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Life Sciences
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March 12, 2025
Law360 Cheat Sheet: Novartis' Fight Over Generic Entresto
Novartis has led a wide-ranging litigation campaign to block generic versions of its bestselling cardiovascular drug Entresto that has involved multidistrict litigation, trips to several circuit courts and cases against the federal government. Here, Law360 breaks down how the various cases intersect and what's still playing out.
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March 12, 2025
SEC Says Ex-Allarity Execs Concealed Doomed FDA Approval
The U.S. Securities and Exchange Commission sued three former executives of clinical-stage pharmaceutical company Allarity Therapeutics Inc. in Massachusetts federal court, alleging Wednesday that they schemed to conceal from the public that the company's new drug application for its flagship drug had no chance of gaining regulatory approval.
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March 12, 2025
Caribou Biosciences Brass Face Investor's Clinical Trials Suit
Executives and directors of Caribou Biosciences Inc. have been hit with a shareholder's derivative suit alleging that they overstated the safety and efficacy of Caribou's cell therapy and concealed that the company was at risk of being unable to fund its operations.
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March 12, 2025
COVID Test Device Maker Settles Fed. Circ. Feuds With Rival
A company that makes saliva collection devices used for COVID-19 tests says it will drop out of Federal Circuit appeals fights with Longhorn Vaccines & Diagnostics stemming from the Patent Trial and Appeal Board canceling 183 of Longhorn's patent claims as a punishment for "egregious abuse of the PTAB process."
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March 12, 2025
Publix Policies Don't Cover Opioid Claims, Court Says
Insurers for Publix have no duty to defend or indemnify the supermarket chain in dozens of public nuisance lawsuits related to the opioid crisis, a Florida federal court said Wednesday, following Publix's renewed request that the court enter a final judgment so it could proceed with appeal.
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March 12, 2025
NC Organ Procurer Sues CMS Over Hospital Waiver
A North Carolina-based organ procurement organization told a federal court Wednesday that the Centers for Medicare & Medicaid Services has violated federal law by giving a waiver to a hospital to work with another organ procurement service from a different region.
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March 12, 2025
Cannabis Tech Co. Seeks Over $1M Interest On $4.2M Verdict
A software company that won a $4.2 million judgment last year on claims that it was wrongly pushed out of a state government contract is urging a Pennsylvania federal court to award more than $1 million in pre- and postjudgment interest on the award.
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March 12, 2025
HHS To Eliminate 6 Regional Offices For Legal Staff
The U.S. Department of Health and Human Services said Tuesday it will close six out of 10 regional offices where attorneys for the agency work.
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March 12, 2025
Harvard Docs Say Gov't Censored Articles With Gender Terms
A pair of Harvard Medical School researchers sued the Trump administration in Massachusetts federal court on Wednesday, claiming their work was erased from a government-run patient safety website because their articles contained terms like "LGBTQ" and "transgender."
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March 12, 2025
Mallinckrodt Investors Ask NJ Court To Approve $46M Deal
A group of Mallinckrodt PLC investors has asked a New Jersey federal judge to grant final approval to a $46 million settlement they reached with executives and directors of the pharmaceutical company to resolve claims that they misrepresented the prospects of a drug the company developed.
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March 12, 2025
McCarter & English Wins $3.77M From Ex-Client In Billing Spat
McCarter & English LLP is entitled to nearly $3.77 million from Jarrow Formulas Inc., a nutritional supplement company that refused to pay its legal bills after losing a trade secrets trial and a subsequent malpractice claim against the firm, a Connecticut federal judge has ruled.
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March 11, 2025
Medical Device Co. Seeks Fed. Circ. Redo Over Patent Trial
A medical device manufacturer is asking the full Federal Circuit to reconsider a panel decision reviving a patent infringement case against it, arguing a lower court judge was fine to allow tardy testimony from a witness who took its side.
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March 11, 2025
Kenvue Unit Can't Nix BIPA Suit Over Neutrogena Skin360 App
A Kenvue unit can't escape a proposed class action alleging it unlawfully stores facial scans of people who use its Neutrogena Skin360 tool in violation of Illinois' biometric privacy statute, after a New Jersey federal judge said those users are not "patient[s] in a healthcare setting" under the statute's healthcare exemption.
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March 11, 2025
'Paucity' Of Proof Thwarts NC State Law Claims In Gardasil MDL
A North Carolina federal judge has found that Merck did not violate state law by not including warnings about its Human Papillomavirus vaccine Gardasil, saying there was a "paucity" of evidence that the vaccines cause certain injuries to recipients.
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March 11, 2025
More ITC Patent Cases Expected After Fed. Circ. 'Sea Change'
A recent Federal Circuit decision discarding the U.S. International Trade Commission's limits on what types of domestic expenses qualify a company to bring a patent suit at the agency marks a pronounced shift that will likely spur considerably more ITC cases, attorneys say.
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March 11, 2025
Pharmacies To Appeal In Bid To Keep Making Weight Loss Drug
A group of compounding pharmacies said Monday they would appeal to the Fifth Circuit after a Texas federal judge denied an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug.
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March 11, 2025
J&J Tells 3rd Circ. No Price Impact In Talc Concealment Suit
Johnson & Johnson urged the Third Circuit on Tuesday to undo class certification of investor claims that the company inflated its stock price by failing to disclose cancer risks associated with its talcum powder products, arguing that the investors could not have relied upon its alleged misrepresentations because there was no impact on the stock market's price.
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March 11, 2025
Brazilian 'Drug King' Ran Black Market Pharmacy, Feds Say
Federal prosecutors said a Brazilian national living in the United States without permission falsely portrayed himself as a pharmacist to sell members of a large Portuguese-speaking community west of Boston an array of medications, including painkillers, steroids and other controlled drugs.
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March 11, 2025
Zydus Cuts Deal With States, Tribes In Opioid Nuisance Suit
Zydus Pharmaceuticals Inc. has reached a deal in principle with states and Native American tribes that should quash claims related to the company's alleged role in exasperating the opioid crisis.
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March 11, 2025
Eli Lilly Suit Over Compounded Drugs Survives Dismissal
A Washington federal judge has trimmed Eli Lilly's lawsuit against two Seattle-area clinics and the doctors who run them for allegedly duping consumers into buying copycat versions of its diabetes and weight loss medications Mounjaro and Zepbound, nixing the pharmaceutical giant's consumer protection claim while preserving its trademark infringement and false advertising allegations.
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March 11, 2025
Alaska's RICO Claims Advance Against PBM In Opioid Suit
An Alaska federal judge has allowed most of the state's Racketeer Influenced and Corrupt Organization Act claims to move forward against pharmacy benefits manager Express Scripts for its alleged role in the opioid epidemic.
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March 11, 2025
Post Hit With False Ad Suit Over Rachael Ray Brand Pet Food
Post sells celebrity chef Rachael Ray's Nutrish brand of pet foods that are falsely labeled as being "natural" with "no artificial preservatives" despite containing citric acid, which is derived from heavy chemical processing, according to a proposed class action filed in California federal court Monday.
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March 11, 2025
Endo Sells International Pharma Biz To Knight For Up To $99M
Pharmaceutical company Endo Inc., led by Davis Polk & Wardwell LLP and Torys LLP, on Tuesday announced plans to sell its international pharmaceuticals business to Davies Ward Phillips & Vineberg LLP-advised Canadian pharmaceutical company Knight Therapeutics Inc. for up to $99 million.
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March 11, 2025
Publix's Suit Over Ga. County's Private Attys 'Beyond Reason'
Publix can't sue a metro Atlanta county to force it to drop its private attorneys who filed an opioid suit against the supermarket chain, the Georgia Court of Appeals has said, ruling that the company "fails to show what right the county has violated by its choice of counsel."
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March 11, 2025
Trump Admin Drops Suit Over COVID Nasal Spray Ads Claims
The U.S. Department of Justice quietly moved Monday to drop a Utah federal court lawsuit filed on behalf of the Federal Trade Commission accusing a sinus nasal spray company of falsely claiming its products could help prevent and treat COVID-19.
Expert Analysis
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Imagine The Possibilities Of Openly Autistic Lawyering
Andi Mazingo at Lumen Law, who was diagnosed with autism about midway through her career, discusses how the legal profession can create inclusive workplaces that empower openly autistic lawyers and enhance innovation, and how neurodivergent attorneys can navigate the challenges and opportunities that come with disclosing one’s diagnosis.
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.
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Parsing 3rd Circ. Ruling On Cannabis, Employee Private Suits
The Third Circuit recently upheld a decision that individuals don't have a private right of action for alleged violations of New Jersey's Cannabis Regulatory, Enforcement Assistance and Marketplace Modernization Act, but employers should stay informed as the court encouraged the state Legislature to amend the law, say attorneys at Mandelbaum Barrett.
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4 Keys To Litigating In An Active Regulatory Environment
For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.
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Kiromic SEC Order Shows Importance Of Self-Reporting
The U.S. Securities and Exchange Commission's recently filed settled charges against Kiromic BioPharma illustrate the critical intersection between U.S. Food and Drug Administration regulatory processes and investor disclosures under the securities laws, and showcase how responding promptly to internal whistleblower reports may reap benefits, say attorneys at Arnold & Porter.
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Series
Documentary Filmmaking Makes Me A Better Lawyer
Becoming a documentary filmmaker has allowed me to merge my legal expertise with my passion for storytelling, and has helped me to hone negotiation, critical thinking and problem-solving skills that are important to both endeavors, says Robert Darwell at Sheppard Mullin.
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Litigation Funding Disclosure Debate: Strategy Considerations
In the ongoing debate over whether courts should require disclosure of litigation funding, funders and plaintiffs tend to argue against such mandates, but voluntarily disclosing limited details about a funding arrangement can actually confer certain benefits to plaintiffs in some scenarios, say Andrew Stulce and Marc Cavan at Longford Capital.
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2025 May Be A Breakout Year For The Cannabis Industry
The cannabis industry faced a slow and frustrating 2024, but consumer trends continue to shift in favor of cannabis, and the new administration may provide the catalyst that the industry needs, says Lynn Gefen at TerrAscend.
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FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape
The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.
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Scope And Nature Of Judicial Relief Will Affect Loper's Impact
The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.
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The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.
The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.
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Series
Adventure Photography Makes Me A Better Lawyer
Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.
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What Vinyl Acetate's Prop 65 Listing Means For Cos.
California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Inherency Ruling Refines Obviousness Framework
The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.
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Navigating The Potential End Of GLP-1 Drug Shortages
The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.