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Life Sciences
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May 08, 2025
Fed. Circ. Weighs If Expert's Testimony Justifies Spine IP Loss
A Federal Circuit panel on Thursday considered how much an expert strayed from a lower court's claim construction in an inventor's patent infringement suit against DePuy Synthes, with one judge questioning if it was merely effective cross-examination that tripped the expert up, and not much more.
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May 08, 2025
Hikma Cuts $50M Deal To End Antitrust Claims In Xyrem MDL
A certified class of Xyrem buyers in 36 states have asked a California federal judge to preliminarily approve Hikma Pharmaceuticals PLC's $50 million deal to resolve antitrust claims accusing Hikma of colluding with rival Jazz Pharmaceuticals to block generic rivals from competing with Jazz's narcolepsy drug.
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May 08, 2025
3rd Circ. Rejects Challenge To Medicare Drug Price Program
The Third Circuit on Thursday rejected AstraZeneca's challenge to the Medicare drug price negotiation program, ruling that the pharmaceutical giant was unable to show how it is injured by the program's guidance or how it violates its due process rights.
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May 08, 2025
Judge Asks DOJ To Define DEI In Health Grant Case
A Massachusetts federal judge on Thursday ordered U.S. Department of Justice lawyers to provide the Trump administration's definitions of diversity, equity and inclusion, saying he needs to know so he can consider whether that is a valid basis for pausing federal health research grants.
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May 08, 2025
Biotech Tells Chancery Drug Co. Abused Merger Prospects
Biotech venture Renovaro Inc. sued cancer-focused, artificial intelligence-assisted drug developer Predictive Oncology Inc. in Delaware's Court of Chancery on Thursday, accusing Predictive of walking away from a merger agreement after its standalone prospects improved upon announcement of the deal.
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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.
Expert Analysis
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AI Will Soon Transform The E-Discovery Industrial Complex
Todd Itami at Covington discusses how generative artificial intelligence will reshape the current e-discovery paradigm, replacing the blunt instrument of data handling with a laser scalpel of fully integrated enterprise solutions — after first making e-discovery processes technically and legally harder.
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IP, Licensing, M&A Trends To Watch In Life Sciences This Year
2025 promises to continue an exciting trajectory for the life sciences industry, with major trends ranging from global harmonization of intellectual property to cross-border licensing activity and an increase of nontraditional financial participants in the mergers and acquisition space, say attorneys at Morgan Lewis.
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When Innovation Overwhelms The Rule Of Law
In an era where technology is rapidly evolving and artificial intelligence is seemingly everywhere, it’s worth asking if the law — both substantive precedent and procedural rules — can keep up with the light speed of innovation, says Reuben Guttman at Guttman Buschner.
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Anticipating Direction Of Cosmetics Regulation Under Trump
It is unclear how cosmetics regulation reform from the last few years will fare under President Donald Trump, but the new administration's emphasis on deregulation and Robert F. Kennedy Jr.'s views on product safety provide some insight, say attorneys at Crowell & Moring.
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Drug Pricing Policy Trends To Expect In 2025 And Beyond
Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.
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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.