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Life Sciences
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August 15, 2024
LA Times Owner Sued Over Control Of Biotech Nonprofit
A biotech research institute has sued board member Dr. Patrick Soon-Shiong, the billionaire owner of the Los Angeles Times, in Washington federal court alleging entities controlled by him contractually owe the institute millions, even as Soon-Shiong is demanding the institute reallocate resources to fund pet projects unrelated to its mission.
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August 15, 2024
Monsanto Gets 3rd Circ. Win In Roundup Failure-To-Warn Case
The Third Circuit ruled Thursday that a Pennsylvania state law failure-to-warn claim in a suit alleging the weed killer Roundup caused a Keystone State man's cancer is preempted by federal law, creating a circuit split on central issues in multidistrict litigation over the Monsanto product.
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August 15, 2024
Pharmacy Can't Dodge Novo Nordisk's Diabetes Drug Suit
A Tennessee federal judge on Thursday declined to throw out a suit by Novo Nordisk Inc. alleging that DCA Pharmacy is selling drugs with the same active ingredient as its Ozempic diabetes medicine without U.S. Food and Drug Administration authorization.
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August 15, 2024
CMS Posts Final Costs For 1st Set Of Drugs After Negotiations
The federal government released on Thursday the final prices of the first 10 drugs negotiated by Medicare under the Inflation Reduction Act, in a long-anticipated move set to shape the future of drug price negotiations.
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August 15, 2024
Price-Fixing Claims Against Par Pharma Tossed After Ch. 11
A Connecticut federal judge on Thursday tossed Par Pharmaceutical Cos. Inc. from two price-fixing lawsuits after the defendant and its parent, Endo International PLC, recently filed the Chapter 11 reorganization plans that they said shielded them from the cases.
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August 15, 2024
NC Small Biz Challenges VA Bid Process For Prostate Drug
A service-disabled veteran-owned small business in North Carolina is challenging the U.S. Department of Veterans Affairs' bid process for prostate medication, saying the terms unfairly favor foreign manufacturers despite purporting to prioritize American-made products.
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August 15, 2024
Pharma Co. TM Dispute Doesn't Belong In Florida, Judge Says
A trademark lawsuit between two drug companies with similar names does not belong in a Florida federal court, a judge in West Palm Beach has ruled.
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August 15, 2024
Okla. Says 10th Circ. PBM Ruling Defies High Court Precedent
Oklahoma urged the U.S. Supreme Court to review a Tenth Circuit decision nullifying certain parts of a state law regulating pharmacy benefit managers, arguing the appeals court's ruling openly conflicts with sister circuits and previous high court rulings while pushing federal benefits law beyond its limits.
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August 15, 2024
Paul Hastings Adds M&A, Shareholder Activism Lawyer
Paul Hastings LLP announced Thursday that it has boosted the firm's mergers and acquisitions and shareholder activism platform with a longtime Goodwin Procter LLP partner.
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August 14, 2024
Costco Wants PFAS Kirkland Brand Baby Wipes Suit Tossed
Costco hit back at a proposed class action over its fragrance-free "natural" baby wipes filed earlier this summer in California federal court, saying that the suit is trying to scare parents by alleging the wipes are tainted with so-called forever chemicals.
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August 14, 2024
J&J Vision Unit Sues Ex-Marketing Exec Over Move To Rival
Johnson & Johnson's vision unit sued a former marketing director on Tuesday, saying her move to a direct competitor is an "imminent threat of immediate, irreparable harm" and asking a New Jersey federal court to enforce her noncompete agreement and other post-employment obligations.
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August 14, 2024
NC Judge OKs $15.2M Deal For Medical Device Investors
A North Carolina federal judge has given the first green light to a $15.25 million settlement that will resolve a securities class action claiming that Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices.
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August 14, 2024
Grassley Asks HHS For Clarity On Cannabis Position
Sen. Chuck Grassley has asked federal health officials to clarify their position on marijuana, arguing that a recent U.S. Department of Health and Human Services report is at odds with its recommendation to loosen restrictions on the drug.
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August 14, 2024
Novartis' $45B Biz Can Survive If Generic Debuts, Judge Says
A D.C. federal judge told Novartis to stop acting like it would be destroyed financially by having a generic version of its best-selling drug Entresto enter the market, saying the drugmaker will be fine if it loses $3 billion in U.S. sales out of its $45 billion global revenue.
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August 14, 2024
AstraZeneca Freed From $107.5M Verdict In Pfizer Patent Case
A federal judge on Wednesday overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents owned by a Pfizer unit, concluding that both patents are invalid for failing to provide sufficient information about the invention.
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August 14, 2024
HHS Calls For More Research, Planning To Combat Heat Risks
Citing a sharp increase in deaths from extreme heat, the Biden administration unveiled a national strategy Wednesday that calls for better communicating the health risks of hot weather to the public and taking other steps to protect people from life-threatening heat waves.
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August 14, 2024
Samsung Biotech Unit Hit With Patent Suit Over Bone Drugs
The pharmaceutical giant Amgen Inc. is fighting a bid by a South Korean rival to sell biosimilar versions of its highly popular bone drugs Prolia and Xgeva, telling a New Jersey federal court that the proposed medications will infringe 34 patents.
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August 14, 2024
Calbiotech Beats Ex-Worker's 401(k) Retaliation Suit
A former Calbiotech Inc. employee must return a $12,500 payment he received after being terminated, a California federal judge ruled, finding he breached his severance agreement by filing a lawsuit claiming he was let go for asking about the life sciences company's 401(k) plan documents.
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August 14, 2024
Suit Claims Giant Uses Banned, Toxic Oil In Orange Soda
A proposed class of soda drinkers is suing The Giant Co. LLC in Pennsylvania federal court, alleging that it makes and sells orange soda made with a kind of vegetable oil that federal regulators banned for its negative effects on the thyroid gland.
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August 14, 2024
Zantac Judge Won't Step Aside Over Wife's Reed Smith Role
A Pennsylvania state judge overseeing the Zantac mass tort litigation against GlaxoSmithKline denied a motion to recuse himself Wednesday after expressing skepticism about the plaintiffs' contention that he could be unconsciously partial because his wife works for a firm defending the drugmaker in other jurisdictions.
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August 13, 2024
SEC Drops Insider Trading Suit Against Ex-Mylan Exec
The U.S. Securities and Exchange Commission on Tuesday dismissed a Pennsylvania federal suit accusing the former chief information officer of Mylan NV of insider trading due to what his attorneys describe as compelling evidence showing his innocence, seven months after the Department of Justice dropped a parallel criminal case.
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August 13, 2024
Entresto Release Delayed As Novartis Goes To Fed. Circ.
A Delaware federal judge said Monday that Novartis is unlikely to prove that it's entitled to an injunction that would block MSN Pharmaceuticals from launching a generic version of its top-selling drug Entresto, but stayed the generic release briefly so Novartis could appeal to the Federal Circuit.
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August 13, 2024
Mother Can't Revive Suit Against GE For Child's Brain Damage
A Pennsylvania appeals panel won't reinstate a mother's suit against General Electric Co. and subsidiary Datex-Ohmeda Inc. alleging that a faulty anesthesia machine caused her child permanent brain damage, finding the trial court rightly found that the state doesn't have jurisdiction over the claims.
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August 13, 2024
Spinal Implant Patents Verdict Must Stand, Pa. Judge Says
A Pennsylvania federal judge declined to order a new trial Tuesday in a patent infringement suit brought against medical device maker Globus Medical Inc., ruling that the jury verdict in the company's favor had sufficient evidentiary support and that the jurors did not seem confused by the law at issue.
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August 13, 2024
NY, NJ And Conn. Score $4.5M Penalty Over Enzo Data Breach
Molecular diagnostics company Enzo Biochem Inc. has agreed to pay a $4.5 million penalty after an investigation found that the company failed to implement recommended security protocols ahead of a data breach that affected millions of patients, New York's attorney general announced Tuesday.
Expert Analysis
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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.
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FDA Warning Letter Tightens Reins On 'Research Only' Labels
A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.
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Practical Pointers After Fed. Circ. Double-Patenting Decision
With the Federal Circuit recently denying a full court review of In re: Cellect, a decision regarding obviousness-type double-patenting, affected patent family holders should evaluate their rights through both patent prosecution and future litigation lenses to minimize risks, say Austin Lorch and Jeff Wolfson at Haynes Boone.