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Life Sciences
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May 22, 2025
Senators Unveil DNA Privacy Bill Amid 23andMe's Ch. 11 Sale
A bipartisan group of U.S. senators on Thursday introduced a bill designed to safeguard customers' genetic information in bankruptcy cases, saying 23andMe's plan to sell users' DNA data to a pharmaceutical company during its Chapter 11 raises new concerns surrounding consumer privacy.
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May 22, 2025
Calif. Docs Bring FDA Stem Cell Regulation Fight To Top Court
Two California clinics that provide stem cell treatments are urging the U.S. Supreme Court to review a Ninth Circuit panel's finding that their treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations.
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May 22, 2025
Justices Urged To Undo Denial Of Fast Track For Gastro Drug
Vanda Pharmaceuticals Inc. is asking the U.S. Supreme Court to reverse the Food and Drug Administration's decision denying fast-track approval for its gastroparesis drug tradipitant, saying it meets the statutory standard for fast-track review as a new treatment with the "potential to address unmet medical needs."
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May 22, 2025
EpiPen Direct Buyers, Mylan Get Final OK On Antitrust Deal
Mylan Pharmaceuticals' $73.5 million settlement with a class of direct EpiPen buyers has received final approval from a Kansas federal judge, closing out claims from institutional drug resellers that Mylan worked with Pfizer to forestall an EpiPen generic from hitting the market and artificially inflating prices for the emergency injectable.
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May 22, 2025
Manufacturer Seeks Over $19M In Beryllium Release Coverage
A medical device manufacturer accused a Zurich unit of breach of contract and bad faith in Massachusetts federal court, seeking at least $19 million in damages after it said storms caused an "unprecedented dispersal" of beryllium at one of its plants in the United Kingdom.
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May 22, 2025
Judge Asks If DEI Is Now 'Homogeneity, Inequity And Exclusion'
A Massachusetts federal judge considering a challenge to the Trump administration's cuts to hundreds of National Institutes of Health grants pressed the U.S. Department of Justice on Thursday for its definition of diversity, equity and inclusion, at one point asking hypothetically whether the government's policy is now "homogeneity, inequity and exclusion."
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May 22, 2025
Conn. AG Targets 'Bootleg' Weight Loss Drug Sellers
Connecticut has launched a consumer protection lawsuit in state court against a Florida-based company and its owner, accusing them of peddling untested and unsafe, research-level, "bootleg" GLP-1 weight loss drugs to customers.
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May 22, 2025
Sanofi To Acquire Goodwin-Led US Biotech Biz For $470M
Drugmaker Sanofi said Thursday that it has agreed to acquire Vigil Neuroscience, a biotechnology company specializing in neurodegenerative diseases, for approximately $470 million to give it a potential new medicine for Alzheimer's disease in a deal guided by Goodwin Procter.
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May 21, 2025
FTC Urges 8th Circ. Not To Pause In-House PBM Case
The Eighth Circuit should once again say no to a request to pause the Federal Trade Commission's in-house case accusing three pharmacy benefit managers of hiking up the price of insulin to line their own pockets, the agency has told the appellate court.
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May 21, 2025
Squires Talks Fortress, PTAB Invalidations In Senate Hearing
The Trump administration's nominee for U.S. Patent and Trademark Office director had his moment before the Senate Judiciary Committee on Wednesday, where he downplayed his controversial connections to litigation finance giant Fortress Investment Group and raised concerns that too many bad patents were being issued.
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May 21, 2025
9th Circ. Judge Asks If Apple's Watch Updates 'Ice Out' Rivals
Two Ninth Circuit judges appeared skeptical Wednesday of Apple Inc.'s arguments against reviving an antitrust suit brought by medical monitoring startup AliveCor Inc. after Apple blocked third-party access to medical data on the Apple Watch, with one judge asking rhetorically whether a "marginal" improvement by Apple could actually be a way to "ice out" competition.
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May 21, 2025
Judge Mulls National Scope Of Bid To Restore COVID Grants
A Washington, D.C., federal judge Wednesday mulled whether it would be appropriate to issue a nationwide injunction blocking the termination of $11 billion public health grants set aside under COVID-era laws in a lawsuit brought by four local governments and a public sector union.
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May 21, 2025
AbbVie Gets Victory In Allergan Shareholder Suit Upheld
An Illinois state appellate panel said Wednesday that a trial court properly dismissed a shareholder class action against biopharmaceutical company AbbVie Inc. that accused the drugmaker of issuing unregistered shares to investors after acquiring Irish pharmaceutical company Allergan.
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May 21, 2025
GOP FTC Renews Calls For Orange Book Patent Delistings
The now-Republican controlled Federal Trade Commission again called on Teva, Novartis, Mylan and other drugmakers to remove patents from a key federal database that partially insulates their drugs from generic competition, arguing Wednesday the patents cover "devices," not drugs, and thus don't warrant such protection.
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May 21, 2025
Kronos Bio Shareholder Says Sale Unfairly Benefits Execs
Kronos Bio is facing a new shareholder suit claiming its plan to be acquired by another biopharmaceutical company will unfairly entitle Kronos executives to "lucrative" benefits unavailable to public shareholders.
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May 21, 2025
Device Maker Who Evaded Tax Gets 2 Years In Prison
A Florida man who sold millions of dollars worth of medical devices that federal prosecutors said were unproven to work was sentenced to two years in prison for evading taxes and ordered to pay $2.3 million in restitution to the Internal Revenue Service.
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May 21, 2025
Walgreens Ducks False Ad Suit Over Mucus Relief Meds
An Illinois federal judge on Tuesday dismissed a potential class action accusing Walgreens of misleading customers by selling them over-the-counter mucus relief medicine containing benzene without warning them of that risk, saying the claims are preempted by a federal drug safety law.
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May 20, 2025
Flo Users Get Class Cert. In Google, Meta Data-Sharing Suit
A California federal judge has granted class status to users of the menstrual cycle tracking app developed by Flo Health Inc. in a suit accusing the company of unlawfully sharing their personal health information with Google and Meta, finding that the defendants' opposition to this move lacked clarity and support.
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May 20, 2025
Barclays Officials Beat Shareholder's Suit At NY High Court
New York's highest court on Tuesday rejected arguments that current and former officials of London-based Barclays PLC can be sued under New York law over a series of scandals that have rocked the bank, a decision that sparked rebuke from the court's chief judge.
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May 20, 2025
Novo Fights To Keep Info Bid In $800M Fraud Dispute Alive
Novo Nordisk is urging a North Carolina federal court not to dismiss its order permitting the Danish drugmaker to seek information bolstering its $800 million fraud claims stemming from a hypertension drug deal, saying the testimony is needed to preserve assets as it pursues arbitration of its claims.
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May 20, 2025
Cancer Drug Co. Beats Investor Suit Over FDA Rejection
Cancer drug company Checkpoint Therapeutics Inc. has permanently escaped a shareholder suit alleging it understated the likelihood the U.S. Food and Drug Administration would refuse approving Checkpoint's lead product candidate, with a New York federal judge ruling company statements were not shown to be false or made with scienter.
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May 20, 2025
Medical Organizations Sue Feds For Removing Health Data
The U.S. Department of Health and Human Services and several constituent agencies are accused of violating the Administrative Procedure Act by illegally purging websites containing critical public health information related to trans and HIV care, vaccines and the prevention of outbreaks of communicable diseases, according to a lawsuit filed Tuesday in Washington federal court.
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May 20, 2025
Medical Supply Co. Faces Ga. Suit Over Unwanted Texts
A Florida-based medical supply company has been hit with a proposed Telephone Consumer Protection Act class action in Georgia federal court by a man who says he received several promotional text messages from the company after he added himself to the National Do Not Call Registry.
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May 20, 2025
Moderna Says Order To Narrow Vax IP Case Should Stay
Moderna has said that a federal judge should ignore a rival mRNA developer's request to rethink his decision limiting issues in a patent suit over the company's COVID-19 vaccines, saying the rival is trying to make new arguments too late.
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May 20, 2025
Creditors Win Fight Against Insider Releases In Azzur Ch. 11
A Delaware bankruptcy judge on Tuesday sustained an objection to insider releases in the Chapter 11 liquidation plan of Azzur Group, finding the pharmaceutical services company had not justified the releases for prepetition conduct of current and former officers, directors, and equity holders.
Expert Analysis
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Series
Collecting Rare Books Makes Me A Better Lawyer
My collection of rare books includes several written or owned by prominent lawyers from early U.S. history, and immersing myself in their stories helps me feel a deeper connection to my legal practice and its purpose, says Douglas Brown at Manatt Health.
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Opinion
New DOJ Leaders Should Curb Ill-Conceived Prosecutions
First-of-their-kind cases have seemingly led to a string of overly aggressive prosecutions in recent years, so newly sworn-in leaders of the U.S. Department of Justice should consider creating reporting channels to stop unwise prosecutions before they snowball, says Jonathan Porter at Husch Blackwell.
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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.