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136-150 of 50562 results
NHS patients in England getting early access to new drugs for lung cancer and sarcoma
NICE's Cancer Drugs Fund (CDF) is driving early access to new drugs for lung cancer and sarcoma for NHS patients in England.
Drug Research > Drug Delivery > News
FDA takes key steps under new drug competition action plan
By PBR Staff Writer
The US Food and Drug Administration (FDA) is taking two new key steps to increase competition in the market for prescription drugs and support entry of lower-cost alternatives.
Production & Manufacturing > Manufacturing > News
Arix Bioscience buys stake in Mitoconix Bio
Healthcare and life science firm Arix Bioscience has acquired a stake in Mitoconix Bio as part of an oversubscribed $20m Series A financing round.
Drug Research > Drug Discovery & Development > News
Pfizer breaks ground on new R&D facility in Missouri
Pfizer has broke ground on a research and development (R&D) and process development facility at 875 W. Chesterfield Parkway, Chesterfield in the US state of Missouri.
Production & Manufacturing > Manufacturing > News
Novartis’ etanercept biosimilar approved in Europe to treat inflammatory diseases
By PBR Staff Writer
The European Commission (EC) has approved Novartis’ Erelzi, the biosimilar of Amgen and Pfizer’s Enbrel (etanercept), for the treatment of multiple inflammatory diseases.
Regulatory Affairs > News
Sanofi, Regeneron secure EC approval for Kevzara to treat rheumatoid arthritis
By PBR Staff Writer
Sanofi and Regeneron Pharmaceuticals have secured approval from the European Commission (EC) for Kevzara (sarilumab) in combination with methotrexate (MTX) to treat adult patients with moderately to severely active rheumatoid arthritis (RA) in adult patients.
Regulatory Affairs > News
bluebird unveils topline interim data from Starbeam study of Lenti-D in CALD
bluebird bio has released topline interim data from the initial cohort of 17 patients in the ongoing Phase 2/3 Starbeam Study (ALD-102) evaluating its investigational gene therapy Lenti-D in under-18 boys with cerebral adrenoleukodystrophy (CALD).
Contract Research & Services > Clinical Trials > News
FDA accepts for filing Icon’s NDA for Dexycu drug therapy
The US Food and Drug Administration (FDA) has accepted for filing Icon Bioscience (IBI), recently submitted new drug application (NDA) for Dexycu (IBI-10090), a novel drug for treating inflammation associated with cataract surgery.
Production & Manufacturing > Process & Production > News
Roche's emicizumab shows substantial reduction in bleeds in phase III studies
By PBR Staff Writer
Roche’s haemophilia A drug emicizumab has showed a significant effect in the phase III Haven 1 and Haven 2 studies.
Contract Research & Services > Clinical Trials > News
European Medicines Agency recommends approval of Humira biosimilar Imraldi
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis' Imraldi for approval, which is a biosimilar candidate referencing Humira (adalimumab).
Regulatory Affairs > News
Pfizer gets CRL on Epogen biosimilar from FDA
By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
Production & Manufacturing > Process & Production > News
Cancer frim Repare Therapeutics announces $68m Series A financing
Repare Therapeutics has secured $68m in a Series A financing round which it will use to advance its platform and pipeline of novel medicines that target genetically defined weaknesses of cancers.
Drug Research > Drug Discovery & Development > News
Eli Lilly completes $90m expansion of biotechnology center in San Diego
Eli Lilly and Company has completed the $90m expansion of its biotechnology center in San Diego, California, US.
Production & Manufacturing > Manufacturing > News
Novartis’ heart drug canakinumab meets primary endpoint in phase III study
By PBR Staff Writer
Novartis’ heart drug ACZ885 (canakinumab) has met primary endpoint in the global phase III Canakinumab anti-inflammatory thrombosis outcomes (Cantos) study.
Contract Research & Services > Clinical Trials > News
GSK’s shingles vaccine Shingrix succeeds in phase 3 revaccination trial
By PBR Staff Writer
GSK’s shingles vaccine candidate Shingrix (HZ/su) met its primary objective of inducing a strong immune response in older patients in a phase 3 revaccination trial.
Contract Research & Services > Clinical Trials > News
136-150 of 50562 results