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Life Sciences
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May 19, 2025
Ex-CTA Worker Can Take Vaccine Bias Claim To Trial
An ex-Chicago Transit Authority employee fired after refusing COVID-19 vaccination can take his religious discrimination claim to a jury this summer after an Illinois federal judge grilled the agency Monday on its assertion that the plaintiff didn't seek an exemption for sincerely held religious beliefs and rejected its argument that he was "cherry-picking" Catholic doctrine.
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May 19, 2025
Feds Get Early Win In Drugmakers' Suit Over 340B Rebates
A D.C. federal judge awarded an early win to the U.S. Department of Health and Human Services on Friday on claims it illegally blocked drugmakers' efforts to implement rebates instead of discounts in a decades-old drug pricing program, finding the agency has the authority to pre-approve the price reduction models.
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May 19, 2025
Bluebird Beats Patent Case Over Blood Disease Therapies
A Delaware federal judge has tossed a lawsuit against Bluebird Bio alleging two of its multimillion-dollar gene therapy treatments for blood disorders infringed patents held by San Rocco Therapeutics LLC, after the dispute had been narrowed by a previous claim construction ruling.
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May 19, 2025
Biotech Services Company Files Ch. 11 With $60M In Debt
Contracted biotechnology research company AmplifyBio filed for Chapter 11 protection late Friday in Ohio bankruptcy court listing about $60 million in debt, saying it intends to sell its assets after failing to realize sufficient revenue to support its capital-intensive operations.
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May 19, 2025
Wachtell-Led Regeneron To Buy 23andMe, Gaining User Data
Regeneron Pharmaceuticals said Monday it emerged as the winning bidder for 23andMe, agreeing to pay $256 million to scoop the once high-flying consumer genomics firm out of bankruptcy while pledging to uphold strict privacy standards.
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May 19, 2025
Covington Corporate M&A Atty Moves To Clifford Chance
Clifford Chance LLP has hired a Covington & Burling LLP partner for its U.S. corporate mergers and acquisitions practice to strengthen its capabilities in the healthcare and life sciences sector, the firm said Monday.
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May 19, 2025
USPTO Seeks Input On Guidelines For Fighting Online Fakes
The U.S. Patent and Trademark Office published a notice in the Federal Register on Monday requesting comments from intellectual property rights holders, online marketplaces and others on draft guidelines to combat the illicit trade and sale of counterfeit goods on the internet.
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May 16, 2025
IPO Pipeline Restarts As Tariff-Related Volatility Eases
Initial public offerings are showing life again after a tariff-induced slumber, buoyed by strong debuts and a growing pipeline as more venture-backed technology startups are lining up public listings before Memorial Day and into June.
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May 16, 2025
J&J Unit Hit With $147M Verdict In Catheter Antitrust Suit
A California federal jury found Friday that Johnson & Johnson's medical technology unit Biosense Webster violated federal and state antitrust laws by withholding clinical support to hospitals using third-party reprocessed catheters, awarding plaintiff Innovative Health more than $147 million in damages.
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May 16, 2025
Biotech Co. Hit With Investor Suits Over Cancer Drug Launch
Cancer treatment company Iovance Biotherapeutics has been hit with two proposed shareholder class actions accusing the company of misleading the public about the success of its commercial rollout of an FDA-approved skin cancer treatment.
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May 16, 2025
Parents Sue Colgate Over Alleged Dangers Of Fluoride Rinse
A proposed class of buyers of oral rinses is suing Colgate-Palmolive Co., alleging it misleadingly advertises its Hello Kids Fluoride Rinse as safe despite the U.S. Food and Drug Administration considering it too dangerous for children under 6 years old.
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May 16, 2025
Bank Balks At Nostrum Ch. 11 Sale Over Drug Disposal Issue
Waterford Bank NA has objected to New Jersey drugmaker Nostrum Laboratories Inc.'s plan to sell an Ohio property, saying the bank doesn't want to be left to pay for the disposal of large quantities of controlled substances left at the site, an issue the parties are now negotiating ahead of a hearing next week.
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May 16, 2025
Illumina Accuses Ex-Workers' Co. Of Infringing Gene Tech IP
Biotechnology giant Illumina Inc. filed a lawsuit Thursday against Element Biosciences in Delaware federal court, accusing the company founded by former Illumina employees of infringing five patents related to automated gene sequencing technology.
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May 16, 2025
Feds Want Ex-McKinsey Exec To Serve Time For Obstruction
Prosecutors urged a Virginia federal judge Thursday to sentence a disbarred, former senior McKinsey & Co. partner to one year in prison for obstructing an investigation into the consulting giant's work with opioid-manufacturer Purdue Pharma, while defense counsel pushed for probation so that he can return to his home in Thailand.
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May 16, 2025
Ex-Womble Bond Atty Heads To Chicago With Shook Hardy
Shook Hardy & Bacon LLP has expanded its Chicago office with the recent addition of an attorney with nearly 40 years of experience representing clients in mass tort matters and commercial disputes.
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May 16, 2025
23 States Win Order Halting Billions In HHS Public Health Cuts
A Rhode Island federal judge on Friday barred the Trump administration from cutting off billions of dollars in funding to state public health programs, determining the abrupt grant terminations likely violated congressional authority over spending.
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May 16, 2025
Cooley, Goodwin Build BioMarin's $270M Inozyme Buy
Biotechnology company BioMarin Pharmaceutical Inc., advised by Cooley LLP, on Friday announced plans to buy clinical-stage biopharmaceutical company Inozyme Pharma Inc., led by Goodwin Procter LLP, in a $270 million all-cash deal.
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May 16, 2025
Trump Admin Settles Vaccine Contract Info Suit For $10K
The Trump administration has reached a $10,000 settlement with a consumer advocacy group over allegedly withholding information about the government's billion-dollar contracts with companies that developed and manufactured the COVID-19 vaccine, including Pfizer and Moderna.
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May 15, 2025
J&J Unit's Economist Rips Rival's $147M Antitrust Damage Bid
Biosense Webster's economic expert took the stand Thursday in California federal court to criticize Innovative Health's claim it suffered $147 million in damages from Biosense's policy withholding clinical support to hospitals using third-party reprocessed catheters, arguing Innovative lost nothing and saved on clinical support costs it otherwise would've incurred.
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May 15, 2025
7th Circ. Weighs AbbVie Whistleblower's Drug Marketing Suit
A Seventh Circuit judge questioned whether a former AbbVie employee has plausibly alleged whistleblower retaliation in a false claims case and whether the drugmaker was holding his complaint to too high a standard Thursday as he explored whether a lower court's dismissal ruling should stand.
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May 15, 2025
Novo's Real Target In Doc Bid Is $800M Arbitration, Co. Says
A Singaporean pharmaceutical company is urging a North Carolina federal court to nix its order permitting Novo Nordisk AS to seek information bolstering its fraud claims stemming from an $800 million hypertension drug deal, saying the Danish drugmaker is improperly looking to prop up an ongoing arbitration instead.
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May 15, 2025
UMich Protesters Say Lives 'Upended' By Campus Bans
An attorney for protesters challenging their bans from the University of Michigan campus told a federal judge Thursday that the trespass orders have "upended" their lives because the vast campus intertwines with the city of Ann Arbor and urged the court to find the bans violated their due process.
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May 15, 2025
Bausch, Mylan Settle Patent Suit Over Generic IBS Drugs
The makers of gastrointestinal drug Trulance have resolved their patent lawsuit, which sought to block several Mylan generic drugs from competing with the drug, in a confidential settlement agreement, according to a West Virginia federal court filing.
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May 15, 2025
Harvard Researcher Held By ICE To Be Returned To Mass.
A Harvard Medical School researcher and Russian national taken into custody by immigration officers who found frog embryos in her luggage three months ago will be returned to Massachusetts to face a smuggling charge, a Louisiana federal judge ordered on Thursday.
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May 15, 2025
Amarin Tells Justices Hikma Has Gotten Far Ahead Of Itself
Amarin Pharma urged the U.S. Supreme Court on Thursday to turn away a generic-drug maker's bid to get an induced infringement suit thrown out, saying the pleadings-stage case is "in its infancy" and that the company is looking for a "safe-harbor from having to litigate at all."
Expert Analysis
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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.
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Parsing 3rd Circ. Ruling On Cannabis, Employee Private Suits
The Third Circuit recently upheld a decision that individuals don't have a private right of action for alleged violations of New Jersey's Cannabis Regulatory, Enforcement Assistance and Marketplace Modernization Act, but employers should stay informed as the court encouraged the state Legislature to amend the law, say attorneys at Mandelbaum Barrett.
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4 Keys To Litigating In An Active Regulatory Environment
For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.
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Kiromic SEC Order Shows Importance Of Self-Reporting
The U.S. Securities and Exchange Commission's recently filed settled charges against Kiromic BioPharma illustrate the critical intersection between U.S. Food and Drug Administration regulatory processes and investor disclosures under the securities laws, and showcase how responding promptly to internal whistleblower reports may reap benefits, say attorneys at Arnold & Porter.
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Series
Documentary Filmmaking Makes Me A Better Lawyer
Becoming a documentary filmmaker has allowed me to merge my legal expertise with my passion for storytelling, and has helped me to hone negotiation, critical thinking and problem-solving skills that are important to both endeavors, says Robert Darwell at Sheppard Mullin.
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Litigation Funding Disclosure Debate: Strategy Considerations
In the ongoing debate over whether courts should require disclosure of litigation funding, funders and plaintiffs tend to argue against such mandates, but voluntarily disclosing limited details about a funding arrangement can actually confer certain benefits to plaintiffs in some scenarios, say Andrew Stulce and Marc Cavan at Longford Capital.
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2025 May Be A Breakout Year For The Cannabis Industry
The cannabis industry faced a slow and frustrating 2024, but consumer trends continue to shift in favor of cannabis, and the new administration may provide the catalyst that the industry needs, says Lynn Gefen at TerrAscend.
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FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape
The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.
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Scope And Nature Of Judicial Relief Will Affect Loper's Impact
The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.
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The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.
The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.
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Series
Adventure Photography Makes Me A Better Lawyer
Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.
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What Vinyl Acetate's Prop 65 Listing Means For Cos.
California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Inherency Ruling Refines Obviousness Framework
The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.
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Navigating The Potential End Of GLP-1 Drug Shortages
The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.