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Life Sciences
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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.
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August 05, 2024
CooperSurgical Says Lab Hid Flawed IVF Product Tests
Fertility technology company CooperSurgical Inc. has accused a Massachusetts testing lab of failing to follow proper procedures and misrepresenting the results of quality assurance testing on a product used in the in vitro fertilization process, leading to a recall.
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August 05, 2024
Freshfields, Wachtell Guide $925M CVC, Mallinckrodt Deal
Dublin-based pharmaceutical company Mallinckrodt has inked a deal to sell its immunotherapy business Therakos to Luxembourg-based private equity firm CVC Capital Partners for $925 million, Mallinckrodt said in a Monday statement.
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August 05, 2024
Rising Star: Ropes & Gray's Tara Fisher
Tara M. Fisher of Ropes & Gray LLP advised cancer drugmaker ImmunoGen Inc. as it navigated a bidding war that culminated in its sale to pharmaceutical giant AbbVie in a $10.1 billion transaction, earning her a spot among the life sciences law practitioners under age 40 honored by Law360 as Rising Stars.
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August 02, 2024
Health Tech Co. Beats Investor Data Platform Fraud Claim
A healthcare technology company has escaped an investor suit challenging the existence of a data platform it touted, as a Connecticut federal judge found a former employee's assertions at the center of the proposed class action weren't enough to show the company knowingly misled investors about the offering.
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August 02, 2024
Ex-Exec Can't Escape Drug Co.'s Trade Secret Suit
The North Carolina Business Court refused to give a win before trial to the former president of a United Therapeutics Corp. subsidiary on a claim that he took trade secrets to a rival, with the court reasoning the drug company took reasonable steps to protect the secrets beyond a three-year limit in his employment agreement.
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August 02, 2024
Wheeling & Appealing: The Latest Must-Know Appellate Action
In this inaugural edition of Wheeling & Appealing, Law360 recaps recent appellate opinions that made waves, quizzes readers about a new word for judicial grievances, and previews August arguments in circuit courts over controversial wage rules and a seven-figure attorney fee award after a digital age intellectual property trial.
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August 02, 2024
US Cannabis Policy Thwarts Research, Health Officials Say
A recent report from federal health regulators confirms what cannabis reform advocates have long said, that placing marijuana in the most restrictive tier under the federal Controlled Substances Act has hindered researchers' ability to study the drug's potential benefits and risks.
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August 02, 2024
McKinsey's $78M Opioid Deal With Health Plans Gets OK
A California federal judge said Friday he'll approve McKinsey & Co. Inc.'s $78 million deal to resolve claims on behalf of approximately 42,000 third-party payors, with class counsel receiving $15.1 million in fees, after the initial settlement was tweaked due to objections from some plaintiffs' attorneys.
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August 02, 2024
Patients Ink $1M Deal To Settle Pharmacy Data-Breach Claims
A home-delivery pharmacy service struck by a data breach in 2021 has agreed to pay $1 million to settle a class action brought by plaintiffs whose personal information was compromised, according to a Friday filing.
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August 02, 2024
3rd Circ. Backs Ex-NJ Firefighter's $50M Drug Fraud Sentence
The Third Circuit backed the eight-year prison sentence handed to a former New Jersey firefighter convicted for his role in a $50 million healthcare fraud scheme, rejecting his argument he was wrongly punished for taking his case to trial.
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August 02, 2024
PTAB Told To Punish Mylan For Allegedly Breaking Fintiv Vow
Novo Nordisk is urging the Patent Trial and Appeal Board to sanction Mylan for pursuing claims to invalidate a patent covering the blockbuster diabetes and weight loss drug Ozempic in Delaware district court, despite an explicit promise not to do so.
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August 02, 2024
Four Plaintiffs Tossed From Merck Gardasil Vaccine MDL
A North Carolina federal judge has thrown out claims from four patients in multidistrict litigation alleging they suffered injuries as a result of taking Merck's Gardasil HPV vaccine, saying three of them didn't file a petition with the federal vaccine injury program on time, while the fourth never filed his petition at all.
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August 02, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen insurance broker Marsh sue the collapsed Greensill Bank, the former chair of the Islamic Students Association of Britain pursue a defamation case against the Jewish Chronicle, Berkshire Hathaway and Lloyd's face action from a shipping company, and alleged fraudster Ronald Bauer hit a loan company with a claim. Here, Law360 looks at these and other new claims in the U.K.
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August 01, 2024
Male Sex Drug Labeled As 'Natural' Contains Viagra, Suit Says
Sellers of the male enhancement drug Ryder XL, purportedly made with natural herbal ingredients, are facing a proposed class action in New Jersey federal court that accuses them of "dosing" consumers with large amounts of Viagra and Cialis without a prescription of physician oversight.
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August 01, 2024
Calif. Jury Clears Bayer In Flea And Tick Med Antitrust Suit
A California federal jury on Thursday cleared Bayer of allegations that it owes millions for cutting anticompetitive deals with pet product retailers to undermine competition from generics makers of flea and tick treatments for dogs.
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August 01, 2024
Latham, Ellenoff Rank Among Top Firms For July IPOs
Latham & Watkins LLP and Ellenoff Grossman Schole LLP were among the leading law firms that steered the most initial public offerings during July, which marked the year's busiest month in terms of IPO proceeds.
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August 01, 2024
AliveCor Asks 9th Circ. To Revive Apple Watch Antitrust Case
Medical monitoring startup AliveCor Inc. told the Ninth Circuit that Apple Inc. should not be immunized from antitrust claims over the removal of access to heart rate data on the Apple Watch because the change was intended to block competition and not improve the device.
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August 01, 2024
Chancery Denies Ex-InterMune CEO $6M Legal Fee Right
Delaware's Chancery Court rejected on Thursday a bid by former InterMune CEO W. Scott Harkonen to escape demands to repay nearly $6 million in legal fees covered by biotech venture InterMune Inc. and insurers during his unsuccessful defense against a 2009 wire fraud conviction, denying all claims for legal fee indemnification.
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August 01, 2024
JPML Won't Form MDL Of 35 Acne Product Benzene Suits
The Judicial Panel on Multidistrict Litigation on Thursday declined to consolidate 35 suits alleging Johnson & Johnson Consumer Inc., CVS Pharmacy Inc., Target Corp. and others sold acne products that could break down into the carcinogen benzene, saying they don't have enough in common to warrant an MDL.
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August 01, 2024
Former Stimlabs Exec Doesn't Have To Hand Over Devices
A Georgia federal judge on Thursday blocked a biomedical technology company's bid to seize the digital devices of a former executive accused of downloading thousands of internal files containing sensitive product information in the days and weeks leading up to her ouster from the company this year.
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August 01, 2024
Novo Nordisk Loses Challenge To Medicare Drug Price Talks
Another challenge to a Medicare drug price negotiation program has failed after a New Jersey federal judge ruled once again that the program is voluntary and rejected claims that it violates the constitutional rights of pharmaceutical giant Novo Nordisk.
Expert Analysis
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Series
Teaching Yoga Makes Me A Better Lawyer
Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.
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How Clinical Trials Affect Patentability In US And Europe
A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.
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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.