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Life Sciences
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June 05, 2025
Sens. Float Automatic Biosimilar Interchangeable Label
A bipartisan group of U.S. senators has reintroduced legislation that would reduce what the lawmakers called barriers to accessing lower-cost versions of biologic drugs, making an adjustment to how biosimilars are deemed interchangeable with their name-brand equivalents.
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June 05, 2025
4 AGs Urge FDA To Lift Abortion Pill Restrictions
Attorneys general from California, Massachusetts, New York and New Jersey on Thursday urged the U.S. Food and Drug Administration to lift restrictions on the abortion drug mifepristone, saying they aren't necessary under statutory requirements for an FDA drug safety program.
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June 05, 2025
3rd Circ. Says Amgen Can Proceed With Subpoena In IP Suit
The Third Circuit on Thursday sided with biotechnology company Amgen Inc. in its efforts to subpoena a competitor that it accused of patent infringement, reasoning that the panel lacked jurisdiction to hear the case because the lower court's decision regarding discovery was not ripe for appeal.
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June 05, 2025
Ex-Bush Admin Atty To Lead HHS Civil Rights Office
The U.S. Department of Health and Human Services has appointed an attorney to lead its civil rights office who brings more than 30 years of experience across the public sector and private practice, including as counsel for HHS during the George W. Bush administration.
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June 05, 2025
High Court Drops Class Cert. Clarification Bid
The U.S. Supreme Court declined Thursday to weigh in on whether federal courts can certify classes that include uninjured members, holding it improperly agreed to hear a disability discrimination case against diagnostics company Labcorp that raised the important question.
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June 04, 2025
Calif. Won't Get Insulin Pricing Case Sent Back To State Court
The New Jersey federal judge overseeing multidistrict litigation accusing Express Scripts, CVS Caremark and other pharmacy benefit managers of conspiring to fix the prices of insulin on Wednesday refused to ship a case brought by the state of California back to state court.
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June 04, 2025
23andMe, Bidders Agree To Post-Ch. 11 Auction Offer Process
The winner of 23andMe's Chapter 11 auction and a nonprofit started by its co-founder can improve their offers to acquire the DNA testing company under procedures agreed to Wednesday in Missouri bankruptcy court, despite disruptions from a tornado warning and an attorney letting slip nonpublic details of an offer.
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June 04, 2025
USPTO Says Study Disproves Pharma Patent Thicket Claims
A U.S. Patent and Trademark Office unit has found that pharmaceutical patent thickets are rare after investigating arguments about their effect on drug pricing, the division's leader said Wednesday as part of a discussion on large patent families.
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June 04, 2025
SEC Gets $1.1M Win Against Alleged Ga. Crypto Scammer
A Georgia man is on the hook for over $1.1 million in penalties after failing to defend himself from U.S. Securities and Exchange Commission allegations he ran an $800,000 affinity fraud scheme involving a purported cryptocurrency he said was backed by gold and stem cell technology.Â
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June 04, 2025
Novo Nordisk Wants Hospital Sanctioned For Insulin Pen Suit
Novo Nordisk Inc. has asked a Connecticut federal judge to sanction Griffin Health Services Corp. for suing the pharmaceutical company after settling a separate insulin pen contamination lawsuit, saying the hospital's complaint left out five important facts that could point blame back toward its own staff.
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June 04, 2025
House Committee Puts Intoxicating-Hemp Ban In Spending Bill
A U.S. House of Representatives committee on Wednesday released a spending bill that includes a major change to the statutory definition of hemp and hemp products in its agriculture appropriations that would effectively rewrite national hemp policy if it becomes law.
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June 04, 2025
Fed. Circ. Upholds Moderna's IP Win Over COVID Vax
A Delaware federal judge rightly interpreted claims of two Alnylam Pharmaceuticals Inc. patents, which means Moderna Inc.'s COVID-19 vaccine doesn't infringe them, the Federal Circuit said Wednesday.
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June 04, 2025
ITC Issues Import Ban In Dermatology Needle Patent Case
The U.S. International Trade Commission has blocked certain imports of skin treatment devices that infringe a series of patents owned by the U.S. subsidiary of a South Korean dermatologist's needle business.
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June 04, 2025
Vape Cos. Urge 5th Circ. To Toss FDA Vape Marketing Rule
A group of small e-cigarette companies is asking the Fifth Circuit to revive their suit challenging the U.S. Food and Drug Administration's rule for premarket authorization of new tobacco products, saying the FDA failed to account for how the rule would affect small businesses.
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June 03, 2025
Calif. Suffers Setback In Tariff Suit, But Gets Shot At 9th Circ.
A California federal judge said Monday that the U.S. Court of International Trade has exclusive jurisdiction over California's lawsuit challenging President Donald Trump's recent tariffs, but declined the federal government's request to transfer the case to the CIT and instead dismissed the suit so that California can appeal her decision to the Ninth Circuit.
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June 03, 2025
Fortrea Faces Investor Suit Over Post-Labcorp Financial Woes
Clinical research company Fortrea Holdings Inc. was hit with a proposed shareholder class action alleging that it overstated the strength of its business model after being spun off from Labcorp Holdings Inc., causing investors harm as the truth about Fortrea's financial struggles emerged.
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June 03, 2025
Pharma Group Can Pursue Challenge To Insulin Pricing Law
A Minnesota federal judge refused Tuesday to throw out a lawsuit over a state law requiring drugmakers to provide insulin to low-income diabetic patients, finding the drug industry's top lobbying group has plausibly alleged that a new registration fee imposed by the law could be unconstitutional.
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June 03, 2025
Patent Deals Accelerate Access To Generics, Drug Group Says
Deals between the makers of brand name drugs and the companies behind their generic versions have led to billions of dollars in healthcare cost savings and faster access to cheaper medicines, according to a new report.
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June 03, 2025
Regeneron Gets $407M After Antitrust Win Over Amgen
Regeneron won a $406.8 million judgment in its antitrust suit against Amgen, following a jury verdict last month saying Amgen illegally undercut the price of Regeneron's anticholesterol drug Praluent through a bundling scheme with two blockbuster Amgen drugs.
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June 03, 2025
6th Circ. Denies PBMs' Privilege Claim In Opioid MDL
A Sixth Circuit panel on Tuesday denied a petition from Cigna's Express Scripts and UnitedHealth's Optum seeking to reverse discovery orders allowing certain personnel files and internal communications into the multidistrict opioid litigation, finding that the two pharmacy benefit managers failed to show extraordinary abuses justifying relief.
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June 03, 2025
Canada Customers Agree To Halt 23andMe Data Breach Suits
23andMe and Canadian customers suing over a data breach agreed on Tuesday to pause lawsuits against non-bankrupt third parties for up to six months amid the DNA testing company's Chapter 11 proceedings in Missouri.
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June 03, 2025
Rosen, Pomerantz To Lead Seattle Biotech Class Action
The Rosen Law Firm PA and Pomerantz LLP will serve as co-lead counsel for shareholders accusing Seattle-based Sana Biotechnology Inc. of misleading investors about its ability to develop certain genetic therapy treatments.
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June 03, 2025
Latham Advises Atai In $390M Merger With Beckley Psytech
U.S.-German biopharmaceutical company atai Life Sciences, advised by Latham & Watkins LLP, said in an announcement Monday that it will acquire Beckley Psytech, led by Mayer Brown LLP and CMS Cameron McKenna Nabarro Olswang LLP, in an all-share transaction that values Beckley at approximately $390 million, creating a combined company focused on fast-acting mental health therapies.
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June 03, 2025
Accord Urges Justices To Reject 'Crush-Resistant' Oxy IP Row
Accord Healthcare Inc. says the U.S. Supreme Court should reject bankrupt OxyContin maker Purdue Pharma LP's attempt to revive its legal effort to use patent laws to block the release of a competing, "crush-resistant" generic painkiller.
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June 03, 2025
Rocket Startup Launches $400M Deal With Wilbur Ross' SPAC
Space and defense-focused startup Innovative Rocket Technologies Inc. plans to go public at a $400 million value by merging with a special purpose acquisition company led by private equity executive and former Trump cabinet official Wilbur Ross.
Expert Analysis
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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
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.
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What To Expect From 'Make America Healthy Again' Actions
The Make America Healthy Again Commission recently established by President Donald Trump and chaired by Robert F. Kennedy Jr. will potentially bring energy and attention to important public health topics, and stakeholders should be aware of pathways for sharing their input and proactively informing proceedings, says Nicholas Manetto at Faegre Drinker.
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How Law Firms Can Counteract The Loneliness Epidemic
The legal industry is facing an urgent epidemic of loneliness, affecting lawyer well-being, productivity, retention and profitability, and law firm leaders should take concrete steps to encourage the development of genuine workplace connections, says Michelle Gomez at Littler and Gwen Mellor Romans at Herald Talent.
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What's At Stake In High Court's Class Member Standing Case
The U.S. Supreme Court’s eventual decision in Labcorp v. Davis could significantly alter how parties prosecute and defend class actions in federal court, particularly if the court determines some proof of member standing is required before a class may be certified, say attorneys at Reed Smith.
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How Citizen Petitions Have Affected Drug Competition
In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.
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5 Keys To Building Stronger Attorney-Client Relationships
Attorneys are often focused on being seen as the expert, but bonding with clients and prospects by sharing a few key personal details provides the basis for a caring, trusted and profoundly deeper business relationship, says Deb Feder at Feder Development.
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Drug Kickback Ruling Will Make FCA Liability Harder To Prove
The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.
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Assessing PE Risk After Mass. False Claims Act Amendments
A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.