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136-150 of 48933 results
Sareum cancer drug candidate wins UK MHRA clinical trial approval
By PBR Staff Writer
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Sareum's clinical trial applications (CTAs) for CHK1 inhibitor drug candidate CCT245737.
Contract Research & Services > Clinical Trials > News
FDA approves biosimilar of J&J's Remicade drug to treat autoimmune diseases
By PBR Staff Writer
Celltrion has secured approval from the US Food and Drug Administration (FDA) for its Inflectra (infliximab-dyyb), a biosimilar version of Johnson & Johnson's (J&J) Remicade drug used to treat autoimmune diseases.
Regulatory Affairs > News
Portola Pharmaceuticals inks deal with Daiichi Sankyo to develop andexanet alfa with edoxaban
Portola Pharmaceuticals has entered into a clinical collaboration agreement with Daiichi Sankyo to develop andexanet alfa as an antidote for edoxaban, Daiichi Sankyo’s Factor Xa inhibitor, in Japan.
Contract Research & Services > Contract Services > News
Capricor Therapeutics says DSMB recommends to continue HOPE-Duchenne clinical trial
Capricor Therapeutics announced that the independent Data Safety Monitoring Board (DSMB) of the Phase I/II HOPE-Duchenne (Halt cardiomyOPathy progrEssion in Duchenne) clinical trial has completed its pre-specified review of the first patient cohort.
Contract Research & Services > Clinical Trials > News
Citius Pharmaceuticals acquires Leonard-Meron Biosciences
Citius Pharmaceuticals has completed the acquisition of Leonard-Meron Biosciences (LMB).
Drug Research > Drug Discovery & Development > News
PsychoGenics drug discovery collaboration with Sunovion achieves milestone
PGI Drug Discovery announced that a compound identified through its drug discovery collaboration with Sunovion Pharmaceuticals has achieved a milestone.
Drug Research > Drug Discovery & Development > News
XBiotech's Xilonix marketing application granted accelerated review in Europe
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted accelerated review for marketing authorization of XBiotech's Xilonix true human monoclonal (IgG1k) antibody to treat advanced colorectal cancer.
Drug Research > Drug Delivery > News
IXICO to support clinical trial for Parkinson's drug OXB 102
By PBR Staff Writer
Oxford BioMedica has awarded a contract to brain health firm IXICO to support clinical trials of a new treatment for Parkinson’s disease.
Contract Research & Services > Clinical Trials > News
Gilead Sciences to acquire Nimbus Apollo in $1.2bn deal
By PBR Staff Writer
Gilead Sciences has agreed to acquire Nimbus Therapeutics' subsidiary Nimbus Apollo and its Acetyl-CoA Carboxylase (ACC) inhibitor program in a transaction valued at up to $1.2bn.
Production & Manufacturing > Manufacturing > News
Bristol-Myers wins positive CHMP opinion for Opdivo in combination with Yervoy to treat advanced melanoma
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Bristol-Myers Squibb's Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Drug Research > Drug Delivery > News
Taiho’s TAS-102 meets primary endpoint of improving overall survival in phase III study in patients with refractory mCRC
Taiho Pharmaceutical Co., Ltd. of Tokyo announced on April 1 results from its Phase III TERRA study on its oral combination anticancer drug TAS-102 (product name in Japan and the US LONSURF, nonproprietary names: trifluridine (FTD) and tipiracil (TPI)) in Asian(China, South Korea and Thailand) patients with refractory metastatic colorectal cancer (mCRC).
Drug Research > Drug Delivery > News
Quantum Pharmaceutical signs five-year contract extension with AAH Pharmaceuticals
Quantum Pharmaceutical Limited, the largest business unit in Quantum Pharma's Specials division, has signed a new five-year contract extension with AAH Pharmaceuticals Limited ("AAH").
Contract Research & Services > Contract Services > News
Rigel completes enrollment of FIT phase 3 program for fostamatinib in ITP
Rigel Pharmaceuticals has completed enrollment for both studies in the FIT Phase 3 clinical program of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, in immune thromboycytopenic purpura (ITP).
Contract Research & Services > Clinical Trials > News
Supernus Pharmaceuticals selects DSG to support two ADHD phase 3 clinical studies
By PBR Staff Writer
Supernus Pharmaceuticals has selected electronic data capture (EDC) clinical trial software provider DSG to support two phase 3 clinical studies on impulsive aggression in pediatric patients being treated for attention deficit/hyperactivity disorder (ADHD).
Automation > IT & Software > News
Injectable eczema drug dupilumab meets primary endpoints in two phase 3 studies
By PBR Staff Writer
Regeneron Pharmaceuticals and Sanofi said their experimental drug for a debilitating skin condition called atopic dermatitis (AD) met its primary endpoints in two phase 3 studies.
Contract Research & Services > Clinical Trials > News
136-150 of 48933 results