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Leerink analysts noted, however, that Uplizna’s slow onset of therapeutic efficacy compares unfavorably to would-be competitors in generalized myasthenia gravis.
FEATURED STORIES
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.
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.
Job Trends
Pfizer Inc. and OPKO Health Inc. announced that the U.S. Food and Drug Administration has approved NGENLA, a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
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.
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M&A didn’t return as hoped for in 2024. The biopharma industry is heading into the J.P. Morgan Healthcare Conference next week in a grim mood.
Novo Nordisk’s GLP-1s outsell Eli Lilly’s thanks to its superior marketing. Here’s how.
Eli Lilly’s request to intervene in a suit filed by compounding pharmacies against the FDA reflects a belief the outcome could affect its business and that the FDA does not adequately represent its interests.
Job postings in California took a dip in December during the holiday period, but activity is expected to pick up in January.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh discuss the industry’s need to catch up with women’s health issues and the innovative lead the APAC region has taken in clinical trials.
With two earlier trials meeting their primary endpoints, Axsome claimed it has the data to support a filing for FDA approval in the second half of 2025.
As market values increase for computational biology and data science, biopharma companies are looking to hire R&D professionals in those areas. A biotech talent acquisition expert shares his insights on these in-demand roles.
Roche has once again returned to China to bolster its antibody-drug conjugate pipeline, this time striking a licensing deal with Innovent for $1 billion in biobucks.
Regulators squeezed in two final approvals before the calendar change with the UK approval of Merck’s Winrevair and the FDA’s greenlight for an injectable formulation of BMS’s cancer blockbuster.
In a highly anticipated readout for the kappa opioid receptor class in major depressive disorder, Neumora’s navacaprant failed to meet the primary and key secondary endpoint in the first of three identical Phase III studies.