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Life Sciences
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May 30, 2025
$5.2M Generic Drug Price-Fixing MDL Deal Gets Final OK
Apotex Corp. will be paying $5.2 million to settle claims from a class of indirect purchasers alleging the drugmaker was working with other pharmaceutical companies to hike up the price of certain generic medications.
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May 30, 2025
Wheeling & Appealing: The Latest Must-Know Appellate Action
Saying that June's circuit court calendars include important arguments in all practice areas would be hyperbolic — but just slightly. That's because significant showdowns are imminent involving appellate procedure principles, "click-to-cancel" rules, government procurement protests, judiciary employment protections and litigation risk insurance — as well as President Donald Trump's felony convictions and extraordinary deportation measures.
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May 30, 2025
Crowdfunding, Reg A Deals Grow Slowly As SEC Weighs Ideas
Equity crowdfunding and expanded Regulation A offerings have grown slowly since going live over the past decade, according to new data, leaving open questions on whether regulators will ease rules to bolster these alternatives to traditional capital raising.
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May 30, 2025
TopCo Settles Suit Over Cough Syrup Billed As 'Non-Drowsy'
The parties in a lawsuit alleging Tussin cough syrup's "non-drowsy" label is deceptive because the syrup makes users sleepy told an Illinois federal judge that they've reached a binding settlement that would end the case.
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May 30, 2025
ITC Issues Import Block On Ascletis Liver Disease Drugs
The U.S. International Trade Commission has issued an order blocking a Hong Kong-listed drug developer from importing treatments for a type of liver disease for the next seven years.
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May 30, 2025
Generic-Drug Makers Near Exit From Depo-Provera MDL
Attorneys for the plaintiffs in a multidistrict litigation claiming Pfizer Inc. failed to adequately warn patients and doctors about the risk of brain tumors associated with the hormonal contraceptive Depo-Provera told a Florida federal judge that they are close to dismissing claims against three manufacturers of generic versions of the drug.
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May 30, 2025
DLA Piper Adds Healthcare Regulatory Atty In DC Office
DLA Piper strengthened its healthcare regulatory resources in Washington, D.C., with the recent addition of an attorney who previously served as acting general counsel for the U.S. Department of Health and Human Services.
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May 30, 2025
Former Pfizer Atty, Motley Rice Adviser Joins DiCello Levitt
A former Pfizer vice president and assistant general counsel, who last June entered into a consulting agreement with Motley Rice LLC, is joining DiCello Levitt as a partner as part of the firm's Washington, D.C., public client practice group, the firm recently announced.
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May 29, 2025
AstraZeneca Inks $51.4M Settlement In Pay-For-Delay Case
AstraZeneca Pharmaceuticals LP and Handa Pharmaceuticals LLC have agreed to shell out a combined $51.4 million to put to rest allegations AstraZeneca paid off generic-drug makers, including Handa, to protect its brand antipsychotic drug Seroquel XR, according to a filing Thursday in Delaware federal court.
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May 29, 2025
CMS Seeks Hospital Responses On Gender Dysphoria Care
The Centers for Medicare & Medicaid Services is asking hospitals to produce information on gender dysphoria care provided to children and adolescents, noting in an oversight letter that the U.S. government has "serious concerns" surrounding hormone therapy and other gender-affirming medical interventions.
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May 29, 2025
Monsanto-Funded Researcher Influenced Panel, Jury Hears
A Missouri jury hearing the latest trial over cancer claims related to Monsanto's glyphosate pesticides heard Thursday that a Monsanto-funded researcher was able to change the course of a prestigious international panel weighing the chemical's carcinogenicity.
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May 29, 2025
Express Scripts Says Arkansas Can't Ban PBM Pharmacies
Pharmacy benefits manager Express Scripts sued the state of Arkansas in federal court Thursday, alleging that the state's recently enacted law banning PBMs from owning pharmacies in the state violated the U.S. Constitution and ran afoul of federal law governing military employee benefits.
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May 29, 2025
Delaware Justices Asked To Review Corporate Law Rework
A biopharmaceutical company stockholder has sought direct certification of a derivative suit to Delaware's Supreme Court, asking for state constitutional review of legislation approved in March that limits avenues for challenges to some corporate acts.
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May 29, 2025
Judge Favors Vanda But Seeks Deal Over Drug Approval
A D.C. federal judge on Thursday seemed ready to rule for Vanda Pharmaceuticals Inc. in its challenge to the U.S. Food and Drug Administration's timelines for approving new drugs but asked both sides to first try negotiating remedies to resolve the dispute.
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May 29, 2025
Ex-USPTO Solicitor Says He's Against Squires Nomination
A former solicitor for the U.S. Patent and Trademark Office has come out against the nomination of John A. Squires to be the next director of the agency, saying in a letter Thursday that he's concerned about the nominee's desire to make existing patents stronger.
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May 29, 2025
Drugstores Say Texas Flouted Rules To Update Pharmacy Regs
The National Association of Chain Drug Stores Inc. told the Texas Supreme Court that updates to statewide policy governing how pharmacies report drug prices flouted Texas rulemaking procedures, telling the state's high court that even if the updates were "good policy" they weren't lawful.
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May 29, 2025
Ex-United Therapeutics Exec Can't Dodge IP Suit
A former United Therapeutics Corp. executive lost his bid to toss his former employer's suit alleging he used stolen intellectual property to develop a lung disease drug for a competitor, with the North Carolina Business Court ruling that it was too soon to determine if the complaint was untimely.
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May 29, 2025
Cochlear Implant Rivals Call Truce Ahead Of UPC Ruling
Two cochlear implant heavyweights have quietly settled their global patent dispute, with both parties agreeing to dismiss a U.S. appeal on Thursday, bringing an abrupt end to the transatlantic clash.
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May 28, 2025
16 States Sue Trump Admin Over Cuts To Science Grants
A coalition of 16 state attorneys general have sued the Trump administration in New York federal court on Wednesday to stop it from cutting millions of dollars in grant funds from the National Science Foundation for scientific research and programs aimed at enhancing diversity, equity and inclusion in STEM fields and environmental justice.
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May 28, 2025
5 Federal Circuit Clashes To Watch In June
The Federal Circuit will hear cases in June that include an attempt to revive and expand a discarded $64 million trade secrets judgment against Goodyear, and a dispute between drugmakers Acorda and Alkermes that asks when licensees who pay royalties on expired patents can get a refund in arbitration.
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May 28, 2025
Regeneron Urges Judge In FCA Kickback Suit To Set Trial Date
Regeneron Pharmaceuticals Inc. on Wednesday pressed a Massachusetts federal judge to ready a long-running False Claims Act suit for a jury and reject the government's second bid for a pretrial win under a different legal theory following a First Circuit setback.
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May 28, 2025
Fla. Judge Told Pharma Co. Rival Also Stole Trade Secrets
A Florida federal judge on Wednesday denied an India-based pharmaceutical company's bid to reject a competitor's defense against a lawsuit alleging trade secrets theft by claiming its accuser is responsible for the same conduct, expressing doubt whether she can rule on such an issue.
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May 28, 2025
Fed. Circ. Lets Stewart Revise Longhorn Sanctions Order
The Federal Circuit on Wednesday granted a bid by the acting head of the U.S. Patent and Trademark Office to allow her to revise the Patent Trial and Appeal Board's decision to cancel 183 of Longhorn Vaccines & Diagnostics' patent claims as a punishment for "egregious abuse of the PTAB process."
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May 28, 2025
3rd Circ. Pauses J&J Unit Appeal In Talc Study Libel Case
The Third Circuit on Wednesday granted a bid by Johnson & Johnson's talc liability unit to stay briefing in its appeal seeking to revive a libel case over a scientific article linking talcum power to mesothelioma.
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May 28, 2025
Drugmaker LIVation Fights Novo Nordisk's Trademark Claims
A Connecticut company, accused by Novo Nordisk Inc. of breaking trademark and unfair trade practices laws by comparing its compounded drugs to Ozempic, says it has taken down online posts the pharma giant challenged in April, claiming Novo Nordisk can no longer prove ongoing harm.
Expert Analysis
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What To Expect For Stem Cell Regulation Under Trump Admin
The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.
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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.