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91-105 of 1875 results
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.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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
Synergy Pharmaceuticals' bowel drug succeeds in phase 3 trial
Synergy Pharmaceuticals has unveiled positive results in first phase 3 trial of Plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
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FDA grants Biohaven’s orphan drug designation request for BHV-0223
The US Food and Drug Administration (FDA) has granted Biohaven Pharmaceutical's orphan drug designation request covering its drug candidate BHV-0223, an orally dissolving tablet being developed for the treatment of Amyotrophic Lateral Sclerosis (ALS), also referred to as Lou Gehrig's disease.
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Gilead Sciences submits NDA to FDA for once-daily triple combo HCV pill
Gilead Sciences has submitted a New Drug Application (NDA) for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients to the U.S. Food and Drug Administration (FDA).
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Cascadian Therapeutics amends HER2CLIMB phase 2 trial of tucatinib
Cascadian Therapeutics announced that after a recent meeting with the US Food and Drug Administration (FDA) and discussions with the Company's external Steering Committee, it has amended the HER2CLIMB Phase 2 clinical trial of tucatinib (also known as ONT-380) by increasing the sample size so that, if successful, the trial could serve as a single pivotal study to support registration.
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FDA grants fast track designation for Theravance's Velusetrag for idiopathic and diabetic gastroparesis
Theravance Biopharma has secured fast track designation from the US Food and Drug Administration (FDA) to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis.
Production & Manufacturing > Process & Production > News
Novo Nordisk seeks US and EU approval for new type 2 diabetes treatment
By PBR Staff Writer
Novo Nordisk is seeking approvals in the US and Europe for semaglutide, a new glucagon-like peptide-1 (GLP-1) analogue administered once-weekly, to treat adults with type 2 diabetes.
Production & Manufacturing > Process & Production > News
Amgen and Allergan submit bevacizumab biosimilar application to EMA
Amgen and Allergan have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab).
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Shire's VONVENDI meets primary endpoint in controlling bleeding in VWD adults in phase 3 study
A phase 3 clinical trial of Shire's VONVENDI [von Willebrand factor (Recombinant)] to treat bleeds in elective surgical settings for adults with severe von Willebrand disease (VWD) has met primary endpoint.
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Pfizer’s Glasdegib improves OS in AML and MDS patients in phase 2 trial
The new phase 2 results demonstrated that Pfizer's investigational compound Glasdegib improved overall survival (OS) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
Production & Manufacturing > Process & Production > News
91-105 of 1875 results