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Life Sciences
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January 27, 2025
Fund Tells Jury No Need To Return $11M Short-Swing Profits
A hedge fund told a Denver federal jury Monday that the $11 million it earned from the short-swing sales of a biopharmaceutical company's stock doesn't need to be returned because the transactions fall under an exception to securities law on insider trading.
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January 27, 2025
Takeda Pushes Meijer Antitrust Suit Into Arbitration
Meijer is going to have to arbitrate its claims that Takeda Pharmaceutical broke antitrust law by cutting a pay-for-delay deal with Par Pharmaceuticals to keep a generic version of Takeda's anti-constipation drug Amitiza off the market for several years.
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January 27, 2025
Jury Will Decide $140M Intuitive Robo-Surgery Antitrust Case
A federal judge on Monday rejected dueling requests for directed verdicts at the wrap of a $140 million antitrust trial over claims that Intuitive Surgical abused its market power in barring a repair provider's refurbished part for Intuitive's surgery robot, saying there's "substantial evidence" for jurors to decide on the parties' claims and counterclaims.
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January 27, 2025
2 Firms Want To Co-Lead Humacyte Investor Suit
Hagens Berman Sobol Shapiro LLP and Pomerantz LLP have asked to co-lead a proposed class of Humacyte Inc. investors alleging that the company failed to disclose quality assurance issues at its manufacturing facilities, which delayed regulatory review for its bioengineered blood vessel product candidate.
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January 27, 2025
FOIA Lawsuit Seeks Marijuana Docs From Health Officials
A nonprofit that advocates for government transparency has filed a federal lawsuit under the Freedom of Information Act seeking to push federal health regulators to release internal communications related to their recommendation to loosen restrictions on marijuana.
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January 27, 2025
Obesity-Focused Metsera Leads Biotech Firms Eyeing IPOs
Obesity-focused drug developer Metsera launched plans on Monday for an estimated $275 million initial public offering, joined by kidney-disease focused Maze Therapeutics, both of which plan to tap the markets this week under combined guidance of four law firms.
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January 27, 2025
Investors Sue Pharma Co. After Cancer Drug Trial Termination
Prostate cancer treatment developer ESSA Pharma Inc. has been hit with a proposed shareholder class action in Wisconsin federal court alleging company shares fell over 70% after the company announced that it was terminating a clinical trial when it discovered its lead product candidate was not as effective as an existing treatment for certain cancer patients.
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January 27, 2025
J&J Talc Unit's $9B Ch. 11 Plan Draws Slew Of Objections
The U.S. Trustee's Office and lawyers representing talc claimants have urged a Texas bankruptcy judge to reject a Johnson & Johnson spinoff's $9 billion plan to settle thousands of cancer claims through Chapter 11, arguing the proposed reorganization must fail because the bankruptcy case was filed in bad faith.
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January 27, 2025
Novo Nordisk's Obesity Drug Study Allegedly Duped Investors
Novo Nordisk was hit with a proposed securities class action in New Jersey federal court Friday, accusing the drugmaker of duping investors about its new weight loss drug CagriSema by failing to disclose that obesity patients were taking different dosages in a clinical study, which allegedly skewed results.
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January 27, 2025
Cencora CLO's Pay Package Nearly Doubled In 2024
The chief legal officer of Cencora Inc. received a $3 million stock boost that raised her total compensation in 2024 to nearly double the previous year.
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January 27, 2025
Justices Turn Away Venue Row In Zantac Carcinogen Claims
The U.S. Supreme Court on Monday declined to review the Second Circuit's split decision that Connecticut state court is the right venue for consolidated claims brought against multiple pharmaceutical companies over alleged carcinogens in heartburn medication Zantac.
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January 25, 2025
Trump Revives Federal Anti-Abortion Policies
President Donald Trump issued two executive orders Friday targeting abortion inside and outside the United States, reinstating a ban on federal funding for certain international family planning groups and revoking a pair of Biden-era directives supporting abortion access.
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January 24, 2025
Intuitive Doesn't Owe 'Free-Riding' Firm $140M, Expert Says
Robotic surgery pioneer Intuitive Surgical isn't a monopolist since it competes with other surgery options and a "free-riding" surgical repair company isn't due up to $140 million in profits allegedly lost due to Intuitive blocking its unauthorized part-refurbishment service, an economist testified Friday in a California antitrust trial.
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January 24, 2025
Senate Bill Not Seen As Death Knell For Skinny Label Suits
A Senate bill aiming to protect generic-drug makers from patent suits when using so-called skinny labels could give the law more clarity if passed, but it likely wouldn't halt such cases since they involve issues that are more complex than lawmakers may realize, attorneys say.
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January 24, 2025
Pfizer To Pay $59M Over Unit's Migraine Drug Kickbacks
The U.S. Department of Justice announced Friday that Pfizer has agreed in New York federal court to pay $59.7 million to resolve allegations that one of its subsidiaries caused false Medicare claims by paying kickbacks to physicians to induce prescriptions of migraine drug Nurtec ODT.
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January 24, 2025
Justices To Clarify Article III Standing For Certified Classes
The U.S. Supreme Court granted LabCorp's request on Friday to clarify federal law regarding whether district courts can certify class actions when some members of the proposed class may lack a cognizable injury in fact.
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January 24, 2025
Ill. Justices OK Workers' Injury Suits Over Dormant Diseases
The Illinois Supreme Court answered the Seventh Circuit's call on Friday to clarify the state's Workers' Occupational Diseases Act in a widow's wrongful death lawsuit against Goodrich Corp., finding the statute can apply to claims for asbestos-related cancer and other diseases that manifest belatedly despite the statute's other temporal restrictions.
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January 24, 2025
Del. Justices Reject Investor Suit Over Dropped Drug Prospect
Delaware's Supreme Court on Friday upheld a Court of Chancery decision dismissing a Ception Therapeutics Inc. stockholder suit alleging breaches of an agreement to use commercially reasonable efforts before Cephalon Inc., which acquired Ception, and Teva Pharmaceuticals USA Inc. abandoned a new drug prospect.
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January 24, 2025
IVF Patients Want CooperSurgical Embryo Loss Suits Joined
Four product liability lawsuits targeting the maker of recalled culture media for in vitro fertilization should be consolidated and sent to the Connecticut Superior Court's complex litigation docket, the parties have agreed, but defendant CooperSurgical Inc. wants them kept out of Stamford.
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January 24, 2025
Biotech Co. Defends Antitrust Counterclaims Against Rival
Biotech company Zymo Research Corp. is defending its claims that German diagnostic competitor Qiagen GmbH's infringement suit is nothing more than an attempt to discredit a competitor, saying Zymo offered to prove it wasn't ripping off Qiagen's tech, only to have Qiagen bury "its head in the sand" and file suit.
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January 24, 2025
Venture-Backed IPO Recovery Could Be Muted, Report Says
The expected recovery for venture-backed initial public offerings in 2025 will likely be muted, a capital markets research firm said Friday, given investors' persistent concerns about valuation and delayed interest rate cuts that may not happen until midyear.
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January 23, 2025
Intuitive Judge Walks Back 'Inappropriate' Witness Instruction
Counsel for Intuitive Surgical objected Thursday to a California federal judge's "inappropriate instruction" to a witness testifying in a trial over allegations it abused its market power by blocking hospitals from using a refurbished part for its surgery robot, prompting the judge to walk back the direction.
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January 23, 2025
4th Circ. Reads Kickback Law Broadly In Loss For Big Pharma
The Fourth Circuit on Thursday affirmed a Virginia federal judge's ruling against a pharmaceuticals industry-backed charity looking to weaken the Anti-Kickback Statute, holding that a proposed program for helping patients cover the cost of drugs could indeed constitute a quid pro quo.
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January 23, 2025
GoodRx, PBMs Sued Over Alleged Generics Price-Fix Scheme
GoodRx and pharmacy benefit managers, including CVS Caremark and Express Scripts, formed a "cartel" to execute a price-fixing scheme by sharing pricing information and agreeing not to outbid each other for reimbursement rates paid to pharmacies for generic drugs, alleges a proposed class action filed Wednesday in California federal court.
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January 23, 2025
Unsigned Bladder Drug Patent Deal Not Binding, Judge Rules
A federal judge has rejected Astellas Pharma's request to enforce a purported settlement with MSN Pharmaceuticals in a patent dispute over MSN's planned generic version of an overactive bladder drug, holding that the deal is not binding because MSN never signed it.
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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Recent Suits Show Antitrust Agencies' Focus On HSR Review
The U.S. Department of Justice's suit this month against KKR for inaccurate and incomplete premerger filings, along with other recent cases, highlights the agency's increasing scrutiny of Hart-Scott-Rodino Act compliance for private equity firms, say attorneys at Willkie.
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The 7th Circ.'s Top 10 Civil Opinions Of 2024
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2024, and explain how they may affect issues related to mass arbitration, consumer fraud, class certification and more.
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Royal Canin Ruling Won't Transform Removal Jurisdiction
The U.S. Supreme Court's ruling in Royal Canin USA v. Wullschleger means that federal district courts must now remand whenever an amended complaint excises grounds for federal jurisdiction — but given existing litigation strategy and case law trends, this may ultimately preserve, rather than alter, the status quo, say attorneys at Norton Rose.
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Lessons From The Pharma Industry On Patent Cliffs
In the next five years, patents for drugs that have generated billions in global sales are set to expire, and companies that view this imminent patent cliff as an opportunity for strategic renewal rather than a challenge will be best positioned to maintain market leadership, says Keegan Caldwell at Caldwell Law.
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Mentorship Resolutions For The New Year
Attorneys tend to focus on personal achievements or career milestones when they set yearly goals, but one important area often gets overlooked in this process — mentoring relationships, which are some of the most effective tools for professional growth, say Kelly Galligan at Rutan & Tucker and Andra Greene at Phillips ADR.
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What Nearshoring Growth In Americas Means For Patents
With the new U.S. administration potentially focused on implementing draconian trade restrictions, nearshoring in the Americas is expected to grow, and patent prosecution attorneys will be kept on their toes as the patent landscape from country to country continues to evolve, says Ernest Huang at Procopio.
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Takeaways From FDA's Updated Confirmatory Trial Guidance
The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.
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The Most Important Schedule I Drug Regulatory Shifts Of 2024
In 2024, psychedelics and cannabis emerged as focal points in medical research, marking a pivotal year in their legal and regulatory journey, but these developments presented both opportunities and challenges within this evolving field, say Kimberly Chew at Husch Blackwell and Stephen Kim at Avicanna.
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Series
Coaching Little League Makes Me A Better Lawyer
While coaching poorly played Little League Baseball early in the morning doesn't sound like a good time, I love it — and the experience has taught me valuable lessons about imperfection, compassion and acceptance that have helped me grow as a person and as a lawyer, says Alex Barnett at DiCello Levitt.
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5 Litigation Funding Trends To Note In 2025
Lawyers and their clients must be prepared to navigate an evolving litigation funding market in 2025, made more complicated by a new administration and the increasing overall cost of litigation, says Jeffery Lula at GLS Capital.
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A Look At FDA's Plans To Establish New OTC Drug Category
The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.
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The Fed. Circ. In 2024: 5 Major Rulings To Know
In 2024, the Federal Circuit provided a number of important clarifications to distinct areas of patent law – including design patent obviousness, expert testimony admissions and patent term adjustments – all of which are poised to have an influence going forward, say attorneys at Knobbe Martens.
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Rethinking Litigation Risk And What It Really Means To Win
Attorneys have a tendency to overestimate litigation risk before summary judgment and underestimate risk after it, but an eight-stage litigation framework can clarify risk at different points and help litigators reassess what true success looks like in any particular case, says Joshua Libling at Arcadia Finance.
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How DOGE's Bite Can Live Up To Its Bark
All signs suggest that the Department of Government Efficiency will be an important part of the new Trump administration, with ample tools at its disposal to effectuate change, particularly with an attentive Republican-controlled Congress, say attorneys at K&L Gates.
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US-China Deal Considerations Amid Cross-Border Uncertainty
With China seemingly set to respond to the incoming U.S. administration's call for strategic decoupling and tariffs, companies on both sides of the Pacific should explore deals and internal changes to mitigate risks and overcome hurdles to their strategic plans, say attorneys at Covington.