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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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Orange Book Warnings Highlight FTC's Drug Price Focus
In light of heightened regulatory scrutiny surrounding drug pricing and the Federal Trade Commission's activity in the recent Teva v. Amneal case, branded drug manufacturers should expect the FTC's campaign against allegedly improper Orange Book listings to continue, say attorneys at Ropes & Gray.
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Firms Must Rethink How They Train New Lawyers In AI Age
As law firms begin to use generative artificial intelligence to complete lower-level legal tasks, they’ll need to consider new ways to train summer associates and early-career attorneys, keeping in mind the five stages of skill acquisition, says Liisa Thomas at Sheppard Mullin.
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PBM Takeaways From Proposed Telehealth Flexibility Bill
The U.S. House of Representatives' proposal to extend certain telehealth flexibilities signals a robust commitment to expanding telehealth access, though its plan to offset additional expenses through pharmacy benefit manager reform could lead to some industry consolidation, say attorneys at Mintz.
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A Plaintiffs-Side Approach To Cochlear Implant Cases
As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.
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Inside Antitrust Agencies' Rollup And Serial Acquisition Moves
The recent request for public comments on serial acquisitions and rollup strategies from the Federal Trade Commission and U.S. Justice Department mark the antitrust agencies' continued focus on actions that fall below premerger reporting thresholds, say attorneys at Paul Weiss.
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Think Like A Lawyer: Always Be Closing
When a lawyer presents their case with the right propulsive structure throughout trial, there is little need for further argument after the close of evidence — and in fact, rehashing it all may test jurors’ patience — so attorneys should consider other strategies for closing arguments, says Luke Andrews at Poole Huffman.
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Series
Playing Chess Makes Me A Better Lawyer
There are many ways that chess skills translate directly into lawyer skills, but for me, the bigger career lessons go beyond the direct parallels — playing chess has shown me the value of seeing gradual improvement in and focusing deep concentration on a nonwork endeavor, says attorney Steven Fink.
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9th Circ. Clarifies ERISA Preemption For Healthcare Industry
The Ninth Circuit's recent ruling in Bristol SL Holdings v. Cigna notably clarifies the broad scope of the Employee Retirement Income Security Act's preemption of certain state law causes of action, standing to benefit payors and health plan administrators, say attorneys at Troutman Pepper.
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Litigation Inspiration: Attys Can Be Heroic Like Olympians
Although litigation won’t earn anyone an Olympic medal in Paris this summer, it can be worthy of the same lasting honor if attorneys exercise focused restraint — seeking both their clients’ interests and those of the court — instead of merely pursuing every advantage short of sanctionable conduct, says Bennett Rawicki at Hilgers Graben.
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Unpacking NY's Revised Hospital Cybersecurity Rule Proposal
The New York State Department of Health's recently revised hospital cybersecurity rule proposal highlights increased expectations and scrutiny around cybersecurity in the healthcare sector, while adapting to both recent industry developments and public comments, say Christine Moundas and Gideon Zvi Palte at Ropes & Gray.
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Short-Term Takeaways From CMS' New Long-Term Care Rules
The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.
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Updated Federal Rules Can Improve Product Liability MDLs
The recent amendment of a federal evidence rule regarding expert testimony and the proposal of a civil rule on managing early discovery in multidistrict legislation hold great promise for promoting the uniform and efficient processes that high-stakes product liability cases particularly need, say Alan Klein and William Heaston at Duane Morris.
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Lean Into The 'Great Restoration' To Retain Legal Talent
As the “great resignation,” in which employees voluntarily left their jobs in droves, has largely dissipated, legal employers should now work toward the idea of a “great restoration,” adopting strategies to effectively hire, onboard and retain top legal talent, says Molly McGrath at Hiring & Empowering Solutions.
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FDA's Data Monitoring Guidance Reveals Future Expectations
As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.
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How Cannabis Rescheduling May Alter Paraphernalia Imports
The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.