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Life Sciences
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January 29, 2025
White House Rescinds Trump's Spending Freeze
The White House on Wednesday rescinded a directive freezing federal funding, saying it wants to end litigation and confusion, but said the move will not end a review of spending to ensure compliance with a series of executive orders by the president.
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January 29, 2025
RFK Jr. Disputes Anti-Vax Label In HHS Confirmation Hearing
Robert F. Kennedy Jr. attempted Wednesday morning to convince Republican and Democratic lawmakers that he is not anti-vaccine, despite many of his past comments to the contrary, as he hopes to convince them to confirm his appointment as head of the U.S. Department of Health and Human Services.
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January 28, 2025
Trump Targets Gender-Affirming Care For Minors In New Order
President Donald Trump ordered federal agencies late Tuesday to take steps to halt gender-affirming care for minors, including by cutting off Medicaid and military health coverage for what he called a "stain on our nation's history."
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January 28, 2025
Minn. AG Settles Novo Nordisk Insulin Claims With Price Cap
Minnesota's attorney general has reached a settlement resolving a long-running lawsuit accusing Novo Nordisk of inflating insulin prices, with the company agreeing to a $35 per month cap on out-of-pocket costs for state residents.
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January 28, 2025
GSK Urges Del. Judge To Enhance $235M Skinny Label Win
GlaxoSmithKline LLC is urging a Delaware federal judge to enhance the $235 million damages award a jury issued against Teva Pharmaceuticals USA Inc. in 2017, now that the dispute over skinny label infringement has returned to district court.
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January 28, 2025
Founder Can't Explain Hedge Fund's Filing Mismatch To Jury
A hedge fund founder told a Denver jury Tuesday that he doesn't know why some of the fund's regulatory filings don't identify it as a director for a Colorado biopharmaceutical company, in a suit brought by stockholders who claim the fund must return $11 million earned from short-swing trades.
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January 28, 2025
Drugs Made In America SPAC Nets $200M To Buy Pharma Biz
Blank-check company Drugs Made In America Acquisition Corp. began trading Tuesday after completing a downsized $200 million initial public offering with the intention of acquiring a U.S.-based pharmaceutical business, represented by Loeb & Loeb LLP and underwriter's counsel Winston & Strawn LLP.
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January 28, 2025
Pharma Co. Gets Final Shot To Ax NC Contract Breach Suit
A pharmaceutical company can make another attempt to escape a software developer's suit alleging he was duped into selling his technology to the company, the North Carolina Business Court has said, months after the state's top court revived the software maker's breach of contract claims.
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January 28, 2025
Questions To Watch For In RFK Jr.'s Confirmation Hearing
Robert F. Kennedy Jr. is set to appear on Capitol Hill as he tries to secure the top position at the U.S. Department of Health and Human Services. Here are some of the questions healthcare lawyers and others want to see addressed about his "Make America Healthy Again" pledge.
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January 28, 2025
7th Circ. Considers Faith Of 2-Step Collective Certification
A Seventh Circuit panel considered Tuesday whether to keep or ditch the two-step certification process for collectives, with one judge calling Eli Lilly & Co.'s decertification argument in an age discrimination suit "spectacularly wrong" and another asking how tolling could change.
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January 28, 2025
Bain Capital Seeks Surgery Partners Buyout At $3.3B Value
Tennessee-based short-stay surgical facility operator Surgery Partners Inc. disclosed Tuesday that its board received a nonbinding proposal the prior day from Bain Capital Private Equity LP that values the company at close to $3.3 billion.
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January 28, 2025
Trump Pledges Tariffs On Semiconductors, Chips, Drugs
The U.S. will soon place tariffs on foreign-manufactured semiconductors, computer chips and pharmaceuticals in an effort to convince foreign companies to move their manufacturing operations stateside, President Donald Trump told House Republicans at a conference.
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January 28, 2025
North Carolina Drug Testing Lab Inks $850K False Billing Deal
A North Carolina laboratory on Tuesday agreed to pay $850,000 to settle acting U.S. Attorney Randall Galyon's claims it was overbilling the Tar Heel State's Medicaid program for urine tests that were not medically necessary in violation of the False Claims Act.
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January 28, 2025
Chinese Pair Sought To Fuel Fentanyl 'Grand Lab,' Feds Say
Prosecutors told a Manhattan federal jury Tuesday that two Chinese nationals sought to furnish chemicals for what they thought would be a huge fentanyl hub in New York City, pointing to what they called damning evidence such as recordings, texts and cryptocurrency transfers.
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January 28, 2025
Creditors Can Join Nostrum Sale Talks, Ch. 11 Judge Rules
A bankruptcy judge on Tuesday approved a bid from the official committee of unsecured creditors in drugmaker Nostrum Laboratories Inc.'s Chapter 11 case to help investment bank Raymond James find a buyer for the debtor's assets.
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January 28, 2025
4 Firms Look To Build $1B Sale Of Evergreen Theragnostics
Radiopharmaceutical-focused healthcare company Lantheus Holdings Inc. on Tuesday announced plans to buy Evergreen Theragnostics Inc. for up to $1 billion or more in a deal steered by four law firms.
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January 27, 2025
Fund Tells Jury No Need To Return $11M Short-Swing Profits
A hedge fund told a Denver federal jury Monday that the $11 million it earned from the short-swing sales of a biopharmaceutical company's stock doesn't need to be returned because the transactions fall under an exception to securities law on insider trading.
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January 27, 2025
Takeda Pushes Meijer Antitrust Suit Into Arbitration
Meijer is going to have to arbitrate its claims that Takeda Pharmaceutical broke antitrust law by cutting a pay-for-delay deal with Par Pharmaceuticals to keep a generic version of Takeda's anti-constipation drug Amitiza off the market for several years.
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January 27, 2025
Jury Will Decide $140M Intuitive Robo-Surgery Antitrust Case
A federal judge on Monday rejected dueling requests for directed verdicts at the wrap of a $140 million antitrust trial over claims that Intuitive Surgical abused its market power in barring a repair provider's refurbished part for Intuitive's surgery robot, saying there's "substantial evidence" for jurors to decide on the parties' claims and counterclaims.
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January 27, 2025
2 Firms Want To Co-Lead Humacyte Investor Suit
Hagens Berman Sobol Shapiro LLP and Pomerantz LLP have asked to co-lead a proposed class of Humacyte Inc. investors alleging that the company failed to disclose quality assurance issues at its manufacturing facilities, which delayed regulatory review for its bioengineered blood vessel product candidate.
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January 27, 2025
FOIA Lawsuit Seeks Marijuana Docs From Health Officials
A nonprofit that advocates for government transparency has filed a federal lawsuit under the Freedom of Information Act seeking to push federal health regulators to release internal communications related to their recommendation to loosen restrictions on marijuana.
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January 27, 2025
Obesity-Focused Metsera Leads Biotech Firms Eyeing IPOs
Obesity-focused drug developer Metsera launched plans on Monday for an estimated $275 million initial public offering, joined by kidney-disease focused Maze Therapeutics, both of which plan to tap the markets this week under combined guidance of four law firms.
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January 27, 2025
Investors Sue Pharma Co. After Cancer Drug Trial Termination
Prostate cancer treatment developer ESSA Pharma Inc. has been hit with a proposed shareholder class action in Wisconsin federal court alleging company shares fell over 70% after the company announced that it was terminating a clinical trial when it discovered its lead product candidate was not as effective as an existing treatment for certain cancer patients.
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January 27, 2025
J&J Talc Unit's $9B Ch. 11 Plan Draws Slew Of Objections
The U.S. Trustee's Office and lawyers representing talc claimants have urged a Texas bankruptcy judge to reject a Johnson & Johnson spinoff's $9 billion plan to settle thousands of cancer claims through Chapter 11, arguing the proposed reorganization must fail because the bankruptcy case was filed in bad faith.
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January 27, 2025
Novo Nordisk's Obesity Drug Study Allegedly Duped Investors
Novo Nordisk was hit with a proposed securities class action in New Jersey federal court Friday, accusing the drugmaker of duping investors about its new weight loss drug CagriSema by failing to disclose that obesity patients were taking different dosages in a clinical study, which allegedly skewed results.
Expert Analysis
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From Concept To Capital: 5 Stages Of Evolving IP Needs
Companies must understand the shifting intellectual property needs throughout an organization’s life cycle in order to protect innovation, which can be done by fortifying the IP portfolio, expanding and leveraging IP assets, and more, says Keegan Caldwell at Caldwell Law.
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Allergan Ruling Reinforces Value Of Patent Term Adjustments
The Federal Circuit’s recent ruling in Allergan v. MSN, which held that patent term adjustment awards for first-filed, first-issued patents cannot be stripped away by later-issuing child patents that expire earlier, means practitioners must consider the potential impact of any action that might reduce the adjustment amount, say attorneys at Cooley.
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FTC Focus: How Scrutiny Of PBMs And Insulin May Play Out
Should Express Scripts' recent judicial challenge to the Federal Trade Commission succeed, any new targets could add litigation and choice of forum to their playbooks, and potential FTC court action on insulin could be forced to parallel venues as the issues between the commission and PBMs evolve, say attorneys at Proskauer.
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Opinion
AI May Limit Key Learning Opportunities For Young Attorneys
The thing that’s so powerful about artificial intelligence is also what’s most scary about it — its ability to detect patterns may curtail young attorneys’ chance to practice the lower-level work of managing cases, preventing them from ever honing the pattern recognition skills that undergird creative lawyering, says Sarah Murray at Trialcraft.
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Series
Round-Canopy Parachuting Makes Me A Better Lawyer
Similar to the practice of law, jumping from an in-flight airplane with nothing but training and a few yards of parachute silk is a demanding and stressful endeavor, and the experience has bolstered my legal practice by enhancing my focus, teamwork skills and sense of perspective, says Thomas Salerno at Stinson.
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And Now A Word From The Panel: The MDL Map
An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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Why Now Is The Time For Law Firms To Hire Lateral Partners
Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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A Look At The Economic Impact Of Drug Patent Differentiation
Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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New Lessons On Managing Earnout Provision Risks
Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.
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3 Patent Considerations For America's New Quantum Hub
Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.