotechnology company claimed in a lawsuit filed in New Jersey federal court.

Expert Analysis

  • State Extended Producer Responsibility Laws: Tips For Cos.

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    As states increasingly shift the onus of end-of-life product management from consumers and local governments to the businesses that produce, distribute or sell certain items, companies must track the changing landscape and evaluate the applicability of these new laws and regulations to their operations, say attorneys at Alston & Bird.

  • Law Firm Executive Orders Create A Legal Ethics Minefield

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    Recent executive orders targeting BigLaw firms create ethical dilemmas — and raise the specter of civil or criminal liability — for the government attorneys tasked with implementing them and for the law firms that choose to make agreements with the administration, say attorneys at Buchalter.

  • Firms Must Embrace Alternative Billing Models Or Fall Behind

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    As artificial intelligence tools eliminate inefficiencies and the Big Four accounting firms enter the legal market, law firms that pivot from the entrenched billable hour model to outcomes-based pricing will see a distinct competitive advantage, says attorney William Brewer.

  • Key Issues To Watch As USPTO Changes Abound

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    As 2025 continues to unfold, changes at the U.S. Patent and Trademark Office — including new leadership, operational reforms, legislative initiatives and AI-related policies — have potential to influence proceedings, including efforts to prosecute patents and adversarial proceedings before the Patent Trial and Appeal Board, say attorneys at Morgan Lewis.

  • Trending At The PTAB: A Pivot On Discretionary Denials

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    Following the U.S. Patent and Trademark Office's rescission of the 2022 Vidal memorandum and a reversion to the standards under Apple v. Fintiv, petitioners hoping to avoid discretionary denials should undertake holistic review of all Fintiv factors, rather than relying on certain fail-safe provisions, say attorneys at Finnegan.

  • How Attorneys Can Master The Art Of On-Camera Presence

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    As attorneys are increasingly presented with on-camera opportunities, they can adapt their traditional legal skills for video contexts — such as virtual client meetings, marketing content or media interviews — by understanding the medium and making intentional adjustments, says Kerry Barrett.

  • Patent Drafting Pointers From Fed. Circ. COVID Test Ruling

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    The Federal Circuit's recent decision in DNA Genotek v. Spectrum Solutions provides several best practice pointers for drafting and prosecuting patent applications, highlighting how nuances in wording can potentially limit the scope of claims or otherwise affect claim constructions, says Irah Donner at Manatt.

  • Opinion

    Congress Must Reform The PTAB To Protect Small Innovators

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    Lawmakers must reintroduce the Promoting and Respecting Economically Vital American Innovation Leadership Act or similar legislation to prevent larger companies from leveraging the Patent Trial and Appeal Board to target smaller patent holders, says Schwegman Lundberg's Russell Slifer, former deputy director of the U.S. Patent and Trademark Office.

  • Series

    Baseball Fantasy Camp Makes Me A Better Lawyer

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    With six baseball fantasy experiences under my belt, I've learned time and again that I didn't make the wrong career choice, but I've also learned that baseball lessons are life lessons, and I'm a better lawyer for my time at St. Louis Cardinals fantasy camp, says Scott Felder at Wiley.

  • Series

    Adapting To Private Practice: From Fed. Prosecutor To BigLaw

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    Making the jump from government to private practice is no small feat, but, based on my experience transitioning to a business-driven environment after 15 years as an assistant U.S. attorney, it can be incredibly rewarding and help you become a more versatile lawyer, says Michael Beckwith at Dickinson Wright.

  • What To Expect For Stem Cell Regulation Under Trump Admin

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    The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.

  • Firms Still Have Lateral Market Advantage, But Risks Persist

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    Partner and associate mobility data from the fourth quarter of 2024 shows that we’re in a new, stable era of lateral hiring where firms have the edge, but leaders should proceed cautiously, looking beyond expected revenue and compensation analyses for potential risks, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.

  • 10 Practical Takeaways From FDA's Biopharma AI Guidance

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    Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.

  • Opinion

    We Must Allow Judges To Use Their Independent Judgment

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    As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.

  • Series

    Performing Stand-Up Comedy Makes Me A Better Lawyer

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    Whether I’m delivering a punchline on stage or a closing argument in court, balancing stand-up comedy performances and my legal career has demonstrated that the keys to success in both endeavors include reading the room, landing the right timing and making an impact, says attorney Rebecca Palmer.

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