Regulations

FDA demands more manufacturing info to review ide-cel, says Bluebird

FDA demands more manufacturing info to review ide-cel, says Bluebird FDA demands more manufacturing info to review ide-cel, says Bluebird

The US FDA has rejected Bluebird Bio’s BLA for ide-cel and asked for more details of how the candidate blood cancer therapy is made.

byGareth Macdonald

May 15, 2020

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1 Min Read

BioMarin prepares to launch Roctavian for hemophilia in an uncertain environment

BioMarin prepares to launch Roctavian for hemophilia in an uncertain environment BioMarin prepares to launch Roctavian for hemophilia in an uncertain environment

byJessica Merrill

May 8, 2020

1 Min Read

UK tweaks GMP during pandemic and backs vaccine development

UK tweaks GMP during pandemic and backs vaccine development UK tweaks GMP during pandemic and backs vaccine development

byGareth Macdonald

May 4, 2020

1 Min Read

Inovio’s COVID-19 vaccine enters clinic buoyed by VGXI manufacturing success

Facilities & Capacity

Inovio’s COVID-19 vaccine enters clinic buoyed by VGXI manufacturing success Inovio’s COVID-19 vaccine enters clinic buoyed by VGXI manufacturing success

Apr 8, 2020

1 Min Read

Sensationalist press propagating unfounded COVID-19 therapies, says ISCT

Sensationalist press propagating unfounded COVID-19 therapies, says ISCT Sensationalist press propagating unfounded COVID-19 therapies, says ISCT

Mar 30, 2020

1 Min Read

US FDA suspends all domestic GMP surveillance inspections

US FDA suspends all domestic GMP surveillance inspections US FDA suspends all domestic GMP surveillance inspections

byJoanne Eglovitch

Mar 26, 2020

1 Min Read

Rapid response vaccine capacity vital for pandemics, BIO-Europe

Rapid response vaccine capacity vital for pandemics, BIO-Europe

Rapid response vaccine capacity vital for pandemics, BIO-Europe

byGareth Macdonald

Compounders complain they can’t make these four drugs once they’re deemed biologics

Compounders complain they can’t make these four drugs once they’re deemed biologics

Compounders complain they can’t make these four drugs once they’re deemed biologics

byJoanne Eglovitch

Individualized gene therapy: FDA considering device-like manufacturing approval process

Individualized gene therapy: FDA considering device-like manufacturing approval process

Individualized gene therapy: FDA considering device-like manufacturing approval process

byDerrick Gingery

Halozyme eyes major drivers in Roche and Janssen subcutaneous approvals

Halozyme eyes major drivers in Roche and Janssen subcutaneous approvals

Halozyme eyes major drivers in Roche and Janssen subcutaneous approvals

byDan Stanton, Editorial director

Manufacturing quality systems first defense against hackers says expert

Manufacturing quality systems first defense against hackers says expert

Manufacturing quality systems first defense against hackers says expert

byGareth Macdonald

FDA approves Seqirus’ adjuvant cell-based flu vaccine Audenz

FDA approves Seqirus’ adjuvant cell-based flu vaccine Audenz

FDA approves Seqirus’ adjuvant cell-based flu vaccine Audenz

byDan Stanton, Editorial director

Akron says biopharma needs GMP framework for ancillary materials

Akron says biopharma needs GMP framework for ancillary materials

Akron says biopharma needs GMP framework for ancillary materials

byGareth Macdonald

Potential Oklahoma anti-vax bill danger to health and industry

Potential Oklahoma anti-vax bill danger to health and industry

Potential Oklahoma anti-vax bill danger to health and industry

byDan Stanton, Editorial director

US FDA predicts gene therapy surge and moves to clarify expectations

US FDA predicts gene therapy surge and moves to clarify expectations

US FDA predicts gene therapy surge and moves to clarify expectations

byGareth Macdonald

Biocon receives FDA Form 483 at Bangalore plant

Biocon receives FDA Form 483 at Bangalore plant

Biocon receives FDA Form 483 at Bangalore plant

Phacilitate 2020: FDA commercial cell and gene therapy forecast ‘unlikely’

Phacilitate 2020: FDA commercial cell and gene therapy forecast ‘unlikely’

Phacilitate 2020: FDA commercial cell and gene therapy forecast ‘unlikely’

byDan Stanton, Editorial director

China Oks first CDMO-made MAb since Drug Administration law revision

China Oks first CDMO-made MAb since Drug Administration law revision

China Oks first CDMO-made MAb since Drug Administration law revision

byDan Stanton, Editorial director

Hemophilia A-OK! FTC thumbs up effectively closes Roche’s $4.3bn Spark buy

Hemophilia A-OK! FTC thumbs up effectively closes Roche’s $4.3bn Spark buy

Hemophilia A-OK! FTC thumbs up effectively closes Roche’s $4.3bn Spark buy

byDan Stanton, Editorial director

Enzyvant hit with CRL due to regenerative therapy manufacturing concerns

Enzyvant hit with CRL due to regenerative therapy manufacturing concerns

Enzyvant hit with CRL due to regenerative therapy manufacturing concerns

byDan Stanton, Editorial director

Purolite resin booming on biopharma uptake and ‘major’ regulatory milestone

Purolite resin booming on biopharma uptake and ‘major’ regulatory milestone

Purolite resin booming on biopharma uptake and ‘major’ regulatory milestone

byGareth Macdonald

Samsung BioLogics boost to cell line dev with patent win over Lonza

Samsung BioLogics boost to cell line dev with patent win over Lonza

Samsung BioLogics boost to cell line dev with patent win over Lonza

byDan Stanton, Editorial director

Zolgensma data: ‘Heavy-handiness’ of FDA a warning to industry, not just Novartis

Zolgensma data: ‘Heavy-handiness’ of FDA a warning to industry, not just Novartis

Zolgensma data: ‘Heavy-handiness’ of FDA a warning to industry, not just Novartis

byDan Stanton, Editorial director

Bavarian Nordic gets FDA tick for monkeypox vaccine

Bavarian Nordic gets FDA tick for monkeypox vaccine

Bavarian Nordic gets FDA tick for monkeypox vaccine

Novavax poised to step up to Executive Order with recombinant flu vaccine

Novavax poised to step up to Executive Order with recombinant flu vaccine

Novavax poised to step up to Executive Order with recombinant flu vaccine

byDan Stanton, Editorial director

Novo Nordisk: Danish and NC plants onside for oral GLP-1 launch

Novo Nordisk: Danish and NC plants onside for oral GLP-1 launch

Novo Nordisk: Danish and NC plants onside for oral GLP-1 launch

byDan Stanton, Editorial director

China laws settle CDMO status but leave regulator lacking capacity for oversight

China laws settle CDMO status but leave regulator lacking capacity for oversight

China laws settle CDMO status but leave regulator lacking capacity for oversight

byGareth Macdonald

FDA warns another unapproved cell therapy firm

FDA warns another unapproved cell therapy firm

FDA warns another unapproved cell therapy firm

byDan Stanton, Editorial director

FDA rejects Mylan and Biocon’s insulin glargine again

FDA rejects Mylan and Biocon’s insulin glargine again

FDA rejects Mylan and Biocon’s insulin glargine again

byDan Stanton, Editorial director

Lineage granted stem cell production patent for cancer vax

Lineage granted stem cell production patent for cancer vax

Lineage granted stem cell production patent for cancer vax

Think your CMO is high maintenance? Let’s hope so

Think your CMO is high maintenance? Let’s hope so

Think your CMO is high maintenance? Let’s hope so

byDan Stanton, Editorial director

EU thumbs up for Biocon biosimilar insulin plant

EU thumbs up for Biocon biosimilar insulin plant

EU thumbs up for Biocon biosimilar insulin plant

FDA and NIIMBL partner to advanced biomanufacturing innovation

FDA and NIIMBL partner to advanced biomanufacturing innovation

FDA and NIIMBL partner to advanced biomanufacturing innovation

byDan Stanton, Editorial director

Pro-biosimilar policies will not ignite US market, Amgen

Pro-biosimilar policies will not ignite US market, Amgen

Pro-biosimilar policies will not ignite US market, Amgen

byDan Stanton, Editorial director

FDA and Novartis back Zolgensma amid data manipulation issues

FDA and Novartis back Zolgensma amid data manipulation issues

FDA and Novartis back Zolgensma amid data manipulation issues

byDan Stanton, Editorial director

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