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Life Sciences
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February 13, 2025
DC Judge Affirms Approval Of Teva's Generic Sleep Drug
A D.C. federal judge upheld the U.S. Food and Drug Administration's approval of Teva's generic version of Vanda's sleep-walking treatment tasimelteon, ruling Thursday that omitting Braille on the labeling is permissible as it would be "aberrant" to allow safe variations in a drug's substance but not for labeling.
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February 13, 2025
Long-Term Zantac Use Raised Cancer Risks, Jury Hears
Chronic ranitidine ingestion was a factor in the development of prostate cancer in two men who are retrying their claims over the active ingredient in Boehringer Ingelheim's over-the-counter Zantac medication, the University of South Carolina's chief urologist testified in Illinois on Thursday.
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February 13, 2025
Maryland Judge Blocks Trump's Orders On Trans Healthcare
A Maryland federal judge on Thursday temporarily blocked the Trump administration from restricting gender-affirming care for people under the age of 19 and required the administration to keep in place federal funding for healthcare providers that provide transgender care.
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February 13, 2025
Merck Investor Sues Over Gardasil China Market Projections
Pharmaceutical giant Merck & Co. Inc. has been hit with a proposed shareholder class action alleging it overstated global demand for its human papillomavirus vaccine Gardasil, damaging investors when it revealed earlier this month it would not meet its revenue projections for the vaccine and paused shipments to China.
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February 13, 2025
9th Circ. Upholds DEA Denial Of Psilocybin Petition
The Ninth Circuit on Thursday affirmed the U.S. Drug Enforcement Administration's rejection of a Seattle physician's request to treat terminally ill patients with psilocybin.
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February 13, 2025
Musk's $97B OpenAI Bid Dubbed A 'Stunt' Amid Other Rumors
After a Wall Street Journal report on Monday revealed that a consortium of investors led by Elon Musk was offering $97.4 billion to buy the nonprofit that controls OpenAI, rumors began to swirl regarding the true intentions behind the billionaire's bid.
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February 13, 2025
Robert F. Kennedy Jr. Confirmed, Sworn In As HHS Secretary
Robert F. Kennedy Jr. is officially the nation's top healthcare official.
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February 13, 2025
Paul Hastings, Cooley Lead Obesity-Focused Aardvark's IPO
Obesity-focused Aardvark Therapeutics Inc. began trading Thursday after pricing a $94 million initial public offering at the bottom of its range, represented by Paul Hastings LLP and underwriters' counsel Cooley LLP, joining a string of biotechnology firms to go public recently.
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February 13, 2025
Greenberg Traurig Adds Goodwin Life Sciences Pro In Texas
Greenberg Traurig LLP has expanded its life sciences and technology practice with a shareholder in Austin, Texas, who has extensive expertise in handling cross-border deals and came aboard from Goodwin Procter LLP.
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February 12, 2025
Judge Finds No Infringement In Alcon's Eye Drop Patent Suit
Alcon Inc. has failed to persuade a Delaware federal court to block the release of a generic glaucoma treatment that would compete with a brand of eye drops the company sells.
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February 12, 2025
Bausch Health Beats Suit Over 'Faking' Financial Stability
Pharmaceutical company Bausch Health Cos. Inc. and its top brass have beaten, for now, a proposed class action accusing them of misleading shareholders about threats to the company's financial stability, with a New Jersey federal judge finding Wednesday that most of the challenged statements in the complaint are inactionable.
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February 12, 2025
Supply Co. Files Failsafe $387M Suit Amid Threat Of Dismissal
A medical supply procurement company has re-upped claims that a pharmaceutical middleman cut it out of a billion-dollar deal with the U.K. government to sell COVID-19 tests after newly unveiled information threatened to derail the long-running litigation.
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February 12, 2025
Aurion Tells Del. Justices IPO Delayed Amid Investor Battle
Cell therapy venture Aurion Biotech told Delaware's Supreme Court on Wednesday that it has delayed a planned initial public offering now at the center of an appeal from a January Court of Chancery ruling that rejected a top investor's challenge to a reverse stock split.
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February 12, 2025
Labcorp Can't Score New Trial After $384M Patent Loss
Clinical lab giant Labcorp has failed to land a new trial in front of U.S. District Judge Alan Albright after a $384.4 million patent infringement judgment against it in a case over a method for testing for genetic disorders during pregnancy.
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February 12, 2025
Paraquat Plaintiffs Urge 7th Circ. To Revive MDL Suits
Four plaintiffs who were set for bellwether trials in multidistrict litigation targeting the herbicide paraquat argued Wednesday that the Seventh Circuit should unwind their summary judgment losses because the district court's ruling was based on "core misunderstandings" about their expert's evidentiary requirements.
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February 12, 2025
RI Judge Won't Pause Order To Unfreeze Funds Amid Appeal
A Rhode Island federal judge refused Wednesday to pause a court order blocking a freeze on funding for federal grants and programs while the Trump administration appeals the ruling to the First Circuit.
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February 12, 2025
Ga. Judge Trims Untimely Paragard IUD Claims From MDL
The Georgia federal judge overseeing the sprawling multidistrict litigation over alleged defects in Paragard intrauterine devices agreed Tuesday to dismiss as untimely dozens of claims against Teva Pharmaceutical and Cooper Cos. from patients in eight states.
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February 12, 2025
Boston's Opioid Damages Claims Tossed As Too Late
Boston waited too long to sue a group of drug benefits intermediaries over their alleged roles in the opioid crisis, a Massachusetts federal judge said in dismissing the city's complaint Tuesday.
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February 11, 2025
Wash. Health Privacy Law Debuts In Amazon Tracking Suit
A Washington resident has launched the first claims under the state's groundbreaking health privacy law, as part of a proposed class action accusing Amazon of unlawfully harvesting location data from tens of millions of mobile phone users through third-party apps that are running the company's software development kit.
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February 11, 2025
Medtronic, Axonics Agree To End Bladder Control Patent Fight
A California federal judge on Tuesday agreed to permanently dismiss Medtronic's long-running dispute accusing Axonics of infringing its patents related to its bladder and bowel control device, three months after Medtronic sought a new trial in the case following a verdict where a federal jury found no infringement by Axonics.
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February 11, 2025
Kratom Producers Hid 'Addictive' Risks, Consumers Say
Companies that make kratom are facing a proposed class action in New York federal court over sales of kratom, standing accused of not disclosing that the substance is just as addictive as opioids.
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February 11, 2025
Teva Says Mixed Coreg Rulings Undermine GSK Damages Bid
Teva Pharmaceuticals has urged a Delaware federal judge to reject GlaxoSmithKline's request to enhance a $235 million infringement award over a skinny label version of GSK's cardiovascular drug Coreg, saying judges at all levels of courts made clear the case wasn't open and shut.
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February 11, 2025
J&J Allies Dub Milestone Fee Reversal 'Crucial' To Del.
The National Association of Manufacturers pushed back Tuesday against Fortis Advisors LLC opposition to a NAM amicus brief seeking Delaware Supreme Court reversal of a medical robotics developer's $1 billion merger milestone damage award after its acquisition by Johnson & Johnson.
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February 11, 2025
Novo Nordisk Mostly Escapes Insulin Pen Contamination Suit
Novo Nordisk has, for now, beaten much of a Connecticut-based hospital's federal lawsuit seeking to hold it financially responsible for the $1 million settlement the hospital paid to patients potentially exposed to blood-borne infections after the medical staff used the pharma company's product.
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February 11, 2025
MSN Urges Fed. Circ. To Reinvalidate Novartis' Entresto IP
A Delaware federal judge properly invalidated a patent covering Novartis Pharmaceuticals' blockbuster cardiovascular drug Entresto for lacking written description, and a panel should never have overridden him, MSN Pharmaceuticals told the full Federal Circuit seeking a rehearing.
Expert Analysis
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Series
Documentary Filmmaking Makes Me A Better Lawyer
Becoming a documentary filmmaker has allowed me to merge my legal expertise with my passion for storytelling, and has helped me to hone negotiation, critical thinking and problem-solving skills that are important to both endeavors, says Robert Darwell at Sheppard Mullin.
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Litigation Funding Disclosure Debate: Strategy Considerations
In the ongoing debate over whether courts should require disclosure of litigation funding, funders and plaintiffs tend to argue against such mandates, but voluntarily disclosing limited details about a funding arrangement can actually confer certain benefits to plaintiffs in some scenarios, say Andrew Stulce and Marc Cavan at Longford Capital.
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2025 May Be A Breakout Year For The Cannabis Industry
The cannabis industry faced a slow and frustrating 2024, but consumer trends continue to shift in favor of cannabis, and the new administration may provide the catalyst that the industry needs, says Lynn Gefen at TerrAscend.
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FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape
The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.
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Scope And Nature Of Judicial Relief Will Affect Loper's Impact
The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.
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The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.
The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.
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Series
Adventure Photography Makes Me A Better Lawyer
Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.
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What Vinyl Acetate's Prop 65 Listing Means For Cos.
California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Inherency Ruling Refines Obviousness Framework
The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.
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Navigating The Potential End Of GLP-1 Drug Shortages
The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.
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High Court Could Further Limit Deference With TCPA Fax Case
The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.
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5 Ways To Create Effective Mock Assignments For Associates
In order to effectively develop associates’ critical thinking skills, firms should design mock assignments that contain a few key ingredients, from messy fact patterns to actionable feedback, says Abdi Shayesteh at AltaClaro.
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Calif. Cannabis Decision Deepens Commerce Clause Divide
In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.
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Opinion
IVF Suits Highlight Need For Better Legal Frameworks
The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.
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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.