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Life Sciences
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July 10, 2024
GOP Bombards Agencies With Demands After Chevron's End
Republican leaders of major congressional committees Wednesday demanded details from dozens of agencies on policies suddenly shrouded in uncertainty after U.S. Supreme Court conservatives overturned the so-called Chevron doctrine, which for 40 years gave regulators flexibility in rulemaking and advantages in related litigation.
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July 10, 2024
Meijer Says Takeda Can't Force Antitrust Suit Into Arbitration
Meijer argued before a Massachusetts federal court that Takeda waited far too long to try to force the supermarket chain to arbitrate its proposed class action accusing the Japanese pharmaceutical company of conspiring to delay a generic version of its anti-constipation drug Amitiza.
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July 10, 2024
Skin Care Tech Co. Says Suit Shows 'Rough' Year, Not Fraud
Skin care and beauty technology company Cutera Inc. asked a federal judge to toss a shareholder lawsuit that alleged the company exaggerated its financial sustainability and hid compliance issues, saying the company's "rough" year does not establish securities fraud.
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July 10, 2024
Buyers Say Teva Had Multipart Scheme To Delay Inhaler Rivals
Employee benefit funds accusing Teva of orchestrating a decadelong scheme to delay generic competition for its QVAR asthma inhalers told a Massachusetts federal court the drugmaker is trying to end the case by addressing merely one aspect of a multipart scheme.
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July 10, 2024
RJ Reynolds Urges Toss Of Menthol Suit Against FDA
Tobacco giant R.J. Reynolds has come to the support of the U.S. Food and Drug Administration in a friend-of-the-court brief, arguing that the court should toss a federal lawsuit against the agency over its purported delays in implementing a ban on menthol cigarettes.
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July 10, 2024
Ex-FDA Regulator Joins Chicago Boutique Amin Wasserman
A former high-level attorney within the U.S. Food and Drug Administration is joining Chicago-based boutique Amin Wasserman Gurnani LLP, which specializes in representing food and dietary supplement companies.
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July 10, 2024
Longtime Axinn Atty To Chair Polsinelli's Hatch-Waxman Team
A practice leader from Axinn Veltrop & Harkrider LLP, known in part for his high-profile work on behalf of pharmaceutical clients, is joining Polsinelli PC to chair its Hatch-Waxman and biologics practice, the firm announced on Tuesday.
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July 10, 2024
Ex-CEO Convicted In COVID Test Kit Fraud Case
A former healthcare software executive was found guilty of securities fraud Wednesday by a New Jersey federal jury in the retrial of a case that ended in a hung jury in December.
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July 09, 2024
Pharma Co. Fined $16.9M For Fake Scripts, Ex-VP Arrested
A subsidiary of bankrupt DMK Pharmaceuticals Corp. faces a $16.9 million criminal fine after pleading guilty to conspiring in a scheme to ship drugs using false prescriptions, federal prosecutors announced Tuesday, adding that the subsidiary's former vice president of sales was also arrested.
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July 09, 2024
Bard Fights 'Patent Misuse' Ruling In $53M Suit At 9th Circ.
Bard urged the Ninth Circuit on Tuesday to reverse a lower court's finding that its attempt to collect $53 million in licensing payments from a medical-device company was a clear case of "patent misuse," arguing that the parties' licensing agreement allows for Bard to collect payments even after the patents-in-suit expired.
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July 09, 2024
South Africa Drops J&J Probe After TB Drug Price Cuts
South Africa's antitrust office has said it's going to drop its investigation over whether Johnson & Johnson engaged in anticompetitive conduct by filing a patent there for a tuberculosis drug, after the drugmaker agreed to lower the cost of bedaquiline by 40% and allow generic versions of the drug on the market.
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July 09, 2024
Fla. Judge Won't Nix Antitrust Claims Against Alcon
The Florida federal judge presiding over the multidistrict litigation alleging disposable contact lens sellers conspired to fix prices refused Tuesday to let Alcon escape antitrust claims by an online contact lens reseller and sent the suit back to New York.
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July 09, 2024
HEC Can't Get Damages Over Injunction In Novartis Feud
A Delaware federal court on Tuesday shot down HEC Pharm Co.'s bid for damages stemming from a preliminary injunction against it over the launch of a generic version of Novartis Pharmaceuticals' blockbuster multiple sclerosis treatment Gilenya.
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July 09, 2024
BCBS Unit Fails To Stop Religious Vaccine Objector Suits
A Blue Cross Blue Shield of Michigan subsidiary can't escape claims it treated differently employees who sought accommodations from a COVID-19 vaccine mandate, a Michigan federal judge ruled Tuesday, finding it plausible that religious discrimination "was at least a motivating factor" in the way the workers were dealt with.
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July 09, 2024
3rd Circ. Rips 2nd Circ. In Asset Freeze Ruling For SEC
The Third Circuit is standing by a lower court's decision to freeze a private equity executive's assets as he fights insider trading claims brought by the U.S. Securities and Exchange Commission, criticizing its sister circuit's approach to handling such issues in a precedential ruling Tuesday.
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July 09, 2024
NJ Panel Revokes Coverage For Pharma Co. In Fraud Row
A pharmaceutical company isn't covered for underlying accusations that it was a middleman in a self-dealing scheme orchestrated by its now-deceased board chairman, a New Jersey state appeals court ruled Tuesday, reversing a decision that a capacity exclusion in the company's directors and officers policy didn't apply.
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July 09, 2024
Purdue Plans 'High-Speed' Bid For New Ch. 11 Plan
Purdue Pharma told a New York bankruptcy judge Tuesday that it plans a two-month "high-speed, high-stakes" attempt to replace the Chapter 11 plan shot down by the U.S. Supreme Court last month before unleashing litigation on its former owning family.
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July 09, 2024
NJ Jury Begins Deliberating COVID Test Kit Fraud Case
Jurors began deliberating Tuesday in the retrial of a securities fraud case that ended with a dramatic mistrial after a juror announced in open court last December that he disagreed with the guilty verdict that had just been delivered by the jury forewoman.
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July 09, 2024
Terrorism Victims Push To Keep Pharma Suit In DC Circ.
Terrorism victims warned the D.C. Circuit against sending to a lower court a lawsuit seeking to link pharmaceutical companies to the attacks that injured them, saying a remand could delay the case and frustrate their efforts to collect evidence.
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July 09, 2024
FTC Says Drug Middlemen Inflate Costs, Squeeze Pharmacies
The Federal Trade Commission said Tuesday that its study of pharmacy benefit managers has shown that six large companies now control 95% of all prescriptions filled in the U.S., allowing them to profit at the expense of patients and independent pharmacies.
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July 09, 2024
Gov't Missed Merck Vax Potency Problem, 3rd Circ. Told
Two whistleblowers claiming that Merck & Co. had exaggerated the potency of its mumps vaccine told a Third Circuit panel Tuesday that the U.S. Centers for Disease Control and Prevention's continued purchasing of the vaccine was not proof that the agency knew but didn't care about the alleged deception.
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July 08, 2024
Emergent, J&J Reach $50M Deal In COVID Vax Supply Fight
Johnson & Johnson has agreed to pay Emergent BioSolutions $50 million to resolve claims stemming from a now-terminated COVID-19 vaccine manufacturing deal, according to a disclosure filed with the U.S. Securities and Exchange Commission on Monday.
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July 08, 2024
Biotech Slaps Intellia With IP Suit Over $100M Regeneron Deal
Biotechnology company BlueAllele Corp. sued Intellia Therapeutics Inc. in Delaware federal court Monday, claiming the rival has infringed on three of its patents related to gene editing and using its invented technology to reap over $100 million under a deal with another biotech, Regeneron Pharmaceuticals Inc.
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July 08, 2024
Jurors Told To Decide Who Is Lying In COVID Test Fraud Case
The task for jurors in the retrial of a securities fraud case over a COVID test kit deal that never materialized will be to determine not whether lies were told but who told them, according to closing arguments delivered Monday in New Jersey federal court.
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July 08, 2024
Blank Check Co. Sagaliam Gets Shareholder Suit Trimmed
A Delaware federal judge on Monday trimmed a shareholder suit brought against blank check company Sagaliam Acquisition Corp. over its planned tie-up with biotech company Enzolytics Inc., saying the plaintiffs failed to adequately plead a breach of fiduciary duty claim.
Expert Analysis
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A Vision For Economic Clerkships In The Legal System
As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.
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Regulating Resurrected Species Under The ESA
As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.
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E-Discovery Quarterly: Recent Rulings On Text Message Data
Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.
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What CRA Deadline Means For Biden Admin. Rulemaking
With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.
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5 Takeaways From FDA's Biosimilars Promotion Guidance
New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.
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Dual-Track IPO-M&A Exit Strategies For Life Science Cos.
A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.
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Does Expert Testimony Aid Preliminary IPR Responses?
Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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Rebuttal
Double-Patenting Ruling Shows Terminal Disclaimers' Value
While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.
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Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.