FDA – Page 6 – pharmaceutical daily

August 11, 2017 Off

FDA grants priority review designation to Gilead Sciences’s HIV drug

The U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for Gilead Sciences’s investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection.

August 7, 2017 Off

FDA’s input on product-specific guidances for generic drug development

By Dino Mustafić

FDA has published 48 finalized product-specific guidances describing its current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.

August 4, 2017 Off

Portola Pharmaceuticals resubmits biologics license application for AndexXa

By Dino Mustafić

Portola Pharmaceuticals has resubmitted its Biologics License Application (BLA) to the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) for AndexXa (andexanet alfa), a reversal agent for Factor Xa inhibitors.

August 2, 2017 Off

FDA accepts AstraZeneca’s drug for multiple B-cell and other cancers.

By Dino Mustafić

The US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor, developed by AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma. This potential new medicine is in development for the treatment of multiple B-cell and other cancers.

July 26, 2017 Off

Ablynx’s Nanobody Fast Track listed by the US FDA, third phase study report in 2017

By Dino Mustafić

Ablynx was granted Fast Track designation for caplacizumab, by the that the U.S. Food and Drug Administration (FDA). That’s the company’s first-in-class anti-von Willebrand factor (vWF) Nanobody developed for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).

July 25, 2017 Off

FDA provides further guidance for HedgePath’s phase 2 study of Gorlin Syndrome capsules

By Dino Mustafić

HedgePath Pharmaceuticals said on Tuesday that the U.S. Food and Drug Administration (FDA) has provided further guidance regarding HPPI’s ongoing, open-label Phase 2 clinical trial studying the effect of SUBA-Itraconazole (SUBA-Cap) oral capsules in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome.

July 21, 2017 Off

Strong FDA workforce for patients’ benefits, scientists invited to join

By Dino Mustafić

The new efforts the FDA is making will provide a solid foundation for recruitment and for responsibly managing our user fee resources, Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration said at the beginning of the week.

July 19, 2017 Off

FDA accepts new IND to expand in U.S. IFNalpha kinoid clinical development program in dermatomyositis

By Dino Mustafić

The U.S. Food and Drug Administration (FDA) has cleared Neovacs’s Investigational New Drug (IND) application for IFNalpha Kinoid in the treatment of dermatomyositis, which allows the Company to initiate in the US its Phase IIa clinical trial already on-going in European countries.

July 18, 2017 Off

Gilead’s tablet for unsuccessfully treated patients with other HCV drugs cleared in USA

By Dino Mustafić

The U.S. Food and Drug Administration on Tuesday approved Gildad’s Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir.

July 18, 2017 Off

FDA OK’s Puma Biotechnology’s cancer drug

By Dino Mustafić

The U.S. Food and Drug Administration has approved Puma Biotechnology’s neratinib for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.