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Life Sciences
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September 09, 2024
Ex-Outcome CEO Says Issues Warrant Bond Pending Appeal
Former Outcome Health CEO Rishi Shah urged an Illinois federal judge Monday to let him remain on bond while he appeals his fraud conviction and sentence, arguing he has teed up multiple substantial issues that could lead the Seventh Circuit to order a redo.
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September 09, 2024
Pa. Supreme Court Snapshot: Benefits, Cannabis, Taxes
The Pennsylvania Supreme Court's September schedule will have the justices pondering when to cancel tax exemptions for hospitals, if stormwater fees are taxes in disguise, and the potential resurrection of requiring medical marijuana products to be tested and approved by two separate laboratories.
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September 09, 2024
Exec Denied New Trial In 'Shadow Trading' Case, Fined $321K
A California federal judge on Monday denied a new trial request from an ex-Medivation Inc. executive found to have used the pharmaceutical company's inside information when he bought a rival's stock, and also ordered him to pay a $321,000 penalty in the U.S. Securities and Exchange Commission's "shadow trading" case.
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September 09, 2024
Insurer Needn't Cover Lab Fraud Suits, Ill. Judge Rules
An insurer has no obligation to defend or indemnify a property management company or its owner in two underlying lawsuits accusing the owner of concealing financial information from a minority owner in a jointly formed laboratory, an Illinois federal judge said, finding that the underlying suits alleged intentional misconduct.
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September 09, 2024
Ex-Finance Exec To Pay SEC $110K In Insider Trading Action
A former finance director of pharmaceutical company Inhibrx Inc. has agreed to pay over $110,000 to resolve U.S. Securities and Exchange Commission allegations that he bought his employer's shares as it prepared to announce good news about its principal drug candidate.
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September 09, 2024
Purdue Sees Another OxyContin Patent Axed
A Delaware federal court decided on Monday that yet another patent issued to bankrupt OxyContin maker Purdue Pharma is invalid, a year and a half after a similar ruling was issued in another case about the company's efforts to assert different patents to stop the same prospective Indian manufacturer of generic painkillers.
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September 09, 2024
Abbott Says Illinois OT Suit Should Join Similar Case In Ohio
Abbott Laboratories asked an Illinois federal judge Friday to send two workers' dispute over unpaid sanitary gear changes and hand washings to Ohio where a similar suit is pending, arguing that the move would promote consistent judgments across the "nearly identical" claims.
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September 09, 2024
House OKs Bill To Bar Contracts With Chinese Biotech Cos.
Driven by concerns about U.S. genetic data being shared with the Chinese government, House lawmakers passed a bill on Monday to bar federal agencies from buying certain biotechnology linked to the Chinese government or from contracting with firms that use those products.
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September 09, 2024
FTC Backs Teva Orange Book Delisting At Fed. Circ.
The Federal Trade Commission is continuing to back Amneal's efforts to have Teva's inhaler patents delisted from the U.S. Food and Drug Administration's Orange Book, telling the Federal Circuit that a lower court was right in determining that Teva's patents do not satisfy the registry's requirements.
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September 09, 2024
Biotech Execs Face Investor Suit Over Medicare Claims
Executives and directors of biopharmaceutical company Ardelyx have been hit with a shareholder derivative suit in Massachusetts federal court alleging the company misled investors over its intentions and ability to apply for a Medicare reimbursement program for its kidney disease treatment.
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September 09, 2024
Generics Makers Want Mo. Sanctioned In Price-Fixing Case
Teva Pharmaceuticals Inc., Mylan Inc. and other generic-drug makers accused by state enforcers of fixing prices have urged a Connecticut federal judge to punish the state of Missouri for failing to provide information requested by the drug companies.
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September 09, 2024
MBX Biosciences Seeks Up To $136M In Upcoming IPO
Indiana-based clinical-stage biopharmaceutical company MBX Biosciences Inc. on Monday set the terms for its initial public offering, with plans to raise up to $136 million.
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September 09, 2024
Baltimore Strikes $80M Opioid Settlement With Teva
Teva Pharmaceuticals will pay Baltimore $80 million to resolve claims that the company inflamed the city's opioid crisis, the city of Baltimore announced Monday ahead of a trial slated to begin next week against the remaining defendants in the Maryland state court litigation.
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September 09, 2024
Novo Nordisk Sues Over Ads For Diabetes, Weight Loss Drugs
A New Jersey company violated trademark and false advertising laws by promoting drugs without a regulatory green light as being generic versions of Novo Nordisk's Ozempic and Wegovy medications, according to a lawsuit filed in New Jersey federal court.
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September 09, 2024
Novartis Settles Sales Rep.'s Gender Bias Suit
A former sales representative with Novartis Pharmaceuticals Corp. has settled a lawsuit against the company alleging she faced gender-motivated retaliation after reporting a co-worker for falsifying records and hurting her sales numbers.
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September 09, 2024
Catching Up With Delaware's Chancery Court
Delaware's Court of Chancery made some expensive decisions last week, ranging from a $130 million stockholder award and a freeze on $450 million in equity financing to a whopping $1 billion bill for fraud and breach of contract damages. New cases aimed at Virgin Galactic, settlements pulled in Hemisphere Media Group Inc. and court hearings involving Apollo Global Management heated up. In case you missed it, here's the roundup of news from Delaware's Court of Chancery.
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September 09, 2024
2nd Circ. Upholds Regeneron's Win In Remote Work Suit
The Second Circuit rejected a former Regeneron Pharmaceuticals Inc. employee's appeal seeking to revive claims it illegally denied her a remote work situation to care for her daughter while she underwent medical care, ruling Monday that there was no evidence the company had willfully broken the law.
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September 09, 2024
Ore. Seeks Dismissal Of Psilocybin Disabilities Suit
Oregon's health regulator has asked a federal judge to dismiss a lawsuit challenging aspects of the state's pioneering regulated psilocybin treatment program, saying that the program's illegality under federal law makes the lawsuit untenable.
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September 06, 2024
AstraZeneca Unit Owes $130M In Chancery Scuttled-Drug Suit
The Delaware Chancery Court awarded $130 million to former shareholders of biopharmaceutical company Syntimmune in their breach of contract fight against AstraZeneca PLC unit Alexion Pharmaceuticals Inc., finding that Alexion failed to make promised payments after it acquired Syntimmune in 2018 and breached key terms of their merger agreement.
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September 06, 2024
Actelion Must Face Tracleer Antitrust Suit With Class Certified
A Maryland federal judge refused Friday to toss an antitrust suit accusing Actelion Pharmaceuticals of illegally denying generics companies the samples they needed to produce generic versions of its hypertension drug Tracleer, while separately certifying a class composed of "hundreds" of insurers and self-funded employers.
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September 06, 2024
Biopharm Co., Directors Sued In Del. Over 'Extreme' Scheme
A five-year run of "extreme and unconscionable self-dealing" has left 62% of Navidea BioPharmaceuticals Inc. equity in the hands of a single stockholder-director, a Delaware Court of Chancery suit has alleged, with the company now deregistered and currently without a viable product.
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September 06, 2024
NJ Medical Co. Claims Ex-Employees Conspired To Form Rival
A New Jersey medical communications agency said Friday that four of its former employees and the onetime U.S. president of biopharmaceutical company PharmaEssentia used its confidential information in a scheme to form a rival firm and steal millions of dollars of work from it.
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September 06, 2024
Ingersoll Rand Blocks Rival From Hiring Ex-Exec In NDA Fight
A Colorado state court has preliminarily blocked the former chief executive of a company acquired by industrial products giant Ingersoll Rand Inc. from working for rival Avantor, finding Ingersoll Rand will likely win its claims that the executive specifically agreed not to work for Avantor as a condition of the acquisition.
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September 06, 2024
Travel Nurse Says Emory Ended Her Contract Over Race Bias
A travel nurse alleged in a lawsuit that Emory Healthcare Inc. unlawfully terminated her three-month contract after she complained that allowing her to administer peritoneal dialysis on Black patients without proper training would be "akin to treating those patients as guinea pigs."
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September 06, 2024
Goodwin-Led Cancer Biotech Eyes Roughly $200M IPO
Drug developer Bicara Therapeutics Inc., advised by Goodwin Proctor LLP, announced on Friday plans to raise around $200 million in its initial public offering, with the proceeds going toward developing bifunctional antibodies designed to treat solid tumors.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Opinion
To Lower Drug Prices, Harris Must Address Patent Thickets
If Vice President Kamala Harris is serious about her pledge to address high drug prices, she must begin by closing loopholes that allow pharmaceutical companies to develop patent thickets that can deter generic or biosimilar companies from entering the market, says Tahir Amin at the Initiative for Medicines, Access & Knowledge.
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How Methods Are Evolving In Textualist Interpretations
Textualists at the U.S. Supreme Court are increasingly considering new methods such as corpus linguistics and surveys to evaluate what a statute's text communicates to an ordinary reader, while lower courts even mull large language models like ChatGPT as supplements, says Kevin Tobia at Georgetown Law.
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Trending At The PTAB: Obviousness In Director Reviews
Three July decisions from the U.S. Patent and Trademark Office favoring petitioners indicate a willingness by the director to review substantive issues, such as obviousness, particularly in cases where the director believes the Patent Trial and Appeal Board provided incorrect or inadequate rationale to support its decisions, say attorneys at Finnegan.
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Why Attorneys Should Consider Community Leadership Roles
Volunteering and nonprofit board service are complementary to, but distinct from, traditional pro bono work, and taking on these community leadership roles can produce dividends for lawyers, their firms and the nonprofit causes they support, says Katie Beacham at Kilpatrick.
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Opinion
Agencies Should Reward Corporate Cyber Victim Cooperation
The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.
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Firms Must Offer A Trifecta Of Services In Post-Chevron World
After the U.S. Supreme Court’s Loper Bright Enterprises v. Raimondo decision overturning Chevron deference, law firms will need to integrate litigation, lobbying and communications functions to keep up with the ramifications of the ruling and provide adequate counsel quickly, says Neil Hare at Dentons.
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Takeaways From UPC's Amgen Patent Invalidity Analysis
The Unified Patent Court Central Division's decision in Regeneron v. Amgen to revoke a patent for lack of inventive step is particularly clear in its reasoning and highlights the risks to patentees of the new court's central revocation powers, say Jane Evenson and Caitlin Heard at CMS.
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5 Ways Life Sciences Cos. Can Manage Insider Trading Risk
In light of two high-profile insider trading jury decisions against life sciences executives this year, public companies in the sector should revise their policies to account for regulators' new and more expansive theories of liability, says Amy Walsh at Orrick.
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5 Tips To Succeed In A Master Of Laws Program And Beyond
As lawyers and recent law school graduates begin their Master of Laws coursework across the country, they should keep a few pointers in mind to get the most out of their programs and kick-start successful careers in their practice areas, says Kelley Miller at Reed Smith.
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Bayer Antitrust Case Hinged On Evolving Market Definition
Generic flea and tick medication manufacturer Tevra's evolving market definition played a key role in the development and outcome of its five-year antitrust litigation against Bayer Healthcare, highlighting challenges that litigants may face when a proposed definition is assessed at trial, say Amy Vegari and Colleen Anderson at Patterson Belknap.
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IP Hot Topic: The Intersection Of Trademark And Antitrust Law
Antitrust claims – like those in the U.S. Department of Justice’s recent case against Apple – are increasingly influencing trademark disputes and enforcement practices, demonstrating how antitrust law can dilute the power of a trademark, say attorneys at Dentons.
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Series
Being An Opera Singer Made Me A Better Lawyer
My journey from the stage to the courtroom has shown that the skills I honed as an opera singer – punctuality, memorization, creativity and more – have all played a vital role in my success as an attorney, says Gerard D'Emilio at GableGotwals.
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What Drug Cos. Must Know About NY Price Transparency Law
Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.
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How Law Firms Can Avoid 'Collaboration Drag'
Law firm decision making can be stifled by “collaboration drag” — characterized by too many pointless meetings, too much peer feedback and too little dissent — but a few strategies can help stakeholders improve decision-making processes and build consensus, says Steve Groom at Miles Mediation.
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What BIPA Reform Law Means For Biometrics Litigation
A recently signed Illinois law amending the Biometric Information Privacy Act limits defendants' liability exposure on a per-scan basis and clarifies that electronic signatures constitute a valid written release, establishing additional issues that courts will need to address in future BIPA litigation, say attorneys at Faegre Drinker.