HIkma responds to FDA about GSK’s Advair Diskus
Hikma has submitted to the US Food and Drug Administration (FDA) its response to deficiencies in its abbreviated new drug application (ANDA) for a generic version of GlaxoSmithKline’s Advair Diskus® (fluticasone propionate and salmeterol inhalation powder).
Former FDA Reviewer joins Nuventra Pharma Sciences
DURHAM, N.C.–(BUSINESS WIRE)–Nuventra Pharma Sciences is pleased to announce the addition of Iftekhar Mahmood, Ph.D., to its growing team of
Neopharma, Elevar Therapeutics form JV to sell anticancer drug Rivoceranib
Abu Dhabi-based pharmaceutical manufacturer Neopharma and US-based Elevar Therapeutics formed a 50-50 joint venture in UAE, to organize selling Rivoceranib, a targeted anticancer drug and conduct clinical trials for other pipeline candidates.
FDA reviews Foamix’s NDA for minocycline topical foam for Rosacea
The FDA has accepted for review Foamix’s New Drug Application (NDA) for FMX103 (minocycline topical foam 1.5%) topical foam, for the treatment of moderate-to-severe papulopustular rosacea in adults.
Takeda sheds select OTC and non-core assets to Acino for over $200 M
Takeda said Tuesday it will sell certain OTC and non-core assets for over $200 million to ACino, to accelerate deleveraging as it said it will simplify portfolio in Takeda’s NEMEA region.
MAGBIO Genomics makes automation friendly RNA purification chemistry for Mawi iSWAB-RNA-v2
HAYWARD, Calif.–(BUSINESS WIRE)–#Africa–Mawi DNA Technologies, a biotechnology company focusing on the development of innovative technologies for biosampling, announces that MAGBIO
Teva to Present New Analyses of Fremanezumab Efficacy and Safety in Adult Patients with Difficult-to-Treat Migraine at 19th Congress of the International Headache Society
Late breaking data examines 10-year cost effectiveness of fremanezumab, while one oral presentation and 29 posters highlight FOCUS Phase IIIb study data in adult patients with migraine and documented inadequate response to 2-4 classes of prior preventive treatments, along with patient survey results and post hoc efficacy results following the 1-year Phase III HALO long-term study
Nexien BioPharma announces that it has been granted a patent by the Israeli Patent Office covering the use of cannabinoids and terpenes for treatment of organophosphate and carbamate toxicity – two common nerve agents
Nexien BioPharma was granted patent for “Use of Cannabinoids and Terpenes for Treatment of Organophosphate and Carbamate Toxicity” by the Israeli Patent Office.
BiondVax Pharmaceuticals enrolls first patients to test flu vaccine candidate
@BiondVax Pharmaceuticals has enrolled first participants in the second cohort of the pivotal, clinical efficacy, Phase 3 trial of the M-001 universal #flu #vaccine candidate.
Teva Presents Positive Results Showing Improvement in Disability and Quality of Life from the Phase IIIb FOCUS study of Fremanezumab in Adults with Migraine
These results include reduction in monthly average migraine days; reduction in migraine related symptoms; and improvements in depression status; work productivity and activity impairment.