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Pharmaceutical Business Review

Merck, Pfizer get FDA nod for Bavencio to treat metastatic Merkel cell carcinoma 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
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

Latest News and Insight by Sector

Production & Manufacturing

FDA grants orphan drug status to Boehringer's BI 836858 to treat MDS
Boehringer Ingelheim has secured orphan drug designation from the US Food and Drug Administration (FDA) for its anti-CD33 monoclonal antibody, BI 836858, to treat myelodysplastic syndromes (MDS).
Production & Manufacturing > Process & Production > News
Canadian drugmaker Apotex unveils $184m US expansion plan
By PBR Staff Writer
Canada-based pharmaceutical firm Apotex said it will invest $184m to expand its facilities in South Florida, US, and create 150 new jobs.
Production & Manufacturing > Manufacturing > News

Drug Research

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
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

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

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
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

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

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
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



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