Meredith Durkin Wolfe

1 week ago | biocentury.com | Meredith Durkin Wolfe

DATA GRAPHICS | Data ByteFour of the five are already approved in the U.S. By Meredith Durkin Wolfe, Director of ResearchEMA’s CHMP recommended five new products for approval at its June meeting. Four are already approved in the U.S. for the same indications. The fifth — allogenic stem cell therapy Zemcelpro from Excellthera Inc. — has not yet been submitted to FDA.

1 week ago | biocentury.com | Meredith Durkin Wolfe

DATA GRAPHICS | DealsAlso in BioCentury’s Deals Report, Biontech acquiring fellow German mRNA co Curevac, Supernus buying Sage, and more By Meredith Durkin Wolfe, Director of ResearchAstrazeneca became the latest big pharma to announced a discovery deal with a Chinese company, signing a $5.3 billion biobucks partnership with CSPC last week. CSPC Pharmaceuticals Group Ltd.

2 weeks ago | biocentury.com | Meredith Durkin Wolfe

DATA GRAPHICS | Data Byte$870M biobucks for oral incretins is week’s biggest deal By Meredith Durkin Wolfe, Director of ResearchASCO data stole the spotlight last week, as only a handful of biopharma companies announced deals, with very few disclosed financial terms. The largest partnership featured Eli Lilly and Co. (NYSE:LLY) engaging Camurus AB (SSE:CAMX) to use its FluidCrystal technology to develop long-acting formulations of up to four Lilly incretins.

3 weeks ago | biocentury.com | Meredith Durkin Wolfe

DATA GRAPHICS | Data BytePDUFA dates on deck for RSV prevention mAb, HIV PrEP LAI By Meredith Durkin Wolfe, Director of ResearchAt least seven PDUFA dates are on FDA’s docket in June, including two new approaches to disease prevention. Both preventative products offer less frequent dosing than approved competitors. Merck & Co. Inc. (NYSE:MRK) is seeking approval of clesrovimab to prevent RSV infection in infants.

3 weeks ago | biocentury.com | Meredith Durkin Wolfe

DATA GRAPHICS | Data ByteOf 33 BLAs approved via the pathway, 20 are for vaccines. Approvals for cancer, rare disease have been on the rise By Meredith Durkin Wolfe, Director of Research, and Steve Usdin, Washington EditorAn analysis of accelerated approvals granted by FDA’s Center for Biologics Evaluation and Research suggests ways that narrowing or widening use of the pathway could change drug development priorities and impact public health.