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Life Sciences
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November 15, 2024
Eli Lilly Says HHS Ignores Drug Discount Double-Dipping
Eli Lilly & Co. claims the U.S. Department of Health and Human Services is unlawfully blocking its efforts to crack down on hospitals the company alleges are double-dipping on medication discounts that are meant to benefit low-income patients, according to a lawsuit filed in D.C. federal court.
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November 15, 2024
Natera Exec Calls Guardant's Cancer Test Claims 'Dangerous'
Natera's president of clinical diagnostics testified at trial Friday in a California federal false advertising case that Guardant Health's claims about Guardant's competing colorectal cancer test were "false and misleading" and also "dangerous."
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November 15, 2024
SEC-Sanctioned Accounting Firm Sued Over Pre-IPO Work
The former public company accounting firm BF Borgers is facing a California state lawsuit by an ex-client that says it was forced to scuttle its plans for an initial public offering after the U.S. Securities and Exchange Commission accused the firm of being a "sham auditing mill."
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November 15, 2024
PBMs Denied Breakup Of Combined FTC Insulin Price Trial
The Federal Trade Commission's allegations that pharmacy benefit manager giants Caremark Rx, Express Scripts and OptumRx are artificially inflating insulin prices through unfair rebate schemes will forge ahead as a single case following an in-house agency judge's refusal to break them into separate proceedings.
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November 15, 2024
Despite Vaccine Spotlight, RFK Jr. A Health Policy 'Unknown'
Robert F. Kennedy Jr., President-elect Donald Trump's pick to be the nation's top health official, has made clear his unorthodox and often false views on public health issues like vaccines. But there's still plenty of policy under his potential control where his stance remains opaque, attorneys say, which could stymie their efforts to prepare for the next four years.
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November 15, 2024
Ariz. Judge Will Decide Proper Venue For CVS Antitrust Suit
A federal judge concluded Thursday that he must decide whether a proposed class action accusing CVS of exploiting a Medicare loophole to charge independent pharmacies exorbitant fees belongs in arbitration, after scolding CVS's attorneys for failing to adequately develop their arguments defending an underlying delegation clause.
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November 15, 2024
DEA Judge Nixes Vet Group's Bid To Take Part In Pot Hearings
An administrative law judge with the U.S. Drug Enforcement Administration on Friday denied a veterans group's bid to participate in upcoming hearings on a proposal to loosen federal restrictions on marijuana.
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November 15, 2024
Abbott Inks $8M Deal With Healthcare Fraudster In TM Suit
A New York federal judge on Thursday green-lit a trademark infringement settlement in which Abbott Laboratories will receive $8 million from a Florida businessman who recently pled guilty to healthcare fraud for his role in a sprawling gray market scheme to profit off of Abbott's line of diabetic test strips meant to be sold internationally.
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November 15, 2024
Ayahuasca Church Urges Justices To Hear Discovery Case
An Arizona church that uses a psychedelic substance in its ceremonies has asked the U.S. Supreme Court to reconsider lower courts' rulings directing the church to turn over members' personal information to federal drug enforcement authorities.
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November 15, 2024
Teva Defends Mifepristone Antitrust Case Against Corcept
Teva Pharmaceuticals has asked a California federal judge to reject a bid to dismiss its lawsuit against the maker of a brand-name drug used to treat a rare cortisol disorder, contending its complaint plausibly alleges an illegal scheme to suppress generic competition.
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November 15, 2024
Attys Get 'Final Warning' In Tepezza Hearing Loss MDL
A magistrate judge has chastised attorneys on both sides of multidistrict litigation involving claims that a thyroid eye disease treatment manufactured by Horizon Pharmaceuticals Inc. causes hearing loss, calling for an end to their "improper" conduct during depositions.
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November 15, 2024
HOA's Insurer Says Pool Chemical Injury Suits Aren't Covered
A homeowners association's insurer told a Virginia federal court it needn't cover underlying lawsuits alleging a lifeguard employed by the association's contractor allowed hazardous chemicals to spread and hurt pool patrons, arguing that its commercial general liability policy excluded bodily injury as a result of pollutants.
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November 15, 2024
Orrick Trial Partner Joins Morgan Lewis In Boston
Morgan Lewis & Bockius LLP announced that an experienced litigator from Orrick Herrington & Sutcliffe LLP joined the firm's Boston office as a partner, enhancing its capacity in areas such as life sciences and regulatory compliance.
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November 15, 2024
Pharma Biz To Pay $47M To Settle Feds' Kickback Claims
A Florida pharmaceutical company and its chief executive have agreed to pay $47 million to settle claims that their practice of paying for certain patient tests crossed the line into being an illegal kickback to increase prescriptions of an enzyme replacement therapy, Boston federal prosecutors said on Friday.
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November 15, 2024
Sterilization Co. Cosmed Hits Ch. 11 Amid Cancer Claims
Sterilization company Cosmed Group Inc. filed for Chapter 11 protection in a Texas bankruptcy court Thursday with over $100 million in liabilities, much of it related to cancer claims over the gas that it uses for sterilization.
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November 14, 2024
Trump's RFK Jr. Pick For HHS Draws Its Share Of Critics
The nomination of Robert F. Kennedy Jr. — well-known for his opposition to vaccines — as the secretary of the U.S. Department of Health and Human Services is President-elect Donald Trump's latest controversial pick for his administration, and one that could disrupt the U.S. Food and Drug Administration and its mission.
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November 14, 2024
Senate Panel Delays Votes On Patent Eligibility And PTAB Bills
The Senate Judiciary Committee on Thursday postponed planned votes on legislation aimed at reducing decisions that inventions are ineligible for patents and setting new limits on Patent Trial and Appeal Board challenges, but approved a bill to let the patent office collect demographic data on inventors.
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November 14, 2024
Judge Finds Dexcom Infringed Abbott Patent That Hung Jury
A judge has found that Dexcom Inc. infringed a glucose monitor patent owned by an Abbott Laboratories unit, with the ruling coming after a Delaware federal jury in March said it was hung on the issue.
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November 14, 2024
Takeda Rips Cert. Order's 'Whale Of Assumption' At 9th Circ.
Takeda Pharmaceutical urged the Ninth Circuit on Thursday to reverse a ruling certifying a class of third-party payors who allege Takeda and Eli Lilly & Co. hid their anti-diabetes drug's bladder-cancer risks, arguing the lower court erroneously made a "whale of an assumption" that 56.7% of prescriptions wouldn't have been written with disclosures.
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November 14, 2024
Boehringer Says Inhaler Antitrust Suit 'Fails On Its Face'
Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim International GMBH have urged a Connecticut federal judge to dismiss a proposed class action brought by health funds accusing it of monopolizing the inhaler market with improper patent listings, arguing the suit fails to allege any competitors were actually hindered by those patents.
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November 14, 2024
Boeing Could Sell Navigation Unit For $6B, And More Rumors
Boeing is mulling a sale of its Jeppesen navigation unit at potential $6 billion price tag, Pfizer may be seeking billions for its hospital drug unit, and a U.S. gas station and convenience store business could be sold at a $1.5 billion value. Here, Law360 breaks down these and other notable deal rumors from the past week.
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November 14, 2024
Trump Picks RFK Jr. To Lead Health & Human Services
President-elect Donald Trump announced Thursday that Robert F. Kennedy Jr., a prominent anti-vaccination activist and former presidential candidate, is his nominee to lead the U.S. Department of Health and Human Services.
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November 13, 2024
Guardant Atty Accuses Natera CEO Of Dishonesty At Trial
A Guardant Health lawyer on Wednesday accused Natera's CEO of being disingenuous when he testified at trial that a Natera ad campaign was aimed at correcting misleading information Guardant promoted about its competing colorectal cancer tests, exclaiming, "It was about money, wasn't it? Can't you just be honest about that?"
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November 13, 2024
Damages Limited In AGs' Generic Drug Price-Fixing Case
A Connecticut federal judge has nixed some claims against Sandoz Inc. and other generic-drug makers in a massive antitrust and unfair trade practices case filed by state attorneys general, finding that a handful of the enforcers cannot seek damages on behalf of their allegedly injured citizens.
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November 13, 2024
Honey Pot Greenwashes 'Plant-Derived' Products, Suit Says
The Honey Pot Co. faces a proposed false advertising class action filed Tuesday in California federal court by customers who allege its line of organic feminine care products, which includes foam washes, wipes, pads and liners, contain synthetic ingredients, despite being labeled as "plant-derived."
Expert Analysis
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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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.