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Life Sciences
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November 21, 2024
SEC Denied Civil Penalties Over Pot Pill Exec's 'Inexperience'
The SEC will score $86,000 in disgorgement and interest from a former executive of C3 International Inc. for falsely claiming the company's cannabis pill was projected to generate millions of dollars in revenue, but the court found the defendant's conduct did not warrant the civil penalty the agency requested.
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November 21, 2024
Boehringer Trial Over Zantac's Cancer Link Ends In Mistrial
A California state judge declared a mistrial Thursday, ending a monthslong trial over product liability claims by a bladder cancer survivor who alleges Boehringer Ingelheim Pharmaceuticals Inc. failed to disclose cancer risks associated with the company's Zantac heartburn medication, according to the plaintiff's counsel.
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November 21, 2024
SEC Seeks More Data On Nasdaq Plan To Speed Up Delistings
The U.S. Securities and Exchange Commission has postponed deciding on a Nasdaq proposal that would accelerate delistings of companies with low-priced stocks that take extended time to regain compliance or rely on reverse-stock splits to elevate their share prices, saying more data is needed before it takes action.
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November 21, 2024
Trump Selects Ex-Fla. AG Pam Bondi As New AG Pick
President-elect Donald Trump announced Thursday that he has selected Pam Bondi, a former attorney general of Florida, as his new pick for U.S. attorney general, just hours after former U.S. Rep. Matt Gaetz withdrew his name from consideration amid allegations of sexual misconduct and drug use.
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November 21, 2024
IP Atty Fights To Revive Allergan FCA Suit At 9th Circ.
A patent attorney urged the Ninth Circuit on Thursday to revive False Claims Act allegations against Allergan over dementia drug patents, arguing his client used his expertise to discover the patents were fraudulently issued to block generics and that these are the kinds of FCA cases the government welcomes from experts.
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November 21, 2024
In Tight Vote, Senate Panel OKs Bill To Set New PTAB Limits
The Senate Judiciary Committee on Thursday narrowly voted to advance a bill that would impose new restrictions on Patent Trial and Appeal Board challenges, with several members expressing concern that it could drive up the cost of prescription drugs.
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November 21, 2024
MVP: Fenwick's Douglas Cogen
Douglas Cogen of Fenwick & West LLP's life sciences practice guided cardiovascular device company Shockwave Medical through a record-breaking acquisition by Johnson & Johnson, while he simultaneously shepherded multiple biopharma companies through multibillion-dollar deals, earning him recognition as a 2024 Law360 Life Sciences MVPs.
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November 20, 2024
Musk, Ramaswamy Say High Court Rulings OK Federal Cuts
Billionaire Elon Musk and former presidential candidate Vivek Ramaswamy, President-elect Donald Trump's picks to lead a newly created "Department of Government Efficiency," on Wednesday said two recent U.S. Supreme Court rulings will give them the authority to cut off power to regulatory agencies and conduct massive federal layoffs.
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November 20, 2024
Ex-Pharma CEO Demands Legal Fees For SEC Probe
Cancer treatment development company Eagle Pharmaceuticals Inc.'s founder and ex-CEO told Delaware's Chancery Court Wednesday that he is entitled to legal fees he says the company owes him in connection with a U.S. Securities and Exchange Commission probe into the company's accounting practices, saying he continues to incur fees in addition to the $875,000 he has already requested.
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November 20, 2024
USPTO Unveils Patent Fee Hikes Set To Take Effect In January
The U.S. Patent and Trademark Office on Wednesday released a final rule that will increase many patent-related fees on Jan. 19, recalibrating some proposed hikes that had drawn criticism from attorneys and industry groups while leaving others intact.
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November 20, 2024
DEA Accused Of Colluding With Reform Foes In Pot Row
Cannabis reform advocates have alleged that the Drug Enforcement Administration "stacked the deck" by colluding with anti-legalization interests and giving them improper opportunities to participate in upcoming hearings on a proposal to loosen federal restrictions on the drug.
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November 20, 2024
PBMs Sue To Block FTC's In-House Insulin Pricing Case
Caremark Rx, Express Scripts and OptumRx have lodged a constitutional challenge of the Federal Trade Commission's in-house case accusing the pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes.
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November 20, 2024
3 States To Challenge Abortion Regs After Docs Drop Claims
Anti-abortion medical groups that were dealt a loss by the U.S. Supreme Court earlier this year have now dropped out of their lawsuit challenging federal approvals for mifepristone, leaving Missouri, Idaho and Kansas to carry on litigation over the abortion medication.
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November 20, 2024
Beasley Allen And J&J Tussle Over Atty Sanctions Bid
Beasley Allen Law Firm accused a Johnson & Johnson talc unit of using "deposition notices as weapons" in its quest to sanction a firm lawyer, while the company said the firm "refused to meaningfully subject itself or its members to any discovery" in its bankruptcy case.
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November 20, 2024
Weil Litigation Leaders Jump To Paul Weiss In NY
The co-chair of Weil Gotshal & Manges LLP's global litigation department and the co-head of Weil's patent litigation practice will soon be joining Paul Weiss Rifkind Wharton & Garrison LLP in New York, the latter firm announced Wednesday.
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November 20, 2024
MVP: Williams & Connolly's David I. Berl
David I. Berl of Williams & Connolly LLP's patent litigation practice helped win a first-of-its-kind trial victory on behalf of Regeneron Pharmaceuticals by employing a novel legal strategy that allowed the biotech giant to quickly adjudicate its patent rights to an eye care medicine, earning him a spot as one of the 2024 Law360 Life Sciences MVPs.
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November 19, 2024
Pfizer Unit Can't Get $75M Left In Insider Trading Deal Fund
A New York federal judge Tuesday agreed with the U.S. Securities and Exchange Commission that roughly $75.2 million leftover in settlement funds should be transferred to the U.S. Treasury — not a Pfizer subsidiary — now that distribution of the $602 million insider trading deal has concluded.
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November 19, 2024
High Court Urged To Let Courts Scrutinize Agency Rulings
District courts should be allowed to question rather than grant "absolute deference" to the Federal Communications Commission's interpretation of key statutory terms in the Telephone Consumer Protection Act, a chiropractic group contended Monday in calling on the U.S. Supreme Court to revive a junk fax class action.
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November 19, 2024
DC Circ. Wonders Where To Land On Terrorism Liability Claims
Hypotheticals were flying Tuesday morning at the D.C. Circuit, where a three-judge panel spent more than two hours trying to figure out whether a recent U.S. Supreme Court decision means they need to stop the revival of a suit accusing pharmaceutical companies of funding terrorism in Iraq.
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November 19, 2024
Blood Vessel Maker Faces Investor Suit Over FDA Findings
Biotechnology company Humacyte Inc. faces an investor's proposed class action alleging the company failed to disclose quality assurance issues at its manufacturing facilities that allegedly delayed regulatory review for its bioengineered blood vessel product candidate, leading to stock price declines.
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November 19, 2024
Costco Shoppers Say Kirkland Fish Oil Pills Hide Heart Risks
Costco shoppers filed a putative false advertising class action in California federal court Monday accusing the big-box retailer of misleading consumers to believe its Kirkland brand of fish oil omega-3 supplements have heart health benefits, despite there being increased risks associated with fish oil, including atrial fibrillation.
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November 19, 2024
Calif. Biotech Firm Vera Taps Veteran Chief Legal Officer
Biotechnology firm Vera Therapeutics is welcoming a new chief legal officer in advance of an anticipated biologics submission to the U.S. Food and Drug Administration for a treatment targeting an autoimmune kidney disease.
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November 19, 2024
10th Circ. Iffy On Colo.'s Remedy To Generic EpiPen Takings
A Tenth Circuit panel on Tuesday pressed Colorado regulators on whether requiring epinephrine auto-injector makers to repeatedly sue over the cost of complying with a state program provides an adequate legal remedy, with one judge saying that that route offers no finality for manufacturers.
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November 19, 2024
J&J Wants Beasley Allen Atty Sanctioned For Depo No-Show
Johnson & Johnson's talc unit called on a Texas bankruptcy court to sanction a Beasley Allen Law Firm attorney for "unilaterally" deciding not to attend a scheduled deposition in the company's bankruptcy case.
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November 19, 2024
McGuireWoods Lands Health Ace, Former GC From Akin In NY
A veteran healthcare and life sciences attorney who previously served as general counsel at pharmaceutical companies Novo Nordisk and Daiichi Sankyo has made the move from Akin Gump Strauss Hauer & Feld LLP to McGuireWoods LLP.
Expert Analysis
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Class Actions At The Circuit Courts: August Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers certification cases touching on classwide evidence of injury from debt collection practices, defining coupon settlements under the Class Action Fairness Act, proper approaches for evaluating attorney fee awards in class action settlements, and more.
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Leveraging Policy Changes To Achieve AI Patent Eligibility
With the latest U.S. Patent and Trademark Office guidance in hand and legislation looming in Congress, innovators should file their artificial intelligence patent applications now — and five strategies can maximize their chances of success, says Nicholas Gallo at Troutman Pepper.
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Planning Law Firm Content Calendars: What, When, Where
During the slower month of August, law firms should begin working on their 2025 content calendars, planning out a content creation and distribution framework that aligns with the firm’s objectives and maintains audience engagement throughout the year, says Jessica Kaplan at Legally Penned.
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Series
Playing Golf Makes Me A Better Lawyer
Golf can positively affect your personal and professional life well beyond the final putt, and it’s helped enrich my legal practice by improving my ability to build lasting relationships, study and apply the rules, face adversity with grace, and maintain my mental and physical well-being, says Adam Kelly at Venable.
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Law Firms Should Move From Reactive To Proactive Marketing
Most law firm marketing and business development teams operate in silos, leading to an ad hoc, reactive approach, but shifting to a culture of proactive planning — beginning with comprehensive campaigns — can help firms effectively execute their broader business strategy, says Paul Manuele at PR Manuele Consulting.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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Opinion
A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.
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Opinion
The Big Issues A BigLaw Associates' Union Could Address
A BigLaw associates’ union could address a number of issues that have the potential to meaningfully improve working conditions, diversity and attorney well-being — from restructured billable hour requirements to origination credit allocation, return-to-office mandates and more, says Tara Rhoades at The Sanity Plea.
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Opinion
It's Time For A BigLaw Associates' Union
As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.
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How Justices Upended The Administrative Procedure Act
In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.
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Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement
While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.