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Product Development

The Phase III trials and pharma sales most likely to be disrupted by COVID-19

The coronavirus outbreak comes at a time when many major multinational pharmas are betting big on the China market for future growth. In an analysis of MNC revenues and dependence on trial sites in China,...

WHO mapping out COVID-19 vaccines

Scientists from biopharma companies, universities and regulatory agencies met at the WHO Feb. 11-12 to draw a roadmap for the development of vaccines to protect against COVID-19 amid a rapidly shifting terrain. While knowledge about...

Preclinical potencies of clinical COVID-19 candidates

Among the several dozen agents in clinical testing for COVID-19, in vitro data against the new coronavirus have only been reported for four, and they support the WHO’s prioritization of remdesivir from Gilead Sciences Inc....

AML’s growing options

For acute myelogenous leukemia patients, 2017 marked the end of a more than 40 year drought in which chemotherapy was the only treatment option. In the last three years, eight new AML therapies have come...

Feb. 13 Product Development Quick Takes: Priority Review for BMS, Seattle Genetics, Deciphera therapies; plus Roche, Ipsen, Merck, Eisai and Amgen-Pfizer

August decision dates for BMS, Seattle Genetics, Deciphera  A trio of cancer therapies have received Priority Review from FDA with August PDUFA dates. Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted a BLA for lisocabtagene maraleucel...

COVID-19 update: Gilead ramping up remdesivir production; Codagenix partners with vaccine giant

Gilead is ramping up manufacturing of remdesivir, which is being tested as a potential treatment for COVID-19, the company told BioCentury Thursday. Gilead said it has not been in contact with BrightGene, a Chinese company...

COVID-19 update: Remdesivir readout in weeks; hospital-use diagnostic under development; antibodies advancing

Initial signals from two ongoing trials in China of Gilead’s remdesivir to treat COVID-19 should be available in a few weeks, Marie-Paule Kieny said at a WHO press conference Wednesday. Assistant Director-General Kieny co-chaired the...

Feb. 11 Product Development Quick Takes: J&J gets BARDA funding for COVID-19 vaccine; plus Novartis-Incyte, LogicBio and Elicio-Natera

BARDA to support Janssen COVID-19 vaccine R&D Johnson & Johnson (NYSE:JNJ) announced a collaboration with HHS that will speed development of a clinical COVID-19 (2019-nCoV) vaccine by its Janssen Pharmaceutical unit. The Biomedical Advanced Research...

Freeline seeking ‘normal’ Factor IX activity via hemophilia gene therapy

Freeline has posted clinical potency data for its hemophilia B gene therapy that suggest its treatment could outperform its more advanced competitors. Chris Hollowood, Freeline Therapeutics Ltd. executive chairman and Syncona Ltd. chief investment officer,...

Exelixis eyeing 2021 combo submission in prostate cancer following new readout

Exelixis believes newly released initial data from a Phase Ib trial cohort to treat prostate cancer could augur future results from the same twice-expanded cohort that could support a regulatory submission of cabozantinib plus Tecentriq...

Alzheimer’s prevention replays the same amyloid failures as the treatment setting

The Phase II/III DIAN-TU trial of Lilly’s solanezumab and Roche’s gantenerumab was always a long shot, given the previous late-stage failures of both agents in Alzheimer’s trials. Perhaps more surprising is that both compounds remain...

Feb. 10 Product Development Quick Takes: Priority Review for Gilead CAR T cell therapy; plus Zai, Aquestive, Biohaven, Oculis, Blue Water, GlycoMimetics, Fluidi

Gilead’s second CAR T under Priority Review  Gilead Sciences Inc. (NASDAQ:GILD) said FDA accepted and granted Priority Review to a BLA for KTE-X19 to treat adults with relapse or refractory mantle cell lymphoma. The anti-CD19...

Adverum gains on Phase I data showing efficacy for wet AMD gene therapy

Updated interim data for Adverum’s intravitreal wet age-related macular degeneration gene therapy bolstered the company’s case that the product could compete with less convenient subretinal gene therapies for the indication. Adverum rose $1.81 (18%) to...

vTv’s potential first-in-class therapy heading for Phase III after clearing Type I diabetes hurdle

Based on the 52% bump that vTv’s shares received on Monday, investors believe new data from a Phase II trial of the company’s glucokinase activator to treat Type I diabetes could portend further success in...

As coronavirus disrupts MNC operations in China, companies look to digital solutions

The coronavirus outbreak in China has triggered a stark call to action across the international biopharma community to treat, diagnose and prevent the spread of the virus, but it has also revealed some cracks in...