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Pharmaceutical Business Review

European Commission conditionally approves Roche’s cancer drug Alecensa Roche's oral ALK inhibitor, Alecensa, has been conditionally approved in the European Union as a monotherapy for anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC) in adults who were earlier treated with crizotinib. Regulatory Affairs > News
FDA grants priority review to Pfizer's antibody-drug conjugate for ALL By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted a priority review designation to Pfizer's anti-CD22 antibody-drug conjugate inotuzumab ozogamicin to treat patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News hVIVO says US body begins trial on malaria and Zika vaccine Biopharmaceutical firm hVIVO PLC on Tuesday said the US National Institute of Health has initiated a phase one clinical trial of AGS-v, an investigational vaccine for mosquito-borne diseases like malaria and Zika.
Contract Research & Services > Clinical Trials > News Abzena signs antibody manufacturing development deal with University College London Abzena has entered into a manufacturing agreement with University College London (UCL).
Production & Manufacturing > Manufacturing > News
European Commission conditionally approves Roche’s cancer drug Alecensa By PBR Staff Writer
Roche's oral ALK inhibitor, Alecensa, has been conditionally approved in the European Union as a monotherapy for anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC) in adults who were earlier treated with crizotinib.
Regulatory Affairs > News Chi-Med starts phase II study of savolitinib in pulmonary sarcomatoid carcinoma Hutchison China MediTech has commenced a phase 2 study of savolitinib in locally advanced or metastatic pulmonary sarcomatoid carcinoma (PSC) in China.
Contract Research & Services > Clinical Trials > News Modus Therapeutics raises £2.9m to support further development of sevuparin for SCD Modus Therapeutics has raised SEK32m (£2.9m) from existing investors KDev Investments, Östersjöstiftelsen and Praktikerinvest to support a phase two study of a sickle cell disease (SCD) drug.
Drug Research > Drug Discovery & Development > News

Latest News and Insight by Sector

Production & Manufacturing

Abzena signs antibody manufacturing development deal with University College London
Abzena has entered into a manufacturing agreement with University College London (UCL).
Production & Manufacturing > Manufacturing > News
Arix Bioscience raises £100m in IPO
Global healthcare and life science company Arix Bioscience has raised £100m in its Initial Public Offering (IPO) on the main market of the London Stock Exchange.
Production & Manufacturing > Manufacturing > News

Drug Research

Modus Therapeutics raises £2.9m to support further development of sevuparin for SCD
Modus Therapeutics has raised SEK32m (£2.9m) from existing investors KDev Investments, Östersjöstiftelsen and Praktikerinvest to support a phase two study of a sickle cell disease (SCD) drug.
Drug Research > Drug Discovery & Development > News
Versant Ventures launches biotechnology firm Jecure Therapeutics
Versant Ventures has launched Jecure Therapeutics, a biotechnology firm focused on the discovery of novel therapeutics to treat non-alcoholic steatohepatitis (NASH) and liver fibrosis.
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

hVIVO says US body begins trial on malaria and Zika vaccine
Biopharmaceutical firm hVIVO PLC on Tuesday said the US National Institute of Health has initiated a phase one clinical trial of AGS-v, an investigational vaccine for mosquito-borne diseases like malaria and Zika.
Contract Research & Services > Clinical Trials > News
Chi-Med starts phase II study of savolitinib in pulmonary sarcomatoid carcinoma
Hutchison China MediTech has commenced a phase 2 study of savolitinib in locally advanced or metastatic pulmonary sarcomatoid carcinoma (PSC) in China.
Contract Research & Services > Clinical Trials > News

Automation

Veeva rolls out cloud application to accelerate regulatory submission delivery
Veeva Systems (VEEV) announced a new cloud application dubbed Veeva Vault Submissions Publishing that incorporates publishing capabilities within Veeva Vault RIM to accelerate regulatory submission delivery.
Automation > IT & Software > News
Arven selects GE Healthcare’s manufacturing platform to expand production capacity at Turkish facility
GE Healthcare’s FlexFactory manufacturing platform has been selected to expand production capacity at Arven Pharmaceuticals' facility in Kirklareli, Turkey.
Automation > IT & Software > News

Regulatory Affairs

FDA grants priority review to Pfizer's antibody-drug conjugate for ALL
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted a priority review designation to Pfizer's anti-CD22 antibody-drug conjugate inotuzumab ozogamicin to treat patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
European Commission conditionally approves Roche’s cancer drug Alecensa
By PBR Staff Writer
Roche's oral ALK inhibitor, Alecensa, has been conditionally approved in the European Union as a monotherapy for anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC) in adults who were earlier treated with crizotinib.
Regulatory Affairs > News



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