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Life Sciences
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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.
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January 13, 2025
Lilly To Buy Scorpion Cancer Program For Up To $2.5B
Ropes & Gray LLP-led Eli Lilly and Co. said Monday it has agreed to purchase a precision breast cancer program of biotechnology company Scorpion Therapeutics Inc. for up to $2.5 billion.
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January 13, 2025
PBMs' Federal Work Irrelevant To Opioid Suit, Mich. AG Says
Michigan's attorney general urged a federal judge Friday to send a case accusing pharmacy benefit managers of stoking the opioid crisis back to the state court where it was originally filed, saying there is nothing federal about the claims.
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January 13, 2025
Cravath-Led J&J Paying $14.6B For Neuropsychiatric Drug Co.
Johnson & Johnson said Monday it has agreed to purchase Intra-Cellular Therapies Inc., a biopharmaceutical company focused on therapies for neuropsychiatric and neurological disorders, for approximately $14.6 billion.
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January 13, 2025
Feds Say NC Medical Biz Owner Overbilled For Nutrient Drinks
A North Carolina businessman who ran a durable medical equipment business under multiple names overbilled the state's Medicaid program $1.85 million for special enteral nutritional formulas used to treat inherited metabolic disorders when he was actually just providing people common nutritional shakes like Ensure, the federal government said.
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January 13, 2025
Supreme Court Turns Away IP Safe Harbor Dispute
The U.S. Supreme Court on Monday said it won't consider whether the Federal Circuit has overexpanded a safe harbor for drug development, in litigation where Meril Life Sciences escaped allegations that it infringed Edwards Lifesciences' heart valve patents.
Expert Analysis
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Series
Round-Canopy Parachuting Makes Me A Better Lawyer
Similar to the practice of law, jumping from an in-flight airplane with nothing but training and a few yards of parachute silk is a demanding and stressful endeavor, and the experience has bolstered my legal practice by enhancing my focus, teamwork skills and sense of perspective, says Thomas Salerno at Stinson.
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And Now A Word From The Panel: The MDL Map
An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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Why Now Is The Time For Law Firms To Hire Lateral Partners
Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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A Look At The Economic Impact Of Drug Patent Differentiation
Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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New Lessons On Managing Earnout Provision Risks
Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.
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3 Patent Considerations For America's New Quantum Hub
Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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How Companies Are Approaching Insider Trading Policies
An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.
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11 Patent Cases To Watch At Fed. Circ. And High Court
As we head into fall, there are 11 patent cases to monitor, touching on a range of issues that could affect patent strategy, such as biotech innovation, administrative rulemaking and patent eligibility, say Edward Lanquist and Wesley Barbee at Baker Donelson.
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Opinion
3rd. Circ. Got It Right On Cancer Warning Claims Preemption
The Third Circuit's recent, eminently sensible ruling in a failure-to-warn case against Roundup manufacturer Monsanto, holding that the Federal Insecticide, Fungicide and Rodenticide Act preempts state law claims, provides a road map that other courts should adopt, says Lawrence Ebner at the Atlantic Legal Foundation.