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Dicerna gets FDA orphan drug status for DCR-PH1 to treat primary hyperoxaluria type 1 By PBR Staff Writer
Dicerna Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its therapeutic candidate, DCR-PH1, to treat primary hyperoxaluria type 1 (PH1), a severe, rare, inherited disorder of the liver.
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Oasmia's Paclical cancer drug gets Russian marketing approval By PBR Staff Writer
Sweden-based Oasmia Pharmaceutical has received market authorization from the Russian Ministry of Health for its lead cancer product Paclical in Russia.
Automation > IT & Software > News Mersana's fleximer immunoconjugate shows potent activity in low HER2-expressing tumor models By PBR Staff Writer
US-based Mersana Therapeutics has reported positive preclinical data for its new HER2-targeting therapy, XMT-1522, in the treatment of cancer.
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RXi Pharma gets FDA orphan drug status for melanoma drug samcyprone
By PBR Staff Writer
RXi Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for its second clinical candidate, Samcyprone, to treat malignant melanoma stage IIb to IV.
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CiRA, Takeda to develop iPS cell applications
By PBR Staff Writer
Kyoto University's Center for iPS Cell Research Application (CiRA) and Takeda Pharmaceutical have entered into a ten-year collaboration to jointly develop clinical applications of induced pluripotent stem cells in areas such as heart failure, diabetes mellitus, neurological disorders and cancer immunotherapy.
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Horizon gets FDA fast track status for actimmune to treat Friedreich's ataxia
By PBR Staff Writer
Irish biopharmaceutical firm Horizon Pharma has granted fast track designation from the US Food and Drug Administration (FDA) for actimmune (interferon gamma-1b) to treat Friedreich's ataxia (FA), a degenerative neuro-muscular disorder.
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Adamas' ADS-5102 gets FDA orphan drug status for LID associated with Parkinson's disease
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug status for Adamas Pharmaceuticals' product candidate ADS-5102 to treat levodopa-induced dyskinesia (LID) associated with Parkinson's disease (PD).
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Celgene to buy 15.3 million Mesoblast shares for $45m
By PBR Staff Writer
Australian regenerative medicine firm Mesoblast has entered into an agreement with Celgene, a US-based global biopharmaceutical firm engaged in the development and commercialization of new therapies to treat cancer and immune-inflammatory related diseases.
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Acura to develop hydrocodone/APAP tablets using Limitx technology
By PBR Staff Writer
US-based Acura Pharmaceuticals has started developing an immediate-release hydrocodone bitartrate with acetaminophen tablet (hydrocodone/APAP) incorporating its new LIMITX abuse deterrent technology.
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Celldex reports positive Phase II EMERGE trial of glembatumumab vedotin to treat breast cancer
By PBR Staff Writer
Celldex Therapeutics has reported positive data from the Phase II EMERGE trial of glembatumumab vedotin, an antibody-drug conjugate, in patients with metastatic breast cancer.
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VBI Vaccines, Sanofi Pasteur collaborate to improve vaccine stability
By PBR Staff Writer
US-based biopharmaceutical firm VBI Vaccines has entered into research collaboration with Sanofi Pasteur to use its lipid particle vaccine (LPV) formulation technology to advance the development of a major Sanofi Pasteur vaccine candidate.
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Novartis, Aduro Biotech partner to accelerate cancer immunotherapy efforts
By PBR Staff Writer
Swiss pharmaceutical firm Novartis has entered into a major multiyear collaboration with US-based Aduro Biotech in order to accelerate its cancer immunotherapy efforts.
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RXi, MirImmune to develop cancer immunotherapies using sd-rxRNA technology
By PBR Staff Writer
US-based RXi Pharmaceuticals and MirImmune have entered into an exclusive license agreement to use RXi's new sd-rxRNA technology in developing new cell-based cancer immunotherapies.
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