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Life Sciences
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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.
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May 23, 2025
Meta, App Maker Flo Can't Escape All Of Privacy Class Action
A California federal judge ruled Thursday that Flo Health Inc. and Meta cannot escape all the claims in a class action brought by users of a menstrual cycle app who allege their privacy was violated, denying parts of both companies' summary judgment bids.
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May 23, 2025
LegitScript Can't Use 'Unclean Hands' To Ax Antitrust Case
The Ninth Circuit on Friday said that pharmacy verification and monitoring service provider LegitScript could not toss an antitrust action brought by PharmacyChecker.com based on assertions that the plaintiff facilitated the illegal importation of foreign drugs, saying that the defense of unclean hands doesn't bar the lawsuit.
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May 23, 2025
Seattle Cancer Center Inks $11.5M Class Data Breach Deal
A Washington state judge has given final approval to an $11.5 million class action settlement to end litigation against Seattle-based Fred Hutchinson Cancer Center over a 2023 data breach that exposed patient information, with the judge awarding $3.8 million in attorney fees in a deal class counsel values at more than $50 million.
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May 23, 2025
Fed. Circ. Dings PTAB Decision Upholding X-Ray Patent
The Federal Circuit on Friday reversed a Patent Trial and Appeal Board ruling that claims in an X-ray patent aren't invalid as anticipated, concluding that the board's claim construction in the matter was incorrect, even though the board denied that it was construing any claims.
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May 23, 2025
Ex-McKinsey Exec Sentenced For Obstructing Purdue Probe
A Virginia federal judge has sentenced a disbarred attorney and former McKinsey & Co. partner to six months in prison for obstructing an investigation into the consulting giant's work with opioid manufacturer Purdue, federal prosecutors announced Friday.
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May 23, 2025
Trump Admin Must Restore 'Censored' Harvard Docs' Articles
A Massachusetts federal judge on Friday ordered the U.S. Department of Health and Human Services to restore articles penned by two Harvard Medical School researchers that contained terms like "transgender" and "LGBTQ," calling their removal a "textbook example of viewpoint discrimination."
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May 23, 2025
FTC Probing Alcon's $430M Lensar Deal
The Federal Trade Commission has requested additional information about Swiss eye care company Alcon Inc.'s planned purchase of Florida-based medical technology developer Lensar Inc. in a deal worth up to $430 million.
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May 23, 2025
Biotech Insider Traded On $3.5B Novartis Deal, Feds Say
A former board member at Chinook Therapeutics orchestrated an insider-trading scheme after learning about Novartis' plans to purchase the biotech company for $3.5 billion in 2023, according to an indictment announced Friday.
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May 23, 2025
Class Of Health Plans Certified In Avandia Marketing MDL
A Pennsylvania federal judge has certified a class of health plans in multidistrict litigation over GlaxoSmithKline's alleged deceptive marketing of the drug Avandia in which the plans claim they wouldn't have paid higher premiums for the drug if they'd known about its potential cardiovascular risks.
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May 23, 2025
My So-Called Retirement: Some IP Lawyers Just Can't Quit
When patent partner Terry Rea set out to retire, the onetime acting director of the U.S. Patent and Trademark Office had her eyes on the independence that retirement promises — flexible hours, fewer deadlines and less stress over having lots of people counting on you.
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May 23, 2025
Cooley Hires 'Next-Gen' Boston Labor & Employment Partner
A Choate Hall & Stewart LLP partner has joined Cooley LLP's labor and employment practice and global litigation department in Boston.
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May 23, 2025
Ballard Spahr Adds IP Transactions Pro From DLA Piper
Ballard Spahr LLP announced Thursday that its New York office has gained a life science and climate change-focused corporate lawyer with a background in licensing and other intellectual property transactions from DLA Piper.
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May 23, 2025
Insulet Foe Rips $30M Atty Fee Ask As 'Over-Lawyered'
A South Korean medical device maker told a Massachusetts federal judge that rival Insulet's request for $30 million in attorney fees following a $60 million trade secrets judgment should be denied, calling that amount "exorbitant" and saying Insulet "consistently over-lawyered disputes."
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May 22, 2025
Fed. Circ. Backs Pfizer Win Against Gene Therapy Patents
The Federal Circuit on Thursday sided with the Patent Trial and Appeal Board's findings that a pair of patents covering a new kind of experimental gene therapy to treat hemophilia were invalid, handing a win to patent challenger Pfizer.
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May 22, 2025
Senators Unveil DNA Privacy Bill Amid 23andMe's Ch. 11 Sale
A bipartisan group of U.S. senators on Thursday introduced a bill designed to safeguard customers' genetic information in bankruptcy cases, saying 23andMe's plan to sell users' DNA data to a pharmaceutical company during its Chapter 11 raises new concerns surrounding consumer privacy.
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May 22, 2025
Calif. Docs Bring FDA Stem Cell Regulation Fight To Top Court
Two California clinics that provide stem cell treatments are urging the U.S. Supreme Court to review a Ninth Circuit panel's finding that their treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations.
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May 22, 2025
Justices Urged To Undo Denial Of Fast Track For Gastro Drug
Vanda Pharmaceuticals Inc. is asking the U.S. Supreme Court to reverse the Food and Drug Administration's decision denying fast-track approval for its gastroparesis drug tradipitant, saying it meets the statutory standard for fast-track review as a new treatment with the "potential to address unmet medical needs."
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May 22, 2025
EpiPen Direct Buyers, Mylan Get Final OK On Antitrust Deal
Mylan Pharmaceuticals' $73.5 million settlement with a class of direct EpiPen buyers has received final approval from a Kansas federal judge, closing out claims from institutional drug resellers that Mylan worked with Pfizer to forestall an EpiPen generic from hitting the market and artificially inflating prices for the emergency injectable.
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May 22, 2025
Manufacturer Seeks Over $19M In Beryllium Release Coverage
A medical device manufacturer accused a Zurich unit of breach of contract and bad faith in Massachusetts federal court, seeking at least $19 million in damages after it said storms caused an "unprecedented dispersal" of beryllium at one of its plants in the United Kingdom.
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May 22, 2025
Judge Asks If DEI Is Now 'Homogeneity, Inequity And Exclusion'
A Massachusetts federal judge considering a challenge to the Trump administration's cuts to hundreds of National Institutes of Health grants pressed the U.S. Department of Justice on Thursday for its definition of diversity, equity and inclusion, at one point asking hypothetically whether the government's policy is now "homogeneity, inequity and exclusion."
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May 22, 2025
Conn. AG Targets 'Bootleg' Weight Loss Drug Sellers
Connecticut has launched a consumer protection lawsuit in state court against a Florida-based company and its owner, accusing them of peddling untested and unsafe, research-level, "bootleg" GLP-1 weight loss drugs to customers.
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May 22, 2025
Sanofi To Acquire Goodwin-Led US Biotech Biz For $470M
Drugmaker Sanofi said Thursday that it has agreed to acquire Vigil Neuroscience, a biotechnology company specializing in neurodegenerative diseases, for approximately $470 million to give it a potential new medicine for Alzheimer's disease in a deal guided by Goodwin Procter.
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May 21, 2025
FTC Urges 8th Circ. Not To Pause In-House PBM Case
The Eighth Circuit should once again say no to a request to pause the Federal Trade Commission's in-house case accusing three pharmacy benefit managers of hiking up the price of insulin to line their own pockets, the agency has told the appellate court.
Expert Analysis
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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.
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Scope And Nature Of Judicial Relief Will Affect Loper's Impact
The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.
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The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.
The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.
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Series
Adventure Photography Makes Me A Better Lawyer
Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.
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What Vinyl Acetate's Prop 65 Listing Means For Cos.
California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Inherency Ruling Refines Obviousness Framework
The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.
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Navigating The Potential End Of GLP-1 Drug Shortages
The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.
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High Court Could Further Limit Deference With TCPA Fax Case
The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.