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Life Sciences
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October 01, 2024
Judge Backs Louisiana 340B Law In Loss For Pharma Lobby
A Louisiana federal court has issued a sweeping loss to Big Pharma's top lobbying group and two pharmaceutical companies that argued a state law improperly expands the scope of the federal drug discount program.
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October 01, 2024
Activists Sue Ark. Officials Over Medical Pot Ballot Measure
Activists attempting to put a measure that would expand medical marijuana access in Arkansas on the ballot brought a lawsuit against John Thurston, the state's secretary of state, on Tuesday, one day after he said that the campaign did not have enough signatures to qualify for the ballot.
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October 01, 2024
Ex-CBD Exec Must Face SEC Fraud Suit Over $13M Deal
The U.S. Securities and Exchange Commission sufficiently backed its claims that a former cannabidiol products executive misled investors, including by making false statements in press releases, a Connecticut federal judge has ruled.
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October 01, 2024
DOJ Says It Is Constitutional To Disarm Pot Patients
The U.S. Department of Justice told a Pennsylvania federal judge Tuesday that a federal policy barring medical marijuana patients from lawfully possessing firearms is constitutional, and it urged the court to dismiss a legal challenge to the statute.
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October 01, 2024
Amgen Must Face Suit It Misled Investors On $10.7B Tax Bill
Amgen lost an attempt to escape a potential class action claiming the pharmaceutical giant hid a $10.7 billion tax bill from investors after a New York federal court ruled there was sufficient evidence for the action to proceed.
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October 01, 2024
Biotech Investors Reach $32.5M Deal Over Failed COVID Test
A class of Talis Biomedical Corp. investors accusing the company of inflating their stock price in the run-up to its IPO and then failing to launch a COVID-19 diagnostic test asked a California federal judge on Monday to preliminarily approve their $32.5 million settlement, citing Talis' shrinking cash reserves and imminent plans to file for bankruptcy.
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October 01, 2024
WilmerHale Lands Latham Life Sciences Ace In Bay Area
WilmerHale has brought on a second former Latham & Watkins LLP partner this year to its life sciences practice in its Palo Alto, California, office, strengthening the firm with an attorney who helped lead the team that guided public biopharmaceutical company BridgeBio Pharma to raise up to $1.25 billion in capital in January.
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October 01, 2024
Nostrum Labs Hits Ch. 11 A Year After Medicaid Settlement
Nostrum Laboratories, a New Jersey drugmaker that paid millions to settle allegations that it underpaid Medicaid drug rebates for its bladder infection drug after it hiked the price more than 400%, filed for Chapter 11 protection with nearly $68.3 million in debt.
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September 30, 2024
Takeda End Payors, Direct Buyers Win Antitrust Class Cert.
A New York federal judge Monday adopted a magistrate judge's recommendation to certify two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.
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September 30, 2024
Wheeling & Appealing: The Latest Must-Know Appellate Action
The year's spookiest month is looking scary-good for appellate aficionados, as famed oral advocates joust in October over net neutrality and Uber's extraordinary bid to unravel multidistrict litigation — just two of the high-profile arguments previewed in this edition of Wheeling & Appealing. October also begins with former President Jimmy Carter turning 100, and we'll test your knowledge of his profound impact on the judiciary.
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September 30, 2024
Consumer 'Overslept' On Some Drowsy Cough Syrup Claims
An Illinois federal judge said Monday a consumer can continue her suit alleging Tussin cough syrup's "non-drowsy" label is deceptive because the syrup made her sleepy, but ruled she waited too long to pursue warranty breach claims.
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September 30, 2024
Bristol-Myers Beats Celgene Investors' Drug Delay Suit
A New York federal judge on Monday tossed UMB Bank's claims that Bristol-Myers Squibb improperly delayed U.S. Food and Drug Administration approval of a cancer treatment to avoid paying shareholders $6.4 billion owed from a 2019 acquisition of Celgene Corp., saying the bank lacked standing to sue.
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September 30, 2024
J&J Backs Off 340B Rebate Plan Following Feds' Objections
Johnson & Johnson abandoned its plan Monday to offer rebates rather than upfront discounts for two medications under the 340B drug pricing law, contending it had no choice after a federal agency threatened to impose excessive penalties.
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September 30, 2024
Generic-Drug Co. Says To Think Again About 'Double Patenting'
An Indian generic-drug maker wants the whole Federal Circuit to take a closer look at the issue of "double patenting," telling it that a recent panel ruling mistakenly breathed new life into pharmaceutical patents covering an anti-diarrhea drug.
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September 30, 2024
Medical Device Co. Wins $25M Verdict In Poaching Trial
Medical device company Cynosure has won a $25 million jury award following a weekslong trial in Massachusetts federal court on its claims that a rival business raided its sales and marketing talent and caused the employees to breach their noncompete and nonsolicitation agreements.
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September 30, 2024
J&J Exec Accused Of File Heist Wants Pause Amid DOJ Case
A former competitive strategy director for Johnson & Johnson accused of stealing confidential files as he left the company to work for Pfizer asked a New Jersey federal court to pause the suit after learning he is under criminal investigation.
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September 27, 2024
Kappos' Bayh-Dole Warning To Clients Draws Debate
An advocate for lowering drug prices squared off Friday against a former U.S. Patent and Trademark Office director about the potential risk of accepting government funds to develop drugs, as part of a discussion at New York University School of Law.
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September 27, 2024
9th Circ. Says Stem Cell Treatment Not Exempt From FDA Rule
Two California clinics' experimental stem cell treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations, the Ninth Circuit ruled Friday, reviving the federal government's bid to stop the clinic from marketing the products as cures for certain diseases without U.S. Food and Drug Administration review.
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September 27, 2024
Why Many Drugs Remain Pricey 40 Years After Hatch-Waxman
In the four decades since Congress passed the Hatch-Waxman Act in an effort to make generic drugs more available, the pharmaceutical industry has used patent thickets, "evergreening" and pay-for-delay tactics to block competition and keep prices of life-saving specialty drugs astronomical, several legal experts told Law360, while the industry argues other parties shoulder more of the blame.
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September 27, 2024
Pharma Co. Amarin Beats Class Action Over Patent Issues
A New Jersey federal judge has tossed a proposed class action against pharmaceutical company Amarin and its top brass, alleging they misled shareholders about their products and the prospects of related patent litigation, saying the investors have failed to plead any actionable misleading statements or omissions made by the defendants.
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September 27, 2024
Life Sciences Firms Energize IPO Market As Recovery Builds
Initial public offerings are closing the year's third quarter on an upswing, led mostly by pre-revenue drug developers and select large companies that are seizing opportunities in friendlier capital markets buoyed by interest-rate cuts, generating momentum that experts say could carry over into next year.
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September 27, 2024
Advil Owner Haleon Paying $637M To Up Stake In China JV
British consumer healthcare giant Haleon plc said Friday that it has agreed to pay the equivalent of roughly $637 million to increase its stake in a Chinese joint venture, Tianjin TSKF Pharmaceutical Co., from 55% to 88%.
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September 27, 2024
Medical Equipment Co., Founder Settle FCA Suit For $20M
A Florida-based medical equipment company and its founder will pay $20 million to settle claims under the federal False Claims Act that they improperly billed government healthcare plans for duplicated and unnecessary sales of devices meant to offer pain relief through electrical stimulation, Pennsylvania prosecutors said Friday.
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September 26, 2024
SEC Fines Cassava $40M Over Alzheimer's Treatment Claims
Neuroscience-focused biopharmaceutical company Cassava Sciences Inc. and two of its former executives agreed to pay over $40 million to resolve U.S. Securities and Exchange Commission claims related to allegedly misleading statements about clinical trial results for a potential Alzheimer's disease therapeutic, the regulator announced on Thursday.
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September 26, 2024
11th Circ. Affirms Convictions In Fla. Shark Rescue Case
The Eleventh Circuit upheld felony theft convictions for two Florida tour boat divers who were prosecuted for freeing sharks they believed were illegally poached, but turned out to be part of a research project conducted with a permit granted by the National Oceanic and Atmospheric Administration.
Expert Analysis
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Opinion
States Should Loosen Law Firm Ownership Restrictions
Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.
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Texas Ethics Opinion Flags Hazards Of Unauthorized Practice
The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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2 Options For Sackler Family After High Court Purdue Ruling
After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.
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Fed. Circ. Skinny Label Ruling Guides On Infringement Claims
The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.
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4 Takeaways From Biotech Patent Invalidity Ruling
The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.
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How To Clean Up Your Generative AI-Produced Legal Drafts
As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.
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Calif. Ruling Heightens Medical Product Maker Liability
The California Supreme Court's decision in Himes v. Somatics last month articulates a new causation standard for medical product manufacturer liability that may lead to stronger product disclosures nationwide and greater friction between manufacturers and physicians, say attorneys at Cooley.
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Constitutional Protections For Cannabis Companies Are Hazy
Cannabis businesses are subject to federal enforcement and tax, but often without the benefit of constitutional protections — and the entanglement of state and federal law and conflicting judicial opinions are creating confusion in the space, says Amber Lengacher at Purple Circle.