BioSpace

Summit shares descend as PD-1/VEGF asset misses early survival mark

Summit Therapeutics planned an early interim progression-free survival readout for HARMONi-3 in the hope of enabling earlier ...
BioSpace

UCB captures Candid in $2.2B autoimmune deal as pharma’s M&A train chugs along

Candid Therapeutics follows closely behind Neurona Therapeutics, which UCB acquired in mid-April in a potential $1.15 billion ...
BioSpace

FDA Action Alert: Argenx, AstraZeneca/Daiichi Sankyo, Biogen/Eisai and Cingulate

The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.
BioSpace

FDA clears Pfizer, Arvinas’ novel breast cancer therapy despite mixed data

Veppanu, the first PROTAC therapy approved by the FDA, improved progression free survival by 43% versus AstraZeneca’s ...
BioSpace

PCI adds US sterile fill/finish capabilities through $1B global expansion drive

Amid disruption to the outsourced fill/finish market, PCI is investing $100 million to more than double the capacity to fill ...
BioSpace

Passage cuts 75% of workforce after FDA trial design request

Passage Bio, which has been working toward a registrational trial for a drug candidate whose indications include ...
BioSpaceOpinion

Opinion: Gene therapy’s evidence problem—lessons from recent FDA decisions

Comprehending the spate of recent rejections in the cell and gene therapy space may require looking no further than ...
BioSpace

Obesity ends oncology’s long reign as top contributor to biopharma pipeline value

In its latest biopharma pipeline report, Deloitte warned that the growing importance of a small pool of potential ...
BioSpaceOpinion

First FDA ODAC meeting without Pazdur highlights conceptual challenges with trial

The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual ...
BioSpace

Chiesi snaps up KalVista for $1.9B, betting big on rare disease med Ekterly

Chiesi Group is taking KalVista Pharmaceuticals under its wing, paying $1.9 billion for the biotech’s oral therapy Ekterly to ...
BioSpace

Amgen positions MariTide as potential ‘best monthly’ obesity drug

Amgen has launched a late-stage program to test the feasibility of switching patients from weekly GLP-1 injections to its own ...
BioSpace

FDA taps Szarama as acting CBER director as Prasad’s tumultuous tenure ends

Katherine Szarama, who has served as Prasad’s deputy at the Center for Biologics Evaluation and Research since December, joins a long list of temporary leaders at the Department of Health and Human ...