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Life Sciences
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May 08, 2025
Elizabeth Holmes Loses Bid For Full 9th Circ. Rehearing
The Ninth Circuit said Thursday it will not reconsider a panel decision refusing to throw out the conviction and 11-year prison sentence of Theranos Inc. founder Elizabeth Holmes.
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May 08, 2025
Ala. Legislature OKs TCJA Research Expense Decoupling
Alabama would decouple from the Tax Cuts and Jobs Act by allowing research expenses to be deducted from a taxpayer's income under a bill sent to the governor.
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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.
Expert Analysis
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Opinion
Weight Drug Suits Highlight Need For Legal Work On Safety
The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.
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10 Issues To Watch In Aerospace And Defense Contracting
This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.
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Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis
In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.
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Compliance Pointers For DOJ's Sweeping Data Security Rule
A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.
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Series
Competitive Weightlifting Makes Me A Better Lawyer
The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.
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The Case For Compliance During The Trump Administration
Given the Trump administration’s shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.
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A Look At HHS' New Opinion On Patient Assistance Programs
A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.
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Opinion
Inconsistent Injury-In-Fact Rules Hinder Federal Practice
A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.
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2 Anti-Kickback Developments Hold Lessons For Biopharma
The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.
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In-House Counsel Pointers For Preserving Atty-Client Privilege
Several recent rulings illustrate the challenges in-house counsel can face when attempting to preserve attorney-client privilege, but a few best practices can help safeguard communications and effectively assert the privilege in an increasingly scrutinized corporate environment, says Daniel Garrie at Law & Forensics.
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How SDNY US Atty Nom May Shape Enforcement Priorities
President Donald Trump’s nominee for U.S. attorney in the Southern District of New York, former U.S. Securities and Exchange Commission Chair Jay Clayton, will likely shift the office’s enforcement priorities, from refining whistleblower policies to deemphasizing novel prosecutorial theories, say attorneys at Cohen & Gresser.
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Improving Comms Between Trial Attys And Tech Witnesses
In major litigation involving complex technology, attorneys should employ certain strategies to collaborate with companies' technical personnel more effectively to enhance both the attorney's understanding of the subject matter and the expert's ability to provide effective testimony in court, say attorneys at Buchalter.
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What's Next For State Regulation Of Hemp Cannabinoids
Based on two recent federal court cases that indisputably fortify broad state authority to regulate intoxicating hemp cannabinoid products, 2025 will feature continued aggressive state regulation of such products as industry stakeholders wait for Congress to release its plans for the next five-year Farm Bill, say attorneys at Foley Hoag.
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Series
Collecting Rare Books Makes Me A Better Lawyer
My collection of rare books includes several written or owned by prominent lawyers from early U.S. history, and immersing myself in their stories helps me feel a deeper connection to my legal practice and its purpose, says Douglas Brown at Manatt Health.
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Opinion
New DOJ Leaders Should Curb Ill-Conceived Prosecutions
First-of-their-kind cases have seemingly led to a string of overly aggressive prosecutions in recent years, so newly sworn-in leaders of the U.S. Department of Justice should consider creating reporting channels to stop unwise prosecutions before they snowball, says Jonathan Porter at Husch Blackwell.