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Life Sciences
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June 26, 2024
House GOP Gears Up For The End Of Chevron Deference
A new memo outlines how House Republicans are gearing up for the U.S. Supreme Court to potentially overturn the decades-old precedent that courts defer to agencies' interpretations of ambiguous statutes, as an opportunity to roll back the Biden administration's policies and reclaim Congress' power.
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June 26, 2024
Squire Patton Adds Epstein Becker Healthcare Atty In DC
An experienced healthcare and life sciences industries attorney has jumped from Epstein Becker Green PC to Squire Patton Boggs LLP in Washington, D.C., the latter firm has announced.
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June 26, 2024
Pharma Co. PhaseBio Can Exit Ch. 11 With Wind-Down Plan
A Delaware bankruptcy judge on Wednesday gave her blessing for pharmaceutical developer PhaseBio Pharmaceuticals Inc. to liquidate its assets and wind down after settlement agreements with creditors and a business partner cleared a path for it to exit Chapter 11 after roughly 19 months.
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June 26, 2024
High Court 'Inadvertently' Posts Order Punting Abortion Case
The U.S. Supreme Court mistakenly released a draft order Wednesday that would allow emergency abortions in Idaho, with a majority saying the court was wrong to consider a state challenge at this time.
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June 26, 2024
High Court Axes Challenge To Biden Admin's Social Media Work
The U.S. Supreme Court wiped out a Fifth Circuit order prohibiting the Biden administration and several federal agencies from working with social media platforms to combat the spread of misinformation Wednesday, finding the states and individuals challenging the collaboration don't have standing to sue.
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June 25, 2024
Riley Safer Expands IP Practice With Chicago Partner
Chicago firm Riley Safer Holmes & Cancila LLP has bolstered its intellectual property practice by bringing on board an experienced litigator from Goldman Ismail Tomaselli Brennan & Baum, the law firm announced Tuesday.
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June 25, 2024
PTAB Wipes Out UMass Skin Disease Treatment Patent
The Patent Trial and Appeal Board has sided with Forte Biosciences in invalidating a University of Massachusetts patent on treating the skin disease vitiligo, ruling that the patent does not adequately describe the invention or enable a skilled person to make and use it.
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June 25, 2024
Fed. Circ. Restores Amarin's Skinny Label Suit Against Hikma
The Federal Circuit revived litigation Tuesday accusing Hikma Pharmaceuticals USA Inc. of inducing physicians to infringe patents covering Amarin Pharma Inc.'s blockbuster cardiovascular drug Vascepa in a case over limited-use generics.
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June 25, 2024
Sarissa Capital, Founder Settle Bioverativ Suit In Del. For $40M
Remaining parties in a Delaware Court of Chancery class action over the $11.6 billion sale of biotech venture Bioverativ Inc. to Sanofi Inc. in 2018 have agreed to settle their outstanding claims for $40 million in cash, according to a stipulation filed with the court Tuesday.
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June 25, 2024
Indiana U Settles Ricin-Carrying Fruit Fly Export Violations
Indiana University has escaped fines, but it must instead educate the broader academic community at large on export controls under a settlement with the U.S. Department of Commerce after the institution sent unlicensed shipments overseas, of fruit flies carrying a subunit of ricin.
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June 25, 2024
Plaintiffs Firms Appealing $2.1B Fee Order In Opioid Case
Motley Rice LLC, Weisman Kennedy & Berris Co. LPA, Stranch Jennings & Garvey PLLC, Crueger Dickinson LLP, Goldstein & Russell PC, Kelley & Ferraro LLP, Spangenberg Shibley & Liber LLP and Meyers & Flowers LLC are appealing $2.13 billion in attorney fees stemming from opioid settlements awarded earlier this month.
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June 25, 2024
Chancery OKs $71M Premier Deal, $14M Four-Firm Fee
Shareholder attorneys led by Friedlander & Gorris who negotiated a $71 million settlement to end derivative Delaware Chancery Court litigation with healthcare-purchasing giant Premier Inc. will get $14 million for their efforts, the total fee award they sought.
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June 25, 2024
UK Billionaire's Pilot Avoids Prison For Insider Trading
A Manhattan federal judge sentenced a former private jet pilot to house arrest Tuesday for insider trading on stock tips from his billionaire boss Joe Lewis, finding that a prison term would be unfair in comparison to Lewis' non-incarceratory sentence.
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June 25, 2024
Lye Buyers Can't Get Court OK For $38.5M Antitrust Deals
A federal judge in Buffalo has rejected three settlements totaling $38.5 million for a proposed class of lye purchasers who alleged producers of the chemical colluded to inflate prices, ruling exceptions to who qualifies for the class make it impossible to determine membership.
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June 25, 2024
Litigation Pro Rejoins GRSM50 In Calif. From DeHay & Elliston
Gordon Rees Scully Mansukhani LLP has strengthened its litigation bench with a partner in Walnut Creek, California, who arrived from DeHay & Elliston LLP and who worked for six years earlier in his career as a senior counsel for GRSM50.
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June 24, 2024
Alleged Contract Killing Sparks Delaware Chancery Lawsuit
Los Angeles biotech firm Renovaro Inc. has sued a former, purported scientific adviser and his husband in Delaware's Court of Chancery for damages tied to an assortment of fraudulent schemes allegedly shielded in part by a contract killing linked to a separate alleged international oil trading scam.
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June 24, 2024
Judge Mulls BioXcel's Duty To Tell Investors Of FDA Troubles
A Connecticut federal judge wondered Monday if executives at the artificial intelligence-driven drugmaker BioXcel Therapeutics Inc. had an opportunity to correct problems that government regulators identified with a key clinical trial and, if so, whether their statements on the subject to investors could be considered false or misleading.
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June 24, 2024
NYC Pharmacy Owners Get Jail Time For $18M Med Fraud
Two brothers who own several New York pharmacies will each have to pay over $18 million in restitution in addition to serving jail time for submitting fraudulent claims to Medicare for pricey cancer medication and funneling illicit proceeds through several shell companies, the U.S. Department of Justice announced Monday.
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June 24, 2024
Justices Undo Terror Victims' Win, Citing Twitter Decision
The U.S. Supreme Court on Monday swept aside a D.C. Circuit ruling that threatened to expose major pharmaceutical companies to liability for terrorist attacks that injured or killed hundreds of U.S. soldiers and civilians in Iraq.
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June 24, 2024
LA Schools Says Pseudoscience Infected 9th Circ. Vax Ruling
The Los Angeles Unified School District said Friday that a split Ninth Circuit panel leaned on pseudoscience when ruling that a rescinded employee COVID-19 vaccination mandate implicated the right of district employees to refuse medical treatment, urging an en banc panel to correct the "fatally flawed" decision.
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June 24, 2024
Ark. AG Sues Pharmacy Benefit Managers Over Opioids
The Arkansas attorney general said Monday that he had sued pharmacy benefit managers Optum Inc. and Express Scripts Inc. in state court, claiming they contributed to the opioid crisis and profited from the drug epidemic.
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June 24, 2024
Suit Over Medical Screws Filed Too Late, Texas Panel Finds
A Texas appeals court won't revive a woman's suit against BioPro Inc. alleging that surgical screws used in her feet were defective, saying the evidence establishes that she filed her suit after the two-year statute of limitations had expired.
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June 24, 2024
Jurisdictional Discovery Ordered In NJ COVID Test Fraud Suit
A New Jersey federal court has denied without prejudice a dismissal bid and ordered "tightly-targeted and prompt jurisdictional discovery" in a Garden State medical supply business' complaint accusing a Texas attorney and his solo practice of aiding in an alleged $2.45 million fraud scheme involving COVID-19 test kits that were never delivered.
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June 24, 2024
Catching Up With Delaware's Chancery Court
Amendments to Delaware's General Corporation Law topped the news out of the Court of Chancery again last week, as the hotly contested measure sailed through the state's legislature. Tesla and its shareholders continued their tug-of-war over attorney fees for Chancery litigation about Elon Musk's pay package, and new cases were filed involving biotechs, car rental companies, workout platforms, telecom towers, and a cargo ship fire in Brazil.
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June 24, 2024
Justices Pass On Conn. School Vaccine Mandate Fight
The U.S. Supreme Court on Monday declined to review a Second Circuit decision that largely upheld the dismissal of a suit challenging a Connecticut law passed during the COVID-19 pandemic that revoked religious exemptions to student vaccine mandates.
Expert Analysis
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Opinion
Biden Admin's March-In Plan Would Hurt Medical Innovation
The Biden administration's proposal to reinterpret the Bayh-Dole Act and allow the government to claw back patents when it determines that a commercialized product's price is too high would discourage private investment in important research and development, says Ken Thorpe at the Rollins School of Public Health.
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A Post-Mortem Analysis Of Stroock's Demise
After the dissolution of 147-year-old firm Stroock late last year shook up the legal world, a post-mortem analysis of the data reveals a long list of warning signs preceding the firm’s collapse — and provides some insight into how other firms might avoid the same disastrous fate, says Craig Savitzky at Leopard Solutions.
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What's On The Horizon In Attorney General Enforcement
A look at recent attorney general actions, especially in the areas of antitrust and artificial intelligence, can help inform businesses on what they should expect in terms of enforcement trends as 10 attorney general races play out in 2024, say attorneys at Cozen O'Connor.
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Preparing For DOJ's Data Analytics Push In FCPA Cases
After the U.S. Department of Justice’s recent announcement that it will leverage data analytics in Foreign Corrupt Practice Act investigations and prosecutions, companies will need to develop a compliance strategy that likewise implements data analytics to get ahead of enforcement risks, say attorneys at Cozen O'Connor.
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Reducing The Risk Of PFAS False Advertising Class Actions
A wave of class actions continues to pummel products that allegedly contain per- or polyfluoroalkyl substances, with plaintiffs challenging advertising that they say misleads consumers by implying an absence of PFAS — but there are steps companies can take to minimize risk, say attorneys at Keller and Heckman.
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Series
Coaching High School Wrestling Makes Me A Better Lawyer
Coaching my son’s high school wrestling team has been great fun, but it’s also demonstrated how a legal career can benefit from certain experiences, such as embracing the unknown, studying the rules and engaging with new people, says Richard Davis at Maynard Nexsen.
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Opinion
New Rule 702 Helps Judges Keep Bad Science Out Of Court
A court's recent decision to exclude dubious testimony from the plaintiffs' experts in multidistrict litigation over acetaminophen highlights the responsibility that judges have to keep questionable scientific evidence out of courtrooms, particularly under recent amendments to Federal Rule of Evidence 702, says Sherman Joyce at the American Tort Reform Association.
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SG's Office Is Case Study To Help Close Legal Gender Gap
As women continue to be underrepresented in the upper echelons of the legal profession, law firms could learn from the example set by the Office of the Solicitor General, where culture and workplace policies have helped foster greater gender equality, say attorneys at Ocean Tomo.
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Opinion
Patent Waiver For COVID Meds Would Harm US Biopharma
If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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10 Lessons From A Deep Dive Into IP Damages
Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.
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What Shareholder Approval Rule Changes Mean For Cos.
The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.
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Reimagining Law Firm Culture To Break The Cycle Of Burnout
While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Expediting Psychedelics Approvals In The EU, UK, Australia
Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
ESG Around The World: Brazil
Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.