Life Sciences

  • August 07, 2024

    Biotech Firm Can't Pause SEC Action During Appeal

    A Colorado federal magistrate judge won't pause a lawsuit by securities regulators against a biotech company accused of misappropriating roughly $9 million while the company appeals an asset freeze, agreeing in a Wednesday order with the SEC's argument that investors would be better served if the case moved ahead.

  • August 07, 2024

    Abbott Brass Trim But Can't Nix Investors' Formula Recall Suit

    A Chicago federal judge on Wednesday substantially trimmed a derivative suit accusing Abbott Laboratories leaders of concealing known safety issues related to recalled infant formula but rejected the defendants' argument that tossing the suit in its entirety was in shareholders' "best interest."

  • August 07, 2024

    Judge's Pharma Comments Could Decide Ineligibility Appeal

    A Federal Circuit panel on Wednesday was willing to explore Astellas Pharma's argument that a Nebraska federal judge should be taken off its infringement case over the bladder medication Myrbetriq, given statements that showed a potential bias against the pharmaceutical industry, but also made clear that such reassignments are rare and difficult.

  • August 07, 2024

    Advocates Tell 9th Circ. To Revive Invisalign Monopoly Suit

    Competition advocates are backing the revival of a class action accusing the makers of Invisalign of monopolizing the market for clear dental aligners, telling the Ninth Circuit in a new amicus brief that a district court summary judgment ruling for Align Technology creates a dangerous precedent for refusal-to-deal cases.

  • August 07, 2024

    Teva Finds Some Big-Pharma Friends In Inhaler Patent Fight

    Two large pharmaceutical companies have weighed in to ask the Federal Circuit to overturn a ruling that found that Teva's branded drugmaking operation misused a key federal patent database in order to block the release of competing generic asthma inhalers.

  • August 07, 2024

    NC Biz Court Bulletin: The Battles Making Summer Sizzle

    A 1983 championship basketball team's intellectual property rights and a public feud between Cadwalader Wickersham & Taft LLP and its insurer are among the legal battles that have kept North Carolina Business Court judges and Tar Heel state private practice attorneys busy this summer. In case you missed those and others, here are the highlights.

  • August 07, 2024

    Amgen Waged Lawfare To Overcharge For Drug, Suit Claims

    Maryland-based independent licensees of the Blue Cross Blue Shield Association claim pharmaceutical giant Amgen Inc. and its subsidiaries have engaged in unlawful monopolistic practices that have inflated the cost of the blockbuster drug Enbrel.

  • August 07, 2024

    Ex-Pharma Exec Gets 20 Months In SEC Contempt Case

    A former pharmaceutical executive who used an alias to flout a 2016 U.S. Securities and Exchange Commission consent judgment barring him from the securities industry was sentenced Wednesday to 20 months in prison by a judge who called him "incorrigible."

  • August 07, 2024

    Law Firms Fight J&J Bid To Revive Talc Subpoenas

    The Beasley Allen Law Firm, the steering committee of talc plaintiffs suing Johnson & Johnson, and a third-party law firm urged the New Jersey federal court this week to reject a bid from the pharmaceutical company to reinstate subpoenas seeking evidence of alleged third-party litigation funding.

  • August 07, 2024

    3 Firms Steer $405M G1-Pharmacosmos Pharma Deal

    G1 Therapeutics Inc., a North Carolina-based developer of cancer therapies, has agreed to sell the business to the U.S. subsidiary of Denmark's Pharmacosmos A/S, for approximately $405 million, the companies said Wednesday.

  • August 07, 2024

    2 FDA Pros Join McGuireWoods From Reed Smith, DOJ

    McGuireWoods LLP said Wednesday it has added two U.S. Food and Drug Administration regulatory lawyers to its Washington, D.C., office — one who joins from Reed Smith LLP and another who joins from the U.S. Department of Justice.

  • August 07, 2024

    Jury Deadlocks In Third Illinois Zantac Cancer Trial

    An Illinois state judge declared a mistrial Wednesday in a man's lawsuit claiming Boehringer Ingelheim's over-the-counter Zantac caused him to develop prostate cancer, after a jury signaled it could not reach a unanimous verdict.

  • August 07, 2024

    Rising Star: King & Spalding's Julia Zousmer

    Julia Zousmer of King & Spalding LLP helped Boehringer Ingelheim nix roughly 50,000 claims by plaintiffs and an entire cohort of experts in multidistrict litigation over its heartburn medication Zantac, earning her a spot among life sciences attorneys under age 40 honored by Law360 as Rising Stars.

  • August 07, 2024

    Pennsylvania Legislation Passed In 2024: A Midyear Report

    Despite a divided legislature in Pennsylvania — the parties have been trading a narrow majority in the House of Representatives and Republicans compose most of the state Senate — lawmakers have managed to send dozens of bills to Democratic Gov. Josh Shapiro's desk in the first half of 2024, including tighter controls on a veterinary drug showing up in heroin, changes to business registrations with the state, and adding arbitration to the tools for family courts.

  • August 06, 2024

    AstraZeneca Can't Duck $107.5M Patent Loss To Pfizer Unit

    An Illinois federal judge on Tuesday refused to upend a jury's determination that AstraZeneca owes $107.5 million in royalty damages for infringing Pfizer-brand cancer treatment patents, rejecting AstraZeneca's arguments that the patents are unenforceable and the asserted claims are invalid.

  • August 06, 2024

    Baby Sock Co. Can't Beat Investor Suit, But SPAC Brass Can

    Digital baby monitoring device manufacturer Owlet Inc. cannot escape a suit accusing it of misleading investors about approvals required from the U.S. Food and Drug Administration to sell its "smart socks," but brass at a blank check company that it merged with will be allowed to exit the suit.

  • August 06, 2024

    Fed. Circ. Told Edwards Filed Safe Harbor Suit With Bad Intent

    The Federal Circuit rightfully held Meril Life Sciences was protected by a patent safe harbor when bringing its preapproval transcatheter heart valve system to an industry conference and that Edwards Lifesciences' attempts to prove otherwise are just delay tactics, Meril told the full court.

  • August 06, 2024

    Tech Giants' Fight To Ax Fintiv Rule Returns To Fed. Circ.

    Apple and three other major technology companies have again asked the Federal Circuit to abolish a rule allowing the Patent Trial and Appeal Board to refuse to review patents based on related litigation in court, saying it is unlawful because it was implemented without formal rulemaking.

  • August 06, 2024

    Denver Food Co. Fired VP For Younger Male, Suit Claims

    A former vice president of a Denver-area food biotech firm has filed a suit claiming the company violated Colorado's gender and age anti-discrimination laws when it fired and ultimately replaced her after she finished training a younger male successor, who was intended to only take over some of her duties.

  • August 06, 2024

    Life Sciences Credit Firm Symbiotic Launches With $600M

    A new credit firm led by veterans in the healthcare industry announced its launch Tuesday, with more than $600 million in capital earmarked for loans to life sciences companies.

  • August 06, 2024

    FDA Posts Two Policy Memos On E-Cig Applications

    The U.S. Food and Drug Administration on Monday posted two memos outlining the agency's thoughts on two aspects of their reviews of applications to market e-cigarettes, which include chemical components that may pose a risk of cancer.

  • August 06, 2024

    Pharma Co. Founder Beats Suit Over Short-Swing Trading

    The founder of Y-mAbs Therapeutics Inc. beat back a suit alleging he realized more than $2.5 million in so-called short-swing profits after he exchanged his Y-mAbs stock for those of another company, with a New York federal judge saying in a ruling of first impression that the founder does not need to return the gains he received.

  • August 06, 2024

    Dem Lawmakers Back FTC's Kroger-Albertsons Challenge

    A group of Democratic lawmakers is supporting the Federal Trade Commission in its suit to block Kroger's $25 billion acquisition of Albertsons, telling an Oregon federal judge in a friend-of-the-court brief that the agency's fears the deal would harm grocery workers and consumers are well-founded.

  • August 06, 2024

    Ex-Pfizer Worker Who Traded On Paxlovid Secrets Gets 9 Mos.

    A Manhattan federal judge sentenced a former Pfizer Inc. statistician from New Jersey to nine months in prison Tuesday after a jury convicted him of insider trading on secrets about his former company's COVID-19 therapy trials for an illegal $272,000 profit.

  • August 06, 2024

    Penn Says BioNTech Owes Royalties For COVID-19 Vax

    BioNTech was hit with a breach of contract suit Monday in Pennsylvania federal court by the University of Pennsylvania over alleged unpaid royalties on global net sales of its blockbuster COVID-19 vaccine Comirnaty, which was developed using the school's crucial messenger RNA patents and has made more than $75 billion.

Expert Analysis

  • And Now A Word From The Panel: Benefits Of MDL Transfers

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    A recent order from the Judicial Panel on Multidistrict Litigation highlights a critical part of the panel's work — moving cases into an existing MDL — and serves as a reminder that common arguments against such transfers don't outweigh the benefits of coordinating discovery and utilizing lead counsel, says Alan Rothman at Sidley Austin.

  • What Rescheduling Could Mean For Cannabis Bankruptcies

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    Bankruptcy courts have historically been closed for cannabis-related businesses, but recent case law coupled with a possible reclassification of cannabis provides cautious optimism, say attorneys at Duane Morris.

  • Opinion

    Pharmacies Need More Protection Against PBM Fee Practices

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    The Centers for Medicare & Medicaid Services' recent reform regarding direct and indirect remuneration fees will mitigate the detrimental effects that pharmacy benefit manager policies have on struggling pharmacies, but more is needed to prevent PBMs from exploiting loopholes, says Bhavesh Desai at Mazina Law.

  • Contract Disputes Recap: Facts Differ But Same Rules Apply

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    Zachary Jacobson and Sarah Barney at Seyfarth examine two decisions illustrating that reliance on a technicality may not save an otherwise untimely appeal, and that enforcement of commercial terms and conditions under a federal supply schedule contract may be possible.

  • Series

    Spray Painting Makes Me A Better Lawyer

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    My experiences as an abstract spray paint artist have made me a better litigator, demonstrating — in more ways than one — how fluidity and flexibility are necessary parts of a successful legal practice, says Erick Sandlin at Bracewell.

  • Takeaways From The 2023 DOJ Fraud Section Report

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    Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.

  • Judge-Shopping Policy Revisal May Make Issue Worse

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    The Judicial Conference at its March meeting unveiled a revised policy with the stated goal of limiting litigants’ ability to judge-shop in patent cases, but the policy may actually exacerbate the problem by tying the issue to judge-shopping in polarizing political cases, making reform more difficult, say Robert Niemeier and William Milliken at Sterne Kessler.

  • 2nd Circ. Baby Food Ruling Disregards FDA's Expertise

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    The Second Circuit's recent decision in White v. Beech-Nut Nutrition, refusing to defer litigation over heavy metals in baby food until the U.S. Food and Drug Administration weighs in on the issue, provides no indication that courts will resolve the issue with greater efficiency than the FDA, say attorneys at Phillips Lytle.

  • Assessing FDA Pathways For Genome-Edited Plant Foods

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    The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.

  • Opinion

    Proposed MDL Management Rule Needs Refining

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    Proponents of the recently proposed Federal Rule of Civil Procedure 16.1 believe it may enhance efficiency in multidistrict litigation proceedings if adopted, but there are serious concerns that it could actually hinder plaintiffs' access to justice through the courts — and there are fundamental flaws that deserve our attention, says Ashleigh Raso at Nigh Goldenberg.

  • Why Oncology Deal Making Continues To Fuel Biotech M&A

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    The biotech sector's potential for advancements in cancer care continues to attract deal-maker interest, and the keys to successful mergers and acquisitions include the ability to integrate innovative therapies, leverage technological advancements and respond to the dynamic needs of patients, say Bryan Luchs and Mike Weir at White & Case.

  • Opinion

    Judicial Independence Is Imperative This Election Year

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    As the next election nears, the judges involved in the upcoming trials against former President Donald Trump increasingly face political pressures and threats of violence — revealing the urgent need to safeguard judicial independence and uphold the rule of law, says Benes Aldana at the National Judicial College.

  • Opinion

    NIST March-In Framework Is As Problematic As 2021 Proposal

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    While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.

  • Document Retention Best Practices To Lower Litigation Risks

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    As new technologies emerge and terabytes of data can be within the purview of a single discovery request, businesses small and large should take four document management steps to effectively minimize risks of litigation and discovery sanctions long before litigation ensues, says Kimbrilee Weber at Norris McLaughlin.

  • Series

    Riding My Peloton Bike Makes Me A Better Lawyer

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    Using the Peloton platform for cycling, running, rowing and more taught me that fostering a mind-body connection will not only benefit you physically and emotionally, but also inspire stamina, focus, discipline and empathy in your legal career, says Christopher Ward at Polsinelli.

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