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Life Sciences
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April 17, 2024
FDA Denies Marketing For 65 MNGO Disposable E-Cigarettes
The latest action by the U.S. Food and Drug Administration on e-cigarettes was to tell a Chinese company to take its range of 65 e-cigarette products in a variety of flavors from menthol to pink lemonade and watermelon off the market.
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April 17, 2024
FDA Tells Justices It Has A Better Vape Case In Mind
The U.S. Food and Drug Administration has told the U.S. Supreme Court that if it wants to address the agency's decision not to approve applications for flavored e-cigarettes, there is a better case in the pipeline than the appeal lodged by Lotus Vaping Technologies that the justices should choose instead.
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April 17, 2024
SEC Has Careful Eye On Disclosures Amid Israel-Hamas War
Against the backdrop of protracted war, the U.S. securities watchdog is urging U.S.-listed Israeli companies to disclose more details describing how the Israel-Hamas conflict is affecting their operations in order to keep investors apprised of risks, lawyers say.
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April 17, 2024
'Ringleader' Of Black Market HIV Drug Scam Gets 9 Years
A New York federal judge on Wednesday sentenced a pharmacy operator to nine years in prison for spearheading a $13 million scheme to sell black market HIV medication and collect fraudulent reimbursements from Medicaid and Medicare.
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April 17, 2024
Manatt Adds NY Bankruptcy, Financial Regulatory Partners
Manatt Phelps & Phillips LLP announced that it hired a pair of experienced New York-based attorneys who focus their practices on regulatory matters as partners in its bankruptcy and financial regulatory practices.
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April 17, 2024
WashU Medical School Settles Claims Of Asylee Bias, Firing
The Washington University School of Medicine in St. Louis has settled claims that it fired a worker who complained that he was being forced to prove he held asylum, according to the U.S. Department of Justice.
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April 17, 2024
Ex-Pharma Exec's Contempt Plea Rejected By Judge
A Massachusetts federal judge on Wednesday rejected a former pharmaceutical executive's agreement to plead guilty to contempt for using an alias to get around a consent judgment in a U.S. Securities and Exchange Commission fraud case, saying both the former executive and the government knew he'd view the sentence as too low.
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April 17, 2024
Elliott Waives BioMarin Board Deal, Moots Del. Suit
Elliott Investment Management LP has waived an agreement with BioMarin Pharmaceutical Inc. that gave the activist investor three new seats on the biopharmaceutical company's board, mooting a Delaware Chancery Court lawsuit that a BioMarin shareholder filed earlier this month.
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April 16, 2024
House Panel Takes Aim At Change Healthcare, FTC Over Hack
A House subcommittee exploring ways to boost cybersecurity in the healthcare industry on Tuesday blasted Change Healthcare for failing to take appropriate steps to block a damaging cyberattack that echoed another recent strike on critical infrastructure and the Federal Trade Commission for not stopping the provider from controlling such a large market share.
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April 16, 2024
Eli Lilly's Insulin Price Cap Deal Collapses After Cert. Denial
Eli Lilly & Co. and insulin buyers have called off a proposed nationwide settlement that would've capped insulin prices and been worth up to $500 million over several years, a decision that was made after the buyers lost a class certification bid early this year, according to the buyers' counsel.
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April 16, 2024
NC Treasurer Backs FTC On Hospital Merger Challenge
North Carolina's treasurer agreed Monday that Novant Health's $320 million plan to pick up a pair of hospitals is a bad idea, throwing its weight behind the Federal Trade Commission's challenge to the deal in federal court.
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April 16, 2024
IBM Gained Most AI Patents By Far In 2023
IBM obtained more U.S. artificial intelligence patents in 2023 than any other company, with its closest competitors falling behind by more than 300 patents, according to a Harrity Patent Analytics report announced Tuesday.
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April 16, 2024
Life Sciences Group Of The Year: Fenwick
Defending Novo Nordisk's patents for diabetes drug Ozempic and guiding Dice Therapeutics through its $2.4 billion acquisition by Eli Lilly & Co. are among the achievements that put Fenwick & West LLP among Law360's 2023 Life Sciences Groups of the Year.
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April 15, 2024
Taro Inks $36M Investor Deal Over Generics Price-Fixing
Taro Pharmaceutical Industries shareholders asked a New York federal judge Monday to greenlight a $36 million settlement resolving proposed class claims that the company misled investors about alleged generic drug price-fixing that led to a drop in stock price upon news of a U.S. Department of Justice antitrust investigation.
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April 15, 2024
Chancery Denies Forte Biosciences' Bid To Toss Investor Suit
Board members of a struggling clinical-stage biopharmaceutical company who allegedly took defensive measures to stay in power after activist investors pushed the company to liquidate must face a stockholder's Delaware Chancery Court derivative suit that they breached their fiduciary duties to shareholders, a vice chancellor said Monday.
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April 15, 2024
Years After Args, 7th Circ. Continues Mootness Fee Attack
A Seventh Circuit panel said Monday that a Chicago federal judge improperly barred a class action objector from intervening in a suit involving controversial "mootness fees" the appellate court has long criticized, saying he failed to articulate a valid legal reason for doing so.
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April 15, 2024
TTAB Sides With Pharma Co.'s Opposition To 'SageForth' TM
The Trademark Trial and Appeal Board has ruled in favor of biopharmaceutical company Sage Therapeutics Inc.' opposition to a psychological service provider's attempt to register "SageForth" as a trademark, saying the name is likely to cause confusion with Sage Therapeutics' treatments for postpartum depression.
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April 15, 2024
Hold This COVID Vax Patent Case, Judge Recommends
One of the suits over Pfizer's blockbuster COVID-19 vaccine hit a snag in Virginia federal court Friday when a judge recommended pausing the case to wait for a ruling in a related dispute over patent ownership involving one of BioNTech's other partners.
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April 15, 2024
Catching Up With Delaware's Chancery Court
Last week, Delaware justices mulled whether one Chancery Court vice chancellor properly voided four company bylaws — just as another vice chancellor voided one more. Fights among Truth Social investors continued, and shareholders launched new cases involving Macy's, United Airlines, and Clayton Dubilier & Rice LLC and Stone Point Capital LLC.
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April 15, 2024
Orrick Adds Kramer Levin Life Sciences Head In NY
The former head of Kramer Levin Naftalis & Frankel LLP's life sciences practice has jumped to the intellectual property litigation team at Orrick Herrington & Sutcliffe LLP in New York, Orrick said Monday.
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April 15, 2024
Pharmacy, Courier Co. Settle Driver's Classification Suit
A delivery driver and a CVS-owned pharmacy and a logistics and courier firm told an Illinois federal court that they have reached a settlement resolving claims that the company misclassified workers as independent contractors and paid them neither minimum nor overtime premium wages.
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April 15, 2024
Justices Won't Nix FDA Labeling Preemption For State Claims
The Supreme Court on Monday let stand lower court findings that the unique authority of the federal Food and Drug Administration preempted and, therefore, justified dismissing a proposed class action that alleged a Johnson & Johnson subsidiary broke Massachusetts law by misbranding Lactaid drug products as dietary supplements.
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April 15, 2024
Life Sciences Group Of The Year: Cooley
Cooley LLP advised Horizon Therapeutics during its massive sale to Amgen Inc. — defeating an antitrust challenge along the way — and helped Moderna Inc. win a patent case centering on its COVID-19 vaccine, earning the firm a place among Law360's 2023 Life Sciences Groups of the Year.
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April 12, 2024
Moderna, Pfizer COVID Vax IP Suit Paused Amid PTAB Review
A Massachusetts federal judge on Friday agreed to pause Moderna Inc.'s COVID-19 vaccine patent infringement suit against Pfizer Inc. and BioNTech until the Patent Trial and Appeal Board weighs in on a pair of patents, issuing a stay despite objections from Moderna.
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April 12, 2024
Ex-Biotech CEO Gets 7 Years In Fake COVID Test Case
A former biotech CEO accused of defrauding investors by touting a phony rapid finger-prick COVID test was sentenced to seven years in prison in D.C. federal court Friday.
Expert Analysis
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Opinion
J&J Bankruptcy Could Thwart Accountability For Victims
Johnson & Johnson's latest attempt at a "Texas Two-Step" bankruptcy proceeding exemplifies the way in which corporate defendants can use bankruptcy to evade accountability, limit resources available to victims, and impose flawed, one-size-fits-all resolutions on diverse groups of plaintiffs, says Michelle Simpson Tuegel at Simpson Tuegel Law.
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Inside The PTAB's Seagen Cancer Drug Patent Decision
The Patent Trial and Appeal Board's recent finding that Seagen's claims for antibody-drug conjugate technology were unpatentable — for lack of enablement, lack of written description and anticipation — mark the latest chapter in the complex patent dispute as the case heads for director review, says Ryan Hagglund at Loeb & Loeb.
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6 Pointers For Attys To Build Trust, Credibility On Social Media
In an era of information overload, attorneys can use social media strategically — from making infographics to leveraging targeted advertising — to cut through the noise and establish a reputation among current and potential clients, says Marly Broudie at SocialEyes Communications.
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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.