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COUR Pharmaceuticals has been around a while, but not until last year did the company solidify behind its ultimate mission with a series A raise.
FDA
The hammer came down on an unspecified number of FDA employees this weekend, days after Robert F. Kennedy Jr. was confirmed as HHS Secretary.
Continuing our SCOPE 2025 coverage, Rohit Nambisan, CEO at Lokavant addresses not only current challenges, but the life sciences industry’s responsibility to maintain scientific integrity.
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Read our takes on the biggest stories happening in the industry.
Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking.
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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.
Ionis will receive $280 million upfront and could get up to $660 million in future milestone payments. Ono will take charge of late-stage development as well as regulatory and commercialization activities.
BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation.