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Pharmaceutical Business Review

GSK reports positive results from Phase III BREAK-3 trial of tafinlar to treat melanoma GlaxoSmithKline (GSK) has reported updated results from a Phase III BREAK-3 trial of Tafinlar (dabrafenib) in patients with BRAF V600E mutant metastatic melanoma. Contract Research & Services > Clinical Trials > News
EMA validates the marketing authorization for lung cancer drug nivolumab By PBR Staff Writer
The European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) for Bristol-Myers Squibb' nivolumab to treat non-small cell lung cancer (NSCLC).
Regulatory Affairs > News TherapeuticsMD starts Phase III trial of TX-004HR to treat VVA By PBR Staff Writer
TherapeuticsMD, a US-based women’s healthcare firm, has started patient enrollment in its Phase III clinical trial of TX-004HR (VagiCap) to treat painful intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Automation > IT & Software > News MacroGenics, Takeda partner to develop four additional dart therapeutics By PBR Staff Writer
US-based biopharmaceutical firm MacroGenics and Japan-based Takeda Pharmaceutical have entered into a collaboration agreement to develop and commercialize up to four product candidates.
Contract Research & Services > Contract Services > News
Otsuka gets FDA approval for dual-chamber syringe for abilify maintena to treat schizophrenia Otsuka Pharmaceutical Development & Commercialization and Lundbeck has announced that the US Food and Drug Administration (FDA) has approved a new formulation of Abilify Maintena (aripiprazole) for extended-release injectable suspension – a pre-filled dual-chamber syringe.
Drug Research > Drug Delivery > News Cannabis Science signs drug development and laboratory services agreement with ImmunoClin Cannabis Science a US Company specializing in cannabis formulation-based drug development and related consulting, has entered into a laboratory services agreement with ImmunoClin Corporation through its wholly-owned UK subsidiary, ImmunoClin, a healthcare company with over thirteen years' experience in providing premiere laboratory and related pre-clinical and clinical research services on a commercial scale.
Contract Research & Services > Contract Research > News Bristol-Myers Squibb reports positive phase III data for Opdivo in advanced melanoma patients Bristol-Myers Squibb Company has announced positive results from CheckMate -037, a Phase 3 randomized, controlled open-label study of Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, versus investigator’s choice chemotherapy (ICC) in patients with advanced melanoma who were previously treated with Yervoy (ipilimumab).
Drug Research > Drug Discovery & Development > News

Latest News and Insight by Sector

Production & Manufacturing

Vitavis launches Pruvin to combat effects of aging on metabolism
By PBR Staff Writer
US-based Vitavis Laboratories has launched its patented, dietary supplement, Pruvin, to combat the effects of aging on metabolism.
Production & Manufacturing > OTC > News
AMAG to buy Lumara's women health business for $675m
By PBR Staff Writer
AMAG Pharmaceuticals has entered the women's healthcare business with the acquisition of Lumara Health for $675m.
Production & Manufacturing > Manufacturing > News

Drug Research

Otsuka gets FDA approval for dual-chamber syringe for abilify maintena to treat schizophrenia
Otsuka Pharmaceutical Development & Commercialization and Lundbeck has announced that the US Food and Drug Administration (FDA) has approved a new formulation of Abilify Maintena (aripiprazole) for extended-release injectable suspension – a pre-filled dual-chamber syringe.
Drug Research > Drug Delivery > News
Bristol-Myers Squibb reports positive phase III data for Opdivo in advanced melanoma patients
Bristol-Myers Squibb Company has announced positive results from CheckMate -037, a Phase 3 randomized, controlled open-label study of Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, versus investigator’s choice chemotherapy (ICC) in patients with advanced melanoma who were previously treated with Yervoy (ipilimumab).
Drug Research > Drug Discovery & Development > News

Inward Investment

Endo offers $2.2bn to acquire Auxilium
By PBR Staff Writer
Irish pain drugmaker Endo International has proposed $2.2bn offer to acquire biopharmaceutical company Auxilium Pharmaceuticals.
Inward Investment > News
Cognizant agrees to buy TriZetto for $2.7bn
By PBR Staff Writer
Cognizant has signed a definitive agreement to acquire US-based healthcare IT software and solutions provider TriZetto for $2.7bn in cash.
News

Packaging

Packaging Coordinators completes acquisition of Biotec
By PBR Staff Writer
Packaging services provider Packaging Coordinators (PCI) has completed the acquisition of UK-based pharmaceutical services provider Biotec for an undisclosed amount.
Packaging > News
Biologics adds frozen storage capabilities to clinical research services
By PBR Staff Writer
Biologics’ Clinical Research Services has announced the addition of frozen storage capabilities to its state-of-the-art facilities and cold-chain packaging and distribution.
Packaging > News

Contract Research & Services

MacroGenics, Takeda partner to develop four additional dart therapeutics
By PBR Staff Writer
US-based biopharmaceutical firm MacroGenics and Japan-based Takeda Pharmaceutical have entered into a collaboration agreement to develop and commercialize up to four product candidates.
Contract Research & Services > Contract Services > News
Cannabis Science signs drug development and laboratory services agreement with ImmunoClin
Cannabis Science a US Company specializing in cannabis formulation-based drug development and related consulting, has entered into a laboratory services agreement with ImmunoClin Corporation through its wholly-owned UK subsidiary, ImmunoClin, a healthcare company with over thirteen years' experience in providing premiere laboratory and related pre-clinical and clinical research services on a commercial scale.
Contract Research & Services > Contract Research > News

Automation

TherapeuticsMD starts Phase III trial of TX-004HR to treat VVA
By PBR Staff Writer
TherapeuticsMD, a US-based women’s healthcare firm, has started patient enrollment in its Phase III clinical trial of TX-004HR (VagiCap) to treat painful intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Automation > IT & Software > News
Mymetics' HIV vaccine candidate gets funding to begin study at Texas Biomedical Research Institute
Mymetics a pioneer in the research and development of virosome-based vaccines to prevent transmission of human infectious diseases across mucosal membranes, has announced that its innovative HIV vaccine candidate will enter a new preclinical trial to confirm excellent results obtained in a previous trial.
Automation > IT & Software > News

Regulatory Affairs

EMA validates the marketing authorization for lung cancer drug nivolumab
By PBR Staff Writer
The European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) for Bristol-Myers Squibb' nivolumab to treat non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
Bristol-Myers Squibb announces multiple regulatory milestones for Opdivo in US and EU
Bristol-Myers Squibb Company announced multiple regulatory milestones for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, in the U.S. and European Union.
Regulatory Affairs > News

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