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Life Sciences
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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."
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May 15, 2025
Curaleaf And Ex-VP In Settlement Talks, Court Told
Curaleaf has tentatively agreed to drop a lawsuit against a former executive it accused of stealing confidential records to share with a rival cannabis firm, according to a notice filed in Florida federal court.
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May 15, 2025
Davis Wright Adds Longtime Knobbe Martens IP Duo In Seattle
Davis Wright Tremaine LLP has brought in two intellectual property partners credited with helping Knobbe Martens open its Seattle office.
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May 15, 2025
Regeneron Wins $271.2M In Amgen Antitrust Suit
A federal jury in Delaware put Amgen Inc. on the hook Thursday for at least $271.2 million in punitive damages arising from an alleged scheme that undercut Regeneron's price for its Praluent anti-cholesterol drug by bundling Amgen's competing, higher-priced Repatha with rebates for two expensive, blockbuster medications.
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May 14, 2025
Actinium Faces Derivative Suit Over FDA Application Claims
Officers and directors of biopharmaceutical company Actinium Pharmaceuticals Inc. face a shareholder derivative action accusing them of breaching their fiduciary duties after the company's lead product candidate failed to secure a certain approval from the U.S. Food and Drug Administration.
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May 14, 2025
J&J Unit's Catheter Policy Stopped Free-Riding, Jury Told
A Johnson & Johnson unit sales director took the stand Wednesday in Innovative Health's antitrust case against its medical technology unit Biosense Webster, defending Biosense's policy cutting off clinical cardiac mapping support to hospitals using third-party reprocessed catheters and explaining that the policy prevented competitors from free-riding on its investments in clinical support training.
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May 14, 2025
RJ Reynolds Can Keep Trial Win In Engle Case, Court Says
A Florida appeals court on Wednesday affirmed a verdict in favor of R.J. Reynolds in an Engle progeny suit over a longtime smoker's death, saying counsel's failure to use all their juror challenges invalidates an argument that a juror was unfairly selected.
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May 14, 2025
Integra Brass Face Investor Suit Over FDA Compliance Lapses
Executives and directors of medical device company Integra Lifesciences Inc. were hit with a derivative suit alleging they misled investors about the company's compliance with regulatory standards for over five years, causing share declines when information regarding Integra's violations emerged.
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May 14, 2025
Regeneron-Amgen Trial Goes To Jury With An Extra Day
Federal jurors started deliberating on a Regeneron Pharmaceuticals Inc. antitrust suit late Wednesday accusing Amgen Inc. of tripping up Regeneron's anti-cholesterol drug insurance eligibility by illegally bundling Amgen's competing version with rebates for two unrelated drugs, with potential triple damages in the balance.
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May 14, 2025
Sage Therapeutics Brass Sued Over Drug Candidate Claims
The top brass of Sage Therapeutics Inc. have been hit with a shareholder derivative suit in New York federal court alleging they misled investors about the safety, efficacy, durability and commercial prospects of three of the company's drug candidates and overstated their likelihood to be approved by the U.S. Food and Drug Administration.
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May 14, 2025
2nd Circ. Has Tough Questions On Nixing Medical Imaging Award
The Second Circuit appeared divided on Wednesday on whether parties to a medical imaging joint venture could agree to designate New York courts to decide whether to vacate an arbitral award issued in Switzerland under their contract without violating an underlying treaty.
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May 14, 2025
10th Circ. Chilly To Biotech's SEC Asset Freeze Challenge
A panel of Tenth Circuit judges seemed skeptical Wednesday that a lower court had abused its discretion in granting a freeze of a biotech firm's assets in a suit brought by the U.S. Securities and Exchange Commission accusing the company and its founders of misappropriating roughly $9 million.
Expert Analysis
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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.
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High Court Could Further Limit Deference With TCPA Fax Case
The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.
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5 Ways To Create Effective Mock Assignments For Associates
In order to effectively develop associates’ critical thinking skills, firms should design mock assignments that contain a few key ingredients, from messy fact patterns to actionable feedback, says Abdi Shayesteh at AltaClaro.