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Life Sciences
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May 08, 2025
Biotech Co. Accelerate Diagnostics Hits Ch. 11 With Sale Plan
Medical technology company Accelerate Diagnostics Inc. filed for Chapter 11 protection in Delaware bankruptcy court Thursday with $90.2 million of debt and a plan to sell the business to lender Indaba Capital Management for $36.9 million.
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May 07, 2025
J&J Unit's Catheter Tying Policy Hurt Rival, Antitrust Jury Told
Innovative Health's CEO told a California federal jury considering its antitrust claims Wednesday that Johnson & Johnson unit Biosense Webster enforced a policy to cut off support to hospitals that didn't use its catheters after Innovative received FDA approval to reprocess Biosense's electrophysiology catheters, devastating Innovative's business.
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May 07, 2025
FDA Gets Win In Eli Lilly Weight Loss Drug Shortage Fight
A Texas federal judge on Wednesday refused to reverse a U.S. Food and Drug Administration decision to remove Eli Lilly & Co.'s popular weight loss drug from a national shortage list, denying a request from pharmacies that produce copycat doses of the drug and entering judgment in favor of the FDA.
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May 07, 2025
Investors Fight J&J, Kenvue Bid To Nix IPO Fraud Suit
A New Jersey federal judge shouldn't reconsider his decision to sustain IPO fraud claims against pharmaceutical giant Johnson & Johnson and a former subsidiary, investors suing the companies said Wednesday by arguing that the judge was right to find that the companies should have disclosed a "serious challenge" to the effectiveness of a common medication ingredient in public filings.
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May 07, 2025
Fertility Co. Accused Of Selling Bogus Tests Wasting Embryos
Women who sought fertility treatment filed a proposed class action against CCRM Fertility in Colorado federal court Wednesday, alleging the fertility clinic chain "aggressively" marketed its preimplantation genetic testing to thousands of vulnerable patients despite knowing the test is unreliable and wasted preciously limited, viable embryos.
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May 07, 2025
Patent Examiners Tell GAO Quantity Beats Quality
Patent examiners at the U.S. Patent and Trademark Office feel like they're pressured to sacrifice patent quality in the interest of getting more patents out the door, the Government Accountability Office said in a report released Wednesday exploring what it called "persistent examination and quality challenges" at the agency.
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May 07, 2025
Fed. Circ. Clears Way For Sun Pharma Alopecia Drug
Incyte Corp. can't challenge a board ruling preserving claims in a Sun Pharmaceutical Industries patent covering an alopecia areata drug, the Federal Circuit said Wednesday, finding the company's plans to sell its own product weren't firm enough to give it standing.
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May 07, 2025
Rite Aid Cleared For Quick Ch. 11 Sale Plans
A New Jersey bankruptcy judge on Wednesday approved retail pharmacy chain Rite Aid's plans to host a Chapter 11 auction next week for prescription files, drug inventory and other pharmacy assets during its second bankruptcy.
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May 07, 2025
$525M Nuke Services Deal Faces Canada Competition Probe
Canada's competition regulator said Wednesday it has obtained court orders to get information from several companies as part of its investigation of nuclear technology firm BWX Technologies Inc.'s proposed $525 million acquisition of nuclear engineering company Kinetrics Inc.
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May 07, 2025
Insulet Pursues EOFlow's Finances After $60M Ruling
A Massachusetts federal judge has ordered a Korean wearable insulin patch maker to respond to discovery requests as Insulet Corp. looks to collect a nearly $60 million trade secrets judgment, including information concerning an ongoing arbitration with Medtronic PLC stemming from a nixed acquisition deal.
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May 07, 2025
Shionogi To Acquire Torii Pharma Through $1.1B Tender Offer
Japanese pharmaceutical company Shionogi & Co. plans to acquire Torii Pharmaceutical Co. through a tender offer that values the Tokyo-listed drugmaker at approximately 156 billion Japanese yen (nearly $1.1 billion), Shionogi said in a Wednesday announcement.
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May 07, 2025
Walgreens Wants 'Far-Fetched' Shareholder Suit Tossed
Walgreens contends that a proposed class action alleging it inflated share prices by concealing the lack of viability of its pharmacy division and primary clinic investment must be dismissed because it lacks factual allegations to back its claim that Walgreens made any misstatements to shareholders about its financial outlook, let alone with fraudulent intent.
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May 07, 2025
Device Seller Asks For Probation In $2.4M Tax Evasion Case
The septuagenarian owner of a Florida medical device company who pled guilty to evading $2.4 million in taxes asked a federal district court Wednesday for his sentence to entail home probation and not prison, given his health challenges and payments he already made to the Internal Revenue Service.
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May 07, 2025
Orrick Hires Boston Duo For Life Sciences Practice
Orrick Herrington & Sutcliffe LLP has added a pair of life sciences and tech company advisors from Wilson Sonsini Goodrich & Rosati PC as Boston partners, the firm said Wednesday.
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May 07, 2025
Masimo Unloads Embattled Audio Unit In $350M Sale
Samsung Electronics subsidiary Harman International has agreed to acquire Masimo Corp.'s consumer audio division, Sound United, for $350 million in cash, with Masimo taking a financial hit on the business it acquired three years ago for about $1 billion.
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May 06, 2025
Post-Ch. 11 Rite Aid Trustee Asks To Take Over Insurance Suit
A trust tied to Rite-Aid's previous bankruptcy exit plan has asked a New Jersey bankruptcy judge for permission to take over for Rite Aid in an adversary case seeking insurance money related to opioid claims.
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May 06, 2025
Medical Device Co. SeaStar Seeks Toss Of Shareholder Suit
SeaStar Medical Inc. has urged a Colorado federal judge to toss a proposed class action alleging the healthcare company misled investors about potential regulatory risks and compliance deficiencies, arguing the amended complaint "attempts to create the illusion of factual particularity through a façade of prolixity."
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May 06, 2025
Quarles & Brady Adds New IP, Real Estate Partners
Quarles & Brady LLP has welcomed a Milwaukee-based intellectual property litigator from Quinn Emanuel Urquhart & Sullivan LLP and a Phoenix-based real estate and public finance attorney from Ice Miller LLP.
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May 06, 2025
Fed. Circ. Asks What Law Applies For Sleep Drug Injunction
The Federal Circuit lifted an injunction Tuesday that had placed limits on Avadel CNS Pharmaceuticals' clinical trials for sleep disorder treatments, but sent the infringement case back to Delaware to determine whether a future injunction should be governed by the Hatch-Waxman Act.
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May 06, 2025
Haemonetics Sues Terumo Over Plasma Tech Patents
A Massachusetts-based developer of blood- and plasma-related medical technology has accused a Colorado-based competitor of infringing four of its plasma collection patents with two variations of a donation system that got approval from the U.S. Food and Drug Administration in 2022 and 2024.
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May 06, 2025
Mylan Agrees To Keep Nausea Generics Off Market Until 2032
Mylan Pharmaceuticals Inc. can enter the market in 2032 with a generic anti-nausea drug to compete with Heron Therapeutics Inc. products after the companies settled patent infringement litigation in Delaware federal court.
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May 06, 2025
Mistrial Declared On Punitive Damages In Bard Cancer Case
A Georgia state judge declared a mistrial as to punitive damages Tuesday in a suit alleging C.R. Bard's ethylene oxide emissions caused a man's cancer, leaving a $20 million compensatory damages verdict in place but inviting a round of briefing on the unusual situation.
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May 06, 2025
Ex-CEO Can't Shake Conviction In COVID Test Kit Fraud Case
The former chief executive of a healthcare software company who touted a $670 million COVID test kit deal that collapsed was denied acquittal Monday by a Newark federal judge who ruled the evidence was sufficient for a reasonable juror to find beyond a reasonable doubt that he had engaged in securities fraud.
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May 06, 2025
Trade Secrets Emerge As Path For Cos. To Protect AI Works
Classifying creations of artificial intelligence tools as trade secrets has become a viable alternative to copyrights and patents — a shift that is presenting businesses using AI with a range of strategies and risks they must consider to protect their innovations.
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May 06, 2025
Trump Orders FDA To Speed Up Drug Plant Approvals
President Donald Trump directed the U.S. Food and Drug Administration to cut the approval timelines for new manufacturing facilities by domestic drugmakers and also to pressure foreign drugmakers to comply with quality control inspections, according to a recent executive order.
Expert Analysis
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Recent Cases Clarify FCA Kickback Pleading Standards
Two recently resolved cases involving pharmaceutical manufacturers may make it more difficult for False Claims Act defendants facing kickback scheme allegations to get claims dismissed for lack of evidence, say Li Yu at Bernstein Litowitz, Ellen London at London & Noar, and Gregg Shapiro at Gregg Shapiro Law.
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Opinion
Antitrust Analysis In Iowa Pathologist Case Misses The Mark
An Iowa federal court erred in its recent decision in Goldfinch Laboratory v. Iowa Pathology Associates by focusing exclusively on market impacts and sidestepping key questions that should be central to antitrust standing analysis, says Daniel Graulich at Baker McKenzie.
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Opinion
State FCAs Should Cover Local Fund Misuse, State Tax Fraud
New Jersey and other states with similar False Claims Acts should amend them to cover misappropriated municipal funding, and state and local tax fraud, which would encourage more whistleblowers to come forward and increase their recoveries, says Kenneth Levine at Stone & Magnanini.
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7 Tips For Associates To Thrive In Hybrid Work Environments
Excerpt from Practical Guidance
As the vast majority of law firms have embraced some type of hybrid work policy, associates should consider a few strategies to get the most out of both their in-person and remote workdays, says James Argionis at Cozen O’Connor.
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Series
Playing Beach Volleyball Makes Me A Better Lawyer
My commitment to beach volleyball has become integral to my performance as an attorney, with the sport continually reminding me that teamwork, perseverance, professionalism and stress management are essential to both undertakings, says Amy Drushal at Trenam.
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What To Expect From 'Make America Healthy Again' Actions
The Make America Healthy Again Commission recently established by President Donald Trump and chaired by Robert F. Kennedy Jr. will potentially bring energy and attention to important public health topics, and stakeholders should be aware of pathways for sharing their input and proactively informing proceedings, says Nicholas Manetto at Faegre Drinker.
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How Law Firms Can Counteract The Loneliness Epidemic
The legal industry is facing an urgent epidemic of loneliness, affecting lawyer well-being, productivity, retention and profitability, and law firm leaders should take concrete steps to encourage the development of genuine workplace connections, says Michelle Gomez at Littler and Gwen Mellor Romans at Herald Talent.
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What's At Stake In High Court's Class Member Standing Case
The U.S. Supreme Court’s eventual decision in Labcorp v. Davis could significantly alter how parties prosecute and defend class actions in federal court, particularly if the court determines some proof of member standing is required before a class may be certified, say attorneys at Reed Smith.
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How Citizen Petitions Have Affected Drug Competition
In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.
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5 Keys To Building Stronger Attorney-Client Relationships
Attorneys are often focused on being seen as the expert, but bonding with clients and prospects by sharing a few key personal details provides the basis for a caring, trusted and profoundly deeper business relationship, says Deb Feder at Feder Development.
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Drug Kickback Ruling Will Make FCA Liability Harder To Prove
The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.
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Assessing PE Risk After Mass. False Claims Act Amendments
A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.
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What Trump Actions Mean For Federal Research Funding
New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.
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How Courts Can Filter Nonmeritorious Claims In Mass Torts
Nonmeritorious claims have been a key obstacle to settlement in many recent high-profile mass torts, but courts may be able to use tools they already have to solve this problem, says Samir Parikh at Wake Forest University.
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Series
Racing Corvettes Makes Me A Better Lawyer
The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.