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Life Sciences
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August 09, 2024
FDA Rejects Latest Effort To Treat PTSD With MDMA
The U.S. Food and Drug Administration has rejected a new drug application to treat post-traumatic stress disorder with the psychedelic drug MDMA, an entactogen also known as ecstasy or molly, the company that backed the effort announced Friday.
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August 09, 2024
Biopharm Co. Alector Sued In Del. For Docs On Director Pay
A stockholder of small cap biopharmaceutical venture Alector Inc has sued the business in Delaware's Court of Chancery for books and records releases, citing company payment of directors at rates roughly twice the amount paid to nonemployee directors of large cap companies in the same sector.
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August 09, 2024
Novartis Wants DC Judge To Quickly Block Entresto Generic
Novartis Pharmaceuticals urged a D.C. federal judge Friday to temporarily restrain the U.S. Food and Drug Administration from officially approving a generic version of the company's blockbuster heart failure medication Entresto.
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August 09, 2024
Pharmacy Escapes Recklessness Claim In Septic Shock Suit
A Pennsylvania federal judge has dismissed a claim seeking punitive damages from a northern Pennsylvania pharmacist brought by a patient who alleges that her endocrinologist and the pharmacy overprescribed corticosteroids that opened holes in her intestines and subsequently made her go into septic shock and become suicidal.
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August 09, 2024
Vidal's Sanctions Make It Clear: Don't Mess With The PTAB
The Patent Trial and Appeal Board has only faced a handful of instances where sanctions took center stage, but the U.S. Patent and Trademark Office director's rulings have made attorneys increasingly aware that pushing ethical boundaries at the board could put their cases and their careers at risk.
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August 09, 2024
Wash. AG Says Kroger Refusing To Delay Merger For Ruling
The Washington Attorney General's Office told a state court that Kroger will not agree to put off closing its planned merger with Albertsons until after a final ruling in the state's merger challenge, but the companies say they've already agreed not to finalize the deal until litigation plays out in another state.
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August 09, 2024
Merck To Buy Autoimmune Treatment Drug For Up To $1.3B
Pharmaceutical giant Merck, advised by Hogan Lovells, said Friday it has agreed to buy a novel, investigational, clinical-stage, bispecific antibody used to treat B cell-associated diseases from Goodwin Procter LLP-led Curon Biopharmaceutical for up to $1.3 billion.
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August 09, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen China Evergrande Group file a commercial fraud claim against its founder's ex-wife, legal action by Manolete Partners against the directors of an insolvent construction company, VietJet tackle a claim by French banking group Natixis and more developments in the "Dieselgate" scandal. Here, Law360 looks at these and other new claims in the U.K.
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August 08, 2024
Mass. Atty, 2 Others Settle SEC Insider Trading Claims
A Massachusetts business lawyer, his friend and his friend's father have agreed to collectively pay more than $230,000 to settle the U.S. Securities and Exchange Commission's allegations they used intel to trade ahead of an announcement made by the biotechnology company Frequency Therapeutics Inc., the SEC said Thursday.
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August 08, 2024
Pot Cos. Get Creative To Boost Brands Despite Feds' TM Ban
The marijuana industry still lives in the shadows of trademark law while the drug remains federally illegal, leaving businesses and their lawyers to seek workarounds to protect their brands.
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August 08, 2024
Apple Wins Bid For 2 Trials In IP Dispute With Masimo
A California federal judge will hold separate trials on Masimo Corp.'s trade secrets and patent claims over the Apple Watch, siding with Apple Inc. and rejecting Masimo's request for one later trial on all the issues, in a case with potentially billions of dollars at stake.
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August 08, 2024
Cooley Hit With Fla. Malpractice Suit Over Financial Docs
Genetic Networks LLC has sued California-based Cooley LLP in Florida state court, alleging the law firm failed to file documentation needed to secure a lien when preparing loan papers for $1.2 million lent to ECI Pharmaceuticals.
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August 08, 2024
Wilson Sonsini, A&O Shearman Guide $688M Biotech Merger
Salt Lake City-based Recursion said Thursday it has inked a deal to purchase fellow drug design and development company Exscientia for approximately $688 million, under the guidance of Wilson Sonsini Goodrich & Rosati PC.
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August 08, 2024
Deals Rumor Mill: Roche, Thoma Bravo, Klarna
Roche is considering divesting cancer data specialist Flatiron Health, Thoma Bravo is exploring a sale of compliance software maker Cority, and fintech startup Klarna is preparing a secondary-share sale ahead of a planned IPO. Here, Law360 breaks down these and other notable deal rumors from the past week.
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August 08, 2024
Rising Star: Williams & Connolly's Elise Baumgarten
Elise Baumgarten of Williams & Connolly LLP was counsel for Endo Pharmaceuticals in a "pay for delay" class action arising from a patent settlement that ended with a verdict in Endo's favor, and she won a major trial for Merck & Co. Inc. in Hatch-Waxman patent litigation, earning her a spot among healthcare law practitioners under age 40 honored by Law360 as Rising Stars.
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August 07, 2024
Exec Unlikely To Get New Trial In SEC's 'Shadow Trading' Suit
A California federal judge said at a hearing Wednesday that he wasn't inclined to grant a new trial in a novel SEC "shadow trading" case, saying "there's no question" that a former executive of Medivation, a pharmaceutical company, knew that he was using inside information from his company when he purchased a rival's stock.
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August 07, 2024
Biotech Firm Can't Pause SEC Action During Appeal
A Colorado federal magistrate judge won't pause a lawsuit by securities regulators against a biotech company accused of misappropriating roughly $9 million while the company appeals an asset freeze, agreeing in a Wednesday order with the SEC's argument that investors would be better served if the case moved ahead.
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August 07, 2024
Abbott Brass Trim But Can't Nix Investors' Formula Recall Suit
A Chicago federal judge on Wednesday substantially trimmed a derivative suit accusing Abbott Laboratories leaders of concealing known safety issues related to recalled infant formula but rejected the defendants' argument that tossing the suit in its entirety was in shareholders' "best interest."
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August 07, 2024
Judge's Pharma Comments Could Decide Ineligibility Appeal
A Federal Circuit panel on Wednesday was willing to explore Astellas Pharma's argument that a Nebraska federal judge should be taken off its infringement case over the bladder medication Myrbetriq, given statements that showed a potential bias against the pharmaceutical industry, but also made clear that such reassignments are rare and difficult.
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August 07, 2024
Advocates Tell 9th Circ. To Revive Invisalign Monopoly Suit
Competition advocates are backing the revival of a class action accusing the makers of Invisalign of monopolizing the market for clear dental aligners, telling the Ninth Circuit in a new amicus brief that a district court summary judgment ruling for Align Technology creates a dangerous precedent for refusal-to-deal cases.
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August 07, 2024
Teva Finds Some Big-Pharma Friends In Inhaler Patent Fight
Two large pharmaceutical companies have weighed in to ask the Federal Circuit to overturn a ruling that found that Teva's branded drugmaking operation misused a key federal patent database in order to block the release of competing generic asthma inhalers.
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August 07, 2024
NC Biz Court Bulletin: The Battles Making Summer Sizzle
A 1983 championship basketball team's intellectual property rights and a public feud between Cadwalader Wickersham & Taft LLP and its insurer are among the legal battles that have kept North Carolina Business Court judges and Tar Heel state private practice attorneys busy this summer. In case you missed those and others, here are the highlights.
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August 07, 2024
Amgen Waged Lawfare To Overcharge For Drug, Suit Claims
Maryland-based independent licensees of the Blue Cross Blue Shield Association claim pharmaceutical giant Amgen Inc. and its subsidiaries have engaged in unlawful monopolistic practices that have inflated the cost of the blockbuster drug Enbrel.
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August 07, 2024
Ex-Pharma Exec Gets 20 Months In SEC Contempt Case
A former pharmaceutical executive who used an alias to flout a 2016 U.S. Securities and Exchange Commission consent judgment barring him from the securities industry was sentenced Wednesday to 20 months in prison by a judge who called him "incorrigible."
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August 07, 2024
Law Firms Fight J&J Bid To Revive Talc Subpoenas
The Beasley Allen Law Firm, the steering committee of talc plaintiffs suing Johnson & Johnson, and a third-party law firm urged the New Jersey federal court this week to reject a bid from the pharmaceutical company to reinstate subpoenas seeking evidence of alleged third-party litigation funding.
Expert Analysis
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When Trade Secret Protection And Nat'l Security Converge
The Trump administration's anti-espionage program focused on China is over, but federal enforcement efforts to protect trade secrets and U.S. national security continue, and companies doing business in high-risk jurisdictions need to maintain their compliance programs to avoid the risk of being caught in the crosshairs of an investigation, say attorneys at Baker McKenzie.
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The Merger Cases That Will Matter At ABA Antitrust Meeting
While the American Bar Association's Antitrust Spring Meeting this week will cover all types of competition law issues in the U.S. and abroad, expect the federal agencies' recent track record in merger enforcement to be a key area of focus on the official panels and in cocktail party chatter, say attorneys at Freshfields.
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Calif. Verdict Showcases SEC's New 'Shadow Trading' Theory
Last week's insider trading verdict, delivered against biopharmaceutical executive Matthew Panuwat by a California federal jury, signals open season on a new area of regulatory enforcement enabled by the U.S. Securities and Exchange Commission's shadow trading theory, say Perrie Weiner and Aaron Goodman at Baker McKenzie.
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Series
Playing Hockey Makes Me A Better Lawyer
Nearly a lifetime of playing hockey taught me the importance of avoiding burnout in all aspects of life, and the game ultimately ended up providing me with the balance I needed to maintain success in my legal career, says John Riccione at Taft.
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For Lawyers, Pessimism Should Be A Job Skill, Not A Life Skill
A pessimistic mindset allows attorneys to be effective advocates for their clients, but it can come with serious costs for their personal well-being, so it’s crucial to exercise strategies that produce flexible optimism and connect lawyers with their core values, says Krista Larson at Stinson.
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HHS Opioid Rule Generally Benefits Providers And Patients
The U.S. Department of Health and Human Services' newly effective rule, the first substantial change to opioid treatment programs and delivery standards in over 20 years, significantly expands access and reduces stigma around certain medications, though the rule is narrow in scope and does have some limitations, say attorneys at Alston & Bird.
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Trump's NY Civil Fraud Trial Spotlights Long-Criticized Law
A New York court’s recent decision holding former President Donald Trump liable for fraud brought old criticisms of the state law used against him back into the limelight — including its strikingly broad scope and its major departures from the traditional elements of common law fraud, say Mark Kelley and Lois Ahn at MoloLamken.
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Opinion
Requiring Leave To File Amicus Briefs Is A Bad Idea
A proposal to amend the Federal Rules of Appellate Procedure that would require parties to get court permission before filing federal amicus briefs would eliminate the long-standing practice of consent filing and thereby make the process less open and democratic, says Lawrence Ebner at the Atlantic Legal Foundation and DRI Center.
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2 Recent Suits Show Resiliency Of Medicare Drug Price Law
Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.
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4 Ways To Motivate Junior Attorneys To Bring Their Best
As Gen Z and younger millennial attorneys increasingly express dissatisfaction with their work and head for the exits, the lawyers who manage them must understand and attend to their needs and priorities to boost engagement and increase retention, says Stacey Schwartz at Katten.
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Defense Attys Must Prep For Imminent AI Crime Enforcement
Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.
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Planning For Healthcare-Private Equity Antitrust Enforcement
U.S. antitrust agency developments could mean potential enforcement actions on healthcare-related acquisitions by private equity funds are on the way, and entities operating in this space should follow a series of practice tips, including early assessment of antitrust risks on both the state and federal level, say Ryan Quillian and John Kendrick at Covington.
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Opinion
Why USPTO Should Issue Inherency Guidance Memo
The U.S. Patent and Trademark Office should issue a new guidance memo in regard to the standard for inherency during the examination process, as the standard is frequently misapplied during prosecution, and consistency of the standard in the USPTO should match that in the federal courts, says Irving Feit at Lucas & Mercanti.
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How Purdue Pharma High Court Case May Change Bankruptcy
The U.S. Supreme Court’s upcoming ruling in Purdue Pharma may be the death of most third-party releases in Chapter 11 cases, and depending on the decision’s breadth, could have much more far-reaching effects on the entire bankruptcy system, say Brian Shaw and David Doyle at Cozen O'Connor.
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3 Health Insurance Paths For Psychedelic-Assisted Therapy
Ahead of potential U.S. Food and Drug Administration approvals for psychedelics as insured treatments, attorneys at Husch Blackwell review pathways for these drugs to achieve coverage as treatments for complex mental health conditions.