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Life Sciences
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June 12, 2024
SPAC Dealmakers Expect Modest Pickup After Market Bottom
Market professionals expect a slow pickup in deals involving special-purpose acquisition companies starting in the second half of 2024, predicting on Wednesday that a leaner market will emerge following the recent crash and imposition of tighter regulations.
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June 12, 2024
Directors Of Defunct Med Tech SPAC Seek Toss Of Del. Suit
Directors of a special purpose acquisition company that merged with now-defunct medical technology company Better Therapeutics Inc. urged Delaware's Court of Chancery on Wednesday to toss a shareholder's suit about the $15 million de-SPAC merger, saying it wasn't like other problematic SPAC deals.
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June 12, 2024
Forte Biosciences Reaches $2M Deal To End Chancery Suit
Clinical-stage biopharmaceutical company Forte Biosciences has reached a multipart, $2 million concession-plus-cash settlement in Delaware's Court of Chancery with a private investment fund that ran a board proxy contest after its calls to liquidate the business were met with poison pill pushback.
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June 12, 2024
'Natural' Toothpaste Brand Loaded With PFAS, Moms Say
Natural toothpaste company RiseWell LLC falsely advertised its kids toothpaste as "natural" and "safe to swallow," two mothers alleged Tuesday in a proposed class action, saying a U.S. Department of Defense-certified laboratory test found 750 times more "forever chemicals" in the toothpaste than researchers found in heavily tainted kale.
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June 12, 2024
32 AGs Urge Justices Take Up Okla. PBM Law Fight
Thirty-two attorneys general urged the U.S. Supreme Court to take up Oklahoma's petition for review of a Tenth Circuit decision holding that federal law preempted portions of a state law regulating pharmacy benefit managers, arguing the justices needed to intervene to resolve a circuit split.
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June 11, 2024
Martin Shkreli Told To Hand Over Wu-Tang Album
A New York federal judge ordered Martin Shkreli on Tuesday to hand over any copies he might have of the Wu-Tang Clan's album he once bought before it was sold off by the federal government to settle a $7.3 million tab from Shkreli's criminal judgment on securities fraud.
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June 11, 2024
Pharmacy Co. Optio Gets Interim OK For $10M DIP Package
Illinois-based specialty pharmacy chain Optio received interim approval at a first-day hearing Tuesday in Delaware bankruptcy court to access a $10 million in new money debtor-in-possession financing to fund its Chapter 11.
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June 11, 2024
Fed. Circ. Reinstates Parts Of Blood Analyzer Secrets Verdict
The Federal Circuit decided Tuesday that a Rhode Island jury was right to find that an Italian company's blood analyzer computer code was stolen by a U.S. rival, but another jury will have to determine any damages.
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June 11, 2024
9th Circ. Judge On Theranos Appeal: 'Good Story' For Holmes
Two Ninth Circuit judges on a three-judge panel expressed concerns Tuesday that the district judge presiding over convicted former Theranos CEO Elizabeth Holmes' criminal trial erred by allowing a layperson witness to offer expert testimony at trial, with one judge saying, "There's a pretty good story here for Ms. Holmes."
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June 11, 2024
AI No Scarier Than Nail Guns Or Microscopes, Kappos Says
Former U.S. Patent and Trademark Office Director David Kappos cautioned attorneys Tuesday to "keep ourselves grounded" about the use of artificial intelligence in intellectual property, saying it's just a tool like a microscope or nail gun, rather than something justifying "panic."
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June 11, 2024
NJ Supreme Court Rejects Bid For Roundup Mass Tort
The New Jersey Supreme Court has rejected a request for litigation against Monsanto Co. and Bayer AG to be designated as multicounty litigation because there are too few cases, according to a notice to the bar published Monday.
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June 11, 2024
Slow IPO Recovery Expected To Accelerate In 2025
More companies are preparing initial public offerings even as the pace of new listings has been slower than anticipated, experts said Tuesday, signaling that an IPO recovery is likely to accelerate next year after investors sort out November election results.
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June 11, 2024
10 Firms Seek $13M Fee For Effexor Antitrust Deal
Ten law firms asked a New Jersey federal judge on Monday to award $13 million in counsel fees and an additional $2.1 million in costs for representing direct buyers in a $39 million settlement with Pfizer Inc. unit Wyeth over an alleged scheme to delay generic competition for the antidepressant drug Effexor XR.
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June 11, 2024
WilmerHale Lands Latham Atty To Help Lead Life Sciences
WilmerHale has added a partner in Palo Alto, California, who is an expert in complex strategic collaboration and licensing transactions, to co-chair its life sciences practice group, the firm said Tuesday.
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June 11, 2024
FDA Urges 11th Circ. To Back E-Cig Ban Over High Nicotine
The U.S. Food and Drug Administration is urging the Eleventh Circuit to not let Bidi Vapor market an e-cigarette product that the agency claimed would expose users to nearly twice as much nicotine as a typical combustible cigarette.
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June 10, 2024
5 Teva Inhaler Patents Kicked Out Of Orange Book
A New Jersey federal judge said Monday that a handful of patents covering Teva-brand asthma inhalers were "improperly listed in the Orange Book," a legal holding that U.S. Federal Trade Commission Chair Lina Khan quickly took some credit for.
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June 10, 2024
Bankrupt UpHealth Warned Of Criminal Charges In India
A court in India said it has received a criminal charge sheet issued by an investigative governmental agency in Calcutta against bankrupt American healthcare company UpHealth, targeting it and executives over accusations that they conspired to defraud a local healthcare system.
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June 10, 2024
DOJ, FDA Form Task Force To Crack Down On Illegal E-Cigs
The U.S. Department of Justice and the U.S. Food and Drug Administration on Monday said that a federal multi-agency task force has been founded to stop illegal sales of e-cigarettes.
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June 10, 2024
Baltimore Lands $45M Deal With Allergan In Opioid Litigation
Baltimore has put to rest its claims that Allergan played a part in the opioid crisis, reaching a $45 million settlement with the pharmaceutical company, an amount the city called "unprecedented" in an announcement on Monday.
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June 10, 2024
9th Circ. Says Choctaw's Dispute With CVS Must Be Arbitrated
A Ninth Circuit panel forced the Choctaw Nation to arbitrate a dispute over prescription drug reimbursement with CVS Health Corp. subsidiaries, affirming an Arizona federal judge's order in a published opinion Monday.
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June 10, 2024
Colo. Justices Say Toxic Tort Plaintiffs Didn't Waive Privilege
Colorado's justices on Monday said plaintiffs suing a medical sterilization plant over exposure to a carcinogen cannot be forced to turn over communications with their lawyers related to an expert report, rejecting the plant's argument that the disclosure of a spreadsheet to an expert waived attorney-client privilege.
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June 10, 2024
Drugmakers Look To Nix Non-Insulin Claims From AG Suit
Novo Nordisk, Eli Lilly and Sanofi-Aventis asked the federal judge overseeing a diabetes drug price-fixing multidistrict litigation to rule for drugmakers on Mississippi's claims the pricing for GLP-1s is illegal, saying in a brief that the drugs are under patent and too new to be included in the insulin-pricing suit.
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June 10, 2024
Parexel Says Staffing Firm Liable For Temp's Alleged Fraud
Clinical research company Parexel International says a Boston-based staffing agency is liable for damages caused by a rogue temporary employee who engaged in "egregious fraud" involving multiple drug trials, according to a complaint filed in Massachusetts state court.
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June 10, 2024
Juul Ends FOIA Suit Over FDA E-Cig Decisions
Vaping company Juul Labs Inc. has agreed to drop its Freedom of Information Act lawsuit against the U.S. Food and Drug Administration that sought to obtain documents related to the agency's order requiring its e-cigarettes to be pulled off the market.
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June 10, 2024
9th Circ. To Hear Args In Psilocybin Right-To-Try Case
A Ninth Circuit panel will hear oral arguments in August in an appeal brought by a Seattle doctor seeking to administer psilocybin to terminal cancer patients under state and federal right-to-try laws.
Expert Analysis
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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.
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
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Why High Court May Have Rejected IP Obviousness Appeal
Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.
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Microplastics At The Crossroads Of Regulation And Litigation
Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.
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The Fed. Circ. In April: Hurdles Remain For Generics
The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Tylenol MDL Highlights Expert Admissibility Headaches
A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.