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Life Sciences
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October 30, 2024
LA Times Owner Faces Investor Suit Over Drug Co.'s Woes
Officers and directors of biotechnology company ImmunityBio Inc., including L.A. Times owner Patrick Soon-Shiong, face a shareholder's derivative complaint alleging the company concealed issues affecting a path to regulatory approval for one of its key product candidates.
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October 30, 2024
After Exeltis Win, Judge Won't Allow Suits On Dropped Patents
A Delaware federal judge has shot down a request that seven patents Insud Pharma's New Jersey-based division Exeltis USA Inc. dropped in patent litigation against Lupin Pharmaceuticals Inc. be dismissed in a way where they could be refiled later.
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October 30, 2024
Publix Denied Early Win Over Opioid Coverage Defense
A Florida federal court rejected Publix's bid for defense cost coverage for dozens of public nuisance lawsuits related to the opioid crisis, finding that the damages sought are too far removed from particular bodily injuries caused "because of" opioid addiction, as required in Publix's policies.
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October 30, 2024
3rd Circ. Told Medicare Drug Price Talks Not Voluntary
Three pharmaceutical companies told the Third Circuit on Wednesday the Medicare drug price negotiation program is anything but voluntary, arguing the appeals court should revive their challenges to the program because it is unconstitutional.
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October 30, 2024
Biopharma Co. Can't Knock Ex-CFO's Bias Suit Out Of Court
A biopharmaceutical development company can't kick a fired executive's bias suit to arbitration, a California federal judge said, ruling that the harassment she said she faced on the job was gendered enough to invoke a federal law curbing out-of-court-resolutions of sex harassment claims.
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October 30, 2024
Ex-Takeda Exec. Gets Nearly 4 Years For Fake Invoice Scam
A former Takeda Pharmaceuticals executive was sentenced Wednesday to 46 months in prison for stealing millions from the drug company through a fake invoice scam that a Boston federal judge characterized as "utterly unnecessary and pointless" and carried out for no other reason than to fund a luxurious lifestyle.
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October 30, 2024
Yale Researcher's Suit Over Loss Of 'Life's Work' Transferred
A Connecticut state court judge in Fairfield is passing on a researcher's lawsuit accusing Yale School of Medicine of destroying two decades of research worth $28 million, transferring the case to the complex litigation docket in Hartford.
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October 30, 2024
Ohio PBM Case Will Wait For High Court Ruling
The Sixth Circuit agreed to pause a case from Ohio state enforcers accusing Express Scripts and Prime Therapeutics of driving up prescription drug prices while the U.S. Supreme Court decides another case dealing with federal versus state jurisdiction.
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October 30, 2024
DLA Piper's FDA Regulation Vice Chair Joins White & Case
The former vice chair of DLA Piper's FDA regulatory practice has joined White & Case LLP's global life sciences and healthcare group and intellectual property practice.
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October 29, 2024
NY Judge Tosses $14B Decongestant MDL
A New York federal judge threw out a streamlined complaint in a multidistrict litigation accusing companies such as Target and Bayer of making and selling ineffective over-the-counter decongestants, finding Tuesday the state claims are expressly preempted, and the proposed class lacks standing on a federal racketeering claim as indirect purchasers.
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October 29, 2024
Y-mAbs Therapeutics Investors Get Final OK For $19.7M Deal
A New York federal judge has granted final approval to a $19.7 million settlement between Y-mAbs Therapeutics and investors who claim the company misrepresented the likelihood that the U.S. Food and Drug Administration would approve the company's signature pediatric nerve cancer treatment, giving class counsel a $6.5 million cut of the deal.
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October 29, 2024
Retired Fed. Circ. Judge Backs Invisalign In Monopoly Cases
Retired Federal Circuit Judge Paul R. Michel warned the Ninth Circuit on Tuesday that reversing a lower court's decision to toss a pair of class actions accusing Invisalign of monopolizing the clear braces and teeth scanners market by illegally refusing to deal with a rival would increase patent owners' legal uncertainties.
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October 29, 2024
Patent Partner Moves From King & Spalding To Steptoe
A former King & Spalding LLP partner has made the jump to Steptoe LLP, filling out the firm's team of California-based litigators who take on patent cases.
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October 29, 2024
4th Circ. Quizzes Drugmaker Challenging W.Va. Abortion Law
An attorney arguing that West Virginia is preempted by federal law from restricting access to an abortion medication faced skeptical questions Tuesday from two judges who suggested it's entirely normal for states to regulate the practice of medicine.
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October 29, 2024
Biopharma Co. Escapes Investor Suit Over Drug Approval Lies
Biopharmaceutical company Spero Therapeutics Inc. has escaped a proposed investor class action accusing it of concealing warning signs that it would not secure regulatory approval of one of its drugs, with the court ruling that Spero's interactions with the U.S. Food and Drug Administration do not indicate Spero should have known its application would be rejected.
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October 29, 2024
Medical Co. Gets No Coverage For Toxic Tort
An insurer for B. Braun Medical Inc. has no duty to defend or indemnify the company against numerous lawsuits accusing B. Braun of exposing residents near one of its medical device manufacturing plants to a carcinogenic gas, a Pennsylvania federal court ruled, finding a pollution exclusion applicable.
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October 29, 2024
Investors Float $21M Deal To End Life Sciences SPAC Suit
Shareholders in special purpose acquisition company CM Life Sciences Holdings have reached a tentative $21 million class settlement in Delaware's Court of Chancery after suing over alleged missing or misleading disclosures in the lead-up to the take-public merger of clinical data and genomics company Sema4 Holdings in July 2021.
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October 29, 2024
Beyond Abortion, 7 Ballot Questions Set To Shape Care
While reproductive rights have led the healthcare debate this election season, voters across the country will shape state policies on a number of other hot issues, including a Medicaid work requirement and coverage for IVF. Law360 Healthcare Authority looks at seven ballot measures that go beyond abortion.
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October 29, 2024
Allergan, Mankind Settle IP Fight Over Lumigan Generic
Allergan Inc. and Mankind Pharma Ltd. asked a Delaware federal court Tuesday to dismiss infringement litigation over Mankind's proposed generic of Allergan's glaucoma drug Lumigan, stipulating that the patent is valid and has been infringed.
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October 29, 2024
Purdue Creditors Can Sue Sacklers For $11.5B
Creditors of bankrupt OxyContin maker Purdue Pharma LP will get the right to sue the company's owners — certain members of the Sackler family — and others for $11.5 billion, should they choose to do so, a New York judge said on Tuesday.
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October 29, 2024
Pa. DA Says ATF's Pot Patients Ban Doesn't Fit With Bruen
A Pennsylvania district attorney is urging a federal judge not to throw out his suit challenging a Bureau of Alcohol, Tobacco, Firearms and Explosives policy blocking medical cannabis patients from buying or owning firearms, saying the U.S. Supreme Court's recent precedent preempts the restriction.
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October 29, 2024
Senate Panel Targets 'Clever' Pharma Pricing
The Senate Judiciary Committee on Tuesday railed against drugmakers and pharmacy benefit managers for allegedly causing the high cost of prescription drugs, arguing that "Big Pharma" has used anticompetitive tactics through patenting to fleece American patients.
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October 29, 2024
Circuit Judge Rips Atty's 'Unearned Windfall' In Liability Case
Although the Sixth Circuit has affirmed a decision awarding roughly $353,000 to a Texas attorney in a decadelong fee dispute over his representation of a client in a product liability case, one circuit judge expressed "extreme disapproval" over the lawyer's conduct in the matter.
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October 29, 2024
Crescent Inks Oncology Merger With $200M In Private Funding
Crescent Biopharma Inc. has agreed to take fellow cancer-focused biotech GlycoMimetics Inc. private in a deal that includes $200 million of investments from well over a dozen firms to help fund the combined company's operations through 2027, GlycoMimetics revealed Tuesday.
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October 29, 2024
PE-Owned Implant Maker Plagued By Lawsuits Hits Ch. 11
Joint implant maker Exactech Inc. on Tuesday filed for Chapter 11 protection in Delaware bankruptcy court with an offer from its lenders to take over the company, as a wave of lawsuits tied to product recalls weighs on the private equity-owned firm.
Expert Analysis
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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.
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Opinion
Litigation Funding Disclosure Key To Open, Impartial Process
Blanket investor and funding agreement disclosures should be required in all civil cases where the investor has a financial interest in the outcome in order to address issues ranging from potential conflicts of interest to national security concerns, says Bob Goodlatte, former U.S. House Representative for Virginia.
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The Licensure Landscape For Psychedelics Manufacturers
As the need for bulk manufacturing of psychedelic substances grows, organizations aiming to support clinical trials or become commercial suppliers must navigate a rigorous and multifaceted journey to obtaining a license from the U.S. Drug Enforcement Administration, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega Corp.
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What NFL Draft Picks Have In Common With Lateral Law Hires
Nearly half of law firm lateral hires leave within a few years — a failure rate that is strikingly similar to the performance of NFL quarterbacks drafted in the first round — in part because evaluators focus too heavily on quantifiable metrics and not enough on a prospect's character traits, says Howard Rosenberg at Baretz+Brunelle.
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Replacing The Stigma Of Menopause With Law Firm Support
A large proportion of the workforce is forced to pull the brakes on their career aspirations because of the taboo surrounding menopause and a lack of consistent support, but law firms can initiate the cultural shift needed by formulating thoughtful workplace policies, says Barbara Hamilton-Bruce at Simmons & Simmons.
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Class Actions At The Circuit Courts: August Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers certification cases touching on classwide evidence of injury from debt collection practices, defining coupon settlements under the Class Action Fairness Act, proper approaches for evaluating attorney fee awards in class action settlements, and more.
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Leveraging Policy Changes To Achieve AI Patent Eligibility
With the latest U.S. Patent and Trademark Office guidance in hand and legislation looming in Congress, innovators should file their artificial intelligence patent applications now — and five strategies can maximize their chances of success, says Nicholas Gallo at Troutman Pepper.
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Planning Law Firm Content Calendars: What, When, Where
During the slower month of August, law firms should begin working on their 2025 content calendars, planning out a content creation and distribution framework that aligns with the firm’s objectives and maintains audience engagement throughout the year, says Jessica Kaplan at Legally Penned.
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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.