BioSpace

As CGT Struggles To Scale, FDA’s New Designation Could Smooth Post-Approval Pivots

Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production ...
BioSpace

J&J’s Anti-Tau Bet Falls Flat in Mid-Stage Alzheimer’s Trial

Johnson & Johnson will discontinue the Phase II Auτonomy study of posdinemab after a scheduled review found the anti-tau ...
BioSpace

Biogen’s Leqembi Rises After Novo GLP-1 Fails in Alzheimer’s

Analysts agree that the failure of Novo Nordisk’s semaglutide to reduce Alzheimer’s disease progression removes a “modest” or ...
BioSpace

Novo’s GLP-1 Fails to Slow Alzheimer’s, Sending Shares Down 10%

We felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success,” Martin Holst Lange, ...
BioSpace

NervGen’s Peptide Achieves Nervous System Repair in Phase II Spinal Cord Injury Study

NervGen will meet with the FDA early next year to align on a regulatory path forward for NVG-291 in chronic spinal cord ...
BioSpace

Bayer Sets Up Redemption Arc for Anticoagulant With ‘Surprisingly Positive’ Phase III Data

Asundexian’s Phase III win could also bode well for Bristol Myers Squibb, which is also developing a Factor XIa inhibitor called milvexian for stroke prevention, analysts said.
BioSpace

FDA Frictions Continue as White House Denies Promotion to Makary’s Aide

Sanjula Jain-Nagpal, associate director of Policy & Research Strategy at the FDA, will be allowed to remain at the agency but ...
BioSpace

FDA Reversals Send UniQure, Biohaven, Capricor, More Into a ‘Tailspin’

Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for ...
BioSpaceOpinion

Opinion: Cell and Gene Therapy Will Transform Lives—If We Let It

Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only ...
BioSpace

FDA Probing Patient Death Linked to Takeda’s Enzyme Replacement Therapy

The regulator has received reports that a group of patients treated with Adzynma had neutralizing antibodies against the ...
BioSpace

6 Biotechs With a Shot at the FDA’s Platform Technology Designation

After revoking Sarepta’s award in July and awarding one to Krystal last month, the FDA’s platform technology designation program appears to be back on track. These six biotechs could be on the ...
BioSpace

J&J, Contineum Fail ‘Risky’ Mid-Stage Multiple Sclerosis Trial

While expressing disappointment, William Blair analysts were unsurprised by the Phase II failure, having assigned the VISTA study a high level of risk given the “mixed” performance of a similar drug ...