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91-105 of 2301 results
GlobalData expects IPF market to more than treble to $3.2bn by 2025
By PBR Staff Writer
Research and consulting firm GlobalData expects that the idiopathic pulmonary fibrosis (IPF) market will increase to $3.2bn by 2025 from just more than $900m in 2015.
Drug Research > Drug Delivery > News
Adaptimmune receives positive opinion for orphan drug status in EU for SPEAR T-cell therapy
The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending Adaptimmune Therapeutics' SPEAR T-cell therapy targeting NY-ESO for designation as an orphan medicinal product for the treatment of soft tissue sarcoma, a solid tumor cancer.
Drug Research > Drug Delivery > News
Ariad Pharmaceuticals seeks FDA approval for brigatinib lung cancer drug
By PBR Staff Writer
Ariad Pharmaceuticals has started a new drug application submission in the US for approval of brigatinib in relapsed, anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC).
Drug Research > Drug Delivery > News
Bausch + Lomb launches PreserVision AREDS 2 Formula + Multivitamin
Valeant Pharmaceuticals International's subsidiary, Bausch + Lomb launched new PreserVision® AREDS 2 Formula + Multivitamin.
Drug Research > Drug Delivery > News
PeptiDream earns milestone for initiation of clinical development for BMS’ first collaboration product candidate
PeptiDream, a public Tokyo-based biopharmaceutical company, has earned a milestone for the dosing of a first patient in a clinical trial by its alliance partner, Bristol-Myers Squibb Company (BMS).
Drug Research > Drug Delivery > News
FDA accepts NLS Pharma's IND for phase II study of Mazindol in adults with ADHD
FDA has accepted an investigational new drug (IND) submitted by NLS Pharma, a Swiss biotech group developing next-generation ADHD therapies for a phase II proof-of-concept clinical trial evaluating the use of Mazindol in adults with Attention Deficit Hyperactivity Disorder (ADHD).
Drug Research > Drug Delivery > News
Therapix Biosciences files application with FDA to approve orphan designation for THX-RS01 drug
Therapix Biosciences has filed an application with the U.S. Food and Drug Administration to approve an orphan drug designation for a drug (THX-RS01) developed based on the entourage technology, which combines cannabinoid substances in treating Tourette syndrome.
Drug Research > Drug Delivery > News
Teva voluntarily suspends marketing for ZECUITY in US
Teva Pharmaceutical Industries announced that it will voluntarily suspend sales, marketing and distribution of ZECUITY (sumatriptan iontophoretic transdermal system).
Drug Research > Drug Delivery > News
Shire secures FDA breakthrough therapy designation for two rare GI drugs
By PBR Staff Writer
Shire has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for two investigational products, SHP621 and SHP625, for rare gastrointestinal (GI) conditions.
Drug Research > Drug Delivery > News
FDA accepts to review sNDA for 72 mcg dose of linaclotide in chronic idiopathic constipation
Ironwood Pharmaceuticals and Allergan announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the 72 mcg dose of linaclotide for use in the treatment of adults with chronic idiopathic constipation (CIC).
Drug Research > Drug Delivery > News
Clinigen, Basilea start MA program for isavuconazole to treat patients with invasive fungal infections in Europe
Clinigen Group and Basilea Pharmaceutica International have initiated a Managed Access program for isavuconazole to treat patients with invasive fungal infections in those European countries where isavuconazole has been approved but is not yet commercially available.
Drug Research > Drug Delivery > News
Lion Biotechnologies closes $100m private financing
Lion Biotechnologies has closed its previously announced private financing with institutional and other accredited investors.
Drug Research > Drug Delivery > News
Insmed withdraws marketing authorization application for ARIKAYCE in Europe
Insmed has withdrawn its Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for ARIKAYCE for the treatment of nontuberculous mycobacteria (NTM) lung disease.
Drug Research > Drug Delivery > News
FDA grants orphan drug designation to Debio 1143 to treat ovarian cancer
The FDA Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation to Debiopharm International's Debio 1143 for treatment of Ovarian Cancer.
Drug Research > Drug Delivery > News
Genisphere signs collaborative research, option to license deal with MedImmune
Genisphere, provider of the 3DNA drug delivery platform, has executed a collaborative research and option to license agreement with MedImmune, the global biologics research and development arm of AstraZeneca.
Drug Research > Drug Delivery > News
91-105 of 2301 results