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Life Sciences
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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.
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November 19, 2024
Akin Adds Another Healthcare Expert To DC Lobbying Team
The former chief health adviser for the Senate Finance Committee's majority has joined Akin Gump Strauss Hauer & Feld LLP's lobbying team in Washington, D.C., weeks after the firm added another healthcare advocate from the national association representing pharmacy benefit managers.
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November 19, 2024
MVP: Covington's Catherine Dargan
Catherine Dargan of Covington & Burling LLP represented Bristol Myers Squibb Co. in its $14 billion acquisition of the company that developed Cobenfy — the first new drug in 35 years to be approved by the Food and Drug Administration for treating schizophrenia — earning her a spot among the 2024 Law360 Life Sciences MVPs.
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November 19, 2024
McDermott Adds IP Pro From Gibson Dunn In Los Angeles
McDermott Will & Emery LLP announced Tuesday that it has hired partner Timothy Best from Gibson Dunn & Crutcher LLP to help bolster its intellectual property practice group, especially its efforts serving life sciences and biotechnology clients.
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November 18, 2024
'You Stepped Over The Line': Judge Rips Quinn Emanuel Atty
A California federal judge told a Quinn Emanuel partner defending Natera Inc. at trial Monday in Guardant Health Inc.'s false advertising case that she'd be sanctioned over her questioning of a Natera expert about Guardant's alleged damages, saying, "You stepped over the line, and you did it several times."
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November 18, 2024
J&J Posts $1.17B Bond For Del. Merger Milestone Appeal
Johnson & Johnson Inc. has posted a $1.167 billion surety-backed bond ahead of its planned appeal challenging a Delaware Chancery Court's finding that it owes more than $1 billion to a medical robotics developer's former shareholders caught up in a post-acquisition dispute.
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November 18, 2024
Melinta Obtains Ban On Generic Antibiotic Injections In IP Row
A drugmaker that recently sold a manufacturing facility to Eli Lilly for nearly $1 billion has failed to persuade a federal judge in Chicago to wipe out patents covering a line of injections that treat infections developed by a recently bankrupt antibiotic developer.
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November 18, 2024
Pa. Lab Seeks Ad Coverage For Libel Suit Over COVID Tests
A Pennsylvania laboratory told a federal court Monday that its insurer must cover it in an underlying lawsuit brought by a COVID-19 test manufacturer in which the manufacturer alleged that the lab sent 19,000 letters to test kit users wrongfully stating that the tests were unreliable.
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November 18, 2024
$100M Deal In Suit Over Walgreens Rx Prices Gets First OK
An Illinois federal judge gave an initial blessing Monday to a $100 million deal resolving claims from consumers and unions that Walgreens unlawfully overcharged insured consumers for prescription drugs while allowing members of its cost savings club to pay less.
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November 18, 2024
Medical Group Wants Justices To Review IP Safe Harbor Fight
A medical device trade group has said the U.S. Supreme Court should take up an appeal of a Federal Circuit decision Edwards Lifesciences said broadened a drug-development safe harbor to avoid patent infringement, saying the circuit court misread the provision.
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November 18, 2024
Biopharm Co. Seelos Files For Ch. 11 After Nasdaq Delisting
Publicly traded biopharmaceutical company Seelos Therapeutics Inc. sought Chapter 11 protection in New York on Saturday, citing between $10 million and $50 million in estimated liabilities.
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November 18, 2024
MVP: Ropes & Gray's Amanda Austin
Amanda Austin of Ropes & Gray's life sciences practice guided Pfizer through its $7 billion deal with Flagship Pioneering, advised Fulcrum Therapeutics in its blockbuster collaboration with Sanofi, and was lead counsel to Ginkgo Bioworks, earning her a spot as one of the 2024 Law360 Life Sciences MVPs.
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November 18, 2024
Supreme Court Turns Down 3 Patent Cases
The U.S. Supreme Court on Monday refused to hear three patent cases dealing with patent eligibility, standing to bring infringement suits and the rules surrounding the launch of generic drugs.
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November 15, 2024
Eli Lilly Says HHS Ignores Drug Discount Double-Dipping
Eli Lilly & Co. claims the U.S. Department of Health and Human Services is unlawfully blocking its efforts to crack down on hospitals the company alleges are double-dipping on medication discounts that are meant to benefit low-income patients, according to a lawsuit filed in D.C. federal court.
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November 15, 2024
Natera Exec Calls Guardant's Cancer Test Claims 'Dangerous'
Natera's president of clinical diagnostics testified at trial Friday in a California federal false advertising case that Guardant Health's claims about Guardant's competing colorectal cancer test were "false and misleading" and also "dangerous."
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November 15, 2024
SEC-Sanctioned Accounting Firm Sued Over Pre-IPO Work
The former public company accounting firm BF Borgers is facing a California state lawsuit by an ex-client that says it was forced to scuttle its plans for an initial public offering after the U.S. Securities and Exchange Commission accused the firm of being a "sham auditing mill."
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November 15, 2024
PBMs Denied Breakup Of Combined FTC Insulin Price Trial
The Federal Trade Commission's allegations that pharmacy benefit manager giants Caremark Rx, Express Scripts and OptumRx are artificially inflating insulin prices through unfair rebate schemes will forge ahead as a single case following an in-house agency judge's refusal to break them into separate proceedings.
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November 15, 2024
Despite Vaccine Spotlight, RFK Jr. A Health Policy 'Unknown'
Robert F. Kennedy Jr., President-elect Donald Trump's pick to be the nation's top health official, has made clear his unorthodox and often false views on public health issues like vaccines. But there's still plenty of policy under his potential control where his stance remains opaque, attorneys say, which could stymie their efforts to prepare for the next four years.
Expert Analysis
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Trump Rollback Of Biden Enviro Policies: What To Expect
Donald Trump's upcoming second presidential term will usher significant shifts in U.S. environmental and natural resource law and policy — and while the Biden administration is racing to secure its legacy, the incoming Trump administration is making plans to dramatically roll back most, if not all, of Biden's environmental initiatives, say attorneys at Beveridge & Diamond.
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Takeaways From State Votes On Abortion In The 2024 Election
Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.
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Key Territory-Split Licensing Lessons For Life Sciences Cos.
Territory-split deals can allow life sciences companies to maximize products' potential across a range of geographic areas, but these deals also present unique challenges requiring highly bespoke structures that can make or break the value of an asset, say attorneys at Covington.
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Legislation Most Likely To Pass In Lame Duck Session
As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.
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Justices Must Weigh Reach Of Civil RICO In Cannabis Case
Oral arguments in Medical Marijuana Inc. v. Horn suggest that a majority of the U.S. Supreme Court may agree that a truck driver's losing his job after unknowingly ingesting THC and failing a drug test does not merit a racketeering claim — but the court may not buy the other side's theory of the case either, say attorneys at Lewis Baach.
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Litigation Strategies In View Of New Double Patenting Rulings
Recent Federal Circuit decisions, including in Allergan v. MSN, raise several issues that patent owners should understand and consider addressing proactively regarding obviousness-type double patenting, at least in their prosecution strategies, say attorneys at Dentons.
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Promoting Diversity In The Selection Of ADR Neutrals
Excerpt from Practical Guidance
Choosing neutrals from diverse backgrounds is an important step in promoting inclusion in the legal profession, and it can enhance the legitimacy and public perception of alternative dispute resolution proceedings, say attorneys at Lowenstein Sandler.
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Series
Playing Ultimate Makes Us Better Lawyers
In addition to being fun, ultimate Frisbee has improved our legal careers by emphasizing the importance of professionalism, teamwork, perseverance, enthusiasm and vulnerability, say Arunabha Bhoumik and Adam Bernstein at Regeneron.
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E-Discovery Quarterly: Recent Rulings On Metadata
Several recent rulings reflect the competing considerations that arise when parties dispute the form of production for electronically stored information, underscoring that counsel must carefully consider how to produce and request reasonably usable data, say attorneys at Sidley.
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Opinion
PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB
The decade-long campaign against the U.S. Patent and Trademark Office's Patent Trial and Appeal Board — currently focused on the PREVAIL Act that's slated for markup in the Senate — is not really about procedural issues, and it is not aimed at securing more accurate patentability decisions, says Clear IP's Joseph Matal, former acting director at the USPTO.
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Striking A Balance Between AI Use And Attorney Well-Being
As the legal industry increasingly adopts generative artificial intelligence tools to boost efficiency, leaders must note the hidden costs of increased productivity, and work to protect attorneys’ well-being while unlocking AI’s full potential, says Ed Sohn at Factor.
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Empathy In Mediation Offers A Soft Landing For Disputes
Experiencing a crash-landing on a recent flight underscored to me how much difference empathy makes in times of crisis or stress, including during mediation, says Eydith Kaufman at Alternative Resolution Centers.
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Series
Being An Artist Makes Me A Better Lawyer
My work as an artist has highlighted how using creativity and precision together — qualities that are equally essential in both art and law — not only improves outcomes, but also leads to more innovative and thoughtful work, says Sarah La Pearl at Segal McCambridge.
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How Judiciary Can Minimize AI Risks In Secondary Sources
Because courts’ standing orders on generative artificial intelligence and other safeguards do not address the risk of hallucinations in secondary source materials, the judiciary should consider enlisting legal publishers and database hosts to protect against AI-generated inaccuracies, say attorneys at Lankler Siffert & Wohl.
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Newly Acquired Information Can Be Key In Drug Label Cases
The question of whether federal law preempts state law claims is often central in pharmaceutical labeling cases, like the Fosamax litigation now before the Third Circuit — but parties must also consider whether there is newly acquired information to justify submitting a proposed labeling change in the first place, say attorneys at Arnold & Porter.