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46-60 of 1839 results
FDA grants orphan drug status to Alexion Pharmaceuticals' ALXN1210
Alexion Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for ALXN1210, a highly innovative, longer-acting anti-C5 antibody that inhibits terminal complement, which is being assessed to treat patients with paroxysmal nocturnal hemoglobinuria (PNH).
Production & Manufacturing > Process & Production > News
FDA grants priority review for Bayer's Stivarga marketing application for liver cancer
The US Food and Drug Administration (FDA) has granted priority review status for Bayer's supplemental New Drug Application (sNDA) for Stivarga (regorafenib) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma (HCC).
Production & Manufacturing > Process & Production > News
FDA accepts to review Ironwood’s NDA for gout drug Duzallo
By PBR Staff Writer
Ironwood Pharmaceuticals’ new drug application (NDA) for its gout drug candidate, Duzallo, has been accepted for review by the US Food and Drug Administration (FDA).
Production & Manufacturing > Process & Production > News
Ionis’ type 2 diabetes candidate shows positive results in phase 2 study
Ionis Pharmaceuticals has reported positive data from phase 2 study of IONIS-GCGR Rx in patients with type 2 diabetes.
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TRACON signs SPA deal with FDA for phase 3 trial of TRC105 in angiosarcoma
TRACON Pharmaceuticals has reached an agreement with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the Company's Phase 3 study evaluating TRC105 for the treatment of patients with advanced angiosarcoma.
Production & Manufacturing > Process & Production > News
Novelion’s subsidiary seeks European approval for metreleptin
Novelion Therapeutics’ subsidiary has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval for metreleptin as replacement therapy to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in a subset of patients with partial lipodystrophy (PL).
Production & Manufacturing > Process & Production > News
Alexion’s eculizumab fails to meet primary endpoint in phase 2/3 trial
Alexion Pharmaceuticals has reported results from the PROTECT Study, a Phase 2/3 registration trial of eculizumab (Soliris) for the prevention of delayed graft function (DGF) after kidney transplantation in adult recipients of a deceased donor kidney.
Production & Manufacturing > Process & Production > News
Inovio’s Zika vaccine evokes strong immune responses in first human trial
By PBR Staff Writer
Inovio Pharmaceuticals said that its DNA-based Zika vaccine (GLS-5700) induced robust immune responses in an early-stage study in human volunteers who have not been infected with the virus.
Production & Manufacturing > Process & Production > News
ViiV Healthcare starts HIV prevention study with cabotegravir
By PBR Staff Writer
ViiV Healthcare has commenced a phase III study to assess cabotegravir, a long-acting injectable integrase strand transfer inhibitor, for the prevention of HIV infection.
Production & Manufacturing > Process & Production > News
FDA extends review of Genentech's application for multiple sclerosis drug OCREVUS
The US Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) date for review of Genentech's Biologics License Application (BLA) for OCREVUS (ocrelizumab) to March 28, 2017.
Production & Manufacturing > Process & Production > News
GSK commences phase III study for triple combination asthma therapy
By PBR Staff Writer
GlaxoSmithKline (GSK) and Innoviva have started started a triple combination therapy phase III study for the treatment of asthma.
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Akcea Therapeutics' metabolic disorder drug succeeds in phase 3 trial
Ionis Pharmaceuticals’ subsidiary Akcea Therapeutics announced that its phase 3 COMPASS clinical trial for volanesorsen met its primary end point of significant mean reduction in triglycerides in patients with severe hypertriglyceridemia
Production & Manufacturing > Process & Production > News
EMA's CHMP backs Merck's Keytruda for first-line treatment of NSCLC
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Merck's Keytruda (pembrolizumab) for the first-line treatment of adults patients with metastatic non-small lung cancer (NSCLC).
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Pfizer's Xtandi fails to meet main goal in prostate cancer study
By PBR Staff Writer
A phase 4 study found that continuing treatment with Pfizer's cancer drug Xtandi (enzalutamide) in addition to a regimen of Zytiga and a steroid failed to show treatment benefit in patients with advanced prostate cancer.
Production & Manufacturing > Process & Production > News
RedHill's Phase III study of RHB-104 in Crohn's disease to continue as planned
By PBR Staff Writer
RedHill Biopharma has received a unanimous recommendation from the independent Data and Safety Monitoring Board (DSMB) to continue the MAP US phase III study with RHB-104 for Crohn’s disease as planned, without any changes.
Production & Manufacturing > Process & Production > News
46-60 of 1839 results