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Life Sciences
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August 20, 2024
J&J Boosting Cardio Portfolio With Up To $1.7B V-Wave Buy
Johnson & Johnson said Tuesday it has agreed to acquire V-Wave Ltd., the maker of an implant device that aims to treat heart failure, for up to $1.7 billion as it looks to bolster its cardiovascular disease portfolio.
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August 19, 2024
TPG Dumped Opioid Co. On 'Unsuspecting' Endo, Suit Says
After pushing Par Pharmaceutical to grow its market share in generic opioids and disregard federal requirements to report suspicious orders, TPG Capital saw other opioid manufacturers being inundated with litigation and sold Par to "an unsuspecting" Endo International PLC, according to a lawsuit filed in New York bankruptcy court.
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August 19, 2024
Biogen Paid To Help Curb Generic Tecfidera Sales, Says Suit
Biogen illegally impaired competition for its multiple sclerosis drug Tecfidera by paying major pharmacy benefit managers to prioritize the brand over generics while it worked to shift the market to a different version of the medication, a multi-employer welfare plan alleged Friday.
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August 19, 2024
NuVasive Beats Fraudulent Inducement Claim At Trial
A Delaware federal jury has rejected a physician's claim that NuVasive Inc. fraudulently induced him to enter into a 2014 agreement related to patents he owns for spinal implant system components — but also rejected the medical device manufacturer's claim that the doctor had breached the deal by suing.
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August 19, 2024
9th Circ. Told Psilocybin Petition Is Backed By Precedent
A Ninth Circuit panel on Monday dissected opposing arguments from the U.S. Drug Enforcement Administration and a Seattle doctor over whether there is precedent to allow the dispensing of psilocybin — a psychedelic compound — to treat terminally ill patients.
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August 19, 2024
Jadex Sells Temperature-Controlled Packaging Biz For $137M
Material sciences company Jadex Inc. is selling its temperature-controlled packaging products business Lifoam Industries LLC to Altor Solutions, led by Gibson Dunn & Crutcher LLP, in a $137 million cash deal, the parties announced in separate Monday statements.
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August 19, 2024
Second Pharmacist To Avoid Meningitis Murder Trial
A pharmacist charged with murder in a deadly fungal meningitis outbreak that killed dozens of people is expected to plead no contest to involuntary manslaughter charges this week, averting a Michigan trial that had been set for November.
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August 19, 2024
Pennsylvania Litigation Highlights Of 2024: A Midyear Report
Pennsylvania courts have been the scene of several explosive cases in the first half of 2024, including one that produced an astronomical $2.25 billion verdict against Bayer AG unit Monsanto in the Roundup mass tort unfolding in the Philadelphia County Court of Common Pleas.
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August 19, 2024
Israeli Co. Sues NC Packaging Firm For Severing $25M Deal
An Israeli smart packaging company is suing North Carolina-based Sealed Air Corp. for allegedly backing out of a $25 million contract for smart sensors, saying Sealed Air lied about their progress developing the product and invented defects to tank the deal.
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August 19, 2024
Biotech Consultant Sues Ex-Partner To Force $2.5M Share Buy
Life sciences consulting firm BioPoint is asking a Massachusetts judge to order a former partner to sell back $2.5 million worth of shares in the closely held company following his ouster, according to a lawsuit filed in state court.
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August 16, 2024
Fed. Circ. Quells Fears Over Double-Patenting Overreach
A recent Federal Circuit decision finding patent claims licensed by Allergan were not invalid for obviousness-type double patenting provided relief to attorneys who were concerned the court had made it easier to invalidate patents that had extended expiration dates to make up for regulatory delays.
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August 16, 2024
Humana To Pay $90M To End 8-Year Medicare Drug FCA Battle
Humana Inc. has agreed to pay the federal government $90 million to settle long-running False Claims Act allegations it submitted fraudulent bids for Medicare prescription drug deals, Phillips & Cohen LLP said Friday in announcing the "first case of its kind" to resolve allegations of fraud in the Medicare Part D contracting process.
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August 16, 2024
Drexel Accounting Prof Convicted Of Evading Tax On $3.3M
New Jersey federal jurors have convicted a Drexel University accounting professor on charges of tax evasion and filing false tax returns after the government accused him of failing to report $3.3 million in income from a Trenton pharmacy.
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August 16, 2024
Baltimore Inks $152.5M Opioid Deal With Cardinal Health
Baltimore announced Friday that it settled claims for $152.5 million with Cardinal Health over its alleged role in helping fuel the city's opioid crisis, reaching the deal with the pharmaceutical distributor ahead of a September trial against five remaining defendants and following separate $45 million settlements with Allergan and CVS.
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August 16, 2024
Birth Control Cos. Say Conn. Injury Suit Must Be Tossed
Several birth control companies have urged a Connecticut state court to toss a lawsuit brought by a woman alleging she was injured by the Filshie Clip contraceptive device, saying there is no jurisdiction because the parties involved in the case have no ties to Connecticut.
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August 16, 2024
States Get Teva Generic Price-Fix Case On Docket As 1st Trial
A Connecticut federal judge has granted a request from a coalition of state attorneys general suing a slew of generic-drug makers to try a case focused on Teva before proceeding with a different case that was first filed.
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August 16, 2024
Walgreens Didn't Disclose PFAS In Bandages, Shopper Says
Walgreens' parent company has been hit with a proposed class suit in Illinois state court claiming the pharmacy retailer illegally markets its flexible fabric bandages as safe while hiding that they contain hazardous "forever chemicals" that are dangerous to human health.
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August 16, 2024
Apple Needs To Wait Its Turn In ITC, Masimo Tells Fed. Circ.
Apple wants to speed up its appeal over a U.S. International Trade Commission patent ruling that forced the company to disable an Apple Watch feature that measures the oxygen in blood, but both its courthouse rival and the agency itself say there's no compelling reason to cut in line.
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August 16, 2024
Ex-CEO Wants Verdict In COVID Test Kit Fraud Case Tossed
A former healthcare software executive found guilty of securities fraud for publicly touting a $670 million COVID test kit deal that ultimately collapsed wants his conviction thrown out, telling a New Jersey federal judge the government failed to establish every element of the crime.
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August 16, 2024
Avantor Sells Clinical Services Biz To PE Shop In $650M Deal
Life sciences tools company Avantor Inc., advised by Arnold & Porter Kaye Scholer LLP, on Friday announced plans to sell its clinical services business to Ropes & Gray LLP-advised Audax Private Equity for $650 million.
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August 16, 2024
Psilocybin Right-To-Try Petition To Get 9th Circ. Hearing
A Ninth Circuit panel will hear oral arguments Monday in an appeal brought by a Seattle doctor seeking to administer psilocybin to terminal cancer patients under state and federal right-to-try laws.
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August 16, 2024
Taxation With Representation: Cleary, Kirkland, Skadden
In this week's Taxation with Representation, Mars Inc. sets a 2024 record with its $36 billion acquisition of Kellanova, Carlyle inks a $3.8 billion purchase with Baxter International Inc., and Performance Food Group Co. agrees to a $2.1 billion cash deal with Cheney Bros. Inc.
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August 16, 2024
NC Litigation Highlights Of 2024: A Midyear Report
Several-high profile cases in North Carolina came to a close in the first half of the year, from a second bribery conviction against an insurance magnate beset by legal woes, to the anticlimactic withdrawal of a state Supreme Court justice's much-watched free speech suit. Here, Law360 looks at those and other notable rulings so far in North Carolina.
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August 16, 2024
New Jersey Litigation Highlights Of 2024: A Midyear Report
A court's upheaval of New Jersey's longstanding "county line" ballot layout for the Democratic primary fueled both sides of the lively political aisle this year, while the same federal judge also riled the state's pharmaceutical hotbed by ending two challenges to Medicare's ability to negotiate drug prices. Here, Law360 looks at some of the notable cases so far in New Jersey.
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August 15, 2024
Talc Jury Delivers $63M Verdict Against J&J, Beauty Care Co.
A South Carolina jury awarded a cancer patient more than $63 million Thursday after he said he developed terminal lung cancer from breathing in asbestos during daily use of Johnson & Johnson's talc-based baby powder.
Expert Analysis
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance
A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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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.