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Life Sciences
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January 15, 2025
Del. Justices Mull 'Reasonable' Effort Duty In Drug Biz Deal
An attorney for former stockholders of Ception Therapeutics Inc. told Delaware's top court on Wednesday that a now-retired vice chancellor "asked the wrong question" in dismissing a suit alleging breaches of an agreement to use commercially reasonable efforts before abandoning a new drug prospect.
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January 15, 2025
DOJ Reports $2.9B Haul Under FCA, Largest In 3 Years
Litigation under the False Claims Act generated a little over $2.9 billion in settlements and judgments in the most recent fiscal year, a 5% bump over 2023's total and the most in three years, according to data released Wednesday by the U.S. Department of Justice.
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January 15, 2025
3rd Circ. Preview: NFL Concussion Benefits Fight Tops January
The case of late NFL players' family members who say they shouldn't have to exhume their loved ones' remains to receive benefits from the national concussion settlement takes center stage in the Third Circuit's January argument session.
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January 15, 2025
Chinese Execs Sent Fentanyl Precursor To NY, Jury Told
A novel fentanyl-trafficking case went to trial in New York federal court on Wednesday, with prosecutors arguing that two Chinese chemical executives inked a multimillion-dollar deal to export the raw materials for the drug to a Manhattan lab in 2023.
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January 15, 2025
Former FDA Official Joins King & Spalding Life Sciences Team
King & Spalding on Wednesday announced that a former U.S. Food and Drug Administration official has joined the firm's government matters and regulation practice group after an eight-year stint at the agency.
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January 15, 2025
FDA Bans Red Dye No. 3, Citing Cancer Link In Animal Studies
The U.S. Food and Drug Administration on Wednesday said that it is banning the use of a red dye, Red No. 3, which gives food and drinks a bright red color but has also been linked to cancer in animals.
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January 15, 2025
Holland & Knight Adds Ex-GOP Rep. To Policy Advisory Team
Holland & Knight LLP has hired seven-term Indiana Republican Congressman Larry Bucshon as a senior policy adviser.
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January 15, 2025
Justices Say Nixing Federal Claims Ends Federal Jurisdiction
The U.S. Supreme Court on Wednesday said a proposed class action over alleged mislabeling of prescription dog food was appropriately sent back to state court, holding that once the plaintiff dropped her federal claims, the federal courts no longer had jurisdiction.
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January 14, 2025
Abbott, Novartis Settle HIV Test Patent Beef Ahead Of Trial
Abbott Laboratories, Novartis and Grifols have reached a settlement in a yearslong battle over a patent covering a method for replicating DNA, putting to rest the litigation less than a month before it was set to go to trial, according to an entry in Illinois federal court posted Monday.
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January 14, 2025
Conn. City Hits PBMs And Pharma Cos. With Insulin Pricing Suit
A city partway between New Haven and Hartford took pharmacy benefit managers and drug makers including CVS Health Corp., Eli Lilly and Co. and Novo Nordisk Inc. to Connecticut federal court on Monday, alleging that they conspired to keep diabetes medications and insulin at needlessly high prices.
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January 14, 2025
Latham Grabs Top Spot For 2024 IPOs By Large Margin
Latham & Watkins LLP guided more initial public offerings than any law firm in 2024, capturing a diverse mix of large listings for companies that seized opportunities to go public as the broader IPO market inched toward recovery, new data shows.
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January 14, 2025
Fed. Circ. Judge Asks What's The Rush In Eylea Biosimilar Case
Counsel for Amgen and a Federal Circuit judge got into a back-and-forth Tuesday concerning the pace of an appeal over a denied injunction on Regeneron's biosimilar of Eylea, with the judge wondering why the attorney was so eager to move things along.
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January 14, 2025
Chancery Hits Co. With $2.9M Atty Fee Bill As Sanction
A California medical device molding company that sought millions from a merger partner for breaches of contract in Delaware's Court of Chancery came away Tuesday with awards of $104,000 for its claims and $2.9 million in attorney fees as a sanction for contempt and spoliation by Symbient Product Development LLC founder Scott Castanon.
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January 14, 2025
Cannabis Reformers Split After DEA Judge Cancels Hearings
The cannabis legal and business world was divided Tuesday after a U.S. Drug Enforcement Administration judge hit pause on widely anticipated and historic public hearings on the merits of a proposal to loosen federal restrictions on marijuana.
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January 14, 2025
Dispute Over Eli Lilly Weight Loss Drug Reignited
Compounding pharmacies have reignited a suit against the U.S. Food and Drug Administration over the removal of a lucrative weight loss drug from the shortage list, with a Texas federal judge ordering both sides to turn in briefing on injunctive relief during a Tuesday hearing.
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January 14, 2025
SEC Sues Elon Musk Over Late Twitter Buy-Up Disclosure
Elon Musk violated securities laws by failing to timely disclose his initial buy-up of Twitter stock ahead of his $44 billion acquisition of the company, allowing him to purchase shares at artificially low prices, the U.S. Securities and Exchange Commission alleged in a D.C. federal lawsuit filed Tuesday.
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January 14, 2025
Eli Lilly Says Colo. Clinic Selling Deceptive Weight Loss Drug
Eli Lilly & Co. has sued a Denver health clinic for allegedly selling "unapproved and potentially dangerous" drugs marketed to treat type 2 diabetes and obesity, which the pharmaceutical company said could give consumers the false impression that its U.S. Food and Drug Administration-approved medications don't work.
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January 14, 2025
TikTok Says NC Can't Fault Platform For Being 'Too Engaging'
TikTok Inc. has asked for an early exit from the North Carolina attorney general's lawsuit accusing the video platform of harming young users, saying it has no significant ties to the Tar Heel state and the AG's office can't otherwise build a case around its platform being "too engaging."
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January 14, 2025
MIT Bio Lab Can't Use Anti-SLAPP To Duck Defamation Suit
The Massachusetts Appeals Court on Tuesday ruled that the state's anti-SLAPP statute could not stop a suit brought by the former head of an MIT-affiliated biomedical research lab who stepped down amid a finding that he harassed a subordinate, though several of his claims were axed nonetheless.
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January 14, 2025
Mass. AG Says Insulin Makers, Middlemen Colluded On Costs
Insulin makers Eli Lilly, Sanofi and Novo Nordisk conspired with pharmacy benefit managers OptumRX, Express Scripts and CVS Caremark to jack up prices by as much as 1,000%, the Massachusetts attorney general alleged in a suit.
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January 13, 2025
Robo-Surgery Part Reset Is Reliable, Expert Tells Antitrust Jury
A mechanical engineering expert who testified Monday in an antitrust trial in California federal court over claims that Intuitive Surgical Inc. abuses its market power by blocking hospitals from extending the life of a surgical robot part said the extension procedure was "thorough" and "reliable."
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January 13, 2025
Ozempic Maker Says Atlanta Clinic Misuses TM To Sell Meds
Novo Nordisk, the pharmaceutical company that makes weight loss drugs Ozempic, Rybelsus and Wegovy, filed suit against an Atlanta anti-aging treatment center in Georgia federal court Friday, alleging trademark infringement, false advertising, unfair competition and deceptive trade practices.
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January 13, 2025
5 Firms Steer Up-To-$750M Sale Of Life Molecular Imaging
Radiopharmaceutical-focused company Lantheus Holdings Inc. announced plans Monday to buy Life Molecular Imaging Ltd. for up to $750 million in a deal built by five law firms.
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January 13, 2025
Acting USPTO Chief Won't Review Seed IP Challenge Denial
The acting leader of the U.S. Patent and Trademark Office shot down a bid by a Cambridge, Massachusetts, gene-editing startup to review decisions rejecting its challenges to patents covering purportedly novel corn seeds developed by a unit of DowDuPont spin-off Corteva.
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January 13, 2025
Goodwin Procter Adds NY IP Attys From Fenwick, Desmarais
Goodwin Procter LLP announced Monday that it was expanding its intellectual property practice in New York with two scientifically talented lawyers, one from Fenwick & West LLP, the other from Desmarais LLP.
Expert Analysis
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Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement
While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.
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Parsing NJ Court's Rationale For Denying Lipitor Class Cert.
A New Jersey federal court's recent Lipitor rulings granting summary judgment and denying motions for class certification for two plaintiff classes offer insight into the level of rigorous analysis required by both parties and their experts to satisfy the requirements of class certification, says Catia Twal at Edgeworth Economics.
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Gilead Drug Ruling Creates Corporate Governance Dilemma
If upheld, a California state appellate court's decision — finding that Gilead is liable for delaying commercialization of a safer HIV drug to maximize profits on another drug — threatens to undermine long-standing rules of corporate law and exposes companies to liability for decisions based on sound business judgment, says Shireen Barday at Pallas.
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3 Leadership Practices For A More Supportive Firm Culture
Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.
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Rebuttal
Cancer Research Org. Is Right To Avoid Corporate Influence
While a previous Law360 guest article criticizes the International Agency for Research on Cancer's processes, its reliance on peer-reviewed literature is proper and its refusal to allow corporate influence is sound science, say Lance Oliver and Ridge Mazingo at Motley Rice.
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Cannabis Biz Real Estate Loan Considerations For Lenders
Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.
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E-Discovery Quarterly: Rulings On Hyperlinked Documents
Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.
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Loper Bright Limits Federal Agencies' Ability To Alter Course
The U.S. Supreme Court's recent decision to dismantle Chevron deference also effectively overrules its 2005 decision in National Cable & Telecommunications Association v. Brand X, greatly diminishing agencies' ability to change regulatory course from one administration to the next, says Steven Gordon at Holland & Knight.
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.