BioCentury | Nov 23, 2020
Product Development

Immunocore charts the path for bispecifics in solid tumors with Phase III readout

With a positive Phase III readout in metastatic uveal melanoma, Immunocore has become the first company to solve one of the biggest challenges in immuno-oncology: applying T cell-engaging bispecifics to solid tumors.  The data suggest...
BioCentury | Nov 21, 2020
Product Development

How Forma is working to show the sickle cell community it’s in for the long haul

As early clinical evidence for its sickle cell disease candidate grows, Forma is prioritizing building relationships with the patient community, with a focus on long-term policy goals and COVID-19 safety...
BioCentury | Nov 14, 2020
Politics, Policy & Law

U.K.’s opportunity as changes come to MHRA, NICE

On the cusp of a new era outside of Europe, the U.K. has an opportunity to create an innovative and interconnected regulatory and reimbursement system that can attract biopharma by accelerating patient...
BioCentury | Nov 13, 2020
Product Development

Cytokinetics sees path to market for omecamtiv mecarbil in more severe heart failure patients

Updated data from the Phase III GALACTIC-HF study of omecamtiv mecarbil show it may be particularly useful in a more severe subgroup of heart failure patients. The latest readout from Cytokinetics...
BioCentury | Nov 7, 2020
Emerging Company Profile

Vaxxinity: supplanting mAbs with vaccines for chronic disease

Vaxxinity aims to disrupt the biologics market with a vaccine platform that replaces mAbs for chronic disease by inducing patients’ immune systems to manufacture therapeutic antibodies in vivo. But...
BioCentury | Oct 27, 2020
Product Development

Oct. 26 Quick Takes: COVID trips up Spectrum’s Rolontis at FDA; plus Jazz-SpringWorks, Novartis’ iptacopan, Kantaro, Eternygen

Delay for Spectrum due to COVID-19 travel restrictionsSpectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said FDA is deferring action on the company’s BLA for its Rolontis eflapegrastim because the agency was unable to inspect Hanmi Bioplant, the drug substance...
BioCentury | Oct 17, 2020
Product Development

How the PanCAN master protocol could promote innovation in pancreatic cancer

The motivation for launching the first adaptive platform trial in pancreatic cancer is to stimulate therapeutic innovation in an indication sorely in need of new ideas. The hope of the non-profit...
BioCentury | Oct 1, 2020
Distillery Therapeutics

Calcium channel-targeting peptide to prevent hypertrophic cardiomyopathy

DISEASE CATEGORY: Cardiovascular INDICATION: Cardiomyopathy A peptide targeting the cardiac calcium channel L-type α-interaction domain, a cytoplasmic portion the channel’s α1C subunit, could prevent hypertrophic cardiomyopathy. In a mouse model of the disease caused by a...
BioCentury | Sep 23, 2020
Product Development

Immunomedics data point to Trodelvy’s $21B potential

New data from Immunomedics suggest its antibody-drug conjugate Trodelvy is on track for the label expansions worked into Gilead’s $21 billion takeout price for the biotech. At the European Society for Clinical Oncology Virtual Congress,...
BioCentury | Sep 10, 2020
Product Development

BioNTech, Pfizer complete exploratory talks with the European Commission for 200M COVID-19 vaccine doses

BioNTech, Pfizer vaccine to supply vaccine to EUOn Wednesday, BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) became the sixth group of COVID-19 vaccine developers to complete exploratory talks on...
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