Life Sciences

  • July 10, 2024

    RJ Reynolds Urges Toss Of Menthol Suit Against FDA

    Tobacco giant R.J. Reynolds has come to the support of the U.S. Food and Drug Administration in a friend-of-the-court brief, arguing that the court should toss a federal lawsuit against the agency over its purported delays in implementing a ban on menthol cigarettes.

  • July 10, 2024

    Ex-FDA Regulator Joins Chicago Boutique Amin Wasserman

    A former high-level attorney within the U.S. Food and Drug Administration is joining Chicago-based boutique Amin Wasserman Gurnani LLP, which specializes in representing food and dietary supplement companies.

  • July 10, 2024

    Longtime Axinn Atty To Chair Polsinelli's Hatch-Waxman Team

    A practice leader from Axinn Veltrop & Harkrider LLP, known in part for his high-profile work on behalf of pharmaceutical clients, is joining Polsinelli PC to chair its Hatch-Waxman and biologics practice, the firm announced on Tuesday.

  • July 10, 2024

    Ex-CEO Convicted In COVID Test Kit Fraud Case

    A former healthcare software executive was found guilty of securities fraud Wednesday by a New Jersey federal jury in the retrial of a case that ended in a hung jury in December.

  • July 09, 2024

    Pharma Co. Fined $16.9M For Fake Scripts, Ex-VP Arrested

    A subsidiary of bankrupt DMK Pharmaceuticals Corp. faces a $16.9 million criminal fine after pleading guilty to conspiring in a scheme to ship drugs using false prescriptions, federal prosecutors announced Tuesday, adding that the subsidiary's former vice president of sales was also arrested.

  • July 09, 2024

    Bard Fights 'Patent Misuse' Ruling In $53M Suit At 9th Circ.

    Bard urged the Ninth Circuit on Tuesday to reverse a lower court's finding that its attempt to collect $53 million in licensing payments from a medical-device company was a clear case of "patent misuse," arguing that the parties' licensing agreement allows for Bard to collect payments even after the patents-in-suit expired.

  • July 09, 2024

    South Africa Drops J&J Probe After TB Drug Price Cuts

    South Africa's antitrust office has said it's going to drop its investigation over whether Johnson & Johnson engaged in anticompetitive conduct by filing a patent there for a tuberculosis drug, after the drugmaker agreed to lower the cost of bedaquiline by 40% and allow generic versions of the drug on the market.

  • July 09, 2024

    Fla. Judge Won't Nix Antitrust Claims Against Alcon

    The Florida federal judge presiding over the multidistrict litigation alleging disposable contact lens sellers conspired to fix prices refused Tuesday to let Alcon escape antitrust claims by an online contact lens reseller and sent the suit back to New York.

  • July 09, 2024

    HEC Can't Get Damages Over Injunction In Novartis Feud

    A Delaware federal court on Tuesday shot down HEC Pharm Co.'s bid for damages stemming from a preliminary injunction against it over the launch of a generic version of Novartis Pharmaceuticals' blockbuster multiple sclerosis treatment Gilenya.

  • July 09, 2024

    BCBS Unit Fails To Stop Religious Vaccine Objector Suits

    A Blue Cross Blue Shield of Michigan subsidiary can't escape claims it treated differently employees who sought accommodations from a COVID-19 vaccine mandate, a Michigan federal judge ruled Tuesday, finding it plausible that religious discrimination "was at least a motivating factor" in the way the workers were dealt with.

  • July 09, 2024

    3rd Circ. Rips 2nd Circ. In Asset Freeze Ruling For SEC

    The Third Circuit is standing by a lower court's decision to freeze a private equity executive's assets as he fights insider trading claims brought by the U.S. Securities and Exchange Commission, criticizing its sister circuit's approach to handling such issues in a precedential ruling Tuesday.

  • July 09, 2024

    NJ Panel Revokes Coverage For Pharma Co. In Fraud Row

    A pharmaceutical company isn't covered for underlying accusations that it was a middleman in a self-dealing scheme orchestrated by its now-deceased board chairman, a New Jersey state appeals court ruled Tuesday, reversing a decision that a capacity exclusion in the company's directors and officers policy didn't apply.

  • July 09, 2024

    Purdue Plans 'High-Speed' Bid For New Ch. 11 Plan

    Purdue Pharma told a New York bankruptcy judge Tuesday that it plans a two-month "high-speed, high-stakes" attempt to replace the Chapter 11 plan shot down by the U.S. Supreme Court last month before unleashing litigation on its former owning family.

  • July 09, 2024

    NJ Jury Begins Deliberating COVID Test Kit Fraud Case

    Jurors began deliberating Tuesday in the retrial of a securities fraud case that ended with a dramatic mistrial after a juror announced in open court last December that he disagreed with the guilty verdict that had just been delivered by the jury forewoman.

  • July 09, 2024

    Terrorism Victims Push To Keep Pharma Suit In DC Circ.

    Terrorism victims warned the D.C. Circuit against sending to a lower court a lawsuit seeking to link pharmaceutical companies to the attacks that injured them, saying a remand could delay the case and frustrate their efforts to collect evidence.

  • July 09, 2024

    FTC Says Drug Middlemen Inflate Costs, Squeeze Pharmacies

    The Federal Trade Commission said Tuesday that its study of pharmacy benefit managers has shown that six large companies now control 95% of all prescriptions filled in the U.S., allowing them to profit at the expense of patients and independent pharmacies.

  • July 09, 2024

    Gov't Missed Merck Vax Potency Problem, 3rd Circ. Told

    Two whistleblowers claiming that Merck & Co. had exaggerated the potency of its mumps vaccine told a Third Circuit panel Tuesday that the U.S. Centers for Disease Control and Prevention's continued purchasing of the vaccine was not proof that the agency knew but didn't care about the alleged deception.

  • July 08, 2024

    Emergent, J&J Reach $50M Deal In COVID Vax Supply Fight

    Johnson & Johnson has agreed to pay Emergent BioSolutions $50 million to resolve claims stemming from a now-terminated COVID-19 vaccine manufacturing deal, according to a disclosure filed with the U.S. Securities and Exchange Commission on Monday.

  • July 08, 2024

    Biotech Slaps Intellia With IP Suit Over $100M Regeneron Deal

    Biotechnology company BlueAllele Corp. sued Intellia Therapeutics Inc. in Delaware federal court Monday, claiming the rival has infringed on three of its patents related to gene editing and using its invented technology to reap over $100 million under a deal with another biotech, Regeneron Pharmaceuticals Inc.

  • July 08, 2024

    Jurors Told To Decide Who Is Lying In COVID Test Fraud Case

    The task for jurors in the retrial of a securities fraud case over a COVID test kit deal that never materialized will be to determine not whether lies were told but who told them, according to closing arguments delivered Monday in New Jersey federal court.

  • July 08, 2024

    Blank Check Co. Sagaliam Gets Shareholder Suit Trimmed

    A Delaware federal judge on Monday trimmed a shareholder suit brought against blank check company Sagaliam Acquisition Corp. over its planned tie-up with biotech company Enzolytics Inc., saying the plaintiffs failed to adequately plead a breach of fiduciary duty claim.

  • July 08, 2024

    Purdue Creditors Look To Sue Sacklers After Justices' Ruling

    The official committee of unsecured creditors in the Chapter 11 case of drugmaker Purdue Pharma asked a New York bankruptcy judge on Monday for standing to bring actions against members of the Sackler family that own the company after the U.S. Supreme Court torpedoed a precarious settlement among the parties.

  • July 08, 2024

    Biotech Co. Alleges Arbitrator Conflict In Patent Award Fight

    Pennsylvania-based biotechnology company Renmatix Inc. is urging the Delaware Court of Chancery to nix an arbitral award favoring Finnish company UPM-Kymmene Corp. in a long-running patent dispute, pointing to an allegedly undisclosed conflict of interest involving the Finnish company's counsel at DLA Piper.

  • July 08, 2024

    Kirkland, Fenwick Steer Lilly's $3.2B Morphic Acquisition

    Eli Lilly and Co. unveiled Monday a $3.2 billion all-cash deal to acquire biopharmaceutical company Morphic Holding Inc., which is developing oral therapies to treat Crohn's disease and other bowel chronic diseases, in a 10-figure transaction guided by Kirkland & Ellis LLP and Fenwick & West LLP.

  • July 08, 2024

    Ex-Ga. Insurance Chief Wants Lighter Term In Kickback Case

    Former Georgia Insurance Commissioner John Oxendine has objected to the government's recommendation that he serve 44 months in prison and pay a $700,000 fine for his role in a multimillion-dollar medical testing kickback scheme, arguing that he is deserving of a lesser sentence.

Expert Analysis

  • Series

    Playing Chess Makes Me A Better Lawyer

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    There are many ways that chess skills translate directly into lawyer skills, but for me, the bigger career lessons go beyond the direct parallels — playing chess has shown me the value of seeing gradual improvement in and focusing deep concentration on a nonwork endeavor, says attorney Steven Fink.

  • Litigation Inspiration: Attys Can Be Heroic Like Olympians

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    Although litigation won’t earn anyone an Olympic medal in Paris this summer, it can be worthy of the same lasting honor if attorneys exercise focused restraint — seeking both their clients’ interests and those of the court — instead of merely pursuing every advantage short of sanctionable conduct, says Bennett Rawicki at Hilgers Graben.

  • Updated Federal Rules Can Improve Product Liability MDLs

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    The recent amendment of a federal evidence rule regarding expert testimony and the proposal of a civil rule on managing early discovery in multidistrict legislation hold great promise for promoting the uniform and efficient processes that high-stakes product liability cases particularly need, say Alan Klein and William Heaston at Duane Morris.

  • Lean Into The 'Great Restoration' To Retain Legal Talent

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    As the “great resignation,” in which employees voluntarily left their jobs in droves, has largely dissipated, legal employers should now work toward the idea of a “great restoration,” adopting strategies to effectively hire, onboard and retain top legal talent, says Molly McGrath at Hiring & Empowering Solutions.

  • How Cannabis Rescheduling May Alter Paraphernalia Imports

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    The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.

  • What The NYSE Proposed Delisting Rule Could Mean For Cos.

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    The New York Stock Exchange's recently proposed rule would provide the exchange with discretionary authority to commence delisting proceedings for a company substantially shifting its primary business focus, raising concerns for NYSE-listed companies over the exact definition of the exchange's proposed "substantially different" standard, say attorneys at Winston & Strawn.

  • FDA Warning Indicates Scrutiny Of Regenerative Health Cos.

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    The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.

  • 2 Regulatory Approaches To Psychedelic Clinical Trials

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    Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.

  • Opinion

    Bankruptcy Judges Can Justly Resolve Mass Tort Cases

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    Johnson & Johnson’s recent announcement of a prepackaged reorganization plan for its talc unit highlights that Chapter 11 is a continually evolving living statute that can address new types of problems with reorganization, value and job preservation, and just treatment for creditors, says Kenneth Rosen at Ken Rosen Advisors PC.

  • Series

    Fishing Makes Me A Better Lawyer

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    Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge​​​​​​​ at Robinson Bradshaw.

  • A Healthier Legal Industry Starts With Emotional Intelligence

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    The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.

  • To Make Your Legal Writing Clear, Emulate A Master Chef

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    To deliver clear and effective written advocacy, lawyers should follow the model of a fine dining chef — seasoning a foundation of pure facts with punchy descriptors, spicing it up with analogies, refining the recipe and trimming the fat — thus catering to a sophisticated audience of decision-makers, says Reuben Guttman at Guttman Buschner.

  • Circuit Judge Writes An Opinion, AI Helps: What Now?

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    Last week's Eleventh Circuit opinion in Snell v. United Specialty Insurance, notable for a concurrence outlining the use of artificial intelligence to evaluate a term's common meaning, is hopefully the first step toward developing a coherent basis for the judiciary's generative AI use, says David Zaslowsky at Baker McKenzie.

  • Fed. Circ. Rulings Crystallize Polymorph Patent 'Obviousness'

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    A comparison of two recent Federal Circuit obviousness challenge decisions regarding polymorph patents provides helpful insight into the assessment of screening arguments, particularly the issue of reasonable expectation of success, say Michael Green and John Molenda at Steptoe.

  • DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges

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    The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.

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