00:47 , Jun 29, 2019 |  BioCentury  |  Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
00:12 , Jun 7, 2019 |  BC Extra  |  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,...
20:40 , Apr 26, 2019 |  BC Week In Review  |  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...
18:10 , Aug 31, 2018 |  BC Week In Review  |  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...
20:43 , Aug 28, 2018 |  BC Extra  |  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...
00:06 , Aug 5, 2017 |  BioCentury  |  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...
07:00 , Oct 19, 2015 |  BioCentury  |  Regulation

Unleashing China's innovators

An ambitious slate of reforms proposed by China's State Council could at last relieve the regulatory bottlenecks that have long hobbled development of innovative drugs in and for China by domestic and multinational pharmas alike....
07:00 , May 18, 2015 |  BC Week In Review  |  Clinical News

PA-824: Phase III started

Not-for-profit TB Alliance began the open-label, South African Phase III Nix-TB trial to evaluate the all-oral regimen of PA-824, Sirturo bedaquiline and Zyvox linezolid in about 200 patients ages >=14. Patients will receive 400 mg...
02:18 , Feb 20, 2015 |  BC Extra  |  Clinical News

TB Alliance begins Phase I trial of TBA-354

The not-for-profit Global Alliance for TB Drug Development began a U.S. Phase I trial of tuberculosis (TB) treatment TBA-354. TB Alliance said the next generation nitroimidazole is the first new TB candidate to enter clinical...
08:00 , Jan 9, 2015 |  BC Extra  |  Company News

Shanghai Fosun boosts R&D budget for innovation

Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKSE:2196) expects to spend more than RMB5 billion ($803.5 milllion) on R&D over a five-year period spanning 2016-20. Fosun said it spent RMB1.5 billion ($238.2 million) on R&D...