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136-150 of 49061 results
Theratechnologies unveils completion of enrollment for phase III Ibalizumab trial
Theratechnologies has been notified by its partner, TaiMed Biologics, Inc., that the enrollment for the Phase III study of ibalizumab, in combination with optimized background regimen (patients' current therapy), for patients infected with multi-drug resistant HIV-1 has been completed as of April 27, 2016.
Contract Research & Services > Clinical Trials > News
Alkermes plans to start second clinical trial of ALKS 7119
Alkermes announced preliminary findings from a phase 1 clinical trial of ALKS 7119, an oral, novel small molecule that acts on multiple key receptor systems in the brain
Contract Research & Services > Clinical Trials > News
Alnylam breaks ground on new manufacturing Facility in Norton, Massachusetts
Alnylam Pharmaceuticals has break ground on a biopharmaceutical manufacturing facility in Norton, Massachusetts.
Production & Manufacturing > Manufacturing > News
Therabron Therapeutics wins FDA fast track designation for rhCC10
Therabron Therapeutics has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for rhCC10 (recombinant human Club Cell 10 kDa Protein), specifically for the prevention of chronic lung disease related to premature birth.
Production & Manufacturing > Process & Production > News
AbbVie agrees to buy Stemcentrx for $5.8bn
By PBR Staff Writer
AbbVie has agreed to acquire cancer drug startup Stemcentrx in a transaction valued at about $5.8bn.
Production & Manufacturing > Manufacturing > News
Neovacs wins FDA approval to extend phase IIb clinical trial in Lupus to US
The US Food and Drug Administration (FDA) has approved Neovacs' investigational new drug application to extend its ongoing Phase IIb clinical trial of IFNα Kinoid to treat Lupus.
Regulatory Affairs > News
Sanofi offers to buy Medivation for $9.3bn
By PBR Staff Writer
French drug maker Sanofi has made a nonbinding offer to acquire the American biopharmaceutical firm Medivation for about $9.3bn.
Production & Manufacturing > Manufacturing > News
European Commission grants marketing authorisation to Lonsurf in mCRC
By PBR Staff Writer
The European Commission (EC) has granted marketing authorization for Taiho Pharmaceutical's Lonsurf (trifluridine/tipiracil), formerly known as TAS-102, to treat advanced metastatic colorectal cancer (mCRC).
Regulatory Affairs > News
Cumberland Pharmaceuticals unveils new program to develop Vasculan for systemic sclerosis
Cumberland Pharmaceuticals has unveiled a new program to develop Vasculan for systemic sclerosis.
Drug Research > Drug Discovery & Development > News
X-Chem achieves milestone in drug discovery collaboration with Alexion Pharmaceuticals
X-Chem has achieved a milestone in its drug discovery collaboration with Alexion Pharmaceuticals, triggering a payment to X-Chem.
Drug Research > Drug Discovery & Development > News
IBC Generium selects Goodwin Biotechnology to optimize process of IgG-based bispecific antibody
International Biotechnology Center "Generium", (LLC IBC Generium), has selected Goodwin Biotechnology for the assay and process technology transfer, process scale-up, and cGMP manufacturing of an IgG-based, bispecific antibody to support early stage clinical trials.
Automation > IT & Software > News
Ocular completes end-of-phase 2 review with FDA for OTX-TP for glaucoma and ocular hypertension
Ocular Therapeutix has completed its End-of-Phase 2 review with the US Food and Drug Administration (FDA) for its OTX-TP (sustained release travoprost) product candidate for the treatment of glaucoma and ocular hypertension.
Drug Research > Drug Delivery > News
Celldex starts phase 1/2 study of glembatumumab vedotin in squamous cell lung cancer
By PBR Staff Writer
Celldex Therapeutics has started a phase 1/2 study of its antibody-drug conjugate, glembatumumab vedotin, in squamous cell lung cancer.
Contract Research & Services > Clinical Trials > News
Novartis' Ilaris wins three FDA breakthrough designations to treat periodic fever syndromes
By PBR Staff Writer
Novartis has secured three breakthrough therapy designations from the US Food and Drug Administration (FDA) for Ilaris (canakinumab) to treat rare types of periodic fever syndromes.
Production & Manufacturing > Process & Production > News
Zymeworks, GSK enter second collaboration to develop bi-specific antibodies
Zymeworks has entered into a new licensing agreement with GSK for the research, development, and commercialization of novel bi-specific antibodies enabled using Zymeworks’ Azymetric drug discovery platform.
Drug Research > Drug Discovery & Development > News
136-150 of 49061 results