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Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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As Marty Makary and Jay Bhattacharya sail through the Senate health committee vote, Weldon’s confirmation hearing is canceled. Guggenheim Partners heralded the last-minute move to revoke Dave Weldon’s nomination as “a positive sign for reigning in vaccine criticism.”
While Houston isn’t yet on the same level as major life sciences hubs, it has plenty to offer and room to grow, according to CNS Pharmaceuticals, RadioMedix and Greater Houston Partnership executives.
The move by Acelyrin’s board comes as the venture capital firm has taken larger and larger stakes in the company in an attempt to disrupt a merger with Alumis.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis and Miruna Sasu, CEO of COTA, discuss the challenges of inclusion and exclusion criteria of clinical trial patients, and reflect on current investment approaches around women’s health.
With what analysts are calling “strong” data, Amgen plans to file a regulatory submission for Uplizna, currently approved for a rare ocular autoimmune disorder, in myasthenia gravis, in the first half of 2025.
Johnson & Johnson and Legend Biotech hope to hit blockbuster status for Carvykti this year.
Both Mallinckrodt and Endo have previously declared bankruptcy, linked to opioid-related lawsuits.
Gilead plans to go straight to Phase III studies for once-yearly lenacapavir, while GSK and ViiV will push forward with their long-acting antivirals after touting positive early-stage results.
According to Judge Kenneth Bell, there is a lack of evidence to conclude that Merck willingly misrepresented the safety of its HPV vaccine Gardasil to patients and prescribers.
Roche and Zealand plan to study petrelintide as a monotherapy and in combination with CT-388, a dual agonist of the GLP-1 and GIP receptors that Roche picked up in its recent acquisition of Carmot Therapeutics.