BioCentury | Aug 7, 2020
Regulation

Guardant’s liquid biopsy approval paves the way for broader adoption of solid tumor profiling

FDA’s approval of a liquid biopsy test from Guardant that produces a comprehensive tumor mutational profile may trigger broader adoption of the tumor screening technology to better match patients to targeted therapies. FDA approved Guardant360...
BioCentury | Jul 14, 2020
Deals

Roche deal clears path for Blueprint’s financial independence

In the year’s largest licensing deal thus far, Blueprint has secured the resources it needs to sustain itself financially while gaining access to Roche’s diagnostic capabilities, a key driver for commercializing its targeted therapies for...
BioCentury | Jul 10, 2020
Finance

2Q20 Wrap: Biotech bounce

After the sudden, COVID-driven market declines that closed out 1Q20, biotech stocks rebounded in the second quarter with a force that has put shares up year to date. Many of the biggest moves came from...
BioCentury | Jun 19, 2020
Product Development

June 18 Quick Takes: Approvals for Ultragenyx, Epizyme, Merck; plus Tecfidera tussle, Tecentriq in TNBC, Sarepta-Selecta, and Gelesis goes to China

A first from Ultragenyx in a rare disease FDA approved Crysvita burosumab-twza from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat tumor-induced osteomalacia in patients age two and older. The anti-FGF23 mAb is the first to be...
BioCentury | May 6, 2020
Regulation

FDA approval of Novartis’ capmatinib heralds arrival of new targeted lung cancer therapies

FDA’s approval of the c-MET inhibitor Tabrecta capmatinib from Novartis is the first for a series of targeted non-small cell lung cancer therapies expected to reach the market this year. It’s also the first approval...
BioCentury | Jan 13, 2020
Company News

Jan. 13 Company Quick Takes: AZ ends fish oil trial; plus Lynparza, Lilly-NextCure, Innovent, Amgen-Qiagen-Guardant, Axsome-Pfizer

AstraZeneca ends CV outcomes trial of Epanova AstraZeneca plc (LSE:AZN; NYSE:AZN) discontinued the Phase III STRENGTH trial after an IDMC determined it is unlikely to show that Epanova improved cardiovascular outcomes in patients with mixed...
BioCentury | Dec 30, 2019
Company News

FDA approves Lynparza as first PARP inhibitor for pancreatic cancer

FDA’s approval of Lynparza for pancreatic cancer notches a trio of firsts: the first drug approved for the indication based on PFS rather than OS, the first PARP inhibitor approved to treat the disease, and...
BioCentury | Nov 23, 2019
Product Development

New reimbursement models are coming to cancer diagnostics

A newly proposed payment model aims to increase reimbursement for cancer diagnostics by incentivizing companies to produce more clinical utility data. However, to drive widespread adoption, companies may also need to look to risk-sharing deals...
BioCentury | Aug 15, 2019
Company News

Genentech gains its first U.S. tissue-agnostic approval with Rozlytrek

Following a Japanese approval in June, Roche’s Genentech unit scored accelerated approval in the U.S. Thursday for its Rozlytrek entrectinib to treat NTRK fusion-positive solid tumors. FDA also approved the inhibitor of ROS1, TrkA, TrkB,...
BioCentury | May 8, 2019
Company News

Management tracks: Immunocore, Kyn, Engitix

Immunocore Ltd. (Abingdon, U.K.) brought on a third ex-AstraZeneca plc (LSE:AZN; NYSE:AZN) executive, hiring Mohammed Dar as head of clinical development and CMO. Dar was VP, clinical development oncology, R&D at AZ's MedImmune LLC subsidiary....
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