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136-150 of 50701 results
Roche secures priority review from FDA for haemophilia A drug emicizumab
By PBR Staff Writer
Roche's emicizumab prophylaxis (preventative) has been granted priority review by the US Food and Drug Administration (FDA) for haemophilia A with factor VIII inhibitors.
Production & Manufacturing > Process & Production > News
Apellis’ APL-2 meets primary endpoint in phase 2 study in patients with geographic atrophy
Apellis Pharmaceuticals’ complement C3 inhibitor, APL-2, met its primary endpoint in phase 2 clinical trial conducted on patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD).
Contract Research & Services > Clinical Trials > News
Cancer Research UK launches clinical trial to test new cancer drug
Cancer Research UK has launched a clinical study to evaluate a new cancer drug in patients with advanced solid tumours in four centres across the UK through its Centre for Drug Development.
Contract Research & Services > Clinical Trials > News
Ultragenyx’ Ace-ER fails in phase 3 GNE Myopathy trial
Ultragenyx Pharmaceutical’s phase 3 study evaluating aceneuramic acid extended release (Ace-ER) in patients with GNE Myopathy (GNEM) failed to meet primary endpoint of showing a statistically significant difference in the upper extremity muscle strength composite score compared to placebo.
Contract Research & Services > Clinical Trials > News
Epygenix gets FDA orphan drug status for EPX-300 to treat Dravet Syndrome
Epygenix Therapeutics has secured orphan drug status from the US Food and Drug Administration (FDA) for its EPX-300 to treat patients with Dravet Syndrome.
Production & Manufacturing > Process & Production > News
ViraCyte announces positive phase 2 trial results
ViraCyte has announced publication of positive data from a Phase 2 clinical trial evaluating its most advanced T-cell immunotherapy product, Viralym-M.
Contract Research & Services > Clinical Trials > News
Grid Therapeutics signs exclusive license agreement to develop novel immuno-oncology antibody
Grid Therapeutics has signed an exclusive license agreement with Duke University to develop the first human derived antibody as a targeted immunotherapy for cancer.
News
Boehringer initiates phase 1 trials of Zealand’s analogs for obesity and diabetes
By PBR Staff Writer
Zealand Pharma says that its partner Boehringer Ingelheim has launched phase 1 clinical trials to assess glucagon/GLP-1 agonist and an amylin analog as new treatment options for obesity and diabetes.
Contract Research & Services > Clinical Trials > News
Pfizer-led consortium begins trial of metastatic breast cancer treatment palbociclib
By PBR Staff Writer
Pfizer, along with Alliance Foundation Trials (AFT) and six other international cancer research groups, has commenced a phase 3 clinical study to assess palbociclib (Ibrance) for the treatment of patients with metastatic breast cancer.
Contract Research & Services > Clinical Trials > News
Ovid Therapeutics recruits first patient in phase 1b/2a trial of TAK-935/OV935 in adults with rare epilepsies
Ovid Therapeutics announced it has randomized the first patient in its Phase 1b/2a clinical trial of TAK-935, also known as OV935, in collaboration with Takeda Pharmaceutical Company Limited.
Contract Research & Services > Clinical Trials > News
EC grants new indication for Soliris to treat refractory generalized myasthenia gravis
Alexion Pharmaceuticals announced that the European Commission (EC) approved the extension of the indication for Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
Regulatory Affairs > News
AstraZeneca, MedImmune, Ethris to develop mRNA therapies for respiratory diseases
By PBR Staff Writer
AstraZeneca and its research and development arm MedImmune have entered into five-year strategic research collaboration with Ethris to develop mRNA therapies for respiratory diseases.
Production & Manufacturing > Manufacturing > News
Ironwood’s Duzallo gets FDA approval for gout-associated hyperuricemia
By PBR Staff Writer
Ironwood Pharmaceuticals’ Duzallo has been approved by the US Food and Drug Administration (FDA) for the treatment of hyperuricemia in patients with uncontrolled gout.
Regulatory Affairs > News
Ligand to receive $2m from WuXi for licensing clinical-stage anti-PD-1 antibody
Ligand Pharmaceuticals will get a payment of $2m from WuXi Biologics subsequent to their licensing of exclusive rights to the anti-PD-1 antibody GLS-010 to Arcus Biosciences in North America, Europe, Japan and other selected territories.
Contract Research & Services > Contract Services > News
Samsung Bioepis, Takeda to co-develop multiple novel biologic therapies
Samsung Bioepis has signed collaboration agreement with Takeda Pharmaceutical to jointly fund and co-develop multiple novel biologic therapies in unmet disease areas.
Drug Research > Drug Discovery & Development > News
136-150 of 50701 results