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Life Sciences
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August 07, 2024
2 FDA Pros Join McGuireWoods From Reed Smith, DOJ
McGuireWoods LLP said Wednesday it has added two U.S. Food and Drug Administration regulatory lawyers to its Washington, D.C., office — one who joins from Reed Smith LLP and another who joins from the U.S. Department of Justice.
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August 07, 2024
Jury Deadlocks In Third Illinois Zantac Cancer Trial
An Illinois state judge declared a mistrial Wednesday in a man's lawsuit claiming Boehringer Ingelheim's over-the-counter Zantac caused him to develop prostate cancer, after a jury signaled it could not reach a unanimous verdict.
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August 07, 2024
Rising Star: King & Spalding's Julia Zousmer
Julia Zousmer of King & Spalding LLP helped Boehringer Ingelheim nix roughly 50,000 claims by plaintiffs and an entire cohort of experts in multidistrict litigation over its heartburn medication Zantac, earning her a spot among life sciences attorneys under age 40 honored by Law360 as Rising Stars.
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August 07, 2024
Pennsylvania Legislation Passed In 2024: A Midyear Report
Despite a divided legislature in Pennsylvania — the parties have been trading a narrow majority in the House of Representatives and Republicans compose most of the state Senate — lawmakers have managed to send dozens of bills to Democratic Gov. Josh Shapiro's desk in the first half of 2024, including tighter controls on a veterinary drug showing up in heroin, changes to business registrations with the state, and adding arbitration to the tools for family courts.
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August 06, 2024
AstraZeneca Can't Duck $107.5M Patent Loss To Pfizer Unit
An Illinois federal judge on Tuesday refused to upend a jury's determination that AstraZeneca owes $107.5 million in royalty damages for infringing Pfizer-brand cancer treatment patents, rejecting AstraZeneca's arguments that the patents are unenforceable and the asserted claims are invalid.
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August 06, 2024
Baby Sock Co. Can't Beat Investor Suit, But SPAC Brass Can
Digital baby monitoring device manufacturer Owlet Inc. cannot escape a suit accusing it of misleading investors about approvals required from the U.S. Food and Drug Administration to sell its "smart socks," but brass at a blank check company that it merged with will be allowed to exit the suit.
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August 06, 2024
Fed. Circ. Told Edwards Filed Safe Harbor Suit With Bad Intent
The Federal Circuit rightfully held Meril Life Sciences was protected by a patent safe harbor when bringing its preapproval transcatheter heart valve system to an industry conference and that Edwards Lifesciences' attempts to prove otherwise are just delay tactics, Meril told the full court.
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August 06, 2024
Tech Giants' Fight To Ax Fintiv Rule Returns To Fed. Circ.
Apple and three other major technology companies have again asked the Federal Circuit to abolish a rule allowing the Patent Trial and Appeal Board to refuse to review patents based on related litigation in court, saying it is unlawful because it was implemented without formal rulemaking.
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August 06, 2024
Denver Food Co. Fired VP For Younger Male, Suit Claims
A former vice president of a Denver-area food biotech firm has filed a suit claiming the company violated Colorado's gender and age anti-discrimination laws when it fired and ultimately replaced her after she finished training a younger male successor, who was intended to only take over some of her duties.
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August 06, 2024
Life Sciences Credit Firm Symbiotic Launches With $600M
A new credit firm led by veterans in the healthcare industry announced its launch Tuesday, with more than $600 million in capital earmarked for loans to life sciences companies.
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August 06, 2024
FDA Posts Two Policy Memos On E-Cig Applications
The U.S. Food and Drug Administration on Monday posted two memos outlining the agency's thoughts on two aspects of their reviews of applications to market e-cigarettes, which include chemical components that may pose a risk of cancer.
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August 06, 2024
Pharma Co. Founder Beats Suit Over Short-Swing Trading
The founder of Y-mAbs Therapeutics Inc. beat back a suit alleging he realized more than $2.5 million in so-called short-swing profits after he exchanged his Y-mAbs stock for those of another company, with a New York federal judge saying in a ruling of first impression that the founder does not need to return the gains he received.
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August 06, 2024
Dem Lawmakers Back FTC's Kroger-Albertsons Challenge
A group of Democratic lawmakers is supporting the Federal Trade Commission in its suit to block Kroger's $25 billion acquisition of Albertsons, telling an Oregon federal judge in a friend-of-the-court brief that the agency's fears the deal would harm grocery workers and consumers are well-founded.
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August 06, 2024
Ex-Pfizer Worker Who Traded On Paxlovid Secrets Gets 9 Mos.
A Manhattan federal judge sentenced a former Pfizer Inc. statistician from New Jersey to nine months in prison Tuesday after a jury convicted him of insider trading on secrets about his former company's COVID-19 therapy trials for an illegal $272,000 profit.
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August 06, 2024
Penn Says BioNTech Owes Royalties For COVID-19 Vax
BioNTech was hit with a breach of contract suit Monday in Pennsylvania federal court by the University of Pennsylvania over alleged unpaid royalties on global net sales of its blockbuster COVID-19 vaccine Comirnaty, which was developed using the school's crucial messenger RNA patents and has made more than $75 billion.
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August 06, 2024
Rising Star: White & Case's Adam Acosta
Adam Acosta of White & Case LLP helped secure a Second Circuit win for AbbVie Inc. in a "pay for delay" suit over its hypertension drug Bystolic, earning him a spot among life sciences attorneys under age 40 honored by Law360 as Rising Stars.
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August 05, 2024
Inari Agriculture Can't Sink Patent Case Over Corn Seed
A legal fight between a DowDuPont spinoff and a Massachusetts plant breeding startup over the exporting of patent-protected corn seed will continue to grow in Delaware federal court, unimpeded by DuPont researchers' decision to publicly deposit their seeds.
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August 05, 2024
Indivior Accused Of Overstating Prospects Of 3 Opioid Drugs
Drugmaker Indivior PLC has been hit with a proposed investor class action in Virginia federal court over claims it overstated the financial prospects of its drugs used to treat opioid use disorders and the company's ability to forecast such financial projections.
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August 05, 2024
Chinese Drug Co. Says Sanctions In Valsartan MDL Too Harsh
Chinese drug firm Zhejiang Huahai Pharmaceutical Co. Ltd. told a New Jersey federal court Friday that sanctions authorizing two adverse jury instructions in multidistrict litigation over generic drugs contaminated with carcinogens should be overturned, arguing the plaintiffs did not allege the bad faith required for such a harsh penalty.
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August 05, 2024
J&J, Generics Spar In Remand On Schizophrenia Drug Patent
Following a Federal Circuit ruling that gave generics makers Teva and Viatris a new shot at trying to invalidate the last remaining patent on Johnson & Johnson's blockbuster schizophrenia drug Invega Sustenna, the parties are sparring over the impact of the appeals court's decision.
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August 05, 2024
GSK Wins Second Ill. Trial On Zantac Cancer Claims
A Chicago jury held Monday that GlaxoSmithKline is not liable for a woman's colorectal cancer, handing the drugmaker a second straight trial victory in hundreds of Illinois suits targeting Zantac heartburn medication and its generic counterparts.
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August 05, 2024
Spectrum, Assertio Hit With Double-Derivative Suit In Del.
Former Spectrum Pharmaceuticals Inc. shareholders sued the company and its acquirer Assertio Inc. in Delaware's Court of Chancery on Monday, asserting double-derivative claims in connection with Spectrum's alleged misleading of investors regarding its development of the lung-cancer drug poziotinib.
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August 05, 2024
Fla. Man Gets 44 Months For $5M MilliporeSigma Export Scam
A Florida federal judge sentenced a Taiwanese citizen who lives in the Sunshine State to three years and eight months in prison for his role in a $5 million scheme to defraud life sciences company MilliporeSigma and the U.S. government by illegally exporting MilliporeSigma products to China.
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August 05, 2024
Centessa Beats Shareholder Suit Over Kidney Drug
A New York federal judge has tossed a shareholder lawsuit alleging that Centessa Pharmaceuticals PLC overstated the prospects of its kidney disease treatment ahead of the drugmaker's initial public offering, saying the plaintiffs have failed to allege any actionable misleading statements or omissions.
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August 05, 2024
Catching Up With Delaware's Chancery Court
Sunken treasure, rock band discord, a wrestling competition, and more news about Elon Musk — all in all, a colorful week in Delaware's Court of Chancery. The First State's famous court of equity also pushed forward on disputes involving a famous social media app, Delaware's largest hospital system, an artificial intelligence company and a budding commodity futures exchange.
Expert Analysis
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HHS Opioid Rule Generally Benefits Providers And Patients
The U.S. Department of Health and Human Services' newly effective rule, the first substantial change to opioid treatment programs and delivery standards in over 20 years, significantly expands access and reduces stigma around certain medications, though the rule is narrow in scope and does have some limitations, say attorneys at Alston & Bird.
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Trump's NY Civil Fraud Trial Spotlights Long-Criticized Law
A New York court’s recent decision holding former President Donald Trump liable for fraud brought old criticisms of the state law used against him back into the limelight — including its strikingly broad scope and its major departures from the traditional elements of common law fraud, say Mark Kelley and Lois Ahn at MoloLamken.
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Opinion
Requiring Leave To File Amicus Briefs Is A Bad Idea
A proposal to amend the Federal Rules of Appellate Procedure that would require parties to get court permission before filing federal amicus briefs would eliminate the long-standing practice of consent filing and thereby make the process less open and democratic, says Lawrence Ebner at the Atlantic Legal Foundation and DRI Center.
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2 Recent Suits Show Resiliency Of Medicare Drug Price Law
Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.
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4 Ways To Motivate Junior Attorneys To Bring Their Best
As Gen Z and younger millennial attorneys increasingly express dissatisfaction with their work and head for the exits, the lawyers who manage them must understand and attend to their needs and priorities to boost engagement and increase retention, says Stacey Schwartz at Katten.
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Defense Attys Must Prep For Imminent AI Crime Enforcement
Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.
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Planning For Healthcare-Private Equity Antitrust Enforcement
U.S. antitrust agency developments could mean potential enforcement actions on healthcare-related acquisitions by private equity funds are on the way, and entities operating in this space should follow a series of practice tips, including early assessment of antitrust risks on both the state and federal level, say Ryan Quillian and John Kendrick at Covington.
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Opinion
Why USPTO Should Issue Inherency Guidance Memo
The U.S. Patent and Trademark Office should issue a new guidance memo in regard to the standard for inherency during the examination process, as the standard is frequently misapplied during prosecution, and consistency of the standard in the USPTO should match that in the federal courts, says Irving Feit at Lucas & Mercanti.
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How Purdue Pharma High Court Case May Change Bankruptcy
The U.S. Supreme Court’s upcoming ruling in Purdue Pharma may be the death of most third-party releases in Chapter 11 cases, and depending on the decision’s breadth, could have much more far-reaching effects on the entire bankruptcy system, say Brian Shaw and David Doyle at Cozen O'Connor.
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3 Health Insurance Paths For Psychedelic-Assisted Therapy
Ahead of potential U.S. Food and Drug Administration approvals for psychedelics as insured treatments, attorneys at Husch Blackwell review pathways for these drugs to achieve coverage as treatments for complex mental health conditions.
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Series
Serving As A Sheriff's Deputy Made Me A Better Lawyer
Skills developed during my work as a reserve deputy — where there was a need to always be prepared, decisive and articulate — transferred to my practice as an intellectual property litigator, and my experience taught me that clients often appreciate and relate to the desire to participate in extracurricular activities, says Michael Friedland at Friedland Cianfrani.
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Fears About The End Of Chevron Deference Are Overblown
While some are concerned about repercussions if the U.S. Supreme Court brings an end to Chevron deference in the Loper and Relentless cases this term, agencies and attorneys would survive just fine under the doctrines that have already begun to replace it, say Daniel Wolff and Henry Leung at Crowell & Moring.
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Negotiating Milestones In Pharma Licenses Requires Care
For life sciences companies, understanding the unique issues that arise in licensing agreements' milestone payment provisions can increase the likelihood and amount of payments received by the licensor and ensure payments are carefully and closely tied to events that truly drive value for the licensee, say Edward Angelini at Amneal Pharmaceutical and Lori Waldron at Sills Cummis.
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Former Minn. Chief Justice Instructs On Writing Better Briefs
Former Minnesota Supreme Court Chief Justice Lorie Gildea, now at Greenberg Traurig, offers strategies on writing more effective appellate briefs from her time on the bench.
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Stay Interviews Are Key To Retaining Legal Talent
Even as the economy shifts and layoffs continue, law firms still want to retain their top attorneys, and so-called stay interviews — informal conversations with employees to identify potential issues before they lead to turnover — can be a crucial tool for improving retention and morale, say Tina Cohen Nicol and Kate Reder Sheikh at Major Lindsey.