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Life Sciences
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May 14, 2025
J&J Unit's Catheter Policy Stopped Free-Riding, Jury Told
A Johnson & Johnson unit sales director took the stand Wednesday in Innovative Health's antitrust case against its medical technology unit Biosense Webster, defending Biosense's policy cutting off clinical cardiac mapping support to hospitals using third-party reprocessed catheters and explaining that the policy prevented competitors from free-riding on its investments in clinical support training.
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May 14, 2025
RJ Reynolds Can Keep Trial Win In Engle Case, Court Says
A Florida appeals court on Wednesday affirmed a verdict in favor of R.J. Reynolds in an Engle progeny suit over a longtime smoker's death, saying counsel's failure to use all their juror challenges invalidates an argument that a juror was unfairly selected.
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May 14, 2025
Integra Brass Face Investor Suit Over FDA Compliance Lapses
Executives and directors of medical device company Integra Lifesciences Inc. were hit with a derivative suit alleging they misled investors about the company's compliance with regulatory standards for over five years, causing share declines when information regarding Integra's violations emerged.
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May 14, 2025
Regeneron-Amgen Trial Goes To Jury With An Extra Day
Federal jurors started deliberating on a Regeneron Pharmaceuticals Inc. antitrust suit late Wednesday accusing Amgen Inc. of tripping up Regeneron's anti-cholesterol drug insurance eligibility by illegally bundling Amgen's competing version with rebates for two unrelated drugs, with potential triple damages in the balance.
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May 14, 2025
Sage Therapeutics Brass Sued Over Drug Candidate Claims
The top brass of Sage Therapeutics Inc. have been hit with a shareholder derivative suit in New York federal court alleging they misled investors about the safety, efficacy, durability and commercial prospects of three of the company's drug candidates and overstated their likelihood to be approved by the U.S. Food and Drug Administration.
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May 14, 2025
2nd Circ. Has Tough Questions On Nixing Medical Imaging Award
The Second Circuit appeared divided on Wednesday on whether parties to a medical imaging joint venture could agree to designate New York courts to decide whether to vacate an arbitral award issued in Switzerland under their contract without violating an underlying treaty.
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May 14, 2025
10th Circ. Chilly To Biotech's SEC Asset Freeze Challenge
A panel of Tenth Circuit judges seemed skeptical Wednesday that a lower court had abused its discretion in granting a freeze of a biotech firm's assets in a suit brought by the U.S. Securities and Exchange Commission accusing the company and its founders of misappropriating roughly $9 million.
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May 14, 2025
Harvard Researcher Charged With Smuggling Amid ICE Case
Federal prosecutors on Wednesday unsealed criminal smuggling charges against a Russian national and Harvard Medical School researcher who has been challenging her monthslong detention by U.S. Immigration and Customs Enforcement after she returned to the U.S. from Europe carrying frog embryos.
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May 14, 2025
Alnylam Halts Patent Row Over Pfizer, BioNTech COVID-19 Vax
Alnylam Pharmaceuticals has decided to end a district court patent case over the COVID-19 vaccine made by Pfizer and BioNTech, asking a Delaware federal judge Tuesday to rule that the companies do not infringe its mRNA patents, while potentially setting the stage for an appeal.
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May 14, 2025
Novo Nordisk, Septerna Ink Up To $2.2B Obesity Drug Deal
Denmark's Novo Nordisk said Wednesday it has signed a drug development deal worth up to $2.2 billion with U.S.-based Septerna, part of its continued push to expand treatments for obesity, Type 2 diabetes and related diseases.
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May 14, 2025
D'Oh! Kimberly-Clark Can't Keep Wage Suit In Federal Court
A Pennsylvania federal judge invoked "The Simpsons" as he granted a Kimberly-Clark employee's request to ship his unpaid overtime proposed class action back to state court, saying the paper goods company is trying to "embiggen" the amount in controversy beyond what's feasible.Â
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May 14, 2025
Eckert Seamans Enters NYC With 11 Hawkins Parnell Attys
Eckert Seamans Cherin & Mellott LLC said Wednesday that it has launched an office in New York City with the addition of an 11-attorney team from Hawkins Parnell & Young LLP, while scaling back its New Jersey presence.
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May 14, 2025
Biotech Firm Verax Tells Court Eviction Could End Company
Biotech company Verax Biomedical Inc. has said it faces the prospect of going out of business unless a Massachusetts judge agrees to block its landlord from proceeding with an eviction, at least through the end of its current lease.
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May 14, 2025
RFK Jr. Defends HHS Cuts, Pledges To 'Spend Smarter'
In his first appearance on Capitol Hill since his confirmation, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday characterized a massive reorganization and reductions in workforce as practical moves to optimize the sprawling agency.
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May 14, 2025
Biogen Sues Ex-Collaborator Over Rights To Drug Tech
Biogen said its partner on a since-shelved Alzheimer's drug is trying to claim rights to an unrelated novel therapeutic that the Massachusetts company recently shared with the Swiss partner under a confidentiality agreement, according to a lawsuit filed Tuesday.
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May 13, 2025
Asterisk Doesn't Save CVS In Sanitizer Row, 9th Circ. Told
An attorney for a man suing CVS Pharmacy urged the Ninth Circuit on Tuesday to revive his claims alleging the company misled consumers with a promise its hand sanitizer kills 99.99% of germs, arguing the asterisk on the front label does not clear the company of wrongdoing despite a recent ruling from the circuit that gives significance to that type of asterisk.Â
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May 13, 2025
PTAB Ramps Up Fintiv Denials After Withdrawal Of Memo
Weeks after the U.S. Patent and Trademark Office withdrew a memo that limited when patent challenges could be rejected based on parallel litigation, the Patent Trial and Appeal Board has denied dozens of petitions by citing upcoming trials, mostly in the Eastern District of Texas.
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May 13, 2025
Magistrate Judge Cuts Defendants In J&J Talc Unit Fraud Suit
A New Jersey magistrate judge on Tuesday dropped a collection of defendants from a class action brought by cancer patients alleging that Johnson & Johnson's maneuvers to settle thousands of tort claims through Chapter 11 involved fraud.
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May 13, 2025
Becton Dickinson Sues Baxter Over Infusion Pump Patents
Becton Dickinson has accused Baxter International of willfully infringing six of its patents for infusion pump technologies used to deliver medications to patients, telling a Delaware federal court that marketing materials for a Baxter infusion pump platform touted several Becton inventions.
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May 13, 2025
Regeneron-Amgen Drug Bundling Trial Heads Toward Jury
An economics expert called by Amgen Inc. told a Delaware federal jury Tuesday that none of the company's deals to bundle other discounted major medications with its cholesterol-reducing drug Repatha foreclosed market competition, a day before jurors begin deliberating on an antitrust suit targeting the practice.
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May 13, 2025
10x Genomics, Bruker Strike Deal After $31M Patent Verdict
Gene sequencing technology firm 10x Genomics and scientific instrument maker Bruker Corp. have reached a settlement in a patent infringement lawsuit that previously led biotechnology company NanoString to file for Chapter 11 bankruptcy relief.
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May 13, 2025
NIH Letters Ending Grants Lack Factual Support, Judge Says
A Massachusetts federal judge said Tuesday that a "blast" of hundreds of virtually identical letters in March canceling National Institutes of Health-funded research projects appeared to offer no factual basis, only unsupported assertions that the projects were unscientific or discriminatory.
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May 13, 2025
PBMs Get Bipartisan Bashing At Hearing On Drug Costs
Senators across party lines slammed pharmacy benefit managers on Tuesday, sometimes in coarse language, as they wrestled with how to reduce drug prices for patients while also preventing the closure of rural pharmacies.
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May 13, 2025
Cancer Centers Want Fed. Circ. To Rehear Antibody IP Fight
The Dana-Farber Cancer Institute and Memorial Sloan-Kettering Cancer Center say the full Federal Circuit should review a decision rejecting Xencor's application for an antibody patent, arguing that the decision wrongly created a new precedent that could be harmful to other patents.
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May 13, 2025
Former J&J, Moderna Exec Joins Goodwin Procter In Boston
Goodwin Procter is continuing to grow its resources in the life sciences practice with the recent addition to the Boston office of an attorney who has gone back to private practice after more than seven years as an in-house counsel for Johnson & Johnson and Moderna.
Expert Analysis
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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 Âé¶¹´«Ã½ & 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 Âé¶¹´«Ã½yer
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.
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Tips For Pharma-Biotech Overlap Reporting In New HSR Form
While there’s no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.
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Opinion
Judge Should Not Have Been Reprimanded For Alito Essay
Senior U.S. District Judge Michael Ponsor's New York Times essay critiquing Supreme Court Justice Samuel Alito for potential ethical violations absolutely cannot be construed as conduct prejudicial to the administration of the business of the courts, says Ashley London at the Thomas R. Kline School of Âé¶¹´«Ã½ of Duquesne University.
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A Look At Drug Price Negotiation Program's Ongoing Impact
More than two years after the passage of the Inflation Reduction Act and the rapid implementation of the drug price negotiation program, attorneys at Ropes & Gray discuss how the IRA has influenced licensing strategies, and how maximum fair prices under the law have economically affected certain drugs.
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Opinion
Congress Must Consider Accurate Data About Patent Thickets
If Congress revisits a controversial bill this year aimed at limiting the number of patents pharmaceutical manufacturers could assert, it must make sure to act based on accurate reports — such as a recent U.S. Patent and Trademark Office study that found no evidence of patent thicketing, says David Kappos at the Council for Innovation Promotion.
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Lights, Camera, Ethics? TV Âé¶¹´«Ã½yers Tend To Set Bad Example
Though fictional movies and television shows portraying lawyers are fun to watch, Hollywood’s inaccurate depictions of legal ethics can desensitize attorneys to ethics violations and lead real-life clients to believe that good lawyers take a scorched-earth approach, says Nancy Rapoport at the University of Nevada, Las Vegas.
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Will 4th Time Be A Charm For NY's 21st Century Antitrust Act?
New York's recently introduced 21st Century Antitrust Act would change the landscape of antitrust enforcement in the state and probably result in a sharp increase in claims — but first, the bill needs to gain traction after three aborted attempts, says Tyler Ross at Shinder Cantor.
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Perspectives
Accountant-Owned Âé¶¹´«Ã½ Firms Could Blur Ethical Lines
KPMG’s recent application to open a legal practice in Arizona represents the first overture by an accounting firm to take advantage of the state’s relaxed law firm ownership rules, but enforcing and supervising the practice of law by nonattorneys could prove particularly challenging, says Seth Laver at Goldberg Segalla.
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The Post-Macquarie Securities Fraud-By-Omission Landscape
While the U.S. Supreme Court's 2024 opinion in Macquarie v. Moab distinguished inactionable "pure omissions" from actionable "half-truths," the line between the two concepts in practice is still unclear, presenting challenges for lower courts parsing statements that often fall within the gray area of "misleading by omission," say attorneys at Katten.
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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.