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Life Sciences
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September 06, 2024
Goodwin-Led Cancer Biotech Eyes Roughly $200M IPO
Drug developer Bicara Therapeutics Inc., advised by Goodwin Proctor LLP, announced on Friday plans to raise around $200 million in its initial public offering, with the proceeds going toward developing bifunctional antibodies designed to treat solid tumors.
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September 06, 2024
Glioblastoma Org. Wants End To Rival's Use Of 'GBM'
The Glioblastoma Foundation has hit a competing nonprofit with a suit alleging that the group's use of the initials "GBM" in its name has ripped off its trademark and sown confusion among donors who can't tell the two organizations apart.
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September 05, 2024
Lawmakers, AGs Urge Justices To OK Denial Of E-Cig Apps
A coalition of state attorneys general and a group of Democratic Congress members are backing the U.S. Food and Drug Administration in its fight to persuade the U.S. Supreme Court to overturn a decision striking down the denials of applications to market flavored vapes.
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September 05, 2024
Law Firms Appeal Atty Fee Denial In Opioid Settlements
Two law firms, Goldstein & Russell PC and Kelley & Ferraro LLP, have claimed in an appeal to the Sixth Circuit that they were improperly shut out of the $2.13 billion attorney fee pool created by recent national opioid settlements with major pharmaceutical companies and pharmacy chains.
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September 05, 2024
Class Attys Vie To Lead Drug Co. Insider Trading Suit In Del.
A courtroom face-off over lead stockholder counsel duties in a Delaware Chancery Court case accusing a biopharmaceutical company's directors of insider trading and fiduciary duty breaches got edgy Thursday, after one of the plaintiff-side legal teams contended that the other's case was irreparably hobbled by conflicts of interest.
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September 05, 2024
Lupin Infringes Exeltis Contraceptive Patents, Judge Finds
Mumbai-based generic-pharmaceuticals company Lupin Pharmaceuticals Inc. has infringed five patents of the estrogen-free contraceptive Slynd, a Delaware federal judge said Wednesday, finding in favor of Spanish pharmaceutical company Insud Pharma and its New Jersey-based division Exeltis USA Inc. on all asserted claims.
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September 05, 2024
Pharma Co. Verrica Fails To Shed Investor Suit Over FDA OK
A Pennsylvania federal judge has partially denied Verrica Phamaceuticals Inc.'s second request to throw out a proposed class action filed by investors who claim the company defrauded them by hiding obstacles it faced in obtaining approval from the U.S. Food and Drug Administration for its lead product.
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September 04, 2024
Albertsons Denied Texas Court Remand In Opioid MDL
An Ohio federal judge overseeing multidistrict litigation over accusations that drug distributors contributed to the opioid epidemic denied a motion to transfer to Texas a portion of the dispute involving pharmacy company Albertsons.
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September 04, 2024
Leech Tishman Combines With Calif. Firm Nelson Hardiman
Leech Tishman is set to add California-based healthcare and life science law firm Nelson Hardiman's 17 attorneys to its Los Angeles office this fall and will do business in the Golden State under the combined name Leech Tishman Nelson Hardiman, the firm announced Tuesday.
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September 04, 2024
Medical Cos. Must Provide Doctor Names In Fla. Qui Tam Suit
A Florida federal judge has ordered several medical companies accused of fraudulently obtaining more Medicare funding than they were owed to produce the names of doctors associated with the companies, saying the difference between employed and affiliate providers isn't relevant.
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September 04, 2024
Bid To Nix Expert Fails As Fed. Circ. OKs $2.3M Patent Verdict
The Federal Circuit on Wednesday upheld a $2.3 million patent verdict against dental imaging device maker Planmeca USA Inc., rejecting the company's argument that plaintiff Osseo Imaging LLC's technical expert was not qualified because his experience came after the invention.
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September 04, 2024
Ga. Justices Won't Disturb Distributors' Opioid Trial Win
The Georgia Supreme Court affirmed a ruling that family members of drug abusers are not entitled to a new trial after a Glynn County jury cleared opioid distributors of wrongdoing, in response to claims regarding an allegedly dishonest juror and flawed jury instructions.
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September 04, 2024
Groups Urge DC Circ. To Reject Pharma Terrorism Liability Claims
Business and nongovernmental organization advocacy groups have urged the D.C. Circuit to rule that terrorism victims can't hold pharmaceutical companies liable for their injuries, citing a U.S. Supreme Court decision rejecting similar liability claims against technology companies.
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September 04, 2024
Zoetis Sanctions Bid Denied In Racehorse Death Suit
A Pennsylvania federal judge denied Wednesday a motion by drugmaker Zoetis Inc. for sanctions against the owners of a 3-year-old racehorse who say it died after being treated with one of the company's antibiotics, saying there's no indication that delays in responding to discovery were in bad faith, and by now the company has received all the relevant documents in the plaintiffs' possession.
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September 04, 2024
Whittaker Seeks $535M Deal In Talc Cases Tied To Berkshire
Bankrupt talc supplier Whittaker Clark & Daniels Inc. asked a New Jersey bankruptcy court to approve a $535 million settlement that will resolve claims against companies including Berkshire Hathaway Inc., chemical distributor Brenntag and DB US Holding Corp.
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September 04, 2024
NC Biz Court Bulletin: Blackbeard IP Fight, Firm Data Breach
As summer winds down, the North Carolina Business Court tackled usage rights pertaining to footage and artifacts from Blackbeard's shipwreck while grappling with uncovering the details of a cyberattack that exposed the data of Cadwalader Wickersham & Taft LLP. In case you missed those and others, here are the highlights.
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September 04, 2024
Chamber Backs Gilead's Immunity In COVID Appeal
The U.S. Chamber of Commerce and a trade association representing drug companies have urged a Michigan state appeals court to rule that Gilead Sciences is immune from a claim that a recalled batch of COVID-19 medication caused a man to suffer two strokes.
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September 04, 2024
Glenmark Will Pay $25M To End Feds' Price-Fixing Suit
Glenmark Pharmaceuticals USA will pay $25 million to resolve allegations that it violated the False Claims Act by conspiring to fix the price of a generic high cholesterol drug, federal prosecutors announced Wednesday.
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September 04, 2024
McCarter & English Rips Challenge To Malpractice Win In NJ
McCarter & English LLP panned a pharmaceutical company's attempt to undo the firm's victory in a malpractice case last month, telling a New Jersey state court that issues the company raised in its motion to reconsider had "no impact" on the decision granting the firm a win.
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September 04, 2024
Trade Group Urges Court To Toss FDA Lab-Test Rule
A clinical-lab trade group and an infectious disease laboratory that sued the U.S. Food and Drug Administration over its new final rule on laboratory-developed tests are asking a federal court to vacate it, saying Congress didn't grant the agency such power.
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September 04, 2024
Ga. Justices Affirm Rejection Of Class In Patient Privacy Suit
The Georgia Supreme Court said Wednesday that a Fulton County trial court acted within its discretion when it denied class certification for a suit over a release of patient records from a private mental health hospital, overturning a Georgia Court of Appeals ruling.
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September 04, 2024
J&J Hit With $1B Damages In Del. Merger Milestone Fight
Johnson & Johnson owes more than $1 billion to a medical robotics developer and entrepreneur caught up in a multibillion-dollar post-acquisition dispute, a Delaware vice chancellor ruled Wednesday.
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September 04, 2024
Arnold & Porter Adds Mintz Healthcare Enforcement Leader
After setting up shop in Boston a little less than a year ago, Arnold & Porter Kaye Scholer LLP announced Tuesday that it was welcoming the co-chair of Mintz Levin Cohn Ferris Glovsky and Popeo PC's healthcare enforcement defense group.
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September 03, 2024
Louisiana Frees Aurobindo, Sandoz From Price-Fixing Suits
The state of Louisiana has dropped its remaining claims in three Connecticut-based lawsuits by a collection of state attorneys general against more than three dozen pharmaceutical companies alleging a generic drug price-fixing scheme, truncating assertions that accuse myriad drugmakers of Sherman Act violations.
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September 03, 2024
Teva Investors Get Go-Ahead To Resume Kickbacks Class Suit
A shareholder's certified class action against pharmaceutical company Teva can resume after being paused for two years, as the company says it is working towards a settlement with the U.S. Department of Justice over related claims it used kickbacks to raise the price of its multiple sclerosis drug Copaxone, a Philadelphia federal judge has decided.
Expert Analysis
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
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Lead Like 'Ted Lasso' By Embracing Cognitive Diversity
The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.
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How Cos. Should Handle Research Org.'s Carcinogen Evals
In light of the International Agency of Research for Cancer's list of substances slated for review over the next five years, manufacturers of chemicals, pharmaceuticals and consumer products should monitor for potentially unbalanced determinations, which could stimulate litigation regarding potential exposure from products, say attorneys at Nelson Mullins.
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Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.
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What's New In The AI Healthcare Regulatory Space
Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.
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Del. Dispatch: 27.6% Stockholder Not A Controller
The Delaware Court of Chancery's recent decision in Sciannella v. AstraZeneca — which found that the pharma giant, a 26.7% stockholder of Viela Bio Inc., was not a controller of Viela, despite having management control — shows that overall context matters when challenging transactions on breach of fiduciary duty grounds, say attorneys at Fried Frank.
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3 Policyholder Tips After Calif. Ruling Denying D&O Coverage
A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.
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1 Year At The UPC: Implications For Transatlantic Disputes
In its first year, the Unified Patent Court has issued important decisions on procedures like provisional measures, but complexities remain when it comes to coordinating proceedings across jurisdictions like the U.S. due to differences in timelines and discovery practices, say attorneys at McDermott.
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Opinion
Now More Than Ever, Lawyers Must Exhibit Professionalism
As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.
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Opinion
High Court Made Profound Mistake In Tossing Purdue Deal
The U.S. Supreme Court's recent decision to throw out Purdue Pharma's Chapter 11 plan jeopardizes a multistate agreement that would provide approximately $7 billion in much-needed relief to help fight the opioid epidemic, with states now likely doomed to spend years chasing individual defendants across the globe, says Swain Wood at Morningstar.
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Series
Serving In The National Guard Makes Me A Better Lawyer
My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.
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Big Business May Come To Rue The Post-Administrative State
Many have framed the U.S. Supreme Court’s recent decisions overturning Chevron deference and extending the window to challenge regulations as big wins for big business, but sand in the gears of agency rulemaking may be a double-edged sword, creating prolonged uncertainty that impedes businesses’ ability to plan for the future, says Todd Baker at Columbia University.
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Opinion
Proposed Terminal Disclaimers Rule Harms Colleges, Startups
Universities and startups are ill-suited to follow the U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers due to their necessity of filing patent applications early prior to contacting outside entities for funds and resources, say attorneys at Sterne Kessler.
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A Midyear Forecast: Tailwinds Expected For Atty Hourly Rates
Hourly rates for partners, associates and support staff continued to rise in the first half of this year, and this growth shows no signs of slowing for the rest of 2024 and into next year, driven in part by the return of mergers and acquisitions and the widespread adoption of artificial intelligence, says Chuck Chandler at Valeo Partners.
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Critical Questions Remain After High Court's Abortion Rulings
The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.