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Pharmaceutical Business Review

FDA accepts to review Merck and Sanofi Pasteur’s BLA for pediatric hexavalent vaccine The US Food and Drug Administration (FDA) has accepted to review Merck and Sanofi Pasteur's Biologics License Application (BLA) filed for their investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB. Drug Research > Drug Delivery > News
Novartis' plaque psoriasis drug candidate AIN457 gets FDA committee recommendation By PBR Staff Writer
The US Food and Drug Administration's (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) has approved Novartis' AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, to treat moderate-to-severe plaque psoriasis in adult patients.
News Matinas submits IND for MAT9001 to treat severe hypertriglyceridemia By PBR Staff Writer
US-based biopharmaceutical firm Matinas BioPharma Holdings has submitted an investigational new drug application (IND) for its lead drug candidate, MAT9001, to the US Food and Drug Administration (FDA) for the treatment of severe hypertriglyceridemia (TG>500mg/dL).
News Baxter introduces Hyqvia in US to treat primary immunodeficiency By PBR Staff Writer
Baxter International and Halozyme Therapeutics have launched Hyqvia as a subcutaneous immunoglobulin treatment for adult patients with primary immunodeficiency (PI) in the US.
News
Enanta Pharmaceuticals provides update on its collaboration agreement with AbbVie Enanta Pharmaceuticals, a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, has announced that it has decided not to exercise its co-development option for ABT-493, Enanta’s next-generation protease inhibitor for hepatitis C virus (HCV) being developed in Enanta’s collaboration with AbbVie.
News Revalesio's RNS60 shows promise in treating Alzheimer's disease and other dementias Revalesio and Rush University Medical Center's Department of Neurological Sciences published findings from two research studies that demonstrate the potential for RNS60 to treat Alzheimer's disease and other forms of dementia by protecting neuronal function, restoring neuronal connections and promoting neuronal plasticity.
News Cannabics Pharmaceuticals receives Cannabinoid R&D lab certification in Israel Cannabics Pharmaceuticals has received Government Certification from the Ministry of Health in Israel for the establishment of an advanced R&D laboratory dedicated to medical research in the field of cannabinoid science.
News

Latest News and Insight by Sector

Production & Manufacturing

Matinas submits IND for MAT9001 to treat severe hypertriglyceridemia
By PBR Staff Writer
US-based biopharmaceutical firm Matinas BioPharma Holdings has submitted an investigational new drug application (IND) for its lead drug candidate, MAT9001, to the US Food and Drug Administration (FDA) for the treatment of severe hypertriglyceridemia (TG>500mg/dL).
News
Baxter introduces Hyqvia in US to treat primary immunodeficiency
By PBR Staff Writer
Baxter International and Halozyme Therapeutics have launched Hyqvia as a subcutaneous immunoglobulin treatment for adult patients with primary immunodeficiency (PI) in the US.
News

Drug Research

Apricus expands development pipeline with in-licensing of US rights for fispemifene
Apricus Biosciences has licensed the U.S. development and commercialization rights for a novel selective estrogen receptor modulator ("SERM"), fispemifene, an investigational treatment for urological conditions in men, from Forendo Pharma, a private therapeutics company based in Finland.
News
FDA accepts to review Merck and Sanofi Pasteur’s BLA for pediatric hexavalent vaccine
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review Merck and Sanofi Pasteur's Biologics License Application (BLA) filed for their investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB.
News

Inward Investment

Endo International to buy Auxilium Pharmaceuticals for $2.6bn
By PBR Staff Writer
Ireland-based Endo International has signed an agreement to acquire Auxilium Pharmaceuticals, in a deal that is worth nearly $2.6bn.
News
Endo offers $2.2bn to acquire Auxilium
By PBR Staff Writer
Irish pain drugmaker Endo International has proposed $2.2bn offer to acquire biopharmaceutical company Auxilium Pharmaceuticals.
News

Packaging

Packaging Coordinators completes acquisition of Biotec
By PBR Staff Writer
Packaging services provider Packaging Coordinators (PCI) has completed the acquisition of UK-based pharmaceutical services provider Biotec for an undisclosed amount.
News
Biologics adds frozen storage capabilities to clinical research services
By PBR Staff Writer
Biologics’ Clinical Research Services has announced the addition of frozen storage capabilities to its state-of-the-art facilities and cold-chain packaging and distribution.
News

Contract Research & Services

Enanta Pharmaceuticals provides update on its collaboration agreement with AbbVie
Enanta Pharmaceuticals, a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, has announced that it has decided not to exercise its co-development option for ABT-493, Enanta’s next-generation protease inhibitor for hepatitis C virus (HCV) being developed in Enanta’s collaboration with AbbVie.
News
Revalesio's RNS60 shows promise in treating Alzheimer's disease and other dementias
Revalesio and Rush University Medical Center's Department of Neurological Sciences published findings from two research studies that demonstrate the potential for RNS60 to treat Alzheimer's disease and other forms of dementia by protecting neuronal function, restoring neuronal connections and promoting neuronal plasticity.
News

Automation

MedImmune’s Phase I OX40 agonist trial uses AgonOx’s OX40 platform
By PBR Staff Writer
US-based biotechnology firm AgonOx has announced that its OX40 platform is being used in AstraZeneca's global biologics research and development arm MedImmune’s Phase I trial of its humanized OX40 agonist, MEDI6383.
News
Aduro expands deal with Janssen to develop product candidates for lung cancer
By PBR Staff Writer
Aduro BioTech has entered into its second agreement with Janssen Biotech, granting an exclusive, worldwide license to certain product candidates designed to treat lung cancer and certain other cancers based on its novel LADD immunotherapy platform.
News

Regulatory Affairs

Novartis' plaque psoriasis drug candidate AIN457 gets FDA committee recommendation
By PBR Staff Writer
The US Food and Drug Administration's (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) has approved Novartis' AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, to treat moderate-to-severe plaque psoriasis in adult patients.
News
Pharmacyclics' Imbruvica gets European approval to treat two blood cancers
By PBR Staff Writer
The European Commission (EC) has granted marketing approval for Pharmacyclics' Imbruvica (ibrutinib), a first-in-class, oral, once-daily, non-chemotherapy treatment for patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukemia (CLL).
News

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