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Life Sciences
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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.
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September 06, 2024
Glioblastoma Org. Wants End To Rival's Use Of 'GBM'
The Glioblastoma Foundation has hit a competing nonprofit with a suit alleging that the group's use of the initials "GBM" in its name has ripped off its trademark and sown confusion among donors who can't tell the two organizations apart.
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September 05, 2024
Lawmakers, AGs Urge Justices To OK Denial Of E-Cig Apps
A coalition of state attorneys general and a group of Democratic Congress members are backing the U.S. Food and Drug Administration in its fight to persuade the U.S. Supreme Court to overturn a decision striking down the denials of applications to market flavored vapes.
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September 05, 2024
Law Firms Appeal Atty Fee Denial In Opioid Settlements
Two law firms, Goldstein & Russell PC and Kelley & Ferraro LLP, have claimed in an appeal to the Sixth Circuit that they were improperly shut out of the $2.13 billion attorney fee pool created by recent national opioid settlements with major pharmaceutical companies and pharmacy chains.
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September 05, 2024
Class Attys Vie To Lead Drug Co. Insider Trading Suit In Del.
A courtroom face-off over lead stockholder counsel duties in a Delaware Chancery Court case accusing a biopharmaceutical company's directors of insider trading and fiduciary duty breaches got edgy Thursday, after one of the plaintiff-side legal teams contended that the other's case was irreparably hobbled by conflicts of interest.
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September 05, 2024
Lupin Infringes Exeltis Contraceptive Patents, Judge Finds
Mumbai-based generic-pharmaceuticals company Lupin Pharmaceuticals Inc. has infringed five patents of the estrogen-free contraceptive Slynd, a Delaware federal judge said Wednesday, finding in favor of Spanish pharmaceutical company Insud Pharma and its New Jersey-based division Exeltis USA Inc. on all asserted claims.
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September 05, 2024
Pharma Co. Verrica Fails To Shed Investor Suit Over FDA OK
A Pennsylvania federal judge has partially denied Verrica Phamaceuticals Inc.'s second request to throw out a proposed class action filed by investors who claim the company defrauded them by hiding obstacles it faced in obtaining approval from the U.S. Food and Drug Administration for its lead product.
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September 04, 2024
Albertsons Denied Texas Court Remand In Opioid MDL
An Ohio federal judge overseeing multidistrict litigation over accusations that drug distributors contributed to the opioid epidemic denied a motion to transfer to Texas a portion of the dispute involving pharmacy company Albertsons.
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September 04, 2024
Leech Tishman Combines With Calif. Firm Nelson Hardiman
Leech Tishman is set to add California-based healthcare and life science law firm Nelson Hardiman's 17 attorneys to its Los Angeles office this fall and will do business in the Golden State under the combined name Leech Tishman Nelson Hardiman, the firm announced Tuesday.
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September 04, 2024
Medical Cos. Must Provide Doctor Names In Fla. Qui Tam Suit
A Florida federal judge has ordered several medical companies accused of fraudulently obtaining more Medicare funding than they were owed to produce the names of doctors associated with the companies, saying the difference between employed and affiliate providers isn't relevant.
Expert Analysis
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.
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Don't Fall On That Hill: Keys To Testifying Before Congress
Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.
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Online Portal Helps Fortify Feds' Unfair Health Practices Fight
The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.
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Series
Walking With My Dog Makes Me A Better Lawyer
Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.
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Think Like A Lawyer: Follow The Iron Rule Of Trial Logic
Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.
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The Art Of Asking: Leveraging Your Contacts For Referrals
Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.
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Trending At The PTAB: Permissible New Reply Arguments
In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.
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Wave Of Final Rules Reflects Race Against CRA Deadline
The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.
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'Beauty From Within' Trend Poses Regulatory Risks For Cos.
Companies capitalizing on the current trend in oral supplements touting cosmetic benefits must note that a product claim that would be acceptable for an externally applied cosmetic may draw much stronger scrutiny from the U.S. Food and Drug Administration when applied to a supplement, say Natalie Rainer and Katherine Staba at K&L Gates.
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McKesson May Change How AKS-Based FCA Claims Are Pled
The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.
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Series
Being An Equestrian Makes Me A Better Lawyer
Beyond getting experience thinking on my feet and tackling stressful situations, the skills I've gained from horseback riding have considerable overlap with the skills used to practice law, particularly in terms of team building, continuing education, and making an effort to reset and recharge, says Kerry Irwin at Moore & Van Allen.
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7th Circ. Mootness Fee Case May Curb Frivolous Merger Suits
On April 15, the Seventh Circuit in Jorge Alcarez v. Akorn Inc. mapped out a framework for courts to consider mootness fees paid to individual shareholders after the voluntary dismissal of a challenge to a public company merger, which could encourage objections to mootness fees and reduce the number of frivolous merger challenges filed, say attorneys at Skadden.
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Fintiv Denials Are On The Rise At PTAB
Following last year's CommScope v. Dali decision, the Patent Trial and Appeal Board is increasingly using Fintiv factors to discretionarily deny inter partes review petitions — and attorneys ignore it at their peril, say Josepher Li and Michelle Armond at Armond Wilson.
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4 Ways To Refresh Your Law Firm's Marketing Strategy
With many BigLaw firms relying on an increasingly obsolete marketing approach that prioritizes stiff professionalism over authentic connection, adopting a few key communications strategies to better connect with today's clients and prospects can make all the difference, say Eric Pacifici and Kevin Henderson at SMB Law.
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Cos. Must Prepare For Calif. Legislation That Would Ban PFAS
Pending California legislation that would ban the sale or distribution of new products containing intentionally added per- and polyfluoroalkyl substances could affect thousands of businesses — and given the bill's expected passage, and its draconian enforcement regime, companies must act now to prepare for it, say attorneys at Alston & Bird.