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Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
FDA
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
THE LATEST
Job security is a hot topic among biopharma professionals. A career coach offers advice for how to evaluate and build it up and what to do if that evaluation leaves you worried.
Good company culture is a crucial aspect of professional life. Look at these 11 important indications of good workplace culture before accepting a job offer or use them to evaluate your new employer.
In the battle over drug prices, one sector of the healthcare industry has risen above all the players as the boogeyman: pharmacy benefit managers. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the lens now focused on PBMs’ business practices.
M&A
The sale of Dermavant clears the way for Roivant to focus on autoimmune-focused Immunovant and a slate of upcoming pivotal trials.
Summit Therapeutics’ ivonescimab has the potential to challenge Merck’s blockbuster checkpoint inhibitor in non-small cell lung cancer, but experts stress the need for diverse and overall survival data.
The mesothelioma approval for the Keytruda combination regimen potentially unlocks a $12 billion market opportunity, according to a recent report from research firm IMARC Group.
Ahead of a Senate health committee hearing next week with Novo Nordisk CEO Lars Jørgensen, Sen. Bernie Sanders claims he has secured assurances from generics developers that they will charge a significantly lower monthly price than the $969 Americans currently pay for the Danish drugmaker’s diabetes blockbuster.
The FDA’s approval of Kisqali in combination with an aromatase inhibitor allows Novartis to target patients with earlier breast cancer who are at risk of recurrence.
If Johnson & Johnson refuses to scrap its proposed changes to the 340B drug pricing for hospitals, it risks the termination of participation in the program and monetary fines, the Health Resources and Services Administration warned.
Infusions of Vertex and CRISPR Therapeutics’ Casgevy and bluebird bio’s Lyfgenia have begun; Moderna targets 10 approvals through 2027; more oral obesity drug data; the latest from ESMO and more.