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Life Sciences
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August 20, 2024
Pathology Trade Group 2nd To Sue FDA Over Lab-Test Rule
A molecular pathology trade group has filed a lawsuit against the U.S. Food and Drug Administration, challenging a recent final rule to regulate laboratory-developed tests as medical devices and arguing the agency has abused its power — the second such case filed in recent months.
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August 20, 2024
A Deep Dive Into Law360 Pulse's 2024 Women In Law Report
The legal industry continues to see incremental gains for female lawyers in private practice in the U.S., according to a Law360 Pulse analysis, with women now representing 40.6% of all attorneys and 51% of all associates.
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August 20, 2024
These Firms Have The Most Women In Equity Partnerships
The legal industry still has a long way to go before it can achieve gender parity at its upper levels. But these law firms are performing better than others in breaking the proverbial glass ceiling that prevents women from attaining leadership roles.
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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.
Expert Analysis
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Big Business May Come To Rue The Post-Administrative State
Many have framed the U.S. Supreme Court’s recent decisions overturning Chevron deference and extending the window to challenge regulations as big wins for big business, but sand in the gears of agency rulemaking may be a double-edged sword, creating prolonged uncertainty that impedes businesses’ ability to plan for the future, says Todd Baker at Columbia University.
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Opinion
Proposed Terminal Disclaimers Rule Harms Colleges, Startups
Universities and startups are ill-suited to follow the U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers due to their necessity of filing patent applications early prior to contacting outside entities for funds and resources, say attorneys at Sterne Kessler.
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A Midyear Forecast: Tailwinds Expected For Atty Hourly Rates
Hourly rates for partners, associates and support staff continued to rise in the first half of this year, and this growth shows no signs of slowing for the rest of 2024 and into next year, driven in part by the return of mergers and acquisitions and the widespread adoption of artificial intelligence, says Chuck Chandler at Valeo Partners.
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Critical Questions Remain After High Court's Abortion Rulings
The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.
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A Look At Acquisition Trends For Radiopharmaceuticals
As radiopharmaceutical drugs are increasingly used for the diagnosis and treatment of certain diseases, interest from Big Pharma entities is following suit, despite some questions around the drugs' capacity to expand beyond their limited niche, says Adrian Toutoungi at Taylor Wessing.
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Opinion
States Should Loosen Law Firm Ownership Restrictions
Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.
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Texas Ethics Opinion Flags Hazards Of Unauthorized Practice
The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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2 Options For Sackler Family After High Court Purdue Ruling
After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.