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Life Sciences
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March 27, 2025
Top EU Court Urged To Uphold €60M Teva Pay-For-Delay Fine
An adviser to the European Union's top court said Thursday that it should uphold €60.5 million ($70.7 million) in fines against Teva and its subsidiary Cephalon for an alleged conspiracy to keep a generic version of Provigil off the shelves.
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March 27, 2025
1st Circ. Denies Gov't Bid To Enforce Funding Freeze
The First Circuit has declined to interfere with a Rhode Island federal judge's order that the government continue releasing federal funds while the Trump administration appeals a ruling blocking its efforts to enforce the freeze.
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March 27, 2025
HHS To Cut 10,000 Jobs As RFK Jr. Reorganizes Agency
The U.S. Department of Health and Human Services said Thursday that it would lay off 10,000 employees as part of a "dramatic" plan to restructure the agency and downsize its workforce by about 24%.
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March 26, 2025
Sotomayor Urges Caution On Nondelegation Doctrine Revamp
U.S. Supreme Court Justice Sonia Sotomayor cautioned her colleagues during oral arguments Wednesday against using a challenge to the Federal Communications Commission's administration of a broadband subsidy program as a way to resurrect the long-dormant nondelegation doctrine. Several conservative justices, however, seemed willing to disregard that admonition.
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March 26, 2025
7 Firms Compete To Lead Novo Nordisk Securities Suit
Levi & Korsinsky LLP, Pomerantz LLP and the Rosen Law Firm PA are among seven law firms vying to lead proposed class claims accusing Novo Nordisk A/S of misleading investors about a clinical trial for an obesity drug.
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March 26, 2025
23andMe Says Ch. 11 Privacy Ombudsman Not Required
DNA testing company 23andMe Inc.'s customer data will be protected in Chapter 11, its attorneys told a Missouri bankruptcy judge Wednesday as it argued that the appointment of a consumer privacy ombudsman is not required.
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March 26, 2025
Full Fed. Circ. Won't Look At Injunction On MSN's Generic Drug
The full Federal Circuit won't revisit a panel's January order barring MSN Laboratories Pvt. Ltd. from launching a generic version of Novartis' bestseller, the cardiovascular drug Entresto, as part of a flurry of moves in litigation related to the treatment.
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March 26, 2025
Drugmaker Execs Hid Approval Process Roadblocks, Suit Says
A Sage Therapeutics Inc. investor sued the company's executives in New York federal court Wednesday alleging they hid significant setbacks affecting the regulatory approval for its drug candidates intended to treat mood disorders and other conditions including Parkinson's and Alzheimer's diseases.
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March 26, 2025
Women Make Up 13% Of Attys In Front Of The PTAB
Women account for 13% of attorneys appearing in front of the Patent Trial and Appeal Board in post-grant proceedings going back to the board's founding in 2012 despite comprising up to 30% of all patent attorneys, according to a report from the PTAB Bar Association.
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March 26, 2025
Walgreens, Kroger Claim Takeda Cut Illegal TWi Generics Deal
Walgreens, Kroger, Albertsons and H-E-B hit Takeda and TWi Pharmaceuticals with an antitrust suit in California federal court Tuesday, accusing the pharmaceutical companies of conspiring to delay the release of the generic version of Takeda's heartburn medication Dexilant, causing the retailers to pay more for the brand-name drug.
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March 26, 2025
Del. Justices Back Axing Suit Over $3B AstraZeneca Viela Sale
The Delaware Supreme Court on Wednesday upheld without elaboration the dismissal of a Court of Chancery lawsuit accusing AstraZeneca PLC of lining up a conflicted, underpriced $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc.
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March 26, 2025
AGs Seek 1st OK For $39M Apotex Deal In Price-Fixing Case
A coalition of 50 state attorneys general on Wednesday asked a Connecticut federal judge to accept a $39.1 million deal settling claims that pharmaceutical company Apotex Corp. schemed with others to fix generic-drug prices, with 70% earmarked for a restitution fund and 30% for consumer notices and attorney fees.
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March 26, 2025
False COVID Cure Claims No Longer Feds' 'Current Priority'
The Trump administration has abandoned another case targeting allegedly false claims that an over-the-counter product could treat, or even cure, COVID-19 by dropping its case against a one-man herbal tea operation.
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March 26, 2025
Fla. Appeals Court Upholds Fees For Medical Pot Businesses
Florida's intermediate appellate court on Wednesday affirmed that the state's Department of Health acted within its authority when it enacted rules requiring medical marijuana dispensaries to pay more than a million dollars in license renewal fees every other year.
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March 26, 2025
Need For Individual Analyses Sinks Class Bid In Vax Bias Suit
A group of former workers claiming they were unlawfully denied medical and religious exemptions from a Pittsburgh public transportation system's COVID-19 vaccination policy cannot proceed as a class, a Pennsylvania federal judge ruled, saying the case involved too many individual issues.
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March 25, 2025
Ex-Masimo CEO Slams Bid To DQ His Hueston Hennigan Attys
Joe E. Kiani, founder and ex-CEO of Masimo Corp., has urged the Delaware Chancery Court to reject the medical technology company's bid to disqualify his attorneys from Hueston Hennigan LLP in its lawsuit over Kiani's quest for a $450 million payout, saying the request is being "weaponized for tactical gain."
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March 25, 2025
Medical Image Co. Gets Fed. Circ. To Back Ax Of Rival's IP
A Federal Circuit ruling Tuesday affirmed administrative patent board holdings that wiped out claims in patents that cover a 3D photography system used in medical imaging and clinical trials.
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March 25, 2025
Drug Co. Wants Fed. Circ. To Undo Pfizer COVID Patent Win
A Boston drug developer that lost its infringement case against Pfizer over the New York company's blockbuster Paxlovid COVID-19 treatment has told the Federal Circuit that a contentious issue regarding a typo in a patent document should have gone to a jury.
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March 25, 2025
Pension Seeks To Opt Class Out Of Cutera Ch. 11 Releases
A pension fund heading up a class action against skin care technology group Cutera has urged a Texas bankruptcy court to find the shareholder has authority to opt all class members out of the company's Chapter 11 plan.
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March 25, 2025
McCarter & English's $3.77M Fee Win Headed For Appeal
A former McCarter & English LLP client will appeal a $3.77 million Connecticut federal court judgment for failing to pay its legal bills following a Kentucky trade secrets case loss, federal court papers indicate.
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March 25, 2025
Merck Betting Up To $2B On China-Developed Cardio Drug
Pharmaceutical giant Merck & Co. Inc., advised by Gibson Dunn & Crutcher LLP and Covington & Burling LLP, said on Tuesday it has entered into an exclusive license agreement with Cooley LLP-led pharmaceutical company Jiangsu Hengrui Pharmaceuticals Co. Ltd. under which Merck will pay up to nearly $2 billion to the Chinese pharmaceutical business.
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March 25, 2025
Meitar-Led Navina Wraps $55M Series C Funding Round
Artificial intelligence-powered clinical intelligence company Navina, advised by Meitar, announced on Tuesday that it clinched a $55 million Series C funding round, bringing its total amount raised to $100 million.
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March 25, 2025
4th Circ. Won't Rehear Drug Price-Fixing Class Action
The Fourth Circuit said Tuesday it will not hold a full court rehearing of its panel decision to back the dismissal of a proposed class action accusing drugmakers of conspiring and inflating the price of a medication for Huntington's disease, a suit the panel called "shaky at best."
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March 24, 2025
Trump Picks Acting CDC Head After Weldon Nomination Fails
President Donald Trump on Monday nominated acting Centers for Disease Control and Prevention head Susan Monarez to take over as the agency's director, a move that comes after Trump pulled his nomination of Dr. Dave Weldon for the position when it became clear Weldon lacked needed support.
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March 24, 2025
Amgen Wants $50M Leukemia Drug Patent Verdict Thrown Out
Amgen has urged a Delaware federal court to grant it a new trial after a federal jury last year found that it owed Germany's Lindis Biotech $50.3 million in damages for encouraging healthcare providers to infringe immunotherapy patents by administering a leukemia treatment.
Expert Analysis
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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.
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FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape
The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.