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Galapagos reports 20-week results from FITZROY study with JAK1 inhibitor filgotinib in Crohn's disease
Galapagos reported 20-week results from its FITZROY study with the investigational, selective JAK1 inhibitor filgotinib in Crohn's disease.
Drug Research > Drug Delivery > News
Tris Pharma launches DYANAVEL XR oral suspension, CII to treat Children with ADHD
Tris Pharma has launched DYANAVEL XR (amphetamine), CII, the first and only extended-release liquid amphetamine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older.
Drug Research > Drug Delivery > News
FDA finds no finds no deficiency with Heron Therapeutics' Sustol NDA
By PBR Staff Writer
The US Food and Drug Administration (FDA) has indicated that there are no substantive deficiencies in Heron Therapeutics' new drug application (NDA) for Sustol (granisetron) Injection (extended release) to treat acute and delayed chemotherapy-induced nausea and vomiting (CINV).
Drug Research > Drug Delivery > News
WHO expert panel recommends use of Sanofi Pasteur's dengue vaccine in endemic countries
By PBR Staff Writer
The World Health Organization's (WHO) strategic advisory group of experts had recommended the use of Sanofi Pasteur's Dengvaxia dengue vaccine in endemic countries.
Drug Research > Drug Delivery > News
Shire submits NDA to FDA for new formulation of Vyvanse CII as chewable tablets
Shire has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a new, alternate formulation of Vyvanse (lisdexamfetamine dimesylate) as a chewable tablet for patients who may have difficulty swallowing or opening a capsule.
Drug Research > Drug Delivery > News
Synthon secures approval for glatiramer acetate 20 mg/mL in Europe
Synthon has successfully concluded the decentralized procedures for glatiramer acetate, a therapeutically equivalent version of the originator medicine Copaxone for the treatment of relapsing remitting multiple sclerosis (RRMS).
Drug Research > Drug Delivery > News
Boehringer Ingelheim's Giotrif secures new NSCLC licence in Europe
The European Commission (EC) has granted marketing authorisation for Boehringer Ingelheim's Giotrif (afatinib) for the treatment of patients with advanced squamous cell carcinoma (SqCC) of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy.
Drug Research > Drug Delivery > News
FDA places clinical hold on late-stage study on IONIS-TTRRx
Ionis Pharmaceuticals provided an update on the IONIS-TTRRx program.
Drug Research > Drug Delivery > News
FDA accepts Adaptimmune's NDA for affinity enhanced T-Cell therapy targeting AFP in liver cancer
The US Food and Drug Administration (FDA) has accepted Adaptimmune Therapeutics' investigational new drug (IND) application for autologous genetically modified T-cells expressing affinity enhanced T-cell receptors (TCRs) specific for alpha fetoprotein (AFP) in patients with locally advanced or metastatic hepatocellular carcinoma, the sixth most common cancer worldwide.
Drug Research > Drug Delivery > News
EC adopts CHMP recommendation to change terms of marketing authorisation for Ruconest
Pharming Group announced that the European Commission adopted the CHMP recommendation to include the treatment of HAE attacks in adolescents with HAE and to remove the requirements for rabbit IgE testing that formed part of the EU label for RUCONEST.
Drug Research > Drug Delivery > News
Lumos Pharma raises $34m in Series B financing
Lumos Pharma, a biotechnology company focused on developing therapeutics for orphan diseases, has completed a $34m Series B financing.
Drug Research > Drug Delivery > News
XBiotech's Xilonix marketing application granted accelerated review in Europe
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted accelerated review for marketing authorization of XBiotech's Xilonix true human monoclonal (IgG1k) antibody to treat advanced colorectal cancer.
Drug Research > Drug Delivery > News
Bristol-Myers wins positive CHMP opinion for Opdivo in combination with Yervoy to treat advanced melanoma
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Bristol-Myers Squibb's Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Drug Research > Drug Delivery > News
Taiho’s TAS-102 meets primary endpoint of improving overall survival in phase III study in patients with refractory mCRC
Taiho Pharmaceutical Co., Ltd. of Tokyo announced on April 1 results from its Phase III TERRA study on its oral combination anticancer drug TAS-102 (product name in Japan and the US LONSURF, nonproprietary names: trifluridine (FTD) and tipiracil (TPI)) in Asian(China, South Korea and Thailand) patients with refractory metastatic colorectal cancer (mCRC).
Drug Research > Drug Delivery > News
Humanwell Healthcare and PuraCap Pharmaceutical to buy Epic Pharma
Humanwell Healthcare Group and PuraCap Pharmaceutical have entered into a definitive agreement to acquire 100% of the membership interests of Epic Pharma, LLC of Laurelton, NY for $550m.
Drug Research > Drug Delivery > News
136-150 of 2301 results