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Life Sciences
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July 17, 2024
ADA Can't Shield Worker From Failed Drug Test, Co. Says
A chemical transportation company urged a South Carolina federal court to toss a former lift operator's lawsuit alleging he was fired for taking legal CBD because of cysts on his brain and spinal cord, arguing disability law doesn't protect workers from positive drug tests for THC.
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July 16, 2024
Gilead Asks Calif. Supreme Court To Ax 'Disastrous' Decision
Gilead Sciences on Monday urged the California Supreme Court to overturn an appellate panel's decision that the company can't ditch claims it held back a safer HIV drug to maximize profits on an older medication, saying that holding manufacturers liable for non-defective products would "yield disastrous policy consequences."
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July 16, 2024
UPC Knocks Out Amgen's Cholesterol Drug Patent
The Unified Patent Court on Tuesday ruled that Amgen's patent covering the cholesterol drug Repatha isn't valid in the European Union, less than a year after justices on the U.S. Supreme Court made a somewhat similar call on U.S. patents covering the same drug.
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July 16, 2024
Chancery Orders Illumina Docs Released In Grail Merger Fight
Benefit fund shareholders of biotech giant Illumina Inc. won a Delaware Court of Chancery order on Tuesday for a rare, limited release of legal advice documents on Illumina's merger agreement with cancer-testing firm Grail Inc., a deal that has cost the company billions in fines and lost value.
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July 16, 2024
Tycoon's Pilot Says Feds' Stock Tip Claims Don't Add Up
A private pilot who used to work for convicted insider trader and U.K. billionaire Joe Lewis is arguing federal prosecutors can't use allegations that his own trades were suspicious to ramp up a sentence for a separate tax evasion charge.
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July 16, 2024
FDA Vet Joins Arnold & Porter As Counsel On Healthcare
After nearly a decade in high-level roles at the U.S. Food and Drug Administration, regulatory pro Andrew Zacher has joined the life sciences and healthcare team at Arnold & Porter.
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July 16, 2024
Drugmaker BioLineRx Beats Investor Suit Over Cash Shortfall
Israeli biotech company BioLineRx has, for now, beaten a proposed class action over claims that it misled investors on its capital shortfall, which caused a major decline in its share price, with a New Jersey federal judge saying the plaintiffs have failed to plead any actionable misleading or false statements.
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July 16, 2024
3rd Circ. Backs Tossing Over 1K Suits In Merck Vaccine MDL
The Third Circuit on Tuesday affirmed the dismissal with prejudice of 1,189 cases in multidistrict litigation alleging Merck & Co. Inc.'s shingles vaccine, Zostavax, caused the disease, saying the district court did not abuse its discretion by requiring medical tests to support the claims.
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July 16, 2024
Manatt Adds Healthcare Transactions Partner From McDermott
Manatt Phelps & Phillips LLP has added a new healthcare partner to its Boston office.
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July 16, 2024
Heart-Focused Biotech Closes $260M Series B Funding Round
Clinical-stage biotechnology company Cardurion Pharmaceuticals Inc. on Tuesday announced that it has raised $260 million in Series B financing that will go toward helping the Burlington, Massachusetts-based company continue developing therapies for the treatment of cardiovascular diseases.
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July 16, 2024
Ex-CBD Exec Gets $533K In Fla. Investment Fraud Suit
A Florida federal judge has awarded $533,600 to a former executive of a CBD company who alleged he was duped by his family members into investing, following a jury trial that ended with a mixed verdict.
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July 16, 2024
Vertex Pharma Widens War On Watchdog's Kickback Views
A lawsuit from gene therapy-drug maker Vertex Pharmaceuticals over fertility treatment access is a new battle over enforcement kickback theories and health officials' interpretation of "inducement."
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July 16, 2024
The 2024 Diversity Snapshot: What You Need To Know
Law firms' ongoing initiatives to address diversity challenges have driven another year of progress, with the representation of minority attorneys continuing to improve across the board, albeit at a slower pace than in previous years. Here's our data dive into minority representation at law firms in 2023.
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July 16, 2024
These Firms Have The Most Diverse Equity Partnerships
Law360’s law firm survey shows that firms' efforts to diversify their equity partner ranks are lagging. But some have embraced a broader talent pool at the equity partner level. Here are the ones that stood out.
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July 15, 2024
Acuitas Seeks Credit For IP Tied To COVID Vax
Acuitas Therapeutics wants to set the record straight about its involvement in a handful of patents that Alnylam Pharmaceuticals asserts were swiped to create the COVID-19 vaccine developed by Pfizer, BioNTech and Acuitas, saying in a lawsuit in Delaware federal court Monday that Acuitas scientists should be listed as co-inventors.
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July 15, 2024
Ex-Pfizer Worker Seeks No Time For Paxlovid Insider Trading
A former Pfizer employee argued that he shouldn't go to prison after a Manhattan federal jury convicted him of insider trading over clinical trial results for the drug Paxlovid, pointing out that a friend of his and co-defendant had dodged a custodial sentence in the case after helping prosecutors.
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July 15, 2024
Walgreens Investor Sues Over Challenged Pharmacy Division
Walgreens Boots Alliance Inc. was hit with a proposed shareholder class action alleging it inflated share prices by concealing the lack of viability of its pharmacy division, which it eventually disclosed needed a major overhaul to become sustainable.
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July 15, 2024
AbbVie Can't Keep CoolSculpting Suit In NJ Fed Court
A New Jersey federal judge on Monday sent back to state court a suit against AbbVie Inc. from a woman alleging that she was injured by a CoolSculpting procedure, saying the pharmaceutical company hasn't shown that the case belongs in federal court.
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July 15, 2024
Theranos Ex-Exec's Lead Atty Joins Boutique Firm In LA
A former BigLaw attorney who was lead defense counsel for Theranos' former president Ramesh Balwani has joined Los Angeles boutique Foundation Law Group LLP to lead its white collar practice, the firm announced Monday.
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July 15, 2024
Catching Up With Delaware's Chancery Court
Chancery Court news was full of fees and settlements last week, with three multimillion-dollar deals getting a court OK, and a daylong discussion over a potentially multibillion-dollar fee award for attorneys who got Tesla CEO Elon Musk's astronomical pay package thrown out. The court also banged the gavel in cases involving e-payment venture SwervePay and managed care company Centene Corp., and heard arguments from software company SAP SE and biotech Renmatix Inc.
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July 15, 2024
Health Services Spinoff Leads 3 IPO Launches Totaling $1.1B
Occupational health services provider Concentra Group Holdings Parent Inc. unveiled a price range Monday for an estimated $551 million initial public offering, leading a trio of companies that launched plans for new listings that would exceed $1.1 billion combined.
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July 12, 2024
Law360 Names 2024's Top Attorneys Under 40
Law360 is pleased to announce the Rising Stars of 2024, our list of 158 attorneys under 40 whose legal accomplishments belie their age.
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July 12, 2024
Del. Court Finds 1 Of 6 Bylaws Invalid But All Unenforceable
Only one of six contested advance-notice bylaws that Florida pharma company AIM Immuno Tech Inc. adopted in response to an activist shareholder's proxy contest is actually invalid but none remain enforceable because the board adopted them primarily to thwart the shareholder's challenge, Delaware's Supreme Court has ruled.
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July 12, 2024
AI Drugmaker BioXcel Beats Investor Fraud Suit, For Now
A Connecticut federal judge has tossed a proposed securities fraud class action against BioXcel Therapeutics Inc., saying that while shareholders sufficiently alleged the AI-driven drugmaker made misleading statements concerning a dementia drug study's compliance issues, they failed to adequately plead the company intended to deceive or defraud investors.
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July 12, 2024
Whistleblower's Attys Get $5.9M After Losing $11.5M Fee Ask
A Massachusetts federal judge awarded a whistleblower's counsel $5.9 million in fees plus $651,845 in costs and expenses after slashing their prior "exorbitant" $11.5 million fee request in May in a decade-old False Claims Act lawsuit alleging Fresenius Medical Care billed Medicare for unnecessary hepatitis tests.
Expert Analysis
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What Rescheduling Could Mean For Cannabis Bankruptcies
Bankruptcy courts have historically been closed for cannabis-related businesses, but recent case law coupled with a possible reclassification of cannabis provides cautious optimism, say attorneys at Duane Morris.
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Opinion
Pharmacies Need More Protection Against PBM Fee Practices
The Centers for Medicare & Medicaid Services' recent reform regarding direct and indirect remuneration fees will mitigate the detrimental effects that pharmacy benefit manager policies have on struggling pharmacies, but more is needed to prevent PBMs from exploiting loopholes, says Bhavesh Desai at Mazina Law.
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Contract Disputes Recap: Facts Differ But Same Rules Apply
Zachary Jacobson and Sarah Barney at Seyfarth examine two decisions illustrating that reliance on a technicality may not save an otherwise untimely appeal, and that enforcement of commercial terms and conditions under a federal supply schedule contract may be possible.
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Series
Spray Painting Makes Me A Better Lawyer
My experiences as an abstract spray paint artist have made me a better litigator, demonstrating — in more ways than one — how fluidity and flexibility are necessary parts of a successful legal practice, says Erick Sandlin at Bracewell.
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Takeaways From The 2023 DOJ Fraud Section Report
Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.
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Judge-Shopping Policy Revisal May Make Issue Worse
The Judicial Conference at its March meeting unveiled a revised policy with the stated goal of limiting litigants’ ability to judge-shop in patent cases, but the policy may actually exacerbate the problem by tying the issue to judge-shopping in polarizing political cases, making reform more difficult, say Robert Niemeier and William Milliken at Sterne Kessler.
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2nd Circ. Baby Food Ruling Disregards FDA's Expertise
The Second Circuit's recent decision in White v. Beech-Nut Nutrition, refusing to defer litigation over heavy metals in baby food until the U.S. Food and Drug Administration weighs in on the issue, provides no indication that courts will resolve the issue with greater efficiency than the FDA, say attorneys at Phillips Lytle.
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Assessing FDA Pathways For Genome-Edited Plant Foods
The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.
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Opinion
Proposed MDL Management Rule Needs Refining
Proponents of the recently proposed Federal Rule of Civil Procedure 16.1 believe it may enhance efficiency in multidistrict litigation proceedings if adopted, but there are serious concerns that it could actually hinder plaintiffs' access to justice through the courts — and there are fundamental flaws that deserve our attention, says Ashleigh Raso at Nigh Goldenberg.
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Why Oncology Deal Making Continues To Fuel Biotech M&A
The biotech sector's potential for advancements in cancer care continues to attract deal-maker interest, and the keys to successful mergers and acquisitions include the ability to integrate innovative therapies, leverage technological advancements and respond to the dynamic needs of patients, say Bryan Luchs and Mike Weir at White & Case.
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Opinion
Judicial Independence Is Imperative This Election Year
As the next election nears, the judges involved in the upcoming trials against former President Donald Trump increasingly face political pressures and threats of violence — revealing the urgent need to safeguard judicial independence and uphold the rule of law, says Benes Aldana at the National Judicial College.
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Opinion
NIST March-In Framework Is As Problematic As 2021 Proposal
While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.
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Document Retention Best Practices To Lower Litigation Risks
As new technologies emerge and terabytes of data can be within the purview of a single discovery request, businesses small and large should take four document management steps to effectively minimize risks of litigation and discovery sanctions long before litigation ensues, says Kimbrilee Weber at Norris McLaughlin.
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Series
Riding My Peloton Bike Makes Me A Better Lawyer
Using the Peloton platform for cycling, running, rowing and more taught me that fostering a mind-body connection will not only benefit you physically and emotionally, but also inspire stamina, focus, discipline and empathy in your legal career, says Christopher Ward at Polsinelli.
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Ala. Frozen Embryo Ruling Creates Risks for Managed Care Orgs
The Alabama Supreme Court's decision in LePage v. Center for Reproductive Medicine last month, declaring that frozen embryos count as children, has not only upended the abortion debate but also raised questions for managed care organizations and healthcare providers that provide, offer or facilitate fertility treatment nationwide, say attorneys at Reed Smith.