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Life Sciences
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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.
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May 06, 2025
Gene-Editing Co. Synthego Hits Ch. 11 With Sights On A Sale
California-based biotechnology company Synthego Corp. filed for Chapter 11 in Delaware bankruptcy court, listing up to $500 million in debt and outlining a plan to sell its assets to its prepetition lender during the proceedings.
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May 05, 2025
DC Circ. Has Doubts About Narcolepsy Drug Appeal
The D.C. Circuit is now set to decide whether the U.S. Food and Drug Administration was wrong to declare a rival narcolepsy treatment not the "same drug" as another produced by Jazz Pharmaceuticals Inc., after appearing highly skeptical of the drug company's arguments that it was.
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May 05, 2025
Liquidia Fends Off Indication Challenge In UTC Tyvaso Fight
A D.C. federal court has rejected United Therapeutics Corp.'s challenge to a U.S. Food and Drug Administration decision allowing Liquidia Technologies Inc. to modify a new drug application to include an additional lung disease indication for a drug competing with UTC's blockbuster lung disease drug Tyvaso.
Expert Analysis
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Reproductive Health Under Trump So Far, And What's Next
Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.
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Series
Playing Football Made Me A Better Lawyer
While my football career ended over 15 years ago, the lessons the sport taught me about grit, accountability and resilience have stayed with me and will continue to help me succeed as an attorney, says Bert McBride at Trenam.
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10 Arbitrations And A 5th Circ. Ruling Flag Arb. Clause Risks
The ongoing arbitral saga of Sullivan v. Feldman, which has engendered proceedings before 10 different arbitrators in Texas and Louisiana along with last month's Fifth Circuit opinion, showcases both the risks and limitations of arbitration clauses in retainer agreements for resolving attorney-client disputes, says Christopher Blazejewski at Sherin and Lodgen.
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Keys To Handling Digital Investigations In Pharma IP Litigation
In the high-stakes realm of pharmaceutical intellectual property litigation, efficient e-discovery and digital investigation workflows are essential to supporting strategic arguments, building defensible cases and proving that the requirements for market entry have been adequately met, says Jerry Lay at FTI Consulting.
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Perspectives
The Benefits Of Aligning States On Legal Paraprofessionals
Texas' proposal to become the latest state to license paraprofessional providers of limited legal services could help firms expand their reach and improve access to justice, but consumers, attorneys and allied legal professionals would benefit even more if similar programs across the country become more uniform, says Michael Houlberg at the University of Denver.
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What's Next For Lab Test Regulation Without FDA Authority
A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.
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10 Soft Skills Every GC Should Master
As businesses face shifting regulatory and technological uncertainty, general counsel will need to strengthen certain soft skills to succeed, from admitting when they make a mistake to maintaining a healthy dose of dispassion, says Douglas Brown at Manatt.
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6 Criteria Can Help Assess Executive Branch Actions
With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.
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An Unrestrained, Bright-Eyed View Of Legal AI's Future
Todd Itami at Covington offers a bright-eyed, laughing-all-the-way, skydive look at what the legal industry could look like after an artificial intelligence revolution, which he believes may happen much sooner and more dramatically than we expect.
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Tracking The Evolution In Litigation Finance
Despite continued innovation, litigation finance remains an immature market with borrowers recieving significantly different terms as lenders learn to value cases, which firms need a strong handle on to ensure lending terms do not overwhelm collateral value, says Robert Wilkins at Lightfoot Franklin.
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Keys To Regulatory Diligence In Life Sciences Transactions
Conducting effective regulatory due diligence for life sciences deals requires careful review of a target company's activities, and separate sets of considerations for commercial and pipeline products, says Anna Zhao at GunnerCooke.
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How Courts Weigh Section 1782 Discovery For UPC Cases
A look at cases from six different federal district courts reveals a number of discretionary factors that influence how courts consider Section 1782 discovery applications in connection with Unified Patent Court proceedings, say attorneys at Finnegan.
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Opinion
In Vape Case, Justices Must Focus On Agencies' Results
With the U.S. Supreme Court's ruling in U.S. Food and Drug Administration v. Wages and White Lion Investments having put off the question of whether agency decisions arrived at erroneously are always invalid, the court should give the results of agency actions more weight than the reasoning behind them when it revisits this case, says Jonathan Sheffield at Loyola University Chicago School of Law.
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Series
Volunteer Firefighting Makes Me A Better Lawyer
While practicing corporate law and firefighting may appear incongruous, the latter benefits my legal career by reminding me of the importance of humility, perspective and education, says Nicholas Passaro at Ford.
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E-Discovery Quarterly: The Perils Of Digital Data Protocols
Though stipulated protocols governing the treatment of electronically stored information in litigation are meant to streamline discovery, recent disputes demonstrate that certain missteps in the process can lead to significant inefficiencies, say attorneys at Sidley.