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Life Sciences
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September 27, 2024
Advil Owner Haleon Paying $637M To Up Stake In China JV
British consumer healthcare giant Haleon plc said Friday that it has agreed to pay the equivalent of roughly $637 million to increase its stake in a Chinese joint venture, Tianjin TSKF Pharmaceutical Co., from 55% to 88%.
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September 27, 2024
Medical Equipment Co., Founder Settle FCA Suit For $20M
A Florida-based medical equipment company and its founder will pay $20 million to settle claims under the federal False Claims Act that they improperly billed government healthcare plans for duplicated and unnecessary sales of devices meant to offer pain relief through electrical stimulation, Pennsylvania prosecutors said Friday.
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September 26, 2024
SEC Fines Cassava $40M Over Alzheimer's Treatment Claims
Neuroscience-focused biopharmaceutical company Cassava Sciences Inc. and two of its former executives agreed to pay over $40 million to resolve U.S. Securities and Exchange Commission claims related to allegedly misleading statements about clinical trial results for a potential Alzheimer's disease therapeutic, the regulator announced on Thursday.
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September 26, 2024
11th Circ. Affirms Convictions In Fla. Shark Rescue Case
The Eleventh Circuit upheld felony theft convictions for two Florida tour boat divers who were prosecuted for freeing sharks they believed were illegally poached, but turned out to be part of a research project conducted with a permit granted by the National Oceanic and Atmospheric Administration.
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September 26, 2024
2nd Circ. Denies Jury Trial In Abbott Labs Gray Market Case
A man and his wife involved in the sale of gray market diabetes test strips on Tuesday were unable to persuade the Second Circuit to undo the $33.4 million judgment they owe to Abbott Laboratories after a federal judge stripped them of their right to a jury trial.
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September 26, 2024
New Report Urges Feds To Take Larger Role In Pot Policy
The rise of state-sanctioned cannabis markets amid the absence of federal regulation has prioritized policies intended to launch marijuana sales over those focused on public health, according to a government-sponsored report made public Thursday.
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September 26, 2024
Walgreens Struggles To Exit 'Non-Drowsy' Label Suit In Wash.
The Washington State Supreme Court questioned Thursday whether Walgreens could avoid state consumer protection claims over its "non-drowsy" cough medicine label by pointing to a lack of federal labeling requirements for the drug, with one justice calling the argument a non sequitur.
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September 26, 2024
NC Medical Equipment Maker Can't Ditch Unfair Biz Suit
The North Carolina Business Court has denied a medical equipment maker's bid to get a win based on the pleadings in a fraudulent concealment and unfair trade practices lawsuit alleging that it stole the business model and a pregnancy support garment design from a rival.
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September 26, 2024
Obesity Drug Developer Leads 2 Upsized IPOs Totaling $310M
Obesity-focused drug developer BioAge Labs Inc. gained in debut trading Thursday after raising $198 million through an upsized initial public offering, leading one of two new listings that netted a combined $310 million under the guidance of four law firms.
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September 26, 2024
Virtua Discriminates Against Pregnant Patients, NJ Alleges
Virtua Health discriminates against pregnant patients by forcing them to undergo drug testing for inpatient admission to its hospitals — a policy that does not apply universally to other patients, New Jersey Attorney General Matthew J. Platkin alleged in a lawsuit filed Thursday in New Jersey state court.
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September 26, 2024
Senate Patent Bill Markups Delayed Until After Election
Congressional hearings scheduled for Thursday to mark up several bills related to patents, including measures dealing with patent eligibility, validity challenges and drug patents, have been postponed until after Election Day due to the Senate's adjournment.
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September 26, 2024
Nobel Winners Behind Gene Editor Seek To Nix Own Patents
The scientists credited with inventing the gene-editing tool CRISPR have voluntarily requested that two key patents be revoked in Europe, after officials suggested they might get nixed over technical issues.
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September 26, 2024
Quest Diagnostics Escapes 401(k) Mismanagement Suit
A New Jersey federal judge tossed a proposed class action alleging Quest Diagnostics Inc. mismanaged its $5 billion retirement plan by failing to chop under performing investment funds from its lineup, pointing to proof that the company acted to rein in questionable funds.
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September 25, 2024
In-House Counsel To Play Central Role At AI Cos., VCs Say
Venture capital firms expect in-house counsel at artificial intelligence companies to play a bigger role in their businesses due to regulatory uncertainties around AI, while a professor who helped pioneer the technology warned that transparency of commercial AI businesses should be "top of mind," attorneys heard at the seventh annual Berkeley Law AI Institute Wednesday.
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September 25, 2024
NY Judge Pauses Abortion 'Reversal' Case As AG Files Appeal
A New York federal judge has ruled that two more anti-abortion pregnancy centers are free to promote abortion pill "reversal" while a legal clash continues over whether the First Amendment protects their right to market the treatment, which is doubted by major medical groups.
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September 25, 2024
Ascension Must Face Additional Suit Over Vaccine Mandate
Ascension Health Alliance must face another proposed class action challenging its 2021 COVID-19 vaccination policy, an Indiana federal judge ruled Wednesday, holding that a group of workers who were suspended or fired after refusing the vaccine on religious grounds have a case against the Catholic healthcare system.
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September 25, 2024
Generics Group Names Ex-BIO, PhRMA Exec As New CEO
The generic drug industry group the Association for Accessible Medicines on Wednesday announced it has appointed a new chief executive officer who brings over a decade of experience in the branded drug industry.
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September 25, 2024
3rd Circ. Preserves Monsanto's Win In Cancer Warning Suit
The Third Circuit refused to reconsider its ruling that federal law preempts a more stringent Pennsylvania statute that mandates cancer warnings on chemicals, preserving Monsanto's win against a man who alleged the company's Roundup herbicide caused his illness.
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September 25, 2024
7th Circ. Judge Surprised Key Argument Left In Footnote
A Seventh Circuit judge seemed unsure Wednesday whether an insurer for Sterigenics could avoid a $75 million legal bill for defending the company from pollution suits, noting that the insurer addressed "the biggest issue in the case" in just a single, vague footnote.
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September 25, 2024
NJ Pharmacy Execs Cop To $33M Kickback Scheme
Two men who ran a New Jersey mail-order pharmacy admitted their roles in a $33 million medication kickback scheme, U.S. Attorney Philip R. Sellinger announced Wednesday.
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September 25, 2024
Wyden Pitches New Bill To Regulate Intoxicating Hemp
U.S. Senator Ron Wyden, D-Ore., introduced a new bill on Wednesday to more tightly regulate products with hemp-derived cannabinoids, with an emphasis on age gating, manufacturing standards and labeling requirements.
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September 25, 2024
DC Circ. Judges Ask If It's Too Late To Fast-Track Gastro Drug
A panel of D.C. Circuit judges grilled an attorney for Vanda Pharmaceuticals on Wednesday over claims Vanda's gastroparesis drug was improperly denied fast-track designation by the Food and Drug Administration, questioning why the company declined to complete animal toxicological studies even after the FDA paused the drug's human trials.
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September 25, 2024
Expect More R&D Guidance Before Regs, IRS Atty Says
The Internal Revenue Service plans to release more guidance governing the tax treatment of research and development expenses before it formally issues proposed regulations that implement the 2017 federal tax law's changes to the incentive, an agency attorney said Wednesday.
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September 25, 2024
Cancer Detection Biz To Go Public Via $694M SPAC Merger
Special purpose acquisition company Breeze Holdings Acquisition Corp. on Wednesday announced that it has agreed to merge with and take public clinical-stage biopharmaceutical company YD Biopharma Ltd. in a deal that gives the combined company an estimated enterprise value of $694 million and was built by three firms.
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September 25, 2024
AmerisourceBergen Can't Escape Workers' 401(k) Fee Suit
AmerisourceBergen Corp. can't escape a proposed class action alleging it allowed its employee 401(k) plan to be saddled with excessive recordkeeping costs, a Kentucky federal judge ruled, saying the workers' claims and calculations were detailed enough to move forward.
Expert Analysis
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Perspectives
Trauma-Informed Legal Approaches For Pro Bono Attorneys
As National Trauma Awareness Month ends, pro bono attorneys should nevertheless continue to acknowledge the mental and physical effects of trauma, allowing them to better represent clients, and protect themselves from compassion fatigue and burnout, say Katherine Cronin at Stinson and Katharine Manning at Blackbird.
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Series
Playing Music Makes Me A Better Lawyer
My deep and passionate involvement in playing, writing and producing music equipped me with skills — like creativity, improvisation and problem-solving — that contribute to the success of my legal career, says attorney Kenneth Greene.
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Proposed Cannabis Reschedule Sidesteps State Law Effects
The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.
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How Attys Can Avoid Pitfalls When Withdrawing From A Case
The Trump campaign's recent scuffle over its bid to replace its counsel in a pregnancy retaliation suit offers a chance to remind attorneys that many troubles inherent in withdrawing from a case can be mitigated or entirely avoided by communicating with clients openly and frequently, says Christopher Konneker at Orsinger Nelson.
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Using A Children's Book Approach In Firm Marketing Content
From “The Giving Tree” to “Where the Wild Things Are,” most children’s books are easy to remember because they use simple words and numbers to tell stories with a human impact — a formula law firms should emulate in their marketing content to stay front of mind for potential clients, says Seema Desai Maglio at The Found Word.
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A Changing Regulatory Landscape For Weight Loss Drugs
As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.
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Opioid Suits Offer Case Study In Abatement Expert Testimony
Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.
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Patent Lessons From 4 Federal Circuit Reversals In April
Four Federal Circuit decisions in April that reversed or vacated underlying rulings provide a number of takeaways, including that obviousness analysis requires a flexible approach, that an invalidity issue of an expired patent can be moot, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Opinion
USPTO's Proposed Disclaimer Rule Would Harm Inventors
The U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers will make the patent system less available to inventors and will unfairly favor defendants in litigation, say Stephen Schreiner at Carmichael IP and Sarah Tsou at Omni Bridgeway.
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Series
Being An EMT Makes Me A Better Lawyer
While some of my experiences as an emergency medical technician have been unusually painful and searing, the skills I’ve learned — such as triage, empathy and preparedness — are just as useful in my work as a restructuring lawyer, says Marshall Huebner at Davis Polk.
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Mitigating Incarceration's Impacts On Foreign Nationals
Sentencing arguments that highlighted the disparate impact incarceration would have on a British national recently sentenced for insider training by a New York district court, when compared to similarly situated U.S. citizens, provide an example of the advocacy needed to avoid or mitigate problems unique to noncitizen defendants, say attorneys at Lankler Siffert.
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Contract Disputes Recap: Saying What Needs To Be Said
Edward Arnold and Bret Marfut at Seyfarth Shaw examine three recent decisions that delve into the meaning and effect of contractual releases, and demonstrate the importance of ensuring that releases, as written, do what the parties intend.
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Lessons On Challenging Class Plaintiffs' Expert Testimony
In class actions seeking damages, plaintiffs are increasingly using expert opinions to establish predominance, but several recent rulings from California federal courts shed light on how defendants can respond, say Jennifer Romano and Raija Horstman at Crowell & Moring.
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Exploring An Alternative Model Of Litigation Finance
A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.
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Del. IP Ruling May Mark Limitation-By-Limitation Analysis Shift
A Delaware federal court's recent ruling in Lindis Biotech v. Amgen, which involved complex technology where the complaint contained neither facts nor a specific allegation directed to a claim limitation, might spark a shift away from requiring a limitation-by-limitation analysis, say Ted Mathias and Ian Swan at Axinn.