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Life Sciences
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May 28, 2025
Regeneron Urges Judge In FCA Kickback Suit To Set Trial Date
Regeneron Pharmaceuticals Inc. on Wednesday pressed a Massachusetts federal judge to ready a long-running False Claims Act suit for a jury and reject the government's second bid for a pretrial win under a different legal theory following a First Circuit setback.
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May 28, 2025
Fla. Judge Told Pharma Co. Rival Also Stole Trade Secrets
A Florida federal judge on Wednesday denied an India-based pharmaceutical company's bid to reject a competitor's defense against a lawsuit alleging trade secrets theft by claiming its accuser is responsible for the same conduct, expressing doubt whether she can rule on such an issue.
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May 28, 2025
Fed. Circ. Lets Stewart Revise Longhorn Sanctions Order
The Federal Circuit on Wednesday granted a bid by the acting head of the U.S. Patent and Trademark Office to allow her to revise the Patent Trial and Appeal Board's decision to cancel 183 of Longhorn Vaccines & Diagnostics' patent claims as a punishment for "egregious abuse of the PTAB process."
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May 28, 2025
3rd Circ. Pauses J&J Unit Appeal In Talc Study Libel Case
The Third Circuit on Wednesday granted a bid by Johnson & Johnson's talc liability unit to stay briefing in its appeal seeking to revive a libel case over a scientific article linking talcum power to mesothelioma.
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May 28, 2025
Drugmaker LIVation Fights Novo Nordisk's Trademark Claims
A Connecticut company, accused by Novo Nordisk Inc. of breaking trademark and unfair trade practices laws by comparing its compounded drugs to Ozempic, says it has taken down online posts the pharma giant challenged in April, claiming Novo Nordisk can no longer prove ongoing harm.
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May 28, 2025
Class Suit Against AI Drugmaker Back On After Mediation Fails
After the parties failed to settle through mediation, a Connecticut federal judge has unpaused the latest iteration of a proposed class action accusing artificial intelligence-driven drugmaker BioXcel Therapeutics Inc. of false and misleading statements about U.S. Food and Drug Administration compliance issues surrounding a dementia drug.
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May 28, 2025
Indian Pharma Co. Hit With Patent Suit Over Fennec's Cancer Drug
An Indian multinational pharmaceutical company is infringing a patent for a drug to treat hearing loss in pediatric cancer patients undergoing chemotherapy, a North Carolina biotechnology company claimed in a lawsuit filed in New Jersey federal court.
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May 28, 2025
Mallinckrodt Investors Get Initial OK For $5.5M Settlement
Investors of drugmaker Mallinckrodt received preliminary approval of their $5.5 million settlement with two executives and a director of the company Wednesday, ending the investors' claims they were misled into believing Mallinckrodt had recovered from bankruptcy and would make a $200 million payment to opioid claimants.
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May 28, 2025
Singapore's Quadria Closes $1B-Plus Healthcare Fund
Singapore-based private equity firm Quadria Capital has closed its third healthcare fund at $1.07 billion, surpassing its $800 million target as it targets companies across Asia.
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May 28, 2025
Mich. School, Student GOP Club Spar In Free Speech Suit
A Michigan school district told a federal judge Wednesday that it could not air an announcement from a high school Republican club because it contained a political viewpoint on an upcoming ballot initiative, urging the court to toss the club's lawsuit alleging the school stifled members' right to free speech.
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May 28, 2025
Vt. Judge To Order Release Of Harvard Researcher
A Vermont federal judge on Wednesday said a Harvard Medical School researcher and Russian national accused of smuggling frog embryos into the United States is entitled to release from immigration custody while she challenges her detention.
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May 28, 2025
Checkpoint Pharma Sued For Docs On $355M Merger Plan
Stockholders of cancer drug developer Checkpoint Pharmaceuticals sued the company in Delaware's Chancery Court for documents on its proposed $355 million acquisition by India-based Sun Pharmaceuticals, alleging conflicts and lack of disclosures regarding the role played by Checkpoint's controlling investor, Fortress Biotech.
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May 28, 2025
China Can't Duck PPE Hoarding Claims By Fla. Medical Pros
A Florida federal judge won't fully dismiss claims from a group of medical professionals alleging that China, through a New Jersey company, hoarded personal protective equipment to create a monopoly at the start of the COVID-19 pandemic, finding the allegations fall within the commercial activity exception to sovereign immunity.
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May 28, 2025
Freshfields Gains New Tech M&A Leadership From Debevoise
Freshfields LLP announced Wednesday that it has hired a former Debevoise & Plimpton LLP attorney in San Francisco to co-lead its U.S. tech and life sciences mergers and acquisitions practice.
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May 28, 2025
Kirkland Hires 3 M&A Partners From Skadden
Kirkland & Ellis LLP announced Wednesday the addition of a three-partner mergers and acquisition team from Skadden Arps Slate Meagher & Flom LLP, among dozens of new hires made by the firm this week.
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May 28, 2025
Cooley Adds Ex-FDA Attorney To DC Life Sciences Group
Cooley LLP has hired a former U.S. Food and Drug Administration attorney, who for the majority of her public service career worked as an associate chief counsel, trying civil actions and criminal prosecutions against those accused of violating regulations for a range of products.
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May 27, 2025
Bluebird Bio Beats Investor Suit Over FDA Cancer Warning
Massachusetts-based biotechnology company Bluebird Bio Inc. has beaten a shareholder suit accusing it of misleading investors about the likelihood of the U.S. Food and Drug Administration's decision requiring a "black box warning" on one of its products due to the cancer risk it posed.
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May 27, 2025
Philips Can't Nix Suit Over Sleep Machine Catching Fire
Medical equipment company Philips cannot end a lawsuit claiming its sleep apnea breathing machine caught fire in the middle of the night, burning a woman's face and consuming her home, a North Carolina federal judge ruled, saying the adult daughter of the victim, who died due to an unrelated illness, can remain the plaintiff.
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May 27, 2025
Bayer, Monsanto On Hook For $611M Roundup Cancer Awards
A Missouri appellate panel Tuesday affirmed a trial court's $611 million award reduced from a jury's $1.56 billion verdict for three people who claimed their cancer was caused by Bayer unit Monsanto Co.'s Roundup weedkiller, saying a law professor's testimony about a Ninth Circuit decision was not prejudicial.
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May 27, 2025
Bankrupt 23andMe To Delist Stock After Regeneron Deal
Bankrupt genetic testing provider 23andMe Inc. said Tuesday it will delist its stock from the Nasdaq exchange, following Regeneron Pharmaceuticals Inc.'s agreement last week to buy the defunct company.
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May 27, 2025
Feds No Longer Advise COVID Shot For Kids, Pregnant Adults
The nation's public health agency on Tuesday pulled the COVID-19 vaccine from the list of recommended shots for healthy children and pregnant adults, a move that experts say could reduce demand for the vaccine and make it more expensive for some families.
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May 27, 2025
Eli Lilly Inks $1B Deal For Non-Opioid Pain-Drug Maker
Eli Lilly announced Tuesday that it has inked a potentially $1 billion deal to buy SiteOne Theraputics, giving the pharmaceutical giant access to a non-opiod pain medicine ready for phase 2 trials.
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May 27, 2025
Justices Deny Food Wrapping Co.'s Prior Art Petition
The owner of invalidated food wrapping patents failed to persuade the U.S. Supreme Court on Tuesday to review its allegations that the Federal Circuit wrongly presumes prior art is always enabled.
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May 23, 2025
Law360 Reveals Titans Of The Plaintiffs Bar
This past year, a handful of attorneys secured billions of dollars in settlements and judgments for both classes and individual plaintiffs against massive companies and organizations like Facebook, Dell, the National Association of Realtors, Johnson & Johnson, UFC and Credit Suisse, earning them recognition as Law360's Titans of the Plaintiffs Bar for 2025.
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May 23, 2025
Fed. Circ. Lifts Stay Against MSN In Entresto Appeal
The Federal Circuit won't make a Delaware federal judge hold off on entering a judgment that would stop MSN Pharmaceuticals from having its generic version of Novartis' blockbuster cardiovascular drug Entresto approved, saying Friday that MSN hasn't pled its case convincingly.
Expert Analysis
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Mitigating Tariff Risks For Healthcare In US And Canada
Healthcare stakeholders should take steps to evaluate the impact of cross-border tariffs, as the historically strong ties between Canada and the U.S. demonstrate the potential for real disruption and harm to the healthcare industry in both countries, say attorneys at Norton Rose.
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4 Ways Women Attorneys Can Build A Legal Legacy
This Women’s History Month, women attorneys should consider what small, day-to-day actions they can take to help leave a lasting impact for future generations, even if it means mentoring one person or taking 10 minutes to make a plan, says Jackie Prester, a former shareholder at Baker Donelson.
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A Judge's Pointers For Adding Spice To Dry Legal Writing
U.S. District Judge Fred Biery shares a few key lessons about how to go against the grain of the legal writing tradition by adding color to bland judicial opinions, such as by telling a human story and injecting literary devices where possible.
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Preparing For Disruptions To Life Sciences Supply Chains
Life sciences companies must assess how new and escalating tariffs — combined with other restrictions on cross-border activity singling out pharmaceutical products and medical devices — will affect supply chains, and they should proactively prepare for antitrust and foreign direct investment regulatory review processes, say attorneys at Weil.
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Mastering The Fundamentals Of Life Sciences Due Diligence
As life sciences transactions continue to gain tremendous momentum, companies participating in these transactions must conduct effective and strategic regulatory due diligence, which involves extensive amounts of information and varies by manifold factors, says Anna Zhao at GunnerCooke.
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Beware Risks Of Arguing Multiple Constructions In IP Cases
Defendants accused of patent infringement often argue for different, potentially contradictory, claim constructions before district courts and the Patent Trial and Appeal Board, but the board may be clamping down on this strategy, say attorneys at Dechert.
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What's At Stake In High Court Transgender Care Suit
The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their access to gender-affirming care, and will likely affect other areas of law and policy involving transgender individuals, including education, employment, healthcare and civil rights, say attorneys at ArentFox Schiff.
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6th Circ. Ruling Paves Path Out Of Loper Bright 'Twilight Zone'
The U.S. Supreme Court’s Loper Bright ruling created a twilight zone between express statutory delegations that trigger agency deference and implicit ones that do not, but the Sixth Circuit’s recent ruling in Moctezuma-Reyes v. Garland crafted a two-part test for resolving cases within this gray area, say attorneys at Wiley.
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A Reminder On Avoiding Improper Venues In Patent Cases
A Texas federal court's recent decision in the Symbology and Quantum cases shows that baseless patent venue allegations may be subject to serious Rule 11 sanctions, providing venue-vetting takeaways for plaintiffs and defendants, say attorneys at Bond Schoeneck.
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NIH Cuts To Indirect Costs May Stifle IP Generation
Although currently blocked by a preliminary injunction, the National Institutes of Health's new policy to cut down on indirect cost funding creates challenges for university research projects, and may hamper the development of intellectual property — which is considered an indirect cost — for years to come, say attorneys at Snell & Wilmer.
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Recent Cases Clarify FCA Kickback Pleading Standards
Two recently resolved cases involving pharmaceutical manufacturers may make it more difficult for False Claims Act defendants facing kickback scheme allegations to get claims dismissed for lack of evidence, say Li Yu at Bernstein Litowitz, Ellen London at London & Noar, and Gregg Shapiro at Gregg Shapiro Law.
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Opinion
Antitrust Analysis In Iowa Pathologist Case Misses The Mark
An Iowa federal court erred in its recent decision in Goldfinch Laboratory v. Iowa Pathology Associates by focusing exclusively on market impacts and sidestepping key questions that should be central to antitrust standing analysis, says Daniel Graulich at Baker McKenzie.
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Opinion
State FCAs Should Cover Local Fund Misuse, State Tax Fraud
New Jersey and other states with similar False Claims Acts should amend them to cover misappropriated municipal funding, and state and local tax fraud, which would encourage more whistleblowers to come forward and increase their recoveries, says Kenneth Levine at Stone & Magnanini.
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7 Tips For Associates To Thrive In Hybrid Work Environments
Excerpt from Practical Guidance
As the vast majority of law firms have embraced some type of hybrid work policy, associates should consider a few strategies to get the most out of both their in-person and remote workdays, says James Argionis at Cozen O’Connor.
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Series
Playing Beach Volleyball Makes Me A Better Lawyer
My commitment to beach volleyball has become integral to my performance as an attorney, with the sport continually reminding me that teamwork, perseverance, professionalism and stress management are essential to both undertakings, says Amy Drushal at Trenam.