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1-15 of 50214 results
Amgen’s Amgevita secures approval in Europe for certain inflammatory diseases
Amgen’s Amgevita (biosimilar adalimumab) has been granted the marketing authorization by the European Commission (EC) in all available indications.
Regulatory Affairs > News
BioLineRx acquires UK cancer immunotherapeutics company Agalimmune
Clinical-stage biopharmaceutical firm BioLineRx has purchased Agalimmune, a private UK-based company with an anti-cancer immunotherapy platform.
Drug Research > Drug Discovery & Development > News
Merck, Pfizer get FDA nod for Bavencio to treat metastatic Merkel cell carcinoma
By PBR Staff Writer
Merck’s EMD Serono and Pfizer have secured approval from the US Food and Drug Administration (FDA) for Bavencio (avelumab) injection 20 mg/mL to treat metastatic Merkel cell carcinoma (mMCC).
Regulatory Affairs > News
Biogen wins patent ruling in multiple sclerosis drug case
By PBR Staff Writer
Biogen has won an intellectual property rights ruling over its multiple sclerosis (MS) drug candidate, Tecfidera following a favorable decision from the US Patent and Trademark Office's Patent Trial and Appeal Board.
News
Akashi gets FDA nod to restart clinical development of DMD drug HT-100
Akashi Therapeutics has secured approval from the US Food and Drug Administration (FDA) to resume clinical development of HT-100 (delayed-release halofuginone) in patients with any of the genetic mutations that cause Duchenne muscular dystrophy (DMD).
Contract Research & Services > Clinical Trials > News
GSK, Regeneron to mine gene data from 500000 volunteer participants in UK
Regeneron Pharmaceuticals announced a major research initiative among the Regeneron Genetics Center (RGC), U.K. Biobank and GSK to generate genetic sequence data from the 500,000 volunteer participants in the U.K. Biobank resource.
Drug Research > Drug Discovery & Development > News
Novartis’ serelaxin fails to meet primary endpoint in heart failure study
By PBR Staff Writer
Novartis' RLX030 (serelaxin) has failed to meet its primary endpoint in a phase III acute heart failure (AHF) study.
Contract Research & Services > Clinical Trials > News
Pierre Fabre, H-Immune partner on immuno-oncology therapeutics
French pharma Pierre Fabre has entered into a strategic research partnership with H-Immune to develop immuno-oncology therapeutics using the latter’s technology platform to generate lead candidates of fully human antibodies.
Drug Research > Drug Discovery & Development > News
X-Chem, Ono to collaborate on multi-target drug discovery
X-Chem, a biotechnology firm focused on developing novel small molecule therapeutics by applying its innovative drug discovery platform, has entered into a partnership with Ono Pharmaceutical.
Drug Research > Drug Discovery & Development > News
Newron’s Xadago gets FDA nod to treat Parkinson’s disease
By PBR Staff Writer
Newron Pharmaceuticals, along with its partners Zambon and US WorldMeds, has secured approval from the US the Food and Drug Administration (FDA) for its Xadago (safinamide) to treat patients with Parkinson’s disease (PD).
Regulatory Affairs > News
Lilly’s abemaciclib meets primary endpoint in phase 3 breast cancer trial
By PBR Staff Writer
A phase 3 study of Lilly’s breast cancer drug, abemaciclib, in combination with fulvestrant, has met its primary endpoint of progression-free survival (PFS).
Contract Research & Services > Clinical Trials > News
Nektar’s NKTR-181 shown to reduce chronic pain in phase 3 trial
Nektar Therapeutics’ NKTR-181 has met primary and secondary endpoints in phase 3 SUMMIT-07 study in chronic pain.
Contract Research & Services > Clinical Trials > News
SalvaRx to invest in Rift Biotherapeutics
SalvaRx, a subsidiary of SalvaRx Group, has agreed to invest in Delaware-based biotechnology company Rift Biotherapeutics which focuses on the development of antibodies for use in oncology.
Drug Research > Drug Discovery & Development > News
Bristol-Myers Squibb, CytomX extend cancer collaboration
By PBR Staff Writer
Bristol-Myers Squibb (BMS) is paying CytomX Therapeutics $200m upfront to add up to eight new candidates to their existing Probody therapeutics collaboration.
Contract Research & Services > Contract Research > News
Oxford BioDynamics participates in rheumatoid arthritis triggers study
Oxford BioDynamics is participating in a collaboration to identify the biological factors that trigger disease relapses, known as flares, in Rheumatoid Arthritis (RA), entitled the BIO-FLARE study (Biological factors that limit sustained remission in Rheumatoid Arthritis).
Drug Research > Drug Delivery > News
1-15 of 50214 results