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Life Sciences
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February 21, 2025
MSN Calls Novartis' Entresto Delisting Protest 'Disingenuous'
Novartis' claim that there's no rush to decide whether a patent covering its blockbuster cardiovascular drug Entresto should be removed from a key drug database is "disingenuous and a complete about-face," MSN Pharmaceuticals has told a Delaware federal judge.
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February 21, 2025
Eli Lilly Has Exclusivity Over Weight Loss Drug, FDA Says
The U.S. Food and Drug Administration asked a Texas federal court to reject a request for an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug, saying the agency based its decision on sound facts and it was within its authority.
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February 21, 2025
Harry Manbeck, Former USPTO Head, Dies At 98
Former U.S. Patent and Trademark Office leader and chief patent counsel at General Electric Co., Harry F. Manbeck Jr., died Wednesday. He was 98.
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February 21, 2025
NFL Alums Accused Of Misusing COVID Outreach Funding
The National Football League's largest alumni organization has been accused by a biotechnology company of trying to misuse Georgia taxpayer dollars intended for a COVID-19 vaccine education program before unlawfully breaking their contract last year.
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February 21, 2025
Pharma Co. Investors Get Final OK For $3M Settlement
Investors in Colorado pharmaceutical company Ampio have gotten final approval for their $3 million deal resolving claims that its leadership mishandled a clinical trial for the company's sole drug candidate and distributed the drug outside the trial for unapproved use, leading to an internal investigation in which two executives were fired and a disclosure that there was "no clinical pathway forward" for the treatment.
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February 21, 2025
Manufacturer Not Covered For Pot Grower Claims, Court Told
Cincinnati Insurance Co. said it has no duty to defend or indemnify a manufacturer accused of misrepresenting the capabilities of its indoor marijuana growing systems, telling a Michigan federal court Friday that underlying claims brought by a cannabis company do not trigger coverage.
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February 21, 2025
UChicago Medical Center Can't Duck Wage Suit
An Illinois federal judge largely allowed a proposed class action brought by UChicago Medical Center workers seeking to recover unpaid wages for the time spent undergoing mandatory, pre-shift COVID-19 screenings to move forward, rejecting the center's argument that the screenings weren't "integral and indispensable" to employees' job duties.
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February 21, 2025
Weight Loss Drug Patient Drops Appeal In Cancer Risk Suit
Days after arguing her case before a skeptical Third Circuit panel, a woman who alleges she suffered financial harm by buying a weight loss drug that purportedly causes cancer — which she said she has not been diagnosed with — has voluntarily dismissed the case.
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February 21, 2025
Veolia Ends One Of Few Remaining Flint Water Suits For $53M
A water engineering firm on Friday said it will pay $53 million to settle claims from the state of Michigan and thousands of Flint residents who allege the company failed to properly identify corrosion control treatment issues or alert officials to the dangers of the city's water, prolonging the water crisis.
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February 21, 2025
Paul Hastings Seeks To End GenapSys Malpractice Action
Paul Hastings LLP has moved for summary judgment in a malpractice action from GenapSys Inc., saying the case is barred because the genomic sequencing company failed to disclose its possible claim until after confirmation of its bankruptcy plan.
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February 21, 2025
NJ High Court Takes Up Pharma Co. Fraud Coverage Row
The New Jersey Supreme Court will review an appeals court's ruling against indemnification in a case of first impression on the applicability of an exclusion barring directors and officers coverage for wrongful acts "in any way involving" an insured's work for an uninsured entity, the high court announced.
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February 21, 2025
WilmerHale Corporate Ace Joins DLA Piper In California
DLA Piper has added a former WilmerHale attorney to strengthen its corporate practice, including bolstering its service to clients in the life sciences and healthcare industries.
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February 21, 2025
NIH Research Cuts Stay On Hold As Judge Mulls Objections
A Boston federal judge on Friday extended her hold on a Trump administration proposal to slash reimbursements from the National Institutes of Health for research grant costs, a move colleges, hospitals and other institutions have said would wreak havoc on scientific research.
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February 20, 2025
DOJ Says Job Protections For ALJs Are Unconstitutional
The U.S. Department of Justice announced Thursday that it no longer backs long-standing job protections for administrative law judges, saying it has determined that the "multiple layers of removal restrictions" shielding ALJs are unconstitutional because they violate the separation of powers doctrine.
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February 20, 2025
Trump Trans Edicts Will Cause More Teen Suicides, States Say
Washington, Colorado, Oregon and Minnesota argued Wednesday for a court order halting President Donald Trump's executive orders targeting federal funding for gender-affirming care for young people, saying the edicts are unconstitutional and have "unleashed unbridled fear and irreparable harms."
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February 20, 2025
Generic-Drug Group Rallies Behind Appeal In Entresto Fight
A generic-drug industry group is weighing in on the Federal Circuit's move last month to revive a patent tied to Entresto, Novartis Pharmaceuticals Corp's blockbuster heart drug, warning that "the pharmaceutical industry is watching this case closely."
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February 20, 2025
Boston, Other Cities And MassBio Back Challenge To NIH Cuts
The city of Boston and 44 other cities, counties and elected officials around the country and, separately, the life sciences industry group Massachusetts Biotechnology Council asked a Massachusetts federal judge on Thursday to extend a temporary restraining order blocking steep cuts to National Institutes of Health reimbursement for research projects.
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February 20, 2025
Green Groups Ask 9th Circ. To Press EPA Again On Atrazine
Environmental groups are urging the Ninth Circuit to reopen a long-running case against the U.S. Environmental Protection Agency over its regulation around the pesticide atrazine, arguing that the agency's yearslong delay in completing a court-ordered review of the chemical has allowed "serious harm to people, plants and wildlife."
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February 20, 2025
Feds Say DC Judge Can't Bar 'Hypothetical' Spending Freezes
A Justice Department attorney argued before a D.C. federal judge Thursday that there is no basis to continue blocking the Trump administration from implementing a blanket suspension on federal spending, saying the court cannot bar "hypothetical" future freezes.
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February 20, 2025
Drug Buyers Get OK On $275M Sandoz Antitrust Settlement
Swiss drugmaker Sandoz and its subsidiaries will pay consumers, insurers and other "end payer plaintiffs" $275 million to settle class action claims that it conspired with other companies to fix the price of certain generic drugs, under a deal that got preliminary approval from a Pennsylvania federal court Wednesday.
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February 20, 2025
Ex-Heritage Pharma CEO Disciplined Over Price-Fixing Case
The New Jersey Supreme Court has retroactively suspended the former chief executive of Heritage Pharmaceuticals Inc. from the state bar for three years over his role in a price-fixing conspiracy.
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February 20, 2025
Ex-Opioid CEO's Billing Spat With Trial Atty Lands In Court
A Manhattan federal judge teed up a briefing schedule Thursday after a fight over expenses erupted between convicted former opioid CEO Laurence Doud and the lawyer who represented him at his criminal trial, who says Doud still owes $150,000.
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February 20, 2025
Research Co. Liable For Bungling $52M COVID-19 Mask Deal
A North Carolina federal judge ruled in favor of an electronics company that made a $52 million deal for masks during the COVID-19 pandemic only to receive no masks and a partial refund, finding the supplier liable for breach of contract.
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February 19, 2025
What To Know About Trump's Likely Pick For USPTO Director
Dilworth Paxson LLP partner John Squires is about to be nominated for director of the U.S. Patent and Trademark Office, about half a dozen sources told Law360 on Tuesday. Here's what you need to know about the attorney who made a name for himself at Goldman Sachs.
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February 19, 2025
Walgreens Says $1B COVID Testing Award Must Be Nixed
Walgreens is urging a Delaware federal judge to rethink his decision enforcing a $987 million arbitral award to a lab testing and diagnostics company in a dispute over COVID-19 tests, arguing Tuesday that he ignored that the arbitrator "invented" language in the contract to arrive at his conclusion.
Expert Analysis
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Perspectives
Accountant-Owned Law 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.
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IP, Licensing, M&A Trends To Watch In Life Sciences This Year
2025 promises to continue an exciting trajectory for the life sciences industry, with major trends ranging from global harmonization of intellectual property to cross-border licensing activity and an increase of nontraditional financial participants in the mergers and acquisition space, say attorneys at Morgan Lewis.
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When Innovation Overwhelms The Rule Of Law
In an era where technology is rapidly evolving and artificial intelligence is seemingly everywhere, it’s worth asking if the law — both substantive precedent and procedural rules — can keep up with the light speed of innovation, says Reuben Guttman at Guttman Buschner.
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Anticipating Direction Of Cosmetics Regulation Under Trump
It is unclear how cosmetics regulation reform from the last few years will fare under President Donald Trump, but the new administration's emphasis on deregulation and Robert F. Kennedy Jr.'s views on product safety provide some insight, say attorneys at Crowell & Moring.
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Drug Pricing Policy Trends To Expect In 2025 And Beyond
Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.
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Imagine The Possibilities Of Openly Autistic Lawyering
Andi Mazingo at Lumen Law, who was diagnosed with autism about midway through her career, discusses how the legal profession can create inclusive workplaces that empower openly autistic lawyers and enhance innovation, and how neurodivergent attorneys can navigate the challenges and opportunities that come with disclosing one’s diagnosis.
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.
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Parsing 3rd Circ. Ruling On Cannabis, Employee Private Suits
The Third Circuit recently upheld a decision that individuals don't have a private right of action for alleged violations of New Jersey's Cannabis Regulatory, Enforcement Assistance and Marketplace Modernization Act, but employers should stay informed as the court encouraged the state Legislature to amend the law, say attorneys at Mandelbaum Barrett.
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4 Keys To Litigating In An Active Regulatory Environment
For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.
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Kiromic SEC Order Shows Importance Of Self-Reporting
The U.S. Securities and Exchange Commission's recently filed settled charges against Kiromic BioPharma illustrate the critical intersection between U.S. Food and Drug Administration regulatory processes and investor disclosures under the securities laws, and showcase how responding promptly to internal whistleblower reports may reap benefits, say attorneys at Arnold & Porter.
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Series
Documentary Filmmaking Makes Me A Better Lawyer
Becoming a documentary filmmaker has allowed me to merge my legal expertise with my passion for storytelling, and has helped me to hone negotiation, critical thinking and problem-solving skills that are important to both endeavors, says Robert Darwell at Sheppard Mullin.
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Litigation Funding Disclosure Debate: Strategy Considerations
In the ongoing debate over whether courts should require disclosure of litigation funding, funders and plaintiffs tend to argue against such mandates, but voluntarily disclosing limited details about a funding arrangement can actually confer certain benefits to plaintiffs in some scenarios, say Andrew Stulce and Marc Cavan at Longford Capital.
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2025 May Be A Breakout Year For The Cannabis Industry
The cannabis industry faced a slow and frustrating 2024, but consumer trends continue to shift in favor of cannabis, and the new administration may provide the catalyst that the industry needs, says Lynn Gefen at TerrAscend.