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Life Sciences
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August 29, 2024
Pa. Justices To Examine Axing Of 'Red Book' Drug Pricing
The Supreme Court of Pennsylvania has agreed to review a decision tossing the "Red Book" pricing values used by the state's Bureau of Workers' Compensation to calculate reimbursement for prescription drug costs.
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August 29, 2024
Jury Clears Ore. Hospital That Implanted FDA-Flagged Mesh
A state jury cleared an Oregon hospital system and a surgeon of liability Wednesday over a patient's claims that prolapse mesh was implanted almost two weeks after the U.S. Food and Drug Administration ordered its maker to stop selling it.
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August 29, 2024
Lannett Says Areva Reneged On Cancer-Drug Deal After Ch. 11
Lannett Pharmaceuticals hit generic-drug maker Areva Pharmaceuticals with a contract suit in Delaware's Court of Chancery on Thursday, accusing Areva of breaching their 2022 agreement that gave Lannett exclusive rights to distribute Areva's injectable anticancer drug after Lannett emerged from a prepackaged Chapter 11 bankruptcy.
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August 29, 2024
Comer Tells PBMs To Correct Record On Role In Drug Pricing
Rep. James Comer, R-Ky., chair of the House Oversight and Accountability Committee, is demanding that the heads of three major pharmacy benefit managers "correct the record" on their testimony made before his committee in July about their roles in drug pricing, including company claims that the PBMs don't steer customers to in-house pharmacies and that they allow non-affiliated pharmacies to negotiate contracts.
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August 29, 2024
Seattle Biotech Can't Immediately Force Out LA Times Owner
Billionaire and Los Angeles Times owner Dr. Patrick Soon-Shiong will not be forced to recuse himself from a Seattle-based biotech research institute board while the nonprofit's breach-of-fiduciary duty lawsuit against him is pending, a Washington federal judge said on Thursday.
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August 29, 2024
Pacira To Appeal Generic's Win In Pain Drug Patent Fight
Pacira Pharmaceuticals Inc. says it is appealing a New Jersey federal judge's decision invalidating its patent on a nonopioid painkiller and opening the way for generic versions of its drug Exparel, a long-acting injectable for managing postsurgical pain.
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August 29, 2024
Nektar Can't Get Docs It Says Show Lilly As 'Thieves, Liars'
A California federal judge Thursday rejected Nektar Therapeutics' request for internal Eli Lilly documents related to separate litigation as Nektar pursues allegations Eli Lilly ruined prospects for a drug the companies were developing together despite Nektar's counsel saying it would "expose Lilly for being thieves, liars."
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August 29, 2024
Convicted Drexel Prof Says Records Would've Swayed Jury
A Drexel University accounting professor convicted on charges of tax evasion and filing false tax returns after the government accused him of failing to report $3.3 million in income from a Trenton pharmacy has asked a New Jersey federal judge for a new trial.
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August 29, 2024
Jazz Hits Teva With Patent Suit Over Narcolepsy Drug
Teva Pharmaceuticals Inc. is infringing a patent for the narcolepsy drug Xywav, Jazz Pharmaceuticals Inc. said in a complaint filed in New Jersey federal court.
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August 28, 2024
Merck Must Face Class Claims In Vaccine Antitrust Suit
Merck cannot strike class claims in antitrust litigation over its rotavirus vaccine, a Pennsylvania federal judge ruled Wednesday, while also allowing the city of Baltimore to eliminate redundancies in its complaint.
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August 28, 2024
CyDex Says Bexson Breached Deal By Misusing Pharma IP
CyDex Pharmaceuticals hit Bexson Biomedical with a contract breach suit in Delaware Chancery Court accusing it of misusing a CyDex-designed molecule to develop unauthorized non-ketamine formulations, and subsequently filing a patent for those formulations, in violation of the parties' agreement.
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August 28, 2024
J&J Spinoff Beats Suit Over Tylenol 'Rapid Release' Labels
A New York federal judge tossed Tuesday a proposed class action accusing a Johnson & Johnson spinoff of misleading consumers by falsely claiming Tylenol's "Rapid Release" gelcaps relieved pain faster than alternative acetaminophen pills, finding the consumer's state claims are preempted by federal regulations.
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August 28, 2024
Lipitor Buyers Seek Final OK For $35M Deal In Antitrust Fight
End-payor plaintiffs asked a New Jersey federal judge Tuesday to give final approval of a $35 million settlement resolving their antitrust claims against Pfizer over the cholesterol medication Lipitor.
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August 28, 2024
Walgreens Brass Hid Pharmacy Division Woes, Suit Says
Walgreens' directors and officers have been hit with a derivative suit by a shareholder who says the company and its executives inflated stock value by publicly expressing confidence in the pharmacy division's growth while hiding its struggles adapting to industry hurdles.
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August 28, 2024
Jazz, Hikma Must Face Bulk Of Xyrem Antitrust Suit
Jazz Pharmaceuticals and Hikma Pharmaceuticals appear bound for trial against most solo insurer and class action antitrust claims over alleged efforts to block generic competitors to Jazz's Xyrem narcolepsy drug, under a newly unsealed California federal court order largely rejecting competing motions for summary judgment.
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August 28, 2024
Calif. Couples Drop FujiFilm Suit Over Destroyed Embryos
California couples who sued a manufacturer of oil used in the in vitro fertilization process claiming the product killed their embryos are looking to drop their federal suit.
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August 28, 2024
Del. Justices OK Mid-Case Appeal In Zantac Class Suit
The Delaware Supreme Court on Tuesday said it would hear a mid-case appeal in mass tort litigation over claims that the heartburn drug ranitidine, widely sold under the name Zantac, caused cancer.
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August 28, 2024
High Court Told Tyvaso Row Petition Based On 'False' Premise
A small pharmaceutical startup behind a drug that would compete with the blockbuster high blood pressure treatment Tyvaso says United Therapeutics is making a "fundamentally false" argument to the U.S. Supreme Court about why an appeals court rejected United Therapeutics' case.
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August 28, 2024
Regeneron Sues Sandoz Over Dozens Of Eye Drug Patents
Regeneron Pharmaceuticals Inc. has taken competing biomedical company Sandoz Inc. to New Jersey federal court with an extensive complaint asserting 46 patents and claiming Sandoz infringed them all with a biosimilar alternative to Regeneron's Eylea brand ophthalmic disorder drug.
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August 28, 2024
Biotech Biz Hid Risks Of Gene-Editing Trial, Investor Claims
Biotechnology firm Verve Therapeutics was hit with a proposed class suit alleging it misled investors about the risks associated with a clinical trial of an experimental gene-editing drug that was halted and caused the company's stock to tumble.
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August 27, 2024
Cherokee Nation's Opioid Suit Sent Back To State Court
An Oklahoma federal judge has adopted a magistrate judge's recommendation to send a Cherokee Nation opioid lawsuit against pharmaceuticals distributor Morris & Dickson back to state court, agreeing that the negligence case isn't predicated on a duty arising out of the federal Controlled Substances Act.
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August 27, 2024
USPTO Sued For Rejecting Blood Pressure Drug Patent
A small drug developer has hit the U.S. Patent and Trademark Office with a second lawsuit in Virginia federal court over the agency's latest rejection of the company's efforts to patent a different dosage of a drug the company markets to treat low blood pressure.
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August 27, 2024
NY Pension Funds Join Illumina Deal Suit Pile-On In Del.
New York state's retirement system and fund have added a new derivative suit to widening stockholder litigation over Illumina Inc.'s $8 billion reacquisition of cancer testing company Grail Inc. despite European Commission regulatory agency opposition.
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August 27, 2024
Fed. Circ. Won't Speed Up Apple Watch Ban Appeal
The Federal Circuit on Tuesday denied Apple Inc.'s request to expedite oral arguments in its appeal challenging the U.S. International Trade Commission's decision banning the tech giant from selling Apple Watches with a "blood oxygen" feature in the Masimo patent case.
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August 27, 2024
Connecticut Litigation To Watch In The 2nd Half Of 2024
The Connecticut state and federal courts will grapple with a number of closely watched cases during the second half of 2024, including three key lawsuits by state Attorney General William Tong.
Expert Analysis
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Series
Playing Golf Makes Me A Better Lawyer
Golf can positively affect your personal and professional life well beyond the final putt, and it’s helped enrich my legal practice by improving my ability to build lasting relationships, study and apply the rules, face adversity with grace, and maintain my mental and physical well-being, says Adam Kelly at Venable.
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Law Firms Should Move From Reactive To Proactive Marketing
Most law firm marketing and business development teams operate in silos, leading to an ad hoc, reactive approach, but shifting to a culture of proactive planning — beginning with comprehensive campaigns — can help firms effectively execute their broader business strategy, says Paul Manuele at PR Manuele Consulting.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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Opinion
A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.
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Opinion
The Big Issues A BigLaw Associates' Union Could Address
A BigLaw associates’ union could address a number of issues that have the potential to meaningfully improve working conditions, diversity and attorney well-being — from restructured billable hour requirements to origination credit allocation, return-to-office mandates and more, says Tara Rhoades at The Sanity Plea.
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Opinion
It's Time For A BigLaw Associates' Union
As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.
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How Justices Upended The Administrative Procedure Act
In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.
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Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement
While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.