Life Sciences

  • March 11, 2024

    Pfizer Defeats French Group's Bid For Vax Docs At 2nd Circ.

    The Second Circuit said Monday that Pfizer doesn't need to give a French nonprofit the communications between its CEO and the European Commission's president related to a COVID-19 vaccine development agreement, ruling the materials are irrelevant to a jurisdictional issue in the group's legal challenge to the pact in France.

  • March 11, 2024

    Catching Up With Delaware's Chancery Court

    Delaware's Court of Chancery became a hot topic in New Orleans last week as litigators and judges at an annual convention acknowledged the First State's corporate law preeminence is under scrutiny. Back home, the court moved ahead on disputes involving Meta Platforms, Abercrombie & Fitch and Donald Trump.

  • March 08, 2024

    Trump 'An Existential Threat' To Rule Of Law, Attys Warn

    Former President Donald Trump represents an "existential threat" to democracy and the rule of law, legal experts said Friday at a conference on white collar crime in San Francisco.

  • March 08, 2024

    Inside The Climactic Clash Over Skyrocketing MDL Caseloads

    A seven-year showdown over the nation's swelling docket of ultra-high-stakes consumer suits is hurtling toward its moment of truth, as a judicial oversight panel weighs impassioned input from big-name attorneys and judges endorsing everything from sweeping overhauls to the tiniest of tweaks.

  • March 08, 2024

    Cahill Has 'Great Ambitions' To Take IP Litigation By Storm

    Cahill Gordon & Reindel LLP has spent the last year building up a new intellectual property practice, with a veteran of top law firms leading the way and attorneys from White & Case LLP joining the firm earlier this year.

  • March 08, 2024

    FDA Pumps Brakes On Eli Lilly Alzheimer's Drug Approval

    The U.S. Food and Drug Administration is delaying an approval decision on Eli Lilly and Co.'s Alzheimer's drug donanemab, the company said Friday, throwing a wrench in what was expected to be a smooth approval process for the experimental neurodegenerative treatment.

  • March 08, 2024

    UK Enforcers To Appeal Nixed £100M Hydrocortisone Fine

    Britain's competition enforcer is planning to appeal a tribunal's ruling that upended more than £100 million ($128.6 million) in fines against several drug companies for allegedly reaching agreements that increased the price of hydrocortisone tablets.

  • March 08, 2024

    Colo. DNA Scientist Fudged Data For 650 Cases, Police Say

    A former DNA scientist for the Colorado Bureau of Investigation manipulated data for years, the bureau announced Friday, stating that an investigation has identified more than 650 cases affected since 2008.

  • March 08, 2024

    7th Circ. Wants 'Roadmap' For Ill. Workplace Disease Law

    The Seventh Circuit has asked the Illinois Supreme Court to weigh in on the state's Workers' Occupational Diseases Act, saying it needs a "roadmap" to handle claims for asbestos and other diseases that manifest belatedly as it considers a widow's suit alleging her husband's exposure to a toxic chemical while working for Goodrich Corp. led to his death.

  • March 08, 2024

    Sorrento Gets OK For $2M Ch. 11 Funding Infusion, Asset Sale

    A Texas bankruptcy judge on Friday approved drug developer Sorrento Therapeutics Inc.'s bid for an asset sale and $2 million in funds to fuel its Chapter 11 case, saying they represented the only option outside of a transition to Chapter 7.

  • March 07, 2024

    Abortion, Drug Costs Top Health Issues in State Of The Union

    President Joe Biden laid out a forceful healthcare agenda in his State of the Union address on Thursday, promising to ramp up efforts to control drug prices and pledging to reinstate the federal right to an abortion if voters elect a pro-abortion Congress.

  • March 07, 2024

    Petition Watch: Student Athletes, Oil Spills & Preemption

    The U.S. Supreme Court receives thousands of petitions for review each term, but only a few make the news. Here, Law360 looks at four petitions filed in the past three weeks that you might've missed: questions over whether student athletes have a business interest in being eligible to play college sports, how much oil is needed to qualify as an oil spill, whether an exemption to the Fourth Amendment applies to artificial intelligence and whether consumers can sue drug companies under state law for violating federal regulations.

  • March 07, 2024

    Judges Say Facing Threats And Vitriol Now Part Of The Job

    Federal judges spoke Thursday about the challenges of the profession in the 21st century, describing how they've either received threats or know of warnings against colleagues, with one jurist saying she received 11 death threats during her first three months on the bench.

  • March 07, 2024

    Judge Doubts Medicare Drug Pricing Amounts To 'Taking'

    A New Jersey federal judge on Thursday bristled at the position by pharmaceutical companies that Medicare's drug price negotiation program is an unconstitutional "taking" that undercuts their bottom line, suggesting that the drug powerhouses needed more numbers to back their argument.

  • March 07, 2024

    IP Forecast: 2nd Circ. To Consider Whether Seltzer Is Beer

    The Modelo brand will head to the Second Circuit next week to argue that a Manhattan jury erred when it found that Corona's flavored seltzer is just about the same as beer in light of a contract that the companies entered. Here's a look at that case — plus all the other major intellectual property matters on deck in the coming week.

  • March 07, 2024

    Harpoon Shareholder Sues For Records On $680M Merck Buy

    A shareholder of Harpoon Therapeutics Inc. sued in Delaware's Court of Chancery Thursday for corporate documents related to the company's proposed $680 million cash buyout by Merck, saying the proposed deal appears to unfairly "lock in a windfall for select Harpoon investors."

  • March 07, 2024

    Sens. Tell Stores To Get Illegal E-Cigs Off Their Shelves

    Five U.S. senators on Thursday told the heads of major convenience store and gas station chains to stop sales of unauthorized flavored e-cigarette products, saying that their illegal sales pose a major threat to public health, especially children's.

  • March 07, 2024

    Fed. Circ. Says IP License May Be Part Of Procurement Deal

    The Federal Circuit on Wednesday revived a software developer's claims that the U.S. Food and Drug Administration misappropriated its data, saying the developer had sufficiently alleged it was party to a government contract that allowed lawsuits under the Contract Disputes Act.

  • March 07, 2024

    Feds Want 3 Years For Trader Who Spied BigLaw Ex's Binder

    Prosecutors asked a Manhattan federal court for a prison sentence of up to three years for a man who orchestrated an insider trading scheme after gleaning information about a yet-to-be-announced merger from his girlfriend, a Covington & Burling associate, calling it a brazen crime that the defendant lied about when confronted.

  • March 07, 2024

    Moses & Singer Healthcare Atty Joins Day Pitney In Hartford

    Day Pitney LLP has added an experienced attorney to its Hartford office as counsel from Moses & Singer LLP in New York.

  • March 07, 2024

    Activist Caligan Sets Sights On Anika Therapeutics Again

    New York-based activist investor Caligan Partners LP disclosed a nearly 10% stake in Anika Therapeutics and nominated two director candidates, a move that comes a year after the hedge fund urged the biotech company to consider "urgent changes" to its operations and structure.

  • March 06, 2024

    Top Calif. Antitrust Atty Says Criminal Cases On The Horizon

    California is poised to start prosecuting criminal antitrust cases under a Golden State law that is "broader" than federal law, a senior assistant attorney general for the California Department of Justice said Wednesday at a San Francisco conference.

  • March 06, 2024

    Garland On AI Crime, And A Taylor Swift Tune For DOJ

    U.S. Attorney General Merrick Garland on Wednesday told a group of lawyers gathered in San Francisco that the U.S. Department of Justice is ramping up its hiring of computer scientists to fight artificial intelligence-driven crime and also revealed which Taylor Swift song he thought should be the department's anthem.

  • March 06, 2024

    Juul MDL Judge Asks Feds To Probe AI Fraud In $45.5M Deal

    A California federal judge Wednesday approved e-cigarette Juul investor Altria's $45.5 million settlement and counsel's $13.65 million fee request to resolve consumer claims in Altria's broader $235 million multidistrict settlement agreement, but said fraudulent claims submitted by AI and "click farms" are a "real problem" prosecutors should investigate.

  • March 06, 2024

    Pa. Pharma Co. Cops To Adulterated-Drug Charges

    A Pennsylvania generic drug manufacturer has pled guilty to federal charges that it sold adulterated drugs in the U.S. into interstate commerce and agreed to pay a $1.5 million penalty, the U.S. Department of Justice said Wednesday.

Expert Analysis

  • How Life Sciences Cos. Can Prevent Securities Class Actions

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    Though the overall volume of securities fraud class actions has dipped in the last couple of years, life sciences companies remain a particularly popular target for these filings and should employ best practices to minimize risk, say Joni Jacobsen and Angela Liu at Dechert.

  • How Law Firms Can Use Account-Based Marketing Strategies

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    Amid several evolving legal industry trends, account-based marketing can help law firms uncover additional revenue-generating opportunities with existing clients, with key considerations ranging from data analytics to relationship building, say Jennifer Ramsey at stage LLC and consultant Gina Sponzilli.

  • 11 Ways Senate Bill Would Alter PTAB Practice

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    Recently proposed legislation, the PREVAIL Act, would change post-grant practice before the U.S. Patent Trial and Appeal Board in several key ways including inter partes review, post-grant review and ex parte reexamination practice, say Jeffrey Shneidman and Jacqueline Tio at Fish & Richardson.

  • Navigating Over-The-Counter Product Ads After FTC Warning

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    Attorneys at Hunton examine advertising substantiation requirements under both the Federal Trade Commission Act and Lanham Act, following recent FTC letters informing hundreds of companies that over-the-counter product marketing claims must be corroborated by scientific evidence.

  • A Reminder For Drug Cos. To Confirm Orange Book Listings

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    A recent policy statement from the Federal Trade Commission highlights the legal danger that pharmaceutical companies can face for improperly listing patents in the U.S. Food and Drug Administration's Orange Book, which is also an issue in the context of Hatch-Waxman litigation, say attorneys at Kirkland.

  • Strategic Succession Planning At Law Firms Is Crucial

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    Senior partners' reluctance to retire, the rise of the nonequity partner tier and generational differences in expectations are all contributing to an increasing number of departures from BigLaw, making it imperative for firms to encourage retirement among senior ranks and provide clearer leadership pathways to junior attorneys, says Laura Leopard at Leopard Solutions.

  • What An NCAA Drug Test Change Could Mean For Cannabis

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    If the NCAA follows through with its decision to remove cannabis from its banned list of substances, it will affect college athletes, athletic directors, public relations employees, and marketing departments at universities and colleges, and it will have a significant economic effect on the cannabis industry, say Stanley Jutkowitz and Sydney Jenkins at Seyfarth.

  • FDA's Lab-Developed Test Rule Faces High Hurdles

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    The U.S. Food and Drug Administration's recently announced plans to explicitly regulate lab-developed tests will likely face resistance from industry stakeholders and congressional actions, and lead to significant litigation, say attorneys at Hogan Lovells.

  • Justices Could Use Purdue To Resolve Related Circuit Split

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    The U.S. Supreme Court will soon hear Harrington v. Purdue Pharma to determine the validity of nonconsensual third-party releases in bankruptcy, but justices should also take the opportunity to resolve a related circuit split over the constitutional authority of bankruptcy judges to issue final rulings on such releases, says Benjamin Feder at Kelley Drye.

  • FTC's Health Co. Suit Indicates Agency's Private Equity Focus

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    The Federal Trade Commission's latest lawsuit against an anesthesia company and its private equity investor highlights the agency's willingness to regulate the health care industry even when relevant acquisitions are relatively dated or when the controlling entity's economic interest is under 50%, say attorneys at Simpson Thacher.

  • Opinion

    'Lead Compound' Rule For Drug Patents Leads Courts Astray

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    For several years, patent challengers in the chemical and pharmaceutical arts have faced an added impediment to invalidating a patent for obviousness — a "lead compound" rule for prior art that is legally wrong, contravenes several U.S. Supreme Court decisions and is antithetical to public policy, says Roy Wepner at Rutgers.

  • What Marijuana Status Change Would Mean For Industry

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    If the Drug Enforcement Administration accepts the U.S. Department of Health and Human Services’ recent recommendation to change marijuana’s classification under federal law, it would be a significant regulatory shift that could foster many industry benefits — but questions, risks and uncertainties at both the state and federal levels would remain, say attorneys at Neal Gerber.

  • Top 4 Antitrust Enforcement Issues In Health Care Today

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    The Federal Trade Commission's recent lawsuit against U.S. Anesthesia Partners exemplifies antitrust enforcement authorities' efforts to aggressively reshape the health care industry, ranging from new proposed rules to withdrawals of previous guidance, say attorneys at Fried Frank.

  • 6 Lessons From Direct Selling Industry's Win Over FTC

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    A Texas federal court’s recent decision in favor of a direct selling company in Federal Trade Commission v. Neora offers long-awaited clarity on what constitutes a pyramid scheme, and lessons for companies seeking to prove their sales are consistent with genuine demand, say Monica Zhong and Branko Jovanovic at Edgeworth.

  • Calif. Climate Disclosure Bills Promise Challenges For Cos.

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    Two novel climate disclosure bills recently passed by the California Legislature will pose challenges for many businesses — especially private companies that are less familiar with climate-related reporting obligations — and will require investments of significant time and effort in processes, procedures and personnel, say John Rousakis and Chris Bowman at O'Melveny.

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