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Pharmaceutical Business Review

European Commission approves Samsung Bioepis’ Remicade biosimilar The European Commission (EC) has approved Samsung Bioepis' Flixabi, a biosimilar version of Johnson & Johnson's Remicade (infliximab) rheumatoid arthritis drug. Regulatory Affairs > News
DCGI gives limited approval to market first Allogeneic cell therapy product in India The Drugs Controller General (India) has granted limited approval for manufacturing & marketing of stem cell based biological product Stempeucel for the treatment of Buerger's Disease.
Regulatory Affairs > News Amgen receives positive CHMP opinion to extend indication of Kyprolis to treat relapsed multiple myeloma Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current indication for Kyprolis (carfilzomib) to include treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.
Production & Manufacturing > Process & Production > News European CHMP adopts positive opinion for Gilead’s Epclusa to treat all genotypes of chronic hepatitis C The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on Gilead Sciences' Marketing Authorization Application (MAA) for Epclusa, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection.
Drug Research > Drug Delivery > News
Genmab to receive $30m milestone payment from Janssen in Darzalex collaboration By PBR Staff Writer
Danish biotechnology firm Genmab will receive $30m payment from Janssen Biotech under Darzalex (daratumumab) collaboration.
Contract Research & Services > Contract Services > News Abivax starts second phase IIa trial of ABX464 in HIV/AIDS patients By PBR Staff Writer
Abivax has enrolled first patient in second phase IIa trial of ABX464 drug candidate in HIV/AIDS patients.
Contract Research & Services > Clinical Trials > News European Commission approves Samsung Bioepis’ Remicade biosimilar By PBR Staff Writer
The European Commission (EC) has approved Samsung Bioepis' Flixabi, a biosimilar version of Johnson & Johnson's Remicade (infliximab) rheumatoid arthritis drug.
Regulatory Affairs > News

Latest News and Insight by Sector

Production & Manufacturing

Amgen receives positive CHMP opinion to extend indication of Kyprolis to treat relapsed multiple myeloma
Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current indication for Kyprolis (carfilzomib) to include treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.
Production & Manufacturing > Process & Production > News
Kitov announces completion of manufacturing pivotal batches of KIT-302 for registration in US
Kitov Pharmaceuticals announced the completion of manufacturing by Dexcel Pharma of pivotal batches required for registration of KIT-302 with the US Food and Drug Administration (FDA).
Production & Manufacturing > Manufacturing > News

Drug Research

European CHMP adopts positive opinion for Gilead’s Epclusa to treat all genotypes of chronic hepatitis C
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on Gilead Sciences' Marketing Authorization Application (MAA) for Epclusa, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection.
Drug Research > Drug Delivery > News
CHMP backs extended approval of Takeda Pharmaceutical's Adcetris
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the current conditional approval of Takeda Pharmaceutical's ADCETRIS (brentuximab vedotin) and recommended its approval for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplantation (ASCT).
Drug Research > Drug Delivery > 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

Genmab to receive $30m milestone payment from Janssen in Darzalex collaboration
By PBR Staff Writer
Danish biotechnology firm Genmab will receive $30m payment from Janssen Biotech under Darzalex (daratumumab) collaboration.
Contract Research & Services > Contract Services > News
Abivax starts second phase IIa trial of ABX464 in HIV/AIDS patients
By PBR Staff Writer
Abivax has enrolled first patient in second phase IIa trial of ABX464 drug candidate in HIV/AIDS patients.
Contract Research & Services > Clinical Trials > News

Automation

Integral Molecular develops B-Cell cloning technology to discover rare antibodies against membrane proteins
Integral Molecular has developed an ultra high-throughput microfluidic B-cell cloning technology that can interrogate tens of millions of immune cells (B-cells), enabling deep mining of entire immune repertoires to discover rare and diverse monoclonal antibodies for therapeutic purposes.
Automation > IT & Software > News
JHL Biotech selects PaizaBio to provide fill-finish services for multiple projects
PaizaBio has secured an agreement with Taiwan-based JHL Biotech to provide fill-finish services for multiple JHL projects.
Automation > IT & Software > News

Regulatory Affairs

DCGI gives limited approval to market first Allogeneic cell therapy product in India
The Drugs Controller General (India) has granted limited approval for manufacturing & marketing of stem cell based biological product Stempeucel for the treatment of Buerger's Disease.
Regulatory Affairs > News
European Commission approves Samsung Bioepis’ Remicade biosimilar
By PBR Staff Writer
The European Commission (EC) has approved Samsung Bioepis' Flixabi, a biosimilar version of Johnson & Johnson's Remicade (infliximab) rheumatoid arthritis drug.
Regulatory Affairs > News



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