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Life Sciences
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August 07, 2025
HHS Wins Another Round In Medicare Drug Negotiation Battle
A Texas federal court dealt another blow to the pharmaceutical industry Thursday when it ruled in favor of Medicare's Drug Price Negotiation Program, turning away arguments that the program is unconstitutional — the third such decision in two days.
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August 07, 2025
BioNTech's Acquisition Of CureVac Ends COVID Vax Case
CureVac's case alleging Pfizer and BioNTech infringed patents related to messenger RNA technology is set to be dismissed after BioNTech announced in June that it would be acquiring CureVac, canceling what would have been the first-ever trial over COVID-19 vaccine patents in the U.S.
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August 07, 2025
BioPharma Co.'s $15M Deal Over Ruined J&J Vaccines OK'd
A Maryland federal judge on Thursday granted final approval to a $15 million settlement to close out a stockholder derivative suit claiming Emergent BioSolutions Inc. and its top brass made a mint selling stock before their allegedly lax oversight led to the contamination of over 15 million Johnson & Johnson COVID-19 vaccine doses.
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August 07, 2025
Michigan AG Fights Bid To Pause PBM Price-Fixing Suit
Michigan's attorney general has said there is no reason to pause her price-fixing suit against pharmacy benefit managers Express Scripts and Prime Therapeutics for a pending dismissal motion, urging a federal judge not to put discovery on ice.
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August 07, 2025
Ex-Worker Sues Firm For Bias After Work On CDC Contract
A former employee sued a management consulting and professional services firm in Georgia federal court Wednesday, alleging he was discriminated against and ultimately fired because of his Islamic faith and PTSD while working on a three-year Centers for Disease Control and Prevention contract.
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August 07, 2025
Novartis Faces $291M Trade Secrets Suit From Hedge Fund
A hedge fund on Thursday accused Novartis, a former investment executive and the executive's longtime friend and business partner of scheming to steal its "innovative hedge fund strategy" after an investment deal between the biotech giant and the hedge fund went south.
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August 07, 2025
Anthem Seeks Exit From Lab's $3.8M Insurance Suit
Anthem Blue Cross Blue Shield of Connecticut again asked a federal judge to let it out of a lab's $3.8 million suit alleging the company failed to pay 3,000 insurance claims for medical tests, arguing that the lab's second amended complaint didn't make up for the deficiencies that got most of the first one dismissed.
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August 07, 2025
2nd Circ. Axes Challenge To Medicare Drug Price Negotiations
In a published opinion Thursday, the Second Circuit turned away Boehringer Ingelheim's constitutional and administrative challenge to the Medicare Drug Price Negotiation Program, finding that the program is voluntary and it was lawfully implemented under the Inflation Reduction Act.
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August 07, 2025
Rising Star: Goodwin's Laura Umbrecht Gulick
Laura Umbrecht Gulick of Goodwin Procter LLP advised Human Immunology Biosciences and Mariana Oncology in billion-dollar deals with Big Pharma last year, earning her a spot among the life sciences law practitioners under age 40 honored by Law360 as Rising Stars.
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August 07, 2025
Investors Back Cancer Ultrasound Tech Firm at $2.25B Value
HistoSonics Inc. said Thursday it has secured a majority stake acquisition led by its management team and backed by a syndicate of investors including K5 Global, Bezos Expeditions and Wellington Management, valuing the maker of the Edison Histotripsy System at about $2.25 billion.
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August 07, 2025
Fed. Circ. Affirms PTAB Ax Of Bone Fusion Device Patents
The Federal Circuit on Thursday upheld Patent Trial and Appeal Board rulings that invalidated claims in a pair of Stryker Corp. patents for a surgical implant that a Berkshire Hathaway-owned rival had challenged.
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August 07, 2025
NC Biz Court Bulletin: Divorce Dust-Ups And Judicial Rebukes
Litigation in the North Carolina Business Court is heating up this summer with new complaints centered on fears a former state politician's divorce proceedings will impede his companies' operations and accusations that a climate technology company has failed to pay out a former engineer's ownership interest.
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August 06, 2025
6th Circ. Rips 'Stalking Horse' Ploy In Drug Negotiation Suit
The pharmaceutical industry will feel the sting of a Wednesday loss in a wide-ranging war over Medicare's power to negotiate drug prices, as the Sixth Circuit tossed a suit and accused one major company of utilizing a "stalking horse" to sue in a more favorable forum.
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August 06, 2025
Ga. Judges Weigh Birth Defect Ruling in Sterigenics Case
A group of Georgia residents who alleged they were injured by emissions from a Sterigenics sterilization plant urged the Georgia Court of Appeals on Wednesday to overturn a lower court's grant of partial summary judgment to the company on the issue of whether the plant's emissions caused birth defects.
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August 06, 2025
Masimo Drops Founder Joe Kiani From 'Empty Voting' Suit
Masimo Corp. has agreed to free its founder, Joe Kiani, from the medical technology company's suit alleging he manipulated a shareholder vote through an "empty voting" scheme, pointing to "the interest of judicial efficiency and economy."
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August 06, 2025
Indivior Beats Investor Suit Over Opioid Drug Sales Forecasts
A Virginia federal judge Wednesday tossed an investor class action accusing drugmaker Indivior PLC of overstating the financial prospects of its drugs used to treat opioid use disorders and its ability to forecast such financial projections, finding, among other things, that the complaint's challenged statements are inactionable.
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August 06, 2025
Insulin Collusion Needn't Be 'Clever' To Exist, 2nd Circ. Says
A Second Circuit panel revived safety-net providers' proposed class action claims against Sanofi, Eli Lilly, Novo Nordisk and AstraZeneca on Wednesday that allege the company agreed to limit discount program participation to spike insulin and weight-loss drug costs, with the appeals court rejecting drugmaker arguments that their actions weren't "clever" enough to be collusion.
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August 06, 2025
State AGs Want Final OK For $39M Apotex Price-Fixing Deal
Nearly every state attorney general in the country has asked a Connecticut federal judge to give final approval to a $39.1 million deal to settle claims that drugmaker Apotex Corp. schemed with others to fix prices and allocate markets for generic drugs, noting that the Florida-based company has already made the payment.
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August 06, 2025
Judge OKs Addition Of Kenvue, Janssen To J&J Talc MDL
A New Jersey federal judge has rejected Johnson & Johnson's challenge to cancer patients' bid to add additional corporate defendants to multidistrict federal litigation over its talcum powder products, finding the additions would not be futile.
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August 06, 2025
Rising Star: Quinn Emanuel's Frank Calvosa
Frank Calvosa of Quinn Emanuel Urquhart & Sullivan LLP helped land a jury trial win for Jazz Pharmaceuticals that protected its $1.8 billion market share of a daytime sleepiness drug, earning him a spot among the life sciences law practitioners under age 40 honored by Law360 as Rising Stars.
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August 06, 2025
FTC Challenges $945M Heart Valve Deal
The Federal Trade Commission filed suit Wednesday against Edwards Lifesciences Corp. over the company's proposed $945 million purchase of JenaValve Technology Inc., arguing the deal would give Edwards control over both of the only firms with ongoing U.S. clinical trials developing an important heart valve replacement device.
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August 06, 2025
2nd Circ. Backs J&J Spinoff In 'Rapid Release' Label Suit
The Second Circuit on Wednesday declined to revive a proposed class action alleging a Johnson & Johnson spinoff company misled consumers by claiming that "Rapid Release" Tylenol gelcaps dissolve faster than other types of Tylenol.
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August 05, 2025
Novo Nordisk Lodges Suits Over 'Knockoff' Semaglutide Meds
Novo Nordisk said Tuesday it has recently filed more than a dozen lawsuits accusing weight loss companies, med spas and pharmacies of tricking patients into purchasing and using unapproved drugs containing semaglutide, which the Danish pharmaceutical company uses in its blockbuster medicines Wegovy and Ozempic.
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August 05, 2025
OptumRx Urges Panel To DQ Motley Rice In LA Opioid Suit
OptumRx told a California appellate panel Tuesday that Motley Rice should be disqualified from representing Los Angeles County in a lawsuit alleging it colluded with drugmakers to fuel the opioid crisis, saying the firm violated state law by using confidential information obtained in the case in other lawsuits it's handling against Optum.
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August 05, 2025
Key Opioid Theory Actually Irrelevant, Drug Cos. Tell 4th Circ.
With federal judges in West Virginia suddenly split over the central legal theory in opioid litigation, major drug distributors are insisting the theory actually doesn't matter, telling the Fourth Circuit it can uphold their triumph in a landmark trial without even touching the hot-button issue.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Series
Creating Botanical Art Makes Me A Better Lawyer
Pressing and framing plants that I grow has shown me that pursuing an endeavor that brings you joy can lead to surprising benefits for a legal career, including mental clarity, perspective and even a bit of humility, says Douglas Selph at Morris Manning.
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Opinion
The Legal Education Status Quo Is No Longer Tenable
As underscored by the fallout from California’s February bar exam, legal education and licensure are tethered to outdated systems, and the industry must implement several key reforms to remain relevant and responsive to 21st century legal needs, says Matthew Nehmer at The Colleges of Law.
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2nd Circ. Reinforces Consensus On Vacating Foreign Awards
In Molecular Dynamics v. Spectrum Dynamics Medical, the Second Circuit recently affirmed that federal district courts do not possess subject matter jurisdiction to vacate foreign arbitral awards, strengthening this consensus across the circuits most active in recognition and enforcement actions, says Ed Mullins at Reed Smith.
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E-Discovery Quarterly: Rulings On Relevance Redactions
In recent cases addressing redactions that parties sought to apply based on the relevance of information — as opposed to considerations of privilege — courts have generally limited a party’s ability to withhold nonresponsive or irrelevant material, providing a few lessons for discovery strategy, say attorneys at Sidley.
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How DOJ's New Data Security Rules Leave HIPAA In The Dust
The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.
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Opinion
Section 1983 Has Promise After End Of Nationwide Injunctions
After the U.S. Supreme Court recently struck down the practice of nationwide injunctions in Trump v. Casa, Section 1983 civil rights suits can provide a better pathway to hold the government accountable — but this will require reforms to qualified immunity, says Marc Levin at the Council on Criminal Justice.
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Trump's 2nd Term Puts Merger Remedies Back On The Table
In contrast with the Biden administration, the second Trump administration has signaled a renewed willingness to resolve merger enforcement concerns through remedies from the outset, particularly when the proposed fix is structural, clearly addresses the harm and does not require burdensome oversight, say attorneys at Cooley.
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Patent Ambiguity Persists After Justices Nix Eligibility Appeal
The Supreme Court recently declined to revisit the contentious framework governing patent eligibility by denying certiorari in Audio Evolution Diagnostics v. U.S., suggesting a necessary recalibration of both patent application and litigation strategies, say attorneys at Skadden.
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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Fed. Circ. In June: Transitional Phrases In Patent Claims
The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.
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Series
Playing Soccer Makes Me A Better Lawyer
Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.
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Strategies For Cos. Navigating US-Indian Pharma Partnerships
Recent policy adjustments implemented by the U.S. government present both new opportunities and heightened regulatory scrutiny for the Indian life sciences industry, amplifying the importance of collaboration between the Indian and U.S. pharmaceutical sectors, say Bryant Godfrey at Foley Hoag and Jashaswi Ghosh at Holon Law Partners.
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DOJ-HHS Collab Crystallizes Focus On Health Enforcement
The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.
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Series
Law School's Missed Lessons: Learning From Failure
While law school often focuses on the importance of precision, correctness and perfection, mistakes are inevitable in real-world practice — but failure is not the opposite of progress, and real talent comes from the ability to recover, rethink and reshape, says Brooke Pauley at Tucker Ellis.
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23andMe Fine Signals ICO's New GDPR Enforcement Focus
Many of the cybersecurity failures identified by the Information Commissioner’s Office in its investigation of 23andMe, recently resulting in a £2.3 million fine, were basic lapses, but the ICO's focus on several new U.K. General Data Protection Regulation considerations will likely carry into the future, say lawyers at Womble Bond.