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Life Sciences
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May 06, 2025
Trump Orders FDA To Speed Up Drug Plant Approvals
President Donald Trump directed the U.S. Food and Drug Administration to cut the approval timelines for new manufacturing facilities by domestic drugmakers and also to pressure foreign drugmakers to comply with quality control inspections, according to a recent executive order.
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May 06, 2025
Gene-Editing Co. Synthego Hits Ch. 11 With Sights On A Sale
California-based biotechnology company Synthego Corp. filed for Chapter 11 in Delaware bankruptcy court, listing up to $500 million in debt and outlining a plan to sell its assets to its prepetition lender during the proceedings.
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May 05, 2025
DC Circ. Has Doubts About Narcolepsy Drug Appeal
The D.C. Circuit is now set to decide whether the U.S. Food and Drug Administration was wrong to declare a rival narcolepsy treatment not the "same drug" as another produced by Jazz Pharmaceuticals Inc., after appearing highly skeptical of the drug company's arguments that it was.
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May 05, 2025
Liquidia Fends Off Indication Challenge In UTC Tyvaso Fight
A D.C. federal court has rejected United Therapeutics Corp.'s challenge to a U.S. Food and Drug Administration decision allowing Liquidia Technologies Inc. to modify a new drug application to include an additional lung disease indication for a drug competing with UTC's blockbuster lung disease drug Tyvaso.
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May 05, 2025
8th Circ. Backs Boehringer's Copyright Win Over Software Co.
The Eighth Circuit upheld a district court's conclusion that Boehringer Ingelheim's veterinary arm and other companies did not infringe the copyrights of software company InfoDeli, saying in an opinion Monday that some elements of the online platforms that InfoDeli built were not entitled to protection.
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May 05, 2025
Regeneron, Amgen Open Drug 'Bundling' Trial In Del.
The founder and CEO of Regeneron Inc. told a federal jury in Delaware on Monday that a major pharmacy benefit insurer told him in mid-2020 his company was wasting its time in trying to keep a cholesterol-drug supply contract, with Amgen Inc. offering a better-priced but allegedly anticompetitive multidrug portfolio.
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May 05, 2025
PTAB Says It's Bedtime For Sleep Apnea Patent Claims
Patent board judges have decided to wipe out all the claims in a patent covering a method to treat sleep apnea, which were challenged by a San Diego sleep apnea outfit that says those claims reflect "97 percent" of a patent case over sleep apnea machines in Delaware federal court.
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May 05, 2025
Trump Admin Urges Dismissal Of States' Abortion Pill Suit
The Trump administration on Monday asked a Texas federal judge to dismiss a lawsuit seeking to roll back access to the abortion medication mifepristone, contending the three states pursuing the case waited too long to file and are suing in the wrong jurisdiction.
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May 05, 2025
Pharma Co. Escapes Investor Liver Drug Trial Suit, For Now
Biopharmaceutical company Akero Therapeutics Inc. and its executives have escaped, for now, a proposed class action alleging they misled investors about the patient population in a clinical trial for Akero's liver disease treatment, with a California federal judge on Monday rejecting the suit's theory of motive for the defendants.
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May 05, 2025
Rite Aid Hits Bankruptcy Less Than A Year After Previous Ch. 11
Drugstore chain Rite Aid Corp. reentered bankruptcy Monday less than a year after its earlier reorganization plan was approved, filing for Chapter 11 protection in New Jersey bankruptcy court with more than $1 billion in debt and plans for an asset sale.
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May 05, 2025
Purdue Tells Justices 'Rigid' Fed. Circ. Rule Threatens Patents
Bankrupt OxyContin-maker Purdue Pharma LP wants the U.S. Supreme Court to revive its legal effort to use patent laws to block the release of a competing "crush-resistant" generic painkiller, challenging a Federal Circuit decision that Purdue calls too "rigid."
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May 05, 2025
Exactech Committee Calls Foul On Ch. 11 Voting Packages
The official committee of unsecured creditors in Exactech Inc.'s Chapter 11 case told a Delaware bankruptcy judge that the company's solicitation packages sent to tort claimants violate court-approved procedures by requiring them to submit five separate ballots for their votes to be counted.
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May 05, 2025
Novartis, Incyte Settle Drug Royalty Fight On Eve Of Trial
A Manhattan federal judge put off trial on Monday in a five-year quest by Novartis to recover what it says are $500 million in missing royalties from its agreement to commercialize an Incyte compound used to treat blood cancers, with the sides announcing they reached a settlement.
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May 05, 2025
High Court Won't Hear Challenge To Miss. Ban On Pot Ads
The U.S. Supreme Court on Monday rejected an opportunity to hear a First Amendment challenge to Mississippi's policy outlawing medical marijuana advertisements, effectively preserving a circuit court decision that upheld the state's ban.
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May 02, 2025
Insulin Giants' Antitrust Victory On Shaky Ground At 2nd Circ.
A major legal triumph for manufacturers of wildly popular medications treating diabetes and obesity suddenly looked precarious Friday at the Second Circuit, where judges sounded open to reviving a proposed class action alleging a multibillion-dollar conspiracy in a controversial drug-discount program.
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May 02, 2025
Boston Scientific, FDA Sued Over 'Unsafe' Spinal Implant
Boston Scientific evaded safety regulations to market a defective spinal cord stimulator and the U.S. Food and Drug Administration rubber-stamped those alterations in an instance of "agency capture," according to a California federal lawsuit filed by a patient suffering from ongoing pain after the device was implanted.
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May 02, 2025
Plaintiffs Seek Redo Over Sterilization Co.'s Trial Tactics
Four women who claimed a Colorado sterilization company caused their cancers asked a state court to order a new trial, arguing the business won a favorable verdict with prejudicial evidence about law firm ads and by suggesting the women are not "real victims but pawns in a scheme orchestrated by their lawyers."
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May 02, 2025
Tax Case Can Proceed Despite Late Name Change, Court Says
The owner of a mail-order medical equipment company can move forward with his lawsuit against the federal government seeking to deduct a $5 million settlement payment, even though he didn't technically add his name to the case until after the deadline, the Court of Federal Claims said.
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May 02, 2025
Fed. Circ. Gives MSN Short Pause For Entresto Appeal
The Federal Circuit told a Delaware federal judge on Friday to hold off entering final judgment in litigation that would delay MSN Pharmaceuticals Inc. from launching a generic version of Novartis' blockbuster heart medication Entresto.
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May 02, 2025
Ex-SCWorx CEO Seeks Sentencing Delay Over Restitution Row
The former chief executive of SCWorx Corp. who was convicted of securities fraud after publicizing a $670 million COVID-19 test kit contract that never materialized told a New Jersey federal court Friday that he's seeking a one-month delay in his sentencing, citing the government's statement that it would pursue more than $140 million in restitution.
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May 02, 2025
CR Bard Owes $20M In Ga. Ethylene Oxide Cancer Trial
A Georgia jury awarded $20 million in compensatory damages on Friday to a man who said his cancer was caused by exposure to ethylene oxide from C.R. Bard's medical sterilization plant, sending the case to a second phase for punitive damages.
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May 02, 2025
Faegre Drinker Lands Patent Team From Wilson Sonsini
Faegre Drinker Biddle & Reath LLP added a partner, an associate and two patent agents from Wilson Sonsini Goodrich & Rosati PC to bolster its intellectual property practice, the firm has announced.
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May 02, 2025
Goodwin Adds Scientist IP Partner From Cooley On West Coast
A seasoned life sciences and intellectual property attorney with a doctorate in biochemistry, biophysics and molecular biology has joined Goodwin Procter LLP on the West Coast, the firm announced.
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May 02, 2025
23andMe Says 1.3M Customers Have Asked To Delete Data
23andMe executives told a meeting of creditors Friday that more than 1.3 million customers have asked the DNA testing company to cancel their accounts and delete their genetic information since it entered Chapter 11.
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May 02, 2025
Taxation With Representation: Goodwin, Haynes Boone
In this week's Taxation With Representation, Merck buys SpringWorks Therapeutics, Novartis AG acquires Regulus Therapeutics Inc., Sabre Corp. sells its Hospitality Solutions business to private equity shop TPG, and TWG Global and Mubadala Capital team up to bolster their investments.
Expert Analysis
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Tips For Pharma-Biotech Overlap Reporting In New HSR Form
While there’s no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.
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Opinion
Judge Should Not Have Been Reprimanded For Alito Essay
Senior U.S. District Judge Michael Ponsor's New York Times essay critiquing Supreme Court Justice Samuel Alito for potential ethical violations absolutely cannot be construed as conduct prejudicial to the administration of the business of the courts, says Ashley London at the Thomas R. Kline School of Law of Duquesne University.
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A Look At Drug Price Negotiation Program's Ongoing Impact
More than two years after the passage of the Inflation Reduction Act and the rapid implementation of the drug price negotiation program, attorneys at Ropes & Gray discuss how the IRA has influenced licensing strategies, and how maximum fair prices under the law have economically affected certain drugs.
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Opinion
Congress Must Consider Accurate Data About Patent Thickets
If Congress revisits a controversial bill this year aimed at limiting the number of patents pharmaceutical manufacturers could assert, it must make sure to act based on accurate reports — such as a recent U.S. Patent and Trademark Office study that found no evidence of patent thicketing, says David Kappos at the Council for Innovation Promotion.
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Lights, Camera, Ethics? TV Lawyers Tend To Set Bad Example
Though fictional movies and television shows portraying lawyers are fun to watch, Hollywood’s inaccurate depictions of legal ethics can desensitize attorneys to ethics violations and lead real-life clients to believe that good lawyers take a scorched-earth approach, says Nancy Rapoport at the University of Nevada, Las Vegas.
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Will 4th Time Be A Charm For NY's 21st Century Antitrust Act?
New York's recently introduced 21st Century Antitrust Act would change the landscape of antitrust enforcement in the state and probably result in a sharp increase in claims — but first, the bill needs to gain traction after three aborted attempts, says Tyler Ross at Shinder Cantor.
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Perspectives
Accountant-Owned Law Firms Could Blur Ethical Lines
KPMG’s recent application to open a legal practice in Arizona represents the first overture by an accounting firm to take advantage of the state’s relaxed law firm ownership rules, but enforcing and supervising the practice of law by nonattorneys could prove particularly challenging, says Seth Laver at Goldberg Segalla.
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The Post-Macquarie Securities Fraud-By-Omission Landscape
While the U.S. Supreme Court's 2024 opinion in Macquarie v. Moab distinguished inactionable "pure omissions" from actionable "half-truths," the line between the two concepts in practice is still unclear, presenting challenges for lower courts parsing statements that often fall within the gray area of "misleading by omission," say attorneys at Katten.
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AI Will Soon Transform The E-Discovery Industrial Complex
Todd Itami at Covington discusses how generative artificial intelligence will reshape the current e-discovery paradigm, replacing the blunt instrument of data handling with a laser scalpel of fully integrated enterprise solutions — after first making e-discovery processes technically and legally harder.
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IP, Licensing, M&A Trends To Watch In Life Sciences This Year
2025 promises to continue an exciting trajectory for the life sciences industry, with major trends ranging from global harmonization of intellectual property to cross-border licensing activity and an increase of nontraditional financial participants in the mergers and acquisition space, say attorneys at Morgan Lewis.
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When Innovation Overwhelms The Rule Of Law
In an era where technology is rapidly evolving and artificial intelligence is seemingly everywhere, it’s worth asking if the law — both substantive precedent and procedural rules — can keep up with the light speed of innovation, says Reuben Guttman at Guttman Buschner.
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Anticipating Direction Of Cosmetics Regulation Under Trump
It is unclear how cosmetics regulation reform from the last few years will fare under President Donald Trump, but the new administration's emphasis on deregulation and Robert F. Kennedy Jr.'s views on product safety provide some insight, say attorneys at Crowell & Moring.
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Drug Pricing Policy Trends To Expect In 2025 And Beyond
Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.
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Imagine The Possibilities Of Openly Autistic Lawyering
Andi Mazingo at Lumen Law, who was diagnosed with autism about midway through her career, discusses how the legal profession can create inclusive workplaces that empower openly autistic lawyers and enhance innovation, and how neurodivergent attorneys can navigate the challenges and opportunities that come with disclosing one’s diagnosis.
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.