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Life Sciences
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July 18, 2024
Ocugen Execs Hit With Derivative Suit Over Shoddy Controls
The top brass at biopharmaceutical company Ocugen Inc. were hit with a derivative suit alleging the company's lack of effective internal financial controls caused it to be misvalued and allowed shareholders to approve proposals based on incomplete information.
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July 18, 2024
GSK, Boehringer Face Jurors Again On Zantac Cancer Claims
GlaxoSmithKline and Boehringer Ingelheim returned to Illinois state court Thursday, where they face separate juries to defend against Zantac users' claims that the drug caused them to develop cancer.
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July 18, 2024
Docs Get Same Hefty Opioid Sentences Despite Top Court Win
Two Alabama doctors accused of unlawfully prescribing patients fentanyl and other opioids failed to shave time off their lengthy prison sentences despite a landmark U.S. Supreme Court decision that raised the bar for such prosecutions.
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July 18, 2024
Pharma Biz Buys Animal Medicine Co. For Up To $520M
Latham & Watkins LLP-advised animal health therapeutics company Invetx, which is currently owned by life sciences-focused investment management firm Novo Holdings, on Thursday announced plans to be bought by veterinary pharmaceuticals company Dechra Pharmaceuticals Ltd., advised by Kirkland & Ellis LLP, for up to $520 million.
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July 18, 2024
Ga. Mineral Co. Can't Nab Win In Row Over Talc Suit Coverage
A Georgia federal judge declined to grant a win to a mineral products company trying to compel a Travelers unit to defend it against an underlying suit claiming that it supplied asbestos-containing talc products.
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July 18, 2024
PharMerica Inks $100M Deal In 13-Year-Old Whistleblower Suit
PharMerica Corp. has agreed to pay $100 million to settle a former New Jersey nursing home owner's long-running whistleblower litigation over an alleged drug kickback scheme, according to the plaintiff's law firm.
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July 17, 2024
ITC Affirms Lab Equipment Co.'s Patent Wasn't Infringed
The U.S. International Trade Commission has upheld an administrative law judge's finding that a California biotechnology outfit did not infringe a German laboratory equipment supplier's patent.
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July 17, 2024
Many AI Patent Eligibility Issues Still Hazy After Guidance
The U.S. Patent and Trademark Office's new guidance on patent eligibility for inventions involving artificial intelligence provides some helpful details for patent applicants, but attorneys say it leaves unanswered questions that will likely require court decisions or legislation to sort out.
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July 17, 2024
Pharma Co. Slams Magistrate's Venue Report In Opioid Suit
A pharmaceuticals distributor is objecting to an Oklahoma federal magistrate judge's recent recommendation to deny as moot the company's bid to dismiss a Cherokee Nation suit accusing it of flooding tribal communities with opioids, saying the case shouldn't be sent to state court.
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July 17, 2024
Chancery Again Spikes Biopharm Board Pay Deal, $600K Fee
A Delaware vice chancellor on Wednesday rejected a second attempt by California-based Iovance Biotherapeutics Inc.'s board to settle a derivative suit challenging allegedly excessive compensation for non-employee directors, citing in part a seeming "end-run" around earlier proposed reforms.
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July 17, 2024
Hospital Trims Its Insulin Pen Claims Against Novo Nordisk
A Connecticut hospital and Novo Nordisk Inc. have agreed to dismiss several of the pharmaceutical giant's corporate entities from a suit seeking to make the company pay for the hospital's $1 million settlement from an underlying patient class action over allegedly defective insulin pens the firm made.
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July 17, 2024
Ex-Genentech Worker Seeks Revival Of 401(k) Investment Suit
A former Genentech employee asked the Ninth Circuit to reopen his proposed class action alleging the biotechnology company kept unwise investment options in its 401(k) plan for years, arguing a trial court applied an erroneously high standard when it tossed the claim.
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July 17, 2024
Boehringer Wants Inhaler Antitrust Case Moved To Mass.
Boehringer Ingelheim Pharmaceuticals Inc. has urged a Connecticut federal court to transfer a proposed class action accusing it of blocking generic versions of two inhaler medications, saying a similar case was filed in Massachusetts several weeks earlier.
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July 17, 2024
Bruised SPAC Market Pins Revival Hopes On Veteran Backers
More special-purpose acquisition companies are conducting initial public offerings, mostly backed by dealmakers who have completed prior mergers, bringing life to a listings market that was largely barren over the past year.
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July 17, 2024
ADA Can't Shield Worker From Failed Drug Test, Co. Says
A chemical transportation company urged a South Carolina federal court to toss a former lift operator's lawsuit alleging he was fired for taking legal CBD because of cysts on his brain and spinal cord, arguing disability law doesn't protect workers from positive drug tests for THC.
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July 16, 2024
Gilead Asks Calif. Supreme Court To Ax 'Disastrous' Decision
Gilead Sciences on Monday urged the California Supreme Court to overturn an appellate panel's decision that the company can't ditch claims it held back a safer HIV drug to maximize profits on an older medication, saying that holding manufacturers liable for non-defective products would "yield disastrous policy consequences."
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July 16, 2024
UPC Knocks Out Amgen's Cholesterol Drug Patent
The Unified Patent Court on Tuesday ruled that Amgen's patent covering the cholesterol drug Repatha isn't valid in the European Union, less than a year after justices on the U.S. Supreme Court made a somewhat similar call on U.S. patents covering the same drug.
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July 16, 2024
Chancery Orders Illumina Docs Released In Grail Merger Fight
Benefit fund shareholders of biotech giant Illumina Inc. won a Delaware Court of Chancery order on Tuesday for a rare, limited release of legal advice documents on Illumina's merger agreement with cancer-testing firm Grail Inc., a deal that has cost the company billions in fines and lost value.
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July 16, 2024
Tycoon's Pilot Says Feds' Stock Tip Claims Don't Add Up
A private pilot who used to work for convicted insider trader and U.K. billionaire Joe Lewis is arguing federal prosecutors can't use allegations that his own trades were suspicious to ramp up a sentence for a separate tax evasion charge.
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July 16, 2024
FDA Vet Joins Arnold & Porter As Counsel On Healthcare
After nearly a decade in high-level roles at the U.S. Food and Drug Administration, regulatory pro Andrew Zacher has joined the life sciences and healthcare team at Arnold & Porter.
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July 16, 2024
Drugmaker BioLineRx Beats Investor Suit Over Cash Shortfall
Israeli biotech company BioLineRx has, for now, beaten a proposed class action over claims that it misled investors on its capital shortfall, which caused a major decline in its share price, with a New Jersey federal judge saying the plaintiffs have failed to plead any actionable misleading or false statements.
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July 16, 2024
3rd Circ. Backs Tossing Over 1K Suits In Merck Vaccine MDL
The Third Circuit on Tuesday affirmed the dismissal with prejudice of 1,189 cases in multidistrict litigation alleging Merck & Co. Inc.'s shingles vaccine, Zostavax, caused the disease, saying the district court did not abuse its discretion by requiring medical tests to support the claims.
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July 16, 2024
Manatt Adds Healthcare Transactions Partner From McDermott
Manatt Phelps & Phillips LLP has added a new healthcare partner to its Boston office.
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July 16, 2024
Heart-Focused Biotech Closes $260M Series B Funding Round
Clinical-stage biotechnology company Cardurion Pharmaceuticals Inc. on Tuesday announced that it has raised $260 million in Series B financing that will go toward helping the Burlington, Massachusetts-based company continue developing therapies for the treatment of cardiovascular diseases.
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July 16, 2024
Ex-CBD Exec Gets $533K In Fla. Investment Fraud Suit
A Florida federal judge has awarded $533,600 to a former executive of a CBD company who alleged he was duped by his family members into investing, following a jury trial that ended with a mixed verdict.
Expert Analysis
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.
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Texas Ethics Opinion Flags Hazards Of Unauthorized Practice
The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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2 Options For Sackler Family After High Court Purdue Ruling
After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.
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Fed. Circ. Skinny Label Ruling Guides On Infringement Claims
The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.
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4 Takeaways From Biotech Patent Invalidity Ruling
The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.
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How To Clean Up Your Generative AI-Produced Legal Drafts
As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.
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Calif. Ruling Heightens Medical Product Maker Liability
The California Supreme Court's decision in Himes v. Somatics last month articulates a new causation standard for medical product manufacturer liability that may lead to stronger product disclosures nationwide and greater friction between manufacturers and physicians, say attorneys at Cooley.
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Constitutional Protections For Cannabis Companies Are Hazy
Cannabis businesses are subject to federal enforcement and tax, but often without the benefit of constitutional protections — and the entanglement of state and federal law and conflicting judicial opinions are creating confusion in the space, says Amber Lengacher at Purple Circle.
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USPTO Disclaimer Rule Would Complicate Patent Prosecution
The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.