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151-165 of 2292 results
EMA reviews cancer medicine Zydelig
The European Medicines Agency (EMA) has, at the request of the European Commission, started a review of the cancer medicine Zydelig (idelalisib), which is authorised in the EU to treat two types of rare blood cancers called chronic lymphocytic leukaemia and follicular lymphoma (one of a group of cancers called non-Hodgkin lymphoma).
Drug Research > Drug Delivery > News
FDA accepts Aeglea's IND application for AEB1102 to treat hematological malignancies
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Aeglea BioTherapeutics' investigational new drug (IND) application for AEB1102 to treat patients with hematological malignancies.
Drug Research > Drug Delivery > News
Actinium Pharmaceuticals starts pursuit of EU Orphan Designation for Iomab-B
Actinium Pharmaceuticals has engaged a leading European-based regulatory affairs consulting firm to pursue orphan medicines designation by the European Medicines Agency (EMA) for Iomab-B.
Drug Research > Drug Delivery > News
Grindeks says Meldonium should not be included in prohibited list
By PBR Staff Writer
Latvian pharmaceutical firm Grindeks said meldonium should not be included in the prohibited list after tennis star Maria Sharapova tested positive for the drug.
Drug Research > Drug Delivery > News
XBiotech submits MAA for candidate colorectal cancer therapy to European Medicines Agency
XBiotech has submitted its Marketing Authorization Application (MAA) for its candidate therapy (Xilonix) for advanced colorectal cancer to the European Medicines Agency (EMA).
Drug Research > Drug Delivery > News
GSK asthma drug Nucala's Cosmos study demonstrates safety profile
By PBR Staff Writer
GlaxoSmithKline (GSK) said its asthma drug, Nucala, demonstrated a similar safety profile in a long-term study compared with previous trials.
Drug Research > Drug Delivery > News
Vaxart starts preclinical testing of oral Zika virus vaccine
Vaxart has initiated preclinical testing of an oral vaccine for Zika virus.
Drug Research > Drug Delivery > News
Clinigen acquires US-approved Totect from Biocodex
Clinigen Group has acquired Totect (dexrazoxane) from Biocodex USA, a product that is patent protected in US, Canada and Mexico.
Drug Research > Drug Delivery > News
McKesson to buy Canadian drug store chain Rexall Health for $2.2bn
By PBR Staff Writer
McKesson has agreed to acquire Canadian pharmacy drug store chain Rexall Health from Katz Group for C$3bn ($2.2bn).
Drug Research > Drug Delivery > News
Savara Pharmaceuticals closes $20m Series C financing round
Savara Pharmaceuticals has closed a $20m Series C financing round.
Drug Research > Drug Delivery > News
FDA accepts Genentech's sBLA to extend indication of Xolair in allergic asthma to pediatric patients
The US Food and Drug Administration (FDA) has accepted for review Genentech's supplemental Biologics License Application (sBLA) to extend the indication of Xolair (omalizumab) in allergic asthma to pediatric patients.
Drug Research > Drug Delivery > News
FDA issues recommendations to reduce risk of Zika virus transmission by human cell and tissue products
As an additional safety measure against the emerging Zika virus outbreak, the U.S. Food and Drug Administration today issued new guidance for immediate implementation providing recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Drug Research > Drug Delivery > News
Concert Pharmaceuticals says CTP-656 solid dose phase 1 results confirmed superior pharmacokinetic profile to Kalydeco
Concert Pharmaceuticals announced new results from Part 1 of its multiple ascending dose Phase 1 clinical trial in which a single-dose tablet formulation of CTP-656 was compared to the commercial tablet formulation of Kalydeco, the current standard of care for cystic fibrosis patients with gating mutations
Drug Research > Drug Delivery > News
Retrophin secures European orphan drug designation for RE-024 to treat pantothenate kinase-associated neurodegeneration
The European Commission has granted orphan drug designation to RE-024, Retrophin's novel investigational phosphopantothenate replacement therapy for pantothenate kinase-associated neurodegeneration (PKAN), a rare and life-threatening genetic disorder with no approved treatment option.
Drug Research > Drug Delivery > News
AstraZeneca invests in US oral biologics firm Rani Therapeutics
By PBR Staff Writer
Anglo-Swedish pharma giant AstraZeneca has invested in the US-based oral biologics firm Rani Therapeutics.
Drug Research > Drug Delivery > News
151-165 of 2292 results