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Pharmaceutical Business Review

BMS’ kidney cancer drug met co-primary endpoint in CheckMate trial Bristol-Myers Squibb’s (BMS) kidney cancer drug Opdivo in combination with Yervoy (ipilimumab) has met the co-primary endpoint of objective response rate (ORR) against sunitinib in CheckMate -214 trial. News
Alvogen to acquire Russia-based Omega Bittner Alvogen has agreed to acquire Omega Bittner, a Russia-based pharmaceutical firm owned by Perrigo Company.
News Aradigm gets NIH grant for Linhaliq in pulmonary non-tuberculous mycobacteria treatment The National Institute of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH) have awarded a Small Business Initiative Research (SBIR) grant to Aradigm to study the treatment of two pulmonary non-tuberculous mycobacteria (PNTM) infections, Mycobacterium avium and Mycobacterium abscessus, with the company’s inhaled liposomal ciprofloxacin products Linhaliq and Lipoquin.
Contract Research & Services > Clinical Trials > News FDA lifts clinical hold on study of Multikine for head and neck cancer By PBR Staff Writer
The US Food and Drug Administration (FDA) has lifted the clinical hold it had imposed on the CEL-SCI and Ergomed co-developed Multikine’s phase 3 head and neck cancer study.
Regulatory Affairs > News
H3 Biomedicine gets FDAorphan drug status for acute myelogenous leukemia treatment The US Food and Drug Administration (FDA) has granted orphan drug designation for H3 Biomedicine's H3B-8800, its lead clinical compound for the treatment of patients with Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML).
Production & Manufacturing > Process & Production > News Vicarius Pharma secures $21.8m financing Vicarius Pharma has secured a CHF21m ($21.8m) investment through a Series A preferred stock financing from private investors.
Drug Research > Drug Discovery & Development > News Ophthotech’s wet-AMD drug Fovista fails in phase 3 AMD trial By PBR Staff Writer
Ophthotech’s anti-PDGF therapy Fovista (pegpleranib) for treating wet age-related macular degeneration (AMD) has failed to meet the primary endpoint in a phase 3 trial.
Contract Research & Services > Clinical Trials > News

Latest News and Insight by Sector

Production & Manufacturing

H3 Biomedicine gets FDAorphan drug status for acute myelogenous leukemia treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation for H3 Biomedicine's H3B-8800, its lead clinical compound for the treatment of patients with Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML).
Production & Manufacturing > Process & Production > News
Gilead gets FDA priority review for bictegravir regimen for HIV treatment
The US Food and Drug Administration (FDA) has granted priority review for Gilead Sciences’ New Drug Application (NDA) for its investigational, fixed-dose combination of bictegravir (50mg) (BIC) and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) for the treatment of HIV-1 infection.
Production & Manufacturing > Process & Production > News

Drug Research

Vicarius Pharma secures $21.8m financing
Vicarius Pharma has secured a CHF21m ($21.8m) investment through a Series A preferred stock financing from private investors.
Drug Research > Drug Discovery & Development > News
Oxford BioMedica announces collaboration for gene and cell therapy manufacturing
A new consortium, led by Oxford BioMedica, will take part in a two-year, £2m project focused on gene and cell therapy manufacturing.
Drug Research > Drug Discovery & Development > News

Inward Investment

New WuXi Life Science to acquire WuXi PharmaTech for $3.3bn
Shanghai-based WuXi PharmaTech has entered into a merger agreement with New WuXi Life Science and its wholly owned subsidiary WuXi Merger, worth a total cash consideration of $3.3bn.
Inward Investment > News
PPF Group acquires minority stake in Cytune Pharma
By PBR Staff Writer
PPF Group, in cooperation with SOTIO has completed acquisition of minority stake in French biotechnology firm Cytune Pharma.
Inward Investment > News

Packaging

Catalent completes acquisition of Australia's Pharmapak
By PBR Staff Writer
US-based Catalent Pharma Solutions has strengthened its ability to provide integrated solutions to customers with the acquisition of Pharmapak Technologies, an Australian pharmaceutical packaging business.
Production & Manufacturing > OTC > News
MP Global Products introduces foam-free packaging for shipment of temperature sensitive pharmaceuticals
MP Global Thermal Packaging Products insulated protective mailers and box liners are specifically designed for temperature control and protection of mail order shipments of temperature sensitive pharma, pet meds, and natural and organic cosmetics.
Packaging > News

Contract Research & Services

Aradigm gets NIH grant for Linhaliq in pulmonary non-tuberculous mycobacteria treatment
The National Institute of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH) have awarded a Small Business Initiative Research (SBIR) grant to Aradigm to study the treatment of two pulmonary non-tuberculous mycobacteria (PNTM) infections, Mycobacterium avium and Mycobacterium abscessus, with the company’s inhaled liposomal ciprofloxacin products Linhaliq and Lipoquin.
Contract Research & Services > Clinical Trials > News
FDA lifts clinical hold on study of Multikine for head and neck cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has lifted the clinical hold it had imposed on the CEL-SCI and Ergomed co-developed Multikine’s phase 3 head and neck cancer study.
Regulatory Affairs > News

Automation

Broad Institute of MIT and Harvard joins discussions to create global CRISPR-Cas9 licensing pool
The Broad Institute of MIT and Harvard has joined discussions to form a non-exclusive CRISPR-Cas9 joint licensing pool coordinated by MPEG LA, an organization that operates patent pool licensing programs in various institutions and countries.
Automation > IT & Software > News
Servier, Transgene to apply viral vectorization technology to engineering of allogenic CAR-T
Servier and Transgene have signed a research agreement on the application of viral vectorization technology for the production of allogenic CAR-T cell therapies.
Automation > IT & Software > News

Regulatory Affairs

FDA lifts clinical hold on study of Multikine for head and neck cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has lifted the clinical hold it had imposed on the CEL-SCI and Ergomed co-developed Multikine’s phase 3 head and neck cancer study.
Regulatory Affairs > News
PharmaTech liquid drugs recalled in US over bacterial contamination
By PBR Staff Writer
The US Food and Drug Administration (FDA) has issued an advisory against consumption of all liquid products manufactured by PharmaTech over concerns of possible contamination with a bacteria called Burkholderia cepacia (B. cepacia).
Regulatory Affairs > News



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