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Life Sciences
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March 14, 2025
Market Turbulence Threatens To Stall IPO Recovery
Stock market volatility is impeding a recovery in initial public offerings that market dealmakers hoped would begin by spring, prompting many IPO lawyers and advisers to defer hopes of a rebound until at least the second half of 2025.
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March 14, 2025
Ex-NJ Health Official Settles Suit Over COVID Whistleblowing
A former New Jersey health official's long-running suit alleging that he was fired for raising concerns about political favoritism connected to COVID-19 testing during the onset of the pandemic appears to have been settled, according to a docket notation.
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March 14, 2025
Fed. Circ. Affirms No Block On Amgen's Eye Med Biosimilar
The Federal Circuit on Friday agreed with a lower court decision declining to temporarily block Amgen's biosimilar of Regeneron's blockbuster eye medication Eylea, affirming that court's application of claim construction precedent in the patent infringement suit.
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March 14, 2025
Antigua Clinic Accused Of Lying About 'Miracle' Cancer Cure
A company called ExThera Medical Corp. has been sued in California federal court over a cure, backed by a billionaire investor, marketed for metastatic cancer but was actually a "dangerous medical experiment."
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March 14, 2025
Biotech Wins Dismissal Of Investor Fraud Claims
A Boston federal judge on Friday dismissed a proposed investor class action against biotech Aldeyra Therapeutics Inc., ruling that the lawsuit's facts tend to support innocent explanations for executives' statements about its two drug prospects.
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March 14, 2025
1st Circ. Asked To Look At Takeda Invoice Fraud Conviction
The husband of a former Takeda Pharmaceuticals vice president is appealing his fraud conviction and 2½-year prison term over a $2.3 million bogus invoice scheme, according to a Friday notice filed to the First Circuit.
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March 14, 2025
Green Groups Sue Fed. Agencies Over Frozen Funding
Environmental groups sued five federal government agencies and their leaders, alleging they illegally froze congressionally approved funding and are hampering the organizations' work.
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March 14, 2025
FTC Urges 8th Circ. Not To Pause Insulin Pricing Case
The Federal Trade Commission has urged the Eighth Circuit not to pause its in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices, telling the appeals court the pharmacy benefit managers have no chance of winning on their constitutional claims.
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March 14, 2025
Dr. Oz Pledges 'Upcoding' Crackdown If Confirmed At CMS
Dr. Mehmet Oz told lawmakers he would combat rising healthcare costs by showing there's a "new sheriff in town" opposed to so-called upcoding by Medicare Advantage plans, as he sought support Friday for his nomination to lead the U.S. Centers for Medicare and Medicaid Services.
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March 14, 2025
Colo. Jury Rejects Claims Sterilization Co. Caused Cancer
A Colorado jury Friday morning rejected four women's claims that emissions from a Terumo BCT Inc. medical sterilization plant caused their cancer, finding after a six-week bellwether trial that the company was not negligent in how it handled emissions of a toxic sterilization chemical.
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March 14, 2025
Taxation With Representation: Davis Polk, Paul Weiss
In this week's Taxation With Representation, Mallinckrodt PLC and Endo Inc. combine, Rocket Cos. buys Redfin, and Endo divests its international pharmaceuticals business to Knight Therapeutics Inc.
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March 13, 2025
SEC's Expansion Of Confidential Filings Likely To Spur Deals
The U.S. Securities and Exchange Commission's latest effort to expand companies' ability to confidentially file for more securities offerings during initial stages should accelerate the pace of public issuances, according to capital markets lawyers.
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March 13, 2025
Fed. Circ. Sides With Merck In Reissued Patent Debate
The Federal Circuit isn't buying that a reissued patent was actually "issued" at the time it was originally awarded, dashing generic-drug makers' hopes of breaking pharmaceutical giant Merck's hold on a blockbuster drug that counteracts the effects of anesthesia.
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March 13, 2025
Merck Asks Justices To Block Fosamax Failure-To-Warn Suits
Merck has asked the U.S. Supreme Court to review a Third Circuit ruling that allowed more than 1,000 state-law failure-to-warn claims over its osteoporosis drug Fosamax, arguing that the U.S. Food and Drug Administration's formal rejection of a such a proposed warning label should block such lawsuits under federal law.
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March 13, 2025
Calif. AG Appealing State Limits On Pay-For-Delay Ban
California enforcers are appealing to the Ninth Circuit after a lower court found that a new state law restricting "reverse payment" settlements between brand-name and generic-drug makers cannot be used to regulate deals that were struck outside the state.
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March 13, 2025
Fed. Circ. Dings Antibody Patent App For Lacking Description
The Federal Circuit on Thursday affirmed a decision from top U.S. Patent and Trademark Office officials in a highly watched and technical dispute over an antibody patent application, concluding that preambles for so-called Jepson claims need sufficient written descriptions.
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March 13, 2025
PBMs Tell FTC 5-Month Delay Too Long For In-House Insulin Trial
The nation's "Big Three" pharmacy benefit managers say they want to get to trial in the Federal Trade Commission's administrative suit against them sooner rather than later, arguing that the agency's request for a five-month delay would be too long, but they're open to a three-week postponement.
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March 13, 2025
HHS Calls Back Terminated Attys Clearing Medicare Appeals
The U.S. Department of Health and Human Services on Thursday moved to reinstate about 15 attorneys who were cut loose in recent weeks, restoring staff many in the agency saw as critical to clearing a backlog of Medicare appeals.
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March 13, 2025
9th Circ. Ends Idaho Abortion Law Row After Mutual Dismissal
A Ninth Circuit panel has dropped an appeal from Idaho claiming the state's strict abortion ban doesn't conflict with a federal law protecting emergency abortions, after the Trump administration announced its decision to drop the Biden-era legal challenge.
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March 13, 2025
6 Firms Steer $6.7B Mallinckrodt, Endo Pharma Merger
Six law firms are guiding a $6.7 billion merger between Ireland's Mallinckrodt PLC and Pennsylvania-based Endo Inc. on a deal announced Thursday that the companies said will create a global pharmaceutical industry leader with projected 2025 revenues of $3.6 billion.
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March 13, 2025
Full 4th Circ. Urged To Rethink Drug Price-Fixing Class Action
The Fourth Circuit's dismissal of a proposed class action accusing drug companies of conspiring to inflate the price of a drug for Huntington's disease has deepened a circuit split on proving injury under the Racketeer Influenced and Corrupt Organizations Act, a group of reimbursement recovery entities has said in asking the full court to rethink the ruling.
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March 13, 2025
J&J Unit Drops Noncompete Suit Against Ex-Marketing Exec
Johnson & Johnson's vision unit has agreed to drop its claims against a former marketing director after reaching a settlement on allegations that she breached a noncompete agreement, according to a Thursday order in New Jersey federal court.
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March 13, 2025
Days Into New Role, FDA's Top Lawyer Is Out
The top lawyer of the U.S. Food and Drug Administration resigned just two days after she was selected for the role, according to a Thursday announcement by the agency on social media site X.
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March 13, 2025
Lacking Votes, White House Pulls Weldon Nomination At CDC
The White House pulled Dr. Dave Weldon's nomination to lead the Centers for Disease Control and Prevention on Thursday after support among GOP lawmakers wavered, and it became clear he didn't have the votes to clear a Senate committee.
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March 12, 2025
Cancer Cause Or Red Herring? Jury Weighs Plant Bellwether
A medical sterilization company told a Colorado jury Wednesday that four women can't get millions in damages based on the "possibility" that emissions from a sterilization plant caused their cancer, at the close of a six-week trial in which the plaintiffs argued the company should be punished for its negligence.
Expert Analysis
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A Look At FDA's Plans To Establish New OTC Drug Category
The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.
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The Fed. Circ. In 2024: 5 Major Rulings To Know
In 2024, the Federal Circuit provided a number of important clarifications to distinct areas of patent law – including design patent obviousness, expert testimony admissions and patent term adjustments – all of which are poised to have an influence going forward, say attorneys at Knobbe Martens.
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Rethinking Litigation Risk And What It Really Means To Win
Attorneys have a tendency to overestimate litigation risk before summary judgment and underestimate risk after it, but an eight-stage litigation framework can clarify risk at different points and help litigators reassess what true success looks like in any particular case, says Joshua Libling at Arcadia Finance.
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How DOGE's Bite Can Live Up To Its Bark
All signs suggest that the Department of Government Efficiency will be an important part of the new Trump administration, with ample tools at its disposal to effectuate change, particularly with an attentive Republican-controlled Congress, say attorneys at K&L Gates.
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US-China Deal Considerations Amid Cross-Border Uncertainty
With China seemingly set to respond to the incoming U.S. administration's call for strategic decoupling and tariffs, companies on both sides of the Pacific should explore deals and internal changes to mitigate risks and overcome hurdles to their strategic plans, say attorneys at Covington.
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Considering The Status Of The US Doctrine Of Patent Misuse
A recent Ninth Circuit decision and a U.K. Court of Appeal decision demonstrate the impact that the U.S. Supreme Court's 2015 decision in Kimble v. Marvel Entertainment has had on the principle that post-patent-expiration royalty payments amount to patent misuse, not only in the U.S. but in English courts as well, say attorneys at Covington.
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Series
Playing Rugby Makes Me A Better Lawyer
My experience playing rugby, including a near-fatal accident, has influenced my legal practice on a professional, organizational and personal level by showing me the importance of maintaining empathy, fostering team empowerment and embracing the art of preparation, says James Gillenwater at Greenberg Traurig.
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Looking Back At 2024's Noteworthy State AG Litigation
State attorneys general across the U.S. took bold steps in 2024 to address unlawful activities by corporations in several areas, including privacy and data security, financial transparency, children's internet safety, and other overall consumer protection claims, say attorneys at Troutman Pepper.
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Opinion
No, Litigation Funders Are Not 'Fleeing' The District Of Del.
A recent study claimed that litigation funders have “fled” Delaware federal court due to a standing order requiring disclosure of third-party financing, but responsible funders have no problem litigating in this jurisdiction, and many other factors could explain the decline in filings, say Will Freeman and Sarah Tsou at Omni Bridgeway.
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Patent Policy Changes To Track Under New Gov't Leadership
The new federal government will likely bring pivotal shifts in U.S. patent policy through legislation and initiatives that reflect a renewed focus on strengthening intellectual property rights, fostering innovation and enhancing the nation's competitive edge, says PK Chakrabarti at Butzel Long.
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Liability Risk For AI In Medical Devices Demands Greater Care
As regulators push for legal reform surrounding artificial intelligence and cases implicating product liability for AI in medical technology continue to rise, manufacturers must adapt and implement new strategies to accommodate evolving risks, say attorneys at Crowell & Moring.
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5 E-Discovery Predictions For 2025 And Beyond
In the year to come, e-discovery will be shaped by new and emerging trends, from the adoption of artificial intelligence provisions in protective orders, to the proliferation of emojis as a source of evidence in contemporary litigation, say attorneys at Littler.
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4 Trade Secret Developments To Follow This Year
Significant developments in trade secret law are likely in 2025, and areas to watch include protection of AI-related innovations, the fate of the Federal Trade Commission's noncompete ban, and questions of the federal Defend Trade Secrets Act's extraterritorial reach, say attorneys at Faegre Drinker.
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Republican Trifecta Amplifies Risks For Cos. In 3 Key Areas
Expected coordination between a Republican Congress and presidential administration may expose companies to simultaneous criminal, civil and congressional investigations, particularly with regard to supply chain risks in certain industries, government contracting and cross-border investment, say attorneys at Morgan Lewis.
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7 Ways 2nd Trump Administration May Affect Partner Hiring
President-elect Donald Trump's return to the White House will likely have a number of downstream effects on partner hiring in the legal industry, from accelerated hiring timelines to increased vetting of prospective employees, say recruiters at Macrae.