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Life Sciences
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September 27, 2024
Life Sciences Firms Energize IPO Market As Recovery Builds
Initial public offerings are closing the year's third quarter on an upswing, led mostly by pre-revenue drug developers and select large companies that are seizing opportunities in friendlier capital markets buoyed by interest-rate cuts, generating momentum that experts say could carry over into next year.
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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.
Expert Analysis
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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2 Options For Sackler Family After High Court Purdue Ruling
After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.
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Fed. Circ. Skinny Label Ruling Guides On Infringement Claims
The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.
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4 Takeaways From Biotech Patent Invalidity Ruling
The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.
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How To Clean Up Your Generative AI-Produced Legal Drafts
As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.
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Calif. Ruling Heightens Medical Product Maker Liability
The California Supreme Court's decision in Himes v. Somatics last month articulates a new causation standard for medical product manufacturer liability that may lead to stronger product disclosures nationwide and greater friction between manufacturers and physicians, say attorneys at Cooley.
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Constitutional Protections For Cannabis Companies Are Hazy
Cannabis businesses are subject to federal enforcement and tax, but often without the benefit of constitutional protections — and the entanglement of state and federal law and conflicting judicial opinions are creating confusion in the space, says Amber Lengacher at Purple Circle.
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USPTO Disclaimer Rule Would Complicate Patent Prosecution
The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.
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Series
Boxing Makes Me A Better Lawyer
Boxing has influenced my legal work by enabling me to confidently hone the skills I've learned from the sport, like the ability to remain calm under pressure, evaluate an opponent's weaknesses and recognize when to seize an important opportunity, says Kirsten Soto at Clyde & Co.
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Purdue Ch. 11 Ruling Reinforces Importance Of D&O Coverage
The U.S. Supreme Court's recent decision in Harrington v. Purdue Pharma, holding that a Chapter 11 reorganization cannot discharge claims against a nondebtor without affected claimants' consent, will open new litigation pathways surrounding corporate insolvency and increase the importance of robust directors and officers insurance, says Evan Bolla at Harris St. Laurent.
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Opinion
Industry Self-Regulation Will Shine Post-Chevron
The U.S. Supreme Court's Loper decision will shape the contours of industry self-regulation in the years to come, providing opportunities for this often-misunderstood practice, says Eric Reicin at BBB National Programs.