BioCentury | Mar 17, 2020
Product Development

March 16 Quick Takes: FDA raises efficacy questions for DBV allergy therapy; plus Novo, Provention, UCB, Pfizer-EMD Serono, Zai, AcelRx-Tetraphase, Medivir-Tan

DBV expects delay for peanut allergy product  DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said the Aug. 5 PDUFA date for its peanut allergy therapy may be extended as FDA has raised questions on the long-term efficacy...
BC Extra | Oct 10, 2019
Company News

bluebird tech to jump-start Novo in gene editing for hemophilia

A deal with bluebird bio is the latest move in Novo Nordisk’s push to remake its R&D, this time by partnering to develop a gene therapy for hemophilia A. The deal comes as sales for...
BC Extra | Jul 8, 2019
Clinical News

July 8 Clinical Quick Takes: Hemophilia data from Sangamo-Pfizer, Novo; plus GamaMabs, Xarelto and more

Sustained Factor VIII levels for Sangamo, Pfizer hemophilia A gene therapy  Sangamo Therapeutics Inc. (NASDAQ:SGMO) and partner Pfizer Inc. (NYSE:PFE) presented data at the International Society on Thrombosis and Haemostasis (ISTH) meeting in Melbourne showing...
BioCentury | Apr 15, 2017
Product Development

Outside factors

This year could see the first regulatory submission from a coming wave of new therapies for hemophilia prophylaxis that do not simply replace missing clotting factors, which has been the standard for care for decades....
BioCentury | Mar 25, 2017
Strategy

Mountain climbing

U.S. pricing pressure on insulin and hemophilia products have caused Novo Nordisk A/S to guide for negative sales and operating profit growth for the first time ever. While newly launched diabetes and obesity products are...
BC Innovations | Jul 16, 2015
Translation in Brief

Bayer's replacement antibody

Bayer AG 's new mAb could treat hemophilia patients who have neutralizing antibodies against coagulation factors, and avoid the frequent IV infusions of factor replacement therapy. In a departure from Bayer AG's historical focus on...
BioCentury | Sep 29, 2014
Regulation

Patient factors

A dearth of options for patients who develop neutralizing antibodies against recombinant blood clotting factor therapies for bleeding disorders was one of the major concerns expressed by patient advocates last week at FDA's patient-focused drug...
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