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Life Sciences
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January 02, 2025
Eye Drug Study Blindsided Pharma Co. Investors, Suit Says
The CEO and directors of biopharmaceutical company Apellis Pharmaceuticals Inc. face shareholder derivative claims they failed to monitor clinical study participants for a serious side effect, leading to plummeting trading prices after a medical association sounded an alarm about the company's drug candidate.
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January 02, 2025
Fox Rothschild Atty Beats Trade Secret Theft Allegations
A federal judge in New Jersey says a company trying to develop cancer drugs had waited too long to sue its former patent lawyer after he allegedly "confessed" over five years ago to helping a Chinese rival file a patent application that allegedly misappropriated trade secrets.
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January 02, 2025
Edwards Brass Face Investor Suit Over Heart Valve Sales
The executives and directors of medical device maker Edwards Lifesciences have been hit with a shareholder derivative suit in California federal court alleging the company understated how industry trends and macroeconomic factors would impact the success of its mainstay device.
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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.
Expert Analysis
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FTC Focus: How Scrutiny Of PBMs And Insulin May Play Out
Should Express Scripts' recent judicial challenge to the Federal Trade Commission succeed, any new targets could add litigation and choice of forum to their playbooks, and potential FTC court action on insulin could be forced to parallel venues as the issues between the commission and PBMs evolve, say attorneys at Proskauer.
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Opinion
AI May Limit Key Learning Opportunities For Young Attorneys
The thing that’s so powerful about artificial intelligence is also what’s most scary about it — its ability to detect patterns may curtail young attorneys’ chance to practice the lower-level work of managing cases, preventing them from ever honing the pattern recognition skills that undergird creative lawyering, says Sarah Murray at Trialcraft.
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Series
Round-Canopy Parachuting Makes Me A Better Lawyer
Similar to the practice of law, jumping from an in-flight airplane with nothing but training and a few yards of parachute silk is a demanding and stressful endeavor, and the experience has bolstered my legal practice by enhancing my focus, teamwork skills and sense of perspective, says Thomas Salerno at Stinson.
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And Now A Word From The Panel: The MDL Map
An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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Why Now Is The Time For Law Firms To Hire Lateral Partners
Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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A Look At The Economic Impact Of Drug Patent Differentiation
Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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New Lessons On Managing Earnout Provision Risks
Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.
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3 Patent Considerations For America's New Quantum Hub
Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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How Companies Are Approaching Insider Trading Policies
An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.