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Life Sciences
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October 21, 2024
Eli Lilly Slams 'Dangerous' Knock-Off Weight Loss Drugs
Eli Lilly & Co. on Monday launched a trio of lawsuits in Indiana, Texas and Washington federal courts accusing three telehealth companies of peddling illicit knockoffs of its weight-loss medications that have not been approved by the U.S. Food and Drug Administration and that pose a danger to patients.
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October 21, 2024
Apple Tells Del. Jury It Wants Smartwatch Infringing To Stop
An Apple attorney told a federal jury in Delaware on Monday that the company is willing to accept only a token damage award from Masimo Corp. for the health tech company's infringement of Apple's smartwatch, but wants the alleged copying barred.
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October 21, 2024
FDA Tells Court Menthol Cigarette Ban Is Still Under Review
The U.S. Food and Drug Administration has said it's still evaluating whether to finalize a proposed ban on menthol cigarettes, urging a California federal court to throw out a lawsuit that's attempting a "judicial end-run" around the ongoing review.
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October 21, 2024
PBMs Keep Door Open To Constitutional Riposte Against FTC
Attorneys for Caremark Rx, Express Scripts and OptumRx kept the door open Monday to challenging the Federal Trade Commission's constitutionality as they face an in-house case accusing the country's three largest pharmacy benefit managers of artificially inflating insulin prices by relying on unfair rebate schemes.
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October 21, 2024
GOP Pols Want Probe Into FDA Laboratory Safety
Three Republican lawmakers on Friday sought information from the U.S. Food and Drug Administration about its oversight of its laboratory safety practices, following a long investigation over an incident about vials of smallpox virus and other hazards found on a National Institutes of Health campus.
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October 21, 2024
Novartis Loses Challenge To Medicare Drug Price Talks
A New Jersey federal judge on Friday tossed Novartis Pharmaceuticals' challenge to a Medicare drug price negotiation program, ruling the company is not required to participate, and that participating in the program does not violate its First Amendment rights.
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October 21, 2024
Goodwin Steers Biotech Firm Septerna's Plans For $175M IPO
Biotechnology firm Septerna Inc. on Monday launched plans for an estimated $175 million initial public offering, joining a hot market for drug developers of late, under guidance from Goodwin Procter LLP and underwriters' counsel Cooley LLP.
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October 21, 2024
McGuireWoods Adds Healthcare Atty From Cooley In NY
McGuireWoods LLP has added a digital health expert from Cooley LLP, aiming to boost its offerings for clients in the space combining healthcare services with information and communications technology, the firm announced Monday.
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October 21, 2024
Catalent CEO Defends Novo Deal, Will Stay On After Buyout
Catalent CEO Alessandro Maselli told the medical company's customers Monday that Catalent will continue to support them following its planned $16.5 billion sale to Novo Holdings, seeking to assure clientele after Sen. Elizabeth Warren and advocacy groups pressured the Federal Trade Commission to scrutinize and potentially block the deal.
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October 18, 2024
Law360 MVP Awards Go To Top Attys From 74 Firms
The attorneys chosen as Law360's 2024 MVPs have distinguished themselves from their peers by securing hard-earned successes in high-stakes litigation, complex global matters and record-breaking deals.
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October 18, 2024
What Attorneys Expect From Harris And Trump On Patents
Patents have scarcely been mentioned during the presidential campaign, but attorneys say that positions taken by the candidates suggest Donald Trump would favor stronger patent rights, while Kamala Harris would focus on steps to make drugs and other patented inventions more widely available.
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October 18, 2024
Chancery Keeps Better Therapeutics SPAC Suit Alive
A Delaware vice chancellor on Friday refused to dismiss a suit challenging the take-public merger of now-defunct Better Therapeutics, saying the investors have sufficiently pleaded direct breach of fiduciary duty claims against the medical technology business' special purpose acquisition company partner and its directors.
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October 18, 2024
Fed. Circ. Won't Question Reviving Vascepa Skinny Label Row
The Federal Circuit has said the full appellate court will not rethink a panel's decision reinstating Vascepa maker Amarin Pharma Inc.'s skinny label patent case against rival U.K. drugmaker Hikma.
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October 18, 2024
Cigna Says Florida Labs Owe $16M After 'Cheating' For Benefits
Three Florida substance abuse laboratories wrongly filed $16 million in claims for medically unnecessary tests and doubled their scheme by failing to seek patient payments, Cigna attorneys told a federal jury on Friday. The labs, however, accused the insurer of breaching policy agreements by failing to pay for services rendered.
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October 18, 2024
Teva Signs Deal With Indirect Buyers In Effexor Antitrust Suit
A class of consumers and third-party payers have reached a deal with Teva Pharmaceuticals to resolve antitrust litigation over a purported scheme to delay generic competition for the antidepressant drug Effexor XR, according to a court filing.
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October 18, 2024
Biotech Co. Wins Injunction Against Ex-Worker In Secrets Suit
Biotech startup Trilobio Inc. won a temporary restraining order against a former employee after a California federal judge concluded the company has a strong likelihood of success on its claims that the worker stole trade secrets to start his own business after being fired for poor performance.
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October 18, 2024
Taxation With Representation: Baker, Simpson, Ropes
In this week's Taxation With Representation, Lundbeck inks a $2.6 billion cash deal for Longboard, Silver Lake agrees to buy Zuora for $1.7 billion, and PPG and American Industrial Partners reach a $550 million deal.
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October 18, 2024
Philly Atty Suspended After Guilty Plea In Pill Mill Scheme
A Philadelphia attorney who pled guilty to filling fraudulent opioid prescriptions in his side job as a part-time pharmacist had his law license suspended for a year and a day, the Supreme Court of Pennsylvania announced.
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October 18, 2024
FTC Faces More Pressure To Block $16.5B Novo-Catalent Deal
A dozen advocacy groups are pushing the Federal Trade Commission to block Novo Holdings' planned $16.5 billion purchase of Catalent, arguing that the deal would stifle competition for certain obesity and gene therapy drugs — and that no remedy can fix that.
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October 18, 2024
Pfizer Escapes 401(k) Fee Suit Due To Poor Comparisons
A Michigan federal judge tossed a former employee's proposed class action claiming Pfizer Inc. let its $21 billion retirement plan be overcharged for recordkeeping fees, crediting the pharmaceutical giant's arguments that the case was only supported with "apples-to-oranges" comparisons.
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October 17, 2024
E-Cig Regs Are Congress' Job, Not FDA's, GOP Pols Tell Justices
Republican lawmakers told the U.S. Supreme Court that Congress, not the U.S. Food and Drug Administration, should regulate flavored e-cigarettes, and that the regulator overstepped its authority by banning the sale of the vape products.
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October 17, 2024
'More Honesty' Needed In Philips IP Row, Judge Says
A Texas federal judge told the owner of a company accused of pilfering around $12 million worth of Philips North America LLC's trade secrets that things might have gone better if he had "been more honest," pointing out that he had given contradictory testimony during a hearing Thursday.
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October 17, 2024
Justices Urged To Fix 'Novel Misreading' Of IP Safe Harbor
Edwards Lifesciences is asking the U.S. Supreme Court to rein in what's covered under a drug-development safe harbor to avoid patent infringement, saying the Federal Circuit wrongfully expanded it in a "novel misreading" of the law.
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October 17, 2024
Northwestern Hits Moderna With Patent Suit Over COVID Vax
Northwestern University has launched a patent infringement lawsuit in Delaware federal court accusing Moderna of wrongly taking research that the school did when the company was making its COVID-19 vaccine.
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October 17, 2024
Amgen Faces Derivative Suit In Del. Over Tax Disclosures
An Amgen Inc. stockholder has sued the company in Delaware's Court of Chancery seeking derivative recoveries for the multinational biopharmaceutical company from its directors and officers based on allegedly false and misleading statements regarding $10.7 billion in federal tax bills and penalties.
Expert Analysis
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Opinion
The Big Issues A BigLaw Associates' Union Could Address
A BigLaw associates’ union could address a number of issues that have the potential to meaningfully improve working conditions, diversity and attorney well-being — from restructured billable hour requirements to origination credit allocation, return-to-office mandates and more, says Tara Rhoades at The Sanity Plea.
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Opinion
It's Time For A BigLaw Associates' Union
As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.
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How Justices Upended The Administrative Procedure Act
In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.
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Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement
While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.
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Parsing NJ Court's Rationale For Denying Lipitor Class Cert.
A New Jersey federal court's recent Lipitor rulings granting summary judgment and denying motions for class certification for two plaintiff classes offer insight into the level of rigorous analysis required by both parties and their experts to satisfy the requirements of class certification, says Catia Twal at Edgeworth Economics.
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Gilead Drug Ruling Creates Corporate Governance Dilemma
If upheld, a California state appellate court's decision — finding that Gilead is liable for delaying commercialization of a safer HIV drug to maximize profits on another drug — threatens to undermine long-standing rules of corporate law and exposes companies to liability for decisions based on sound business judgment, says Shireen Barday at Pallas.
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3 Leadership Practices For A More Supportive Firm Culture
Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.
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Rebuttal
Cancer Research Org. Is Right To Avoid Corporate Influence
While a previous Law360 guest article criticizes the International Agency for Research on Cancer's processes, its reliance on peer-reviewed literature is proper and its refusal to allow corporate influence is sound science, say Lance Oliver and Ridge Mazingo at Motley Rice.
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Cannabis Biz Real Estate Loan Considerations For Lenders
Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.