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Drug Development Pharma

karolinska-institutet-science-park
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Aprea enters research collaboration

Aprea Therapeutics announces a collaboration with Memorial Sloan Kettering Cancer Center to study the effects of reactivation of tumor suppressor protein p53 by APR-246. The goal of the collaboration is to evaluate and characterize preclinical efficacy of APR-246 in combination with multiple other anti-cancer agents and across multiple tumor types.…

lars-hedbys
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Idogen’s technology granted European patent

Idogen announces that the European Patent Office will formally grant a patent application, covering the company’s tolerogenic vaccine technology. The EPO approval strengthens the company’s patent portfolio for the vaccine technology. A patent in the same patent family has already been granted in Japan and a Notice of Allowance has…

sobi-study
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Sobi receives approval from the EMA

Swedish Orphan Biovitrum has received approval from the European Medicines Agency (EMA) for the grouped type II 15 K Variation for Elocta (efmoroctocog alfa). The variation involves several changes, including the approval of Elocta drug substance manufacturing in 15 000 litre scale bioreactors.  Elocta is a recombinant extended half-life factor VIII…

sean_bohen_AZ
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AZ’s Siliq approved by the FDA

AstraZeneca’s partner Valeant Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved Siliq (brodalumab) injection for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.…

copenhagen
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Denmark bids to host EMA headquarters in Copenhagen

Last week, the Danish Government officially announced its candidacy for hosting the European Medicines Agency (EMA) in Denmark. ”The Danish Medicines Agency is excited about the Danish Government’s decision. The EMA is the most important European coordination forum in the pharmaceutical field, and Copenhagen offers a visionary and innovative life…

sara-gunnerås
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Swedish drug development on the rise

Earlier today, SwedenBIO presented its annual report on the Swedish drug discovery and development pipeline, showing for example that the number of clinical stage drug development projects has increased from 63 to 144 in 5 years. The report provides facts and figures about the current Swedish drug development pipeline for…

sobi
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Sobi’s SOBI003 granted orphan designation

Swedish Orphan Biovitrum has been granted orphan designation by the European Commission (EC) for the company’s development product candidate SOBI003, a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome). SOBI003 will be included in the EU Community Register of Orphan Medicinal Products. MPS…

nordic nanovector
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New findings from Nordic Nanovector

Nordic Nanovector announces that two papers recently published in The Journal of Nuclear Medicine have shown that pre-dosing with the anti-CD37 antibody lilotomab (previously referred to as HH1), prior to injection with Betalutin (177Lu-lilotomab) reduces haematological toxicity without adversely impacting the amount of radiation absorbed by the tumour. Betalutin is…

jan_van_de_winkel
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Genmab announces European Regulatory Submission

Genmab announced yesterday that Janssen Pharmaceutica has submitted a variation to the Marketing Authorization to the European Medicines Agency (EMA) seeking to broaden the existing marketing authorization for daratumumab (DARZALEX) to include treatment of adult patients with multiple myeloma who have received at least one prior therapy. The submission of…

alzheimers
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AZ, Lilly receive fast track designation

AstraZeneca and Eli Lilly and Company have received US Food and Drug Administration (FDA) Fast Track designation for the development programme in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial. The FDA’s Fast Track programme is designed to expedite the…

lundbeck
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Lundbeck’s Idalopirdine granted Fast Track Designation

Lundbeck and Otsuka Pharmaceutical Development & Commercialization has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational agent idalopirdine for the treatment of mild to moderate Alzheimer’s disease. Idalopirdine is a selective 5HT6 receptor antagonist with a different hypothesized mechanism of action…

genmab
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Genmab submits FDA application for Daratumumab

Genmab has announced that its licensing partner, Janssen Biotech, Inc. has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the use of daratumumab (DARZALEX) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who…