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Life Sciences
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January 02, 2025
Issa Again Selected To Lead House IP Subcommittee
Rep. Darrell Issa, R-Calif., will again lead the House subcommittee overseeing intellectual property in the upcoming Congress, a role in which he has sponsored bills seeking to limit how many patents can be asserted in biosimilar cases and require disclosure of litigation funding.
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January 02, 2025
1st Private Co. Joins Insulin Price-Fixing MDL
A Florida-based car dealer is the first private company to join a multidistrict litigation accusing Novo Nordisk, Eli Lilly and Sanofi-Aventis of fixing the prices of insulin and other drugs to treat diabetes.
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January 02, 2025
A-Rod's SPAC Deal Seeks Extra Innings, Plus More IPOs Filed
The period between Christmas Eve and Jan. 1 wasn't completely quiet on the capital markets deals front, with A-Rod's special purpose acquisition company seeking an extension to complete its merger and several new IPOs being filed. Here, Law360 looks at the capital markets news from the holiday break.
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January 02, 2025
Ozempic Caused Severe Pain And Hospitalization, Suit Says
Pharmaceutical giant Novo Nordisk has been sued in Connecticut federal court by a 67-year-old woman claiming it did not properly disclose the risk of gastroparesis associated with its popular weight loss drug Ozempic, which allegedly caused her severe stomach pain and vomiting that led to a 10-day hospitalization.
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January 02, 2025
Eli Lilly Slams Suit Alleging Shortage Of Weight-Loss Drug
Eli Lilly is seeking permission to join a legal fight over whether compounding pharmacies can keep making copycat versions of the company's lucrative weight-loss and diabetes drug, telling a federal court Wednesday that its interests aren't adequately represented by federal regulators.
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January 02, 2025
Hikma Wants Extension At High Court In Skinny Label Case
Hikma Pharmaceuticals USA Inc. wants an extra month to file its petition challenging the Federal Circuit's revival of a suit claiming the company induced physicians to infringe patents covering Amarin Pharma Inc.'s blockbuster cardiovascular drug Vascepa, citing the case's importance and the busy schedules of attorneys.
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January 02, 2025
Roche Strikes $80M Oncology Drug Deal With Chinese Biotech
A multimillion-dollar agreement kicked off biotech deals in the new year when Swiss pharma giant Roche and Chinese biotech Innovent Biologics announced Wednesday that they had entered into an exclusive licensing agreement focused on a new oncology drug.
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January 02, 2025
'Crush-Resistant' OxyContin Patents Fail At Fed. Circ.
In one of its last major moves in 2024, the Federal Circuit decided to reject an appeal from the bankrupt maker of OxyContin, which is trying to use patent laws to block the release of a competing "crush-resistant" generic painkiller.
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January 02, 2025
Aetna Sues Drugmakers In Conn., Alleging Generics Price-Fixing
Health insurer Aetna has sued 23 drugmakers, including Novartis and Pfizer, over an alleged scheme to fix the prices of 111 generic medications, citing information gleaned from a congressional probe, lawsuits by state attorneys general, a Pennsylvania multidistrict litigation proceeding, and U.S. Department of Justice findings.
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January 02, 2025
Beasley Allen Aims To Toss Suit From Ex-Ally Firm
Beasley Allen has called on a Mississippi federal court to dismiss or transfer a defamation and breach of contract lawsuit from The Smith Law Firm PLLC over their joint venture agreement for talc litigation against Johnson & Johnson, arguing the case should be tossed in favor of its own suit filed earlier in Alabama.
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January 02, 2025
IRS, Treasury Float Regs On Excise Taxes For Drugmakers
The IRS and Treasury proposed rules for charging excise taxes to drugmakers that refuse to negotiate drug prices with Medicare under requirements of the 2022 tax and climate law, saying the tax only would apply to manufacturers and importers that initially sell the drugs.
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January 01, 2025
Healthcare and Life Science Deals Attys Expect In 2025
As the healthcare industry heads into 2025, deals attorneys are optimistic as they look to falling interest rates and a potentially more business-friendly administration set to enter the White House.
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January 01, 2025
The Top 5 High Court Cases To Watch This Spring
The U.S. Supreme Court justices will return from the winter holidays to tackle major First Amendment questions and several administrative law disputes — all arising from the Fifth Circuit — that could further change how federal agencies promulgate rules and defend them.
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January 01, 2025
High-Stakes Healthcare Court Battles To Watch In 2025
With pivotal health law cases on the docket in 2025, attorneys will be watching how the incoming Trump administration proceeds in ongoing litigation over abortion care, the Affordable Care Act and the Medicare drug price negotiation program.
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January 01, 2025
Healthcare And Life Science Policies To Watch In 2025
Healthcare and life sciences attorneys will have their eyes on Washington, D.C., in the next few months. They will be keen to understand how a new presidential administration and a new Congress with razor-thin GOP control will approach a bevy of fraught issues.
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January 01, 2025
Product Liability Cases To Watch In 2025
Cases that attorneys will be keeping an eye on in the coming year involve Monsanto and a circuit rift over preemption regarding Roundup cancer claims, as well as mass torts over claims that social media harm minors' mental health.
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January 01, 2025
Patent Policy To Watch In 2025
Patent attorneys are awaiting new leadership at the U.S. Patent and Trademark Office and the U.S. International Trade Commission, and are tracking several bills in Congress. Here's what else they should be following in the new year.
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January 01, 2025
IPO Outlook Brightens As More Companies Eye 2025 Listings
Capital markets attorneys are preparing to advise more companies toward initial public offerings in 2025, given evidence that a rising number of candidates are joining the pipeline in expectation of a long-awaited resurgence in new listings. Here, Law360 looks at what deals attorneys and market participants expect.
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January 01, 2025
Patent Cases To Watch In 2025
The Federal Circuit has taken on a rare en banc patent case looking at damages, while the U.S. Supreme Court has been asked to review when foreign damages can be incorporated into patent awards. Here's what you need to know about these cases and others that attorneys are keeping an eye on in 2025.
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January 01, 2025
Top Federal Tax Cases To Watch In 2025
Over the next year, tax practitioners will be closely monitoring suits that challenge the IRS' use of the economic substance doctrine, take advantage of the U.S. Supreme Court's landmark decision curbing federal agencies' regulatory authority and dispute the government's handling of worker retention credits. Here, Law360 looks at key federal tax cases to follow in 2025.
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January 01, 2025
Patent Litigation Trends To Watch In 2025
Litigation funding resulting in more heated disputes, artificial intelligence tools becoming a fact of life for patent attorneys and increased use of patent reexaminations are among the trends attorneys will be keeping tabs on in the coming year.
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December 23, 2024
Ex-Pharma Exec Charged With $38M Insider Trading Scheme
A former chief science officer of pharmaceutical company Humanigen faces charges in New Jersey federal court that he dumped shares of the company before it publicly announced its potential COVID-19 drug did not receive federal approval, according to an indictment unsealed Monday.
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December 23, 2024
HHS Can't Enforce Abortion Privacy Rule Against Texas Doctor
A Texas federal judge has granted a Lone Star State doctor a reprieve from a new U.S. Department of Health and Human Services rule that aims to protect the privacy of abortion providers and patients, saying that the rule likely exceeds the Health Insurance Portability and Accountability Act's statutory authority.
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December 20, 2024
Sens. Aim To Protect Generics With Skinny Labels In New Bill
A bipartisan group of senators from Colorado, Arkansas, Vermont and Maine have introduced a bill that would shield generic-drug and biosimilar manufacturers from infringement liability when using approved "skinny labels."
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December 20, 2024
South Korean Needle Operation Secures Patent Win At ITC
The U.S. subsidiary of a South Korean dermatologist's needle business has convinced a judge at the U.S. International Trade Commission that several rivals in the marketplace for selling microneedles to plastic surgeons are infringing patents.
Expert Analysis
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Law Firms Should Move From Reactive To Proactive Marketing
Most law firm marketing and business development teams operate in silos, leading to an ad hoc, reactive approach, but shifting to a culture of proactive planning — beginning with comprehensive campaigns — can help firms effectively execute their broader business strategy, says Paul Manuele at PR Manuele Consulting.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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Opinion
A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.
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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.