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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
DC Circ. Says Mining Cos. Can't Appeal Retiree Health Win
Four former subsidiaries of the now-defunct coal company Consol Energy Inc. can't challenge an arbitration award that banned unilateral changes to union-represented retirees' health benefits plan, the D.C. Circuit held Friday, saying the ex-subsidiaries weren't parties to the award and aren't injured by it.
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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
The Long Road To Legalizing Pot In Florida And South Dakota
Voters in Florida and South Dakota will have the opportunity this Election Day to legalize recreational marijuana for adults 21 and over, and while the two efforts vary in their particulars, they both follow years of work by legalizers to craft a proposal that could gain court approval.
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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
Aetna Illegally Axed Exec's Disability Benefits, Judge Says
A California federal judge said Aetna was wrong to end an executive's disability benefits after it found he suffered from a mental illness instead of a physical disability, stating the insurer used flawed doctor opinions and may have been motivated by cutting costs.
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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
Jury's $1M Paralysis Verdict Against Insurer Overturned
A Texas federal judge overturned a jury's verdict and decided an insurer didn't have to cover a $1 million settlement between a former high school gymnast who became quadriplegic after taking LSD and the owners of the home where he ingested the drugs.
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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
Fannie Mae Seeks Memory Care Receiver After $28.3M Default
Fannie Mae asked a federal judge to appoint a receiver for three North Carolina senior living facilities after arguing that borrower Affinity Living Communities defaulted on $28.3 million worth of loans from the government-backed lender by missing three months of payments.
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August 09, 2024
Off The Bench: NCAA Antitrust Woes, Ohio Trans Sports Ban
In this week's Off The Bench, the NCAA still faces pushback from athletes after an NIL settlement, transgender youth athletes in Ohio lost their legislative battle, and the Seventh Circuit set an insurance broker straight on its actions in an NFL team's settlement with a former player.
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August 09, 2024
Trulieve Settles Fired Retail Worker's Race Bias Suit
Florida-based cannabis company Trulieve has agreed to settle a mixed-race former employee's suit alleging he was fired after complaining that a manager repeatedly made racist comments, including calling him a slur, the worker told a Florida federal court.
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August 08, 2024
15 Red-State AGs Sue To Block ACA Coverage For Dreamers
Fifteen states led by Kansas Attorney General Kris Kobach sued the Biden administration Thursday over a new regulation that is expected to allow about 100,000 immigrants brought to the U.S. as children without authorization to enroll in federal health insurance programs through Affordable Care Act exchanges.
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August 08, 2024
4th Circ. Upholds Asylum Denial Over Forced Hospitalizations
The Fourth Circuit on Thursday refused to revive an Indian foreign exchange student's bid for asylum, saying in a published opinion that his multiple involuntary hospitalizations in India and the administration of electroshock therapy to treat diagnosed mental illnesses did not amount to persecution.
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August 08, 2024
In Reddit Hot Seat, Chopra Touts CFPB Medical Debt Proposal
Consumer Financial Protection Bureau Director Rohit Chopra took to social media on Thursday to pitch the agency's proposed ban on medical debt reporting, defending it against concerns that the plan could interfere with credit scores and encourage people to skip out on medical bills.
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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
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
Atty Accuses NYC Agency Of Bias, EEOC Charge Retaliation
A staff attorney accused the New York City Administration for Children Services of abruptly revoking his years-old disability accommodations while he was recovering from heart surgery, alleging in a federal lawsuit Wednesday that the administration tried to force him to quit after he filed a state court action and a charge of discrimination with the Equal Employment Opportunity Commission.
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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
Hunters, Breeder Say CDC Overstepped With Dog Import Ban
Hunting groups and a breeder challenged a U.S. Centers for Disease Control and Prevention rule barring them from bringing young puppies into the U.S., telling a Michigan federal court that the agency overstepped to prevent the spread of rabies.
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August 08, 2024
Hospitals Tell High Court HHS Errs In SSI Pay Formula
A group of hospitals argued to the U.S. Supreme Court on Wednesday that the U.S. Department of Health and Human Services is misinterpreting a formula used to calculate billions of dollars in special payments every year for hospitals treating people receiving Supplemental Security Income.
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August 08, 2024
Watchdog Tees Up £6M Fine For IT Co. Over NHS Cyberattack
The U.K.'s data privacy regulator said it intends to fine a British software company £6 million ($7.6 million) over failings that allowed hackers to disrupt the National Health Service and steal the sensitive personal information of more than 80,000 individuals.
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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.
Expert Analysis
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A Changing Regulatory Landscape For Weight Loss Drugs
As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.
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Opioid Suits Offer Case Study In Abatement Expert Testimony
Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.
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Patent Lessons From 4 Federal Circuit Reversals In April
Four Federal Circuit decisions in April that reversed or vacated underlying rulings provide a number of takeaways, including that obviousness analysis requires a flexible approach, that an invalidity issue of an expired patent can be moot, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Opinion
USPTO's Proposed Disclaimer Rule Would Harm Inventors
The U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers will make the patent system less available to inventors and will unfairly favor defendants in litigation, say Stephen Schreiner at Carmichael IP and Sarah Tsou at Omni Bridgeway.
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Series
Being An EMT Makes Me A Better Lawyer
While some of my experiences as an emergency medical technician have been unusually painful and searing, the skills I’ve learned — such as triage, empathy and preparedness — are just as useful in my work as a restructuring lawyer, says Marshall Huebner at Davis Polk.
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How HHS Discrimination Rule Affects Gender-Affirming Care
The U.S. Department of Health and Human Services' new final rule, which reinterprets the Affordable Care Act's anti-discrimination provision, greatly clarifies protections for gender-affirming care and will require compliance considerations from sponsors and administrators of most group health plans, say attorneys at McDermott.
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Opinion
'Natural Person' Or Not, AI-Made IP Deserves Protection
The entire legal edifice rests on a determination that an artificial system is not a so-called natural person, and although this may appear to be straightforward on its face, rapid advances in technology may soon force us to revisit our understanding of a natural person, says Manav Das at McDonnell Boehnen.
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Lessons On Challenging Class Plaintiffs' Expert Testimony
In class actions seeking damages, plaintiffs are increasingly using expert opinions to establish predominance, but several recent rulings from California federal courts shed light on how defendants can respond, say Jennifer Romano and Raija Horstman at Crowell & Moring.
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Exploring An Alternative Model Of Litigation Finance
A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.
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FTC Noncompete Rule's Impact On Healthcare Nonprofits
Healthcare entities that are nonprofit or tax-exempt and thus outside of the pending Federal Trade Commission noncompete rule's reach should evaluate a number of potential risk factors and impacts, starting by assessing their own status, say Ben Shook and Tania Archer at Moore & Van Allen.
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Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors
Though developers of gene and cell therapy products commonly assume that a legal safe harbor protects them from patent infringement suits, recent case law shows that not all preapproval uses of patented technology are necessarily protected, say Natasha Daughtrey and Joshua Weinger at Goodwin.
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Series
Teaching Yoga Makes Me A Better Lawyer
Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.
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How Clinical Trials Affect Patentability In US And Europe
A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.