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Life Sciences
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March 14, 2024
Drug Wholesalers Want Preliminary OK On $265M Sandoz Deal
A group of direct purchasers of generic drugs has asked a Pennsylvania federal court for approval of a $265 million settlement with Swiss drugmaker Sandoz over allegations of federal antitrust violations.
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March 14, 2024
Trial Challenging NC Abortion Restrictions Pushed To July
A July trial date has been set in a closely watched constitutional challenge seeking to dismantle a state law that restricts access to abortions in North Carolina after 12 weeks, marking a pushback from the court's earlier projected spring timetable for the trial.
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March 14, 2024
EPA Slashes Ethylene Oxide Emissions Levels For Sterilizers
The U.S. Environmental Protection Agency on Thursday finalized new Clean Air Act standards that it said will reduce emissions of ethylene oxide from commercial sterilization facilities by 90%, an action the agency said is necessary to help reduce the impact of the carcinogen on communities.
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March 13, 2024
9th Circ. Unsure If Abortion Pill Suit Harms Red States
Two Ninth Circuit judges on Wednesday challenged Idaho and other Republican-led states' bid to intervene in Washington's lawsuit seeking to expand access to the abortion pill mifepristone, asking if the states could back up their claims of economic harm.
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March 13, 2024
Pharma Co. CEO Partly Beats Investor Suit Over Kidney Drug
A California federal judge has tossed for good some claims against Tricida Inc. CEO Gerrit Klaerner in a suit alleging he and the company misled inventors about the ability of Tricida's new kidney disease drug to gain regulatory approval, saying that many of Klaerner's challenged statements are opinions and that he didn't act with knowledge of wrongdoing.
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March 13, 2024
HHS To Investigate Whether Cyberattack Exposed Patient Data
The U.S. Department of Health and Human Services opened an investigation Wednesday into the cyberattack on Change Healthcare to determine whether the hack exposed patients' confidential data or violated other privacy protections.
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March 13, 2024
Planned Parenthood Foe Calls Immunity Claim 'Half-Baked'
Attorneys for a pseudonymous relator who sued Planned Parenthood over allegations that it improperly billed Medicaid programs urged the Fifth Circuit on Wednesday to reject the group's position that it was shielded by attorney immunity, calling the entity's argument "half-baked."
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March 13, 2024
Aetna Can't Avoid Bias Suit Over Fertility Treatment Policy
Aetna must face a proposed class action alleging it readily covers fertility treatments for infertile heterosexual women but forces non-heterosexual women to spend thousands out of pocket before paying for their treatments, with a Connecticut federal judge saying it doesn't matter if the insurer didn't control the health plan's terms.
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March 13, 2024
Jury Must Weigh Willfulness In Secrets Case, Calif. Court Says
A California state appellate court has found a jury will have to decide whether a former director at Applied Medical Distribution Corp. willfully misappropriated trade secrets from his former employer.
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March 13, 2024
BigLaw Paper Poacher Gets 15 Mos. In Merck Insider Case
A Manhattan federal judge hit a former FBI trainee from Pennsylvania with a 15-month prison sentence Wednesday for illegally trading on a Merck & Co. deal using secrets gleaned from legal papers in the possession of his BigLaw ex-girlfriend.
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March 12, 2024
Eli Lilly GC's Pay Jumped To $7M In 2023 Amid Stock Boom
Eli Lilly & Co. legal chief Anat Hakim's total pay package rose to $7 million last year, up 33% from 2022, according to Lilly's latest proxy statement, as the pharmaceutical giant has experienced booming drug sales and positive investor sentiment.
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March 12, 2024
Daiichi Urges Court To OK Arbitrator's Award Against Seagan
Japanese drugmaker Daiichi Sankyo has asked a Seattle federal judge not to toss an arbitral award refusing Seagen Inc.'s claims for billions of dollars in a dispute over cancer drug patents, saying the U.S. biotech company has incorrectly lodged a petition to vacate the award.
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March 12, 2024
Federal Circuit Won't Reconsider Axing Tyvaso Patent
The full Federal Circuit on Tuesday declined to review a panel ruling from late last year that sided with a Patent Trial and Appeal Board decision that there was nothing patentable about a way of administering a blockbuster pulmonary hypertension drug.
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March 12, 2024
Judiciary Touts New Policy To Rein In Judge Shopping
The Judicial Conference of the United States on Tuesday said it has updated a policy on random case assignments to ensure litigants can't shop for the judge of their choice by going to a one-judge division of a district court.
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March 12, 2024
NY Jury Rules Some Claims About Prevagen Are Misleading
A New York federal jury said some statements made by Quincy Bioscience about its memory booster Prevagen were misleading to consumers but found that most statements about the supplement were made on solid grounds.
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March 12, 2024
2nd Circ. Revives Parts Of McKesson Whistleblower Suit
The Second Circuit on Tuesday revived parts of a lawsuit brought by a McKesson Corp. whistleblower who accuses the pharmaceutical company of a kickback scheme, finding that the lower court should reconsider the claims that were brought under state anti-kickback laws.
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March 12, 2024
Breast Implant Co.'s $90M DIP OK'd With Creditor Protections
Bankrupt breast implant maker Sientra Inc. received final court approval in Delaware bankruptcy court for its $90 million debtor-in-possession financing after adding in lien challenge protections for unsecured creditors.
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March 12, 2024
Ex-Biopharma CEO Sues For Post-Sale Share Appraisal In Del.
The co-founder of Caraway Therapeutics Inc. sued in Delaware's Court of Chancery on Tuesday for an appraisal of his shares following the company's November merger with a subsidiary of pharmaceutical giant Merck, alleging that it "was an unfair cash-out transaction" and that he is owed at least a million more shares.
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March 12, 2024
Sorrento Ch. 11 Will Stay In Texas
A Texas bankruptcy judge Tuesday denied requests to transfer the Chapter 11 case of drug developer Sorrento Therapeutics Inc. out of the Lone Star State for having insufficient ties to the venue.
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March 12, 2024
Reps Push Regulators For Answers On Marijuana Research
A bipartisan pair of congress members on opposite sides of the cannabis legalization issue joined forces on Tuesday to blast federal agencies for not effectively implementing a bill whose stated purpose was to expedite research into marijuana's potential harms and benefits.
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March 12, 2024
Nurses' Challenge To NJ Vaccine Mandate Moot, Judge Rules
A New Jersey federal judge tossed a suit challenging Gov. Phil Murphy's vaccine mandate for healthcare workers, ruling the case is moot because the mandate had been rescinded.
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March 12, 2024
Pharmacy Calls $11M False Claims Case A 'House Of Cards'
A compounding pharmacy and its president trashed the Connecticut attorney general's $11 million false claims and kickback allegations against them as a "house of cards" that awarded "a sweetheart cooperation deal" to an alleged co-conspirator and improperly benefited private attorneys, calling instead for a judgment against the state.
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March 12, 2024
Paul Weiss' Digital Tech Chair On AI's Promises And Perils
While generative artificial intelligence promises to increase access to justice and kill the billable hour, we don't know how to prevent it from unleashing misinformation and disinformation on the electorate, says Katherine Forrest, a former Manhattan federal judge who is now chair of Paul Weiss Rifkind Wharton & Garrison LLP's digital technology group.
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March 12, 2024
Insider Trader Cites 'Carelessness' Of BigLaw Ex-Girlfriend
A former FBI trainee who kickstarted an insider trading scheme by looking at the confidential files of his then-girlfriend, a Covington & Burling LLP associate, has told a sentencing judge he isn't trying to downplay the seriousness of his actions by pointing to her "carelessness."
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March 11, 2024
Acadia Investors Get Class Cert. In Suit Over Parkinson's Drug
A California federal judge on Monday certified a class of Acadia Pharmaceuticals investors in a lawsuit accusing the company of making false and misleading statements regarding the likelihood that its Parkinson's psychosis drug would also be approved for the broader use of dementia-related psychosis.
Expert Analysis
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An Overview Of Congress' Proposed Drug Shortage Solutions
Recently, Congress has seen a number of bipartisan bills that seek to prevent and respond to national drug shortages, though disagreements over the right vehicle and timeline have slowed progress, says Miranda Franco at Holland & Knight.
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Considerations And Calculations For DOJ Clawback Program
The U.S. Department of Justice’s clawback pilot program announced earlier this year presents numerous questions for businesses, and both hypothetical and recent real-world examples capture how companies’ cost-benefit analyses about whether to claw back compensation in exchange for penalty reductions may differ, say Yogesh Bahl and Jonathan Hecht at Resolution Economics.
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SEC's Life Sciences Actions Utilize Novel Tools And Theories
Recent enforcement actions show that the U.S. Securities and Exchange Commission is employing new forms of data analytics and noteworthy applications of insider trading laws in its scrutiny of fraud within the life sciences and health industries, say Edward Imperatore and Jina Choi at MoFo.
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What Case Trends Reveal About Life Sciences Results At ITC
A look at recent U.S. International Trade Commission case data shows that pharmaceuticals, medical devices and other life sciences products constitute a growing share of the technologies involved in Section 337 investigations, with overwhelmingly positive results for companies seeking to protect their IP rights from foreign competitors, say Brian Busey and Daniel Muino at MoFo.
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Series
ESG Around The World: Japan
Japan is witnessing rapid developments in environmental, social and corporate governance policies by making efforts to adopt a soft law approach, which has been effective in encouraging companies to embrace ESG practices and address the diversity of boards of directors, say Akira Karasawa and Landry Guesdon at Iwata Godo.
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How And Why Your Firm Should Implement Fixed-Fee Billing
Amid rising burnout in the legal industry and client efforts to curtail spending, pivoting to a fixed-fee billing model may improve client-attorney relationships and offer lawyers financial, logistical and stress relief — while still maintaining profit margins, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Potential Broader Effects Of FDA's Lab-Developed Test Rule
Though it's unclear whether the U.S. Food and Drug Administration's proposed rule for regulating lab-developed tests will ever go into effect, it nonetheless functions as a threatened hammer that may make legislative efforts to regulate such tests more palatable, say attorneys at King & Spalding.
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Opinion
Judicial Independence Needs Defense Amid Political Threats
Amid recent and historic challenges to the judiciary from political forces, safeguarding judicial independence and maintaining the integrity of the legal system is increasingly urgent, says Robert Peck at the Center for Constitutional Litigation.
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2 New Ways FDA Is Changing Lab-Developed Test Regulation
The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.
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FDI Considerations For UK Venture Capital Transactions
With the U.K. National Security and Investment Act highlighting foreign direct investment matters for venture capital transactions, investors dealing with companies connected to the U.K. should be alive to how the act's requirements can affect deal timelines, structures and terms, say lawyers at Covington.
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How Life Sciences Cos. Can Prevent Securities Class Actions
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.
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How Law Firms Can Use Account-Based Marketing Strategies
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.
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11 Ways Senate Bill Would Alter PTAB Practice
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.
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Navigating Over-The-Counter Product Ads After FTC Warning
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.
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A Reminder For Drug Cos. To Confirm Orange Book Listings
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.