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Life Sciences
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March 24, 2025
Trump Picks Acting CDC Head After Weldon Nomination Fails
President Donald Trump on Monday nominated acting Centers for Disease Control and Prevention head Susan Monarez to take over as the agency's director, a move that comes after Trump pulled his nomination of Dr. Dave Weldon for the position when it became clear Weldon lacked needed support.
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March 24, 2025
Amgen Wants $50M Leukemia Drug Patent Verdict Thrown Out
Amgen has urged a Delaware federal court to grant it a new trial after a federal jury last year found that it owed Germany's Lindis Biotech $50.3 million in damages for encouraging healthcare providers to infringe immunotherapy patents by administering a leukemia treatment.
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March 24, 2025
Kenvue, J&J Must Face Investor Suit Over FDA Concerns
Consumer health products business Kenvue Inc. and former parent company Johnson & Johnson cannot escape a consolidated lawsuit accusing the companies of failing to warn investors about the potential ineffectiveness of leading products like Tylenol and Sudafed ahead of Kenvue's initial public offering, a New Jersey federal judge ruled on Monday.
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March 24, 2025
Justices Urged To Weigh In On Skinny Label Dispute
A generic-drug industry organization and a group of scholars are urging the U.S. Supreme Court to scrutinize a Federal Circuit decision they say undermines the process for getting generic drugs to market under so-called skinny labels.
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March 24, 2025
Period App Users Get $3.5M In Privacy Deal With Analytics Co.
A defunct mobile analytics company caught up in a proposed class action alleging a menstruation tracking app impermissibly shared health information with Google and others has agreed to a $3.5 million settlement with app users, given its "limited pool of funds," app users informed a California federal court on Friday.
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March 24, 2025
United Healthcare Escapes Some Of Diagnostic Co.'s Claims
A Texas federal judge has wiped away a good portion of a cancer diagnostics company's suit against United Healthcare Services Inc., but left intact the company's claim that United breached an implied contract when it started to take back money it had already paid out.
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March 24, 2025
Investors Blame Electrotherapy Co.'s Practices For Stock Drop
Electrotherapy device maker Zynex Inc. faces a proposed investor class action claiming it harmed shareholders after it was booted from at least one insurer network for U.S. military members, allegedly due to oversupplying its customers.
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March 24, 2025
Seattle Biotech Duped Investors On Drug Progress, Suit Says
Seattle's Sana Biotechnology Inc. is the target of a proposed class action filed on Monday by a shareholder who alleges the company misled investors about its ability to develop genetic therapy treatments for oncology and central nervous system disorders.
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March 24, 2025
Apple, Sony, Others Facing ITC Probes Over Imports
The U.S. International Trade Commission has said it is launching a series of investigations into whether imports of products such as video game consoles, nose cleaning devices and semiconductors have infringed various U.S. patents.
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March 24, 2025
Fla. Judge OKs $19.3M In Spinal Products Noncompete Suit
A Florida federal judge approved a $19.3 million judgment against the owner of a distributor and his affiliated companies, finding that he owes damages for breaching an exclusive sales agreement with a spinal products manufacturer in a case with a "tortured history" that lasted for more than six years.
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March 24, 2025
Norton Rose, Latham Steer Alcon's $430M Lensar Buy
Eye care company Alcon, advised by Norton Rose Fulbright, unveiled on Monday an agreement to purchase medical technology developer Lensar, which is represented by Latham & Watkins LLP, for up to $430 million.
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March 21, 2025
Novartis Urges Court To Make FDA Block Entresto Generic
Novartis says the U.S. Food & Drug Administration has made a drug marketing exclusivity window "meaningless" and wants a D.C. federal judge to block a rival from selling a generic drug that would compete with its blockbuster heart medication Entresto.
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March 21, 2025
Fed. Circ. Revives Blood Pump Patent Suit Against J&J Unit
The Federal Circuit on Friday reinstated a blood pump patent suit by a unit of Swedish medical device company Getinge AB against a Johnson & Johnson MedTech subsidiary, faulting a Massachusetts federal judge's claim construction that led the parties to stipulate that there was no infringement.
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March 21, 2025
Bausch & Lomb Says Amcor Must Pay For Botched Bottles
A packaging company evaded quality controls to deliver defective plastic bottles that caused a slowdown in manufacturing at a Bausch & Lomb facility, the eye care company has claimed in a complaint filed in Michigan federal court.
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March 21, 2025
Judge Accused Of Bias Expresses Regret Over MDL Remarks
The chief judge of the Eleventh Circuit has dismissed a judicial ethics complaint alleging that a Florida federal judge had shown impermissible bias in favor of women leading the multidistrict litigation over the hormonal contraceptive drug Depo-Provera, after the judge said she "regrets any misunderstanding" and took steps to address the issue.
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March 21, 2025
New Mexico Lawmakers Approve Medical Psilocybin Bill
New Mexico lawmakers have given final approval to legislation to create a regulated medical psilocybin program, sending the proposal to the governor's desk.
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March 21, 2025
Exactech Strikes $10M Deal With TPG In Ch. 11
Counsel for medical implant maker Exactech Friday told a Delaware bankruptcy judge it has reached a $10 million settlement of potential claims against its equity sponsor a week before it will seek approval to send its Chapter 11 plan out for a vote.
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March 21, 2025
Taxation With Representation: Cravath, Paul Weiss, Cooley
In this week's Taxation With Representation, Google acquires Wiz, QXO Inc. acquires Beacon Roofing Supply, and the Boston Celtics are bought by a group led by private equity firm co-founder William Chisholm.
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March 21, 2025
AstraZeneca To Invest $2.5B In China Research Hub
Pharmaceutical giant AstraZeneca on Friday announced plans to invest $2.5 billion in Beijing over the next five years to establish a new global strategic research and development center, inking agreements with three biotechs to help develop new treatments and advance life sciences in China.
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March 21, 2025
Fed. Circ. Backs Actavis' $12M Patent Suit Cost Deduction
Drugmaker Actavis can take a $12 million tax deduction for money it spent fending off lawsuits while securing approval to sell generic birth control and other drugs, the Federal Circuit ruled Friday, affirming the U.S. Court of Federal Claims' decision that the costs were deductible as ordinary business expenses.
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March 20, 2025
Texas Says Planned Parenthood Can't Get Atty Immunity
Texas has urged the full Fifth Circuit to reconsider a panel's decision concluding that Planned Parenthood is entitled to attorney immunity in a whistleblower suit accusing the organization of improperly billing Medicaid programs, saying state-law attorney immunity doesn't apply.
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March 20, 2025
Class In Bayer 'One A Day' Gummies Lawsuit Gets Judge's OK
A New York federal judge on Wednesday certified a class of consumers who allege that the labeling on Bayer's "One A Day" vitamin gummies is misleading, finding that an expert's survey found that the consumers found that it was so.
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March 20, 2025
8th Circ. Won't Pause FTC's Insulin Pricing Case
The Eighth Circuit refused Thursday to pause the Federal Trade Commission's in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices while the pharmacy benefit managers challenge the constitutionality of the proceedings.
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March 20, 2025
MiMedx Challenges FDA Classification Of Wound Care Powder
Biomedical company MiMedx Group urged a Georgia federal judge on Thursday to overturn the U.S. Food and Drug Administration's classification of a wound care treatment as a biological product, arguing the agency misapplied its own regulations.
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March 20, 2025
6th Circ. Judge Skeptical Of Mich. Newborn Screening Ruling
A Sixth Circuit panel questioned Thursday if Michigan's practice of holding onto blood samples collected through a newborn health screening program violates parents' rights to make medical decisions for their children, with one judge saying he didn't see evidence for that proposition.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Firms Still Have Lateral Market Advantage, But Risks Persist
Partner and associate mobility data from the fourth quarter of 2024 shows that we’re in a new, stable era of lateral hiring where firms have the edge, but leaders should proceed cautiously, looking beyond expected revenue and compensation analyses for potential risks, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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10 Practical Takeaways From FDA's Biopharma AI Guidance
Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.
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Opinion
We Must Allow Judges To Use Their Independent Judgment
As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.
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Series
Performing Stand-Up Comedy Makes Me A Better Lawyer
Whether I’m delivering a punchline on stage or a closing argument in court, balancing stand-up comedy performances and my legal career has demonstrated that the keys to success in both endeavors include reading the room, landing the right timing and making an impact, says attorney Rebecca Palmer.
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Unpacking The Illicit E-Cigarette Crackdown By State AGs
A bipartisan coalition of attorneys general for nine states and the District of Columbia announced a coordinated effort to curb illicit electronic cigarette sales, illustrating the rising prominence of state attorneys general using consumer protection laws to address issues of national scope, especially when federal efforts prove ineffective, say attorneys at Troutman.
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Lawmakers Shouldn't Overlook Rare Disease Therapies' Value
As the ORPHAN Cures Act is pending in Congress, policymakers assessing the value of certain drugs for price regulation should consider data beyond what is collected in clinical trials, say Alice Chen at the University of Southern California, and Molly Frean and Yao Lu at Analysis Group.
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Series
Adapting To Private Practice: From SEC To BigLaw
As I adjusted to the multifaceted workflow of a BigLaw firm after leaving the U.S. Securities and Exchange Commission, working side by side with new colleagues on complex matters proved the fastest way to build a deep rapport and demonstrate my value, says Jennifer Lee at Jenner & Block.
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China High Court Ruling Could Encourage Antitrust Litigation
Practitioners defending U.S. companies in China should take note of a Chinese Supreme Court ruling that plaintiffs can file suits based on either where the alleged action, or where the result of such action, occurred — which will promote civil litigation by minimizing procedural battles over forum selection, says Yang Yang at Leaqual Law Firm.
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Making The Case For Rest In The Legal Profession
For too long, a culture of overwork has plagued the legal profession, but research shows that attorneys need rest to perform optimally and sustainably, so legal organizations and individuals must implement strategies that allow for restoration, says Marissa Alert at MDA Wellness, Carol Ross-Burnett at CRB Global, and Denise Robinson at The Still Center.
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How Amended Rule 702 Affects Testimony In Patent Litigation
In 2023, Federal Rule of Evidence 702 was amended to address the apparent failure of some courts to prevent unreliable expert evidence from reaching a jury, but a statistical analysis of Daubert decisions in 2022 and 2024 shows that courts remain divided about how to apply consistent evidence standards, say attorneys at Perkins Coie.
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What Trump's Order Means For The Legal Status Of IVF
An executive order signed by President Donald Trump last month signals the administration's potential intention to increase protections for in vitro fertilization services, though more concrete actions would be needed to resolve the current uncertainty around IVF access or bring about a binding legal change, says Jeanne Vance at Weintraub Tobin.
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Mitigating Tariff Risks For Healthcare In US And Canada
Healthcare stakeholders should take steps to evaluate the impact of cross-border tariffs, as the historically strong ties between Canada and the U.S. demonstrate the potential for real disruption and harm to the healthcare industry in both countries, say attorneys at Norton Rose.
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4 Ways Women Attorneys Can Build A Legal Legacy
This Women’s History Month, women attorneys should consider what small, day-to-day actions they can take to help leave a lasting impact for future generations, even if it means mentoring one person or taking 10 minutes to make a plan, says Jackie Prester, a former shareholder at Baker Donelson.
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A Judge's Pointers For Adding Spice To Dry Legal Writing
U.S. District Judge Fred Biery shares a few key lessons about how to go against the grain of the legal writing tradition by adding color to bland judicial opinions, such as by telling a human story and injecting literary devices where possible.
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Preparing For Disruptions To Life Sciences Supply Chains
Life sciences companies must assess how new and escalating tariffs — combined with other restrictions on cross-border activity singling out pharmaceutical products and medical devices — will affect supply chains, and they should proactively prepare for antitrust and foreign direct investment regulatory review processes, say attorneys at Weil.