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Life Sciences
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July 17, 2024
Boehringer Wants Inhaler Antitrust Case Moved To Mass.
Boehringer Ingelheim Pharmaceuticals Inc. has urged a Connecticut federal court to transfer a proposed class action accusing it of blocking generic versions of two inhaler medications, saying a similar case was filed in Massachusetts several weeks earlier.
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July 17, 2024
Bruised SPAC Market Pins Revival Hopes On Veteran Backers
More special-purpose acquisition companies are conducting initial public offerings, mostly backed by dealmakers who have completed prior mergers, bringing life to a listings market that was largely barren over the past year.
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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.
Expert Analysis
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How Clinical Trials Affect Patentability In US And Europe
A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.
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A Vision For Economic Clerkships In The Legal System
As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.
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Regulating Resurrected Species Under The ESA
As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.
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E-Discovery Quarterly: Recent Rulings On Text Message Data
Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.
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What CRA Deadline Means For Biden Admin. Rulemaking
With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.
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5 Takeaways From FDA's Biosimilars Promotion Guidance
New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.
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Dual-Track IPO-M&A Exit Strategies For Life Science Cos.
A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.
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Does Expert Testimony Aid Preliminary IPR Responses?
Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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Rebuttal
Double-Patenting Ruling Shows Terminal Disclaimers' Value
While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.
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Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.