BioCentury | Mar 27, 2020
Regulation

CHMP decisions set stage for approval of Novartis’ SMA gene therapy, Celgene’s Zeposia for MS, Sanofi’s comeback cancer drug

EMA’s CHMP backed conditional approval of an MAA for Zolgensma to treat spinal muscular atrophy in its March set of recommendations, which were made via a virtual meeting because of the COVID-19 outbreak. The agency...
BC Innovations | Aug 26, 2019
Product Development

Vax to the future: How Anthony Fauci is thinking about next-gen vaccines and other NIAID priorities

From his vantage point overseeing NIH’s infectious disease agenda, Anthony Fauci has identified vaccine development as an area poised to make big leaps. He says the institute’s prioritization of platform technologies holds more promise than...
BC Extra | Aug 14, 2019
Company News

Aug. 14 Company Quick Takes: Myriad plunges on sales concerns; plus AbbVie-Allergan, TB Alliance, Akari, Carmine

Myriad falls on sales forecast, GeneSight concerns  Myriad Genetics Inc. (NASDAQ:MYGN) tumbled $19.05 (43%) to $25.50 Wednesday, the day after the molecular diagnostics maker reported 4Q revenues of $215 million, below FactSet’s consensus of $222...
BC Extra | Aug 13, 2019
Company News

Aug. 13 Company Quick Takes: Pharming licenses Novartis' CDZ173; plus Novartis, Merck-Harvard, Mustang, J&J

Pharming licenses Novartis autoimmune candidate  Pharming Group N.V. (Euronext:PHARM) gained rights to PI3Kδ inhibitor CDZ173 from Novartis AG (NYSE:NVS; SIX:NOVN) for patients with activated PI3Kδ syndrome, a primary immune deficiency. Novartis will receive $20 million...
BC Extra | Jun 7, 2019
Company News

June 6 Company Quick Takes: Take two for Celgene's ozanimod; plus Protalix, ABPI, Axovant and Mylan

Celgene resubmits NDA for ozanimod   FDA and EMA accepted submissions from Celgene Corp. (NASDAQ:CELG) for ozanimod to treat multiple sclerosis. The PDUFA date for the selective S1PR1 and S1PR5 modulator is March 25, 2020,...
BC Week In Review | Apr 26, 2019
Company News

FDA panel to review candidate for hard-to-treat tuberculosis

FDA’s Antimicrobial Drugs Advisory Committee will meet June 6 to discuss an NDA from Global Alliance for TB Drug Development (TB Alliance) for oral pretomanid (PA-824) to treat adults with pulmonary extensively drug resistant and...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
BC Week In Review | Aug 31, 2018
Clinical News

TB Alliance starts pivotal trial of four-drug regimen

The Global Alliance for TB Drug Development (TB Alliance) began the pivotal Phase IIc SimpliciTB trial evaluating an oral four-drug regimen called BPaMZ to treat tuberculosis. SimpliciTB will compare BPaMZ, which comprises a once-daily combination...
BC Extra | Aug 28, 2018
Clinical News

TB Alliance starts pivotal trial of four-drug regimen

The Global Alliance for TB Drug Development (TB Alliance) began the pivotal Phase IIc SimpliciTB trial evaluating an oral four-drug regimen called BPaMZ to treat tuberculosis. SimpliciTB will compare BPaMZ, which comprises a once-daily combination...
BioCentury | Aug 5, 2017
Regulation

Enabling efficiency in TB

In combination with adaptive study designs, a real-time biomarker of treatment response that is making its way toward FDA could shave years off the development of tuberculosis regimens, according to multiple stakeholders who attended a...
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