Regulations

Alexion on track with FcRn antibody after manufacturing hitch

Alexion on track with FcRn antibody after manufacturing hitch Alexion on track with FcRn antibody after manufacturing hitch

After inheriting an impurity in the drug product of antibody ALXN1830, Alexion Pharmaceuticals says new batches will be available by the end of the year.

byDan Stanton, Editorial director

Jul 25, 2019

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1 Min Read

Single-use techs are garbage, eventually, and that’s great for biopharma

Upstream & Downstream Processing

Single-use techs are garbage, eventually, and that’s great for biopharma Single-use techs are garbage, eventually, and that’s great for biopharma

byGareth Macdonald

Jul 10, 2019

1 Min Read

Biocon going digital to fix insulin plant hit with another FDA 483

Biocon going digital to fix insulin plant hit with another FDA 483 Biocon going digital to fix insulin plant hit with another FDA 483

Jul 9, 2019

1 Min Read

Bluebird’s gene therapy latest to feel ‘inevitable’ teething problems

Therapeutic Class

Bluebird’s gene therapy latest to feel ‘inevitable’ teething problems Bluebird’s gene therapy latest to feel ‘inevitable’ teething problems

Jun 27, 2019

1 Min Read

Henlius' trastuzumab: EU to assess first China-made biosimilar

Henlius' trastuzumab: EU to assess first China-made biosimilar Henlius' trastuzumab: EU to assess first China-made biosimilar

Jun 25, 2019

1 Min Read

Vaccines the ‘backwaters of the pharma industry’ due to low price expectation

Vaccines the ‘backwaters of the pharma industry’ due to low price expectation Vaccines the ‘backwaters of the pharma industry’ due to low price expectation

Jun 6, 2019

1 Min Read

Stem cell clinic crackdown continues with FDA letter to R3

Stem cell clinic crackdown continues with FDA letter to R3

Stem cell clinic crackdown continues with FDA letter to R3

byDan Stanton, Editorial director

On the origin of serum: Controlling FBS supply, a riposte from the ESPA

On the origin of serum: Controlling FBS supply, a riposte from the ESPA

On the origin of serum: Controlling FBS supply, a riposte from the ESPA

byDan Stanton, Editorial director

Novartis wins approval for $2.1m gene therapy Zolgensma

Novartis wins approval for $2.1m gene therapy Zolgensma

Novartis wins approval for $2.1m gene therapy Zolgensma

byDan Stanton, Editorial director

FDA issues draft guidance on biosimilar analytical studies

FDA issues draft guidance on biosimilar analytical studies

FDA issues draft guidance on biosimilar analytical studies

byDan Stanton, Editorial director

Pfizer urges FDA for flexibility in considering interchangeability studies

Pfizer urges FDA for flexibility in considering interchangeability studies

Pfizer urges FDA for flexibility in considering interchangeability studies

byDan Stanton, Editorial director

Subcutaneous success a boon for Halozyme, but biosimilars hit royalties

Subcutaneous success a boon for Halozyme, but biosimilars hit royalties

Subcutaneous success a boon for Halozyme, but biosimilars hit royalties

byDan Stanton, Editorial director

FDA pledges to support cell and gene therapy manufacturing innovation

FDA pledges to support cell and gene therapy manufacturing innovation

FDA pledges to support cell and gene therapy manufacturing innovation

byGareth Macdonald

Success for Bioepis as FDA approves a second Enbrel biosimilar

Success for Bioepis as FDA approves a second Enbrel biosimilar

Success for Bioepis as FDA approves a second Enbrel biosimilar

byDan Stanton, Editorial director

Novartis prepped for ‘unprecedented’ Zolgensma demand

Facilities & Capacity

Novartis prepped for ‘unprecedented’ Zolgensma demand

Novartis prepped for ‘unprecedented’ Zolgensma demand

byDan Stanton, Editorial director

GSK expects normal HPV vaccine supply to resume in June

GSK expects normal HPV vaccine supply to resume in June

GSK expects normal HPV vaccine supply to resume in June

byDan Stanton, Editorial director

Shareholders' nod puts $74bn BMS Celgene merger back on track

Shareholders' nod puts $74bn BMS Celgene merger back on track

Shareholders' nod puts $74bn BMS Celgene merger back on track

byDan Stanton, Editorial director

bluebird opens gene therapy plant as EMA backs gene therapy

bluebird opens gene therapy plant as EMA backs gene therapy

bluebird opens gene therapy plant as EMA backs gene therapy

byDan Stanton, Editorial director

Biogen stock plunges $18bn on Alzheimer’s MAb failure

Biogen stock plunges $18bn on Alzheimer’s MAb failure

Biogen stock plunges $18bn on Alzheimer’s MAb failure

byDan Stanton, Editorial director

Two Form 483s not indicative of systemic manufacturing issues, Biocon

Two Form 483s not indicative of systemic manufacturing issues, Biocon

Two Form 483s not indicative of systemic manufacturing issues, Biocon

byDan Stanton, Editorial director

Biosimilar… but different: FDA tweaking nonproprietary name guidance

Biosimilar… but different: FDA tweaking nonproprietary name guidance

Biosimilar… but different: FDA tweaking nonproprietary name guidance

byDan Stanton, Editorial director

Precision Bio $100m IPO to support allo CAR-T build-out

Precision Bio $100m IPO to support allo CAR-T build-out

Precision Bio $100m IPO to support allo CAR-T build-out

byDan Stanton, Editorial director

FDA commissioner resignation ‘a great day for rogue stem cell clinics’

FDA commissioner resignation ‘a great day for rogue stem cell clinics’

FDA commissioner resignation ‘a great day for rogue stem cell clinics’

byDan Stanton, Editorial director

Under fire, BMS insists $74bn Celgene deal ‘next step in proven strategy’

Under fire, BMS insists $74bn Celgene deal ‘next step in proven strategy’

Under fire, BMS insists $74bn Celgene deal ‘next step in proven strategy’

byDan Stanton, Editorial director

Immunomedics: Data integrity and quality issues cited in FDA 483

Immunomedics: Data integrity and quality issues cited in FDA 483

Immunomedics: Data integrity and quality issues cited in FDA 483

byDan Stanton, Editorial director

FDA guidelines aim to improve quality and lower costs

FDA guidelines aim to improve quality and lower costs

FDA guidelines aim to improve quality and lower costs

Phacilitate: Cell & gene industry flocks to Miami

Therapeutic Class

Phacilitate: Cell & gene industry flocks to Miami

Phacilitate: Cell & gene industry flocks to Miami

byDan Stanton, Editorial director

Trastuzumab triple: FDA approves Merck and Samsung Bioepis biosimilar

Trastuzumab triple: FDA approves Merck and Samsung Bioepis biosimilar

Trastuzumab triple: FDA approves Merck and Samsung Bioepis biosimilar

byDan Stanton, Editorial director

Cell and gene therapies: FDA expects 10 to 20 approvals per year by 2025

Cell and gene therapies: FDA expects 10 to 20 approvals per year by 2025

Cell and gene therapies: FDA expects 10 to 20 approvals per year by 2025

byDan Stanton, Editorial director

Biotech patents: How to protect from IP threats

Biotech patents: How to protect from IP threats

Biotech patents: How to protect from IP threats

FDA paves way for insulin biosimilars, but will they be interchangeable?

FDA paves way for insulin biosimilars, but will they be interchangeable?

FDA paves way for insulin biosimilars, but will they be interchangeable?

byDan Stanton, Editorial director

MacroGenics clinical hold has no wider implications for bispecifics, say analysts

MacroGenics clinical hold has no wider implications for bispecifics, say analysts

MacroGenics clinical hold has no wider implications for bispecifics, say analysts

Pfizer Kansas plant hit by FDA 483 with 8 repeat observations

Pfizer Kansas plant hit by FDA 483 with 8 repeat observations

Pfizer Kansas plant hit by FDA 483 with 8 repeat observations

byDan Stanton, Editorial director

EU gives conditional nod for Takeda Shire megamerger

EU gives conditional nod for Takeda Shire megamerger

EU gives conditional nod for Takeda Shire megamerger

byDan Stanton, Editorial director

StemGenex warned as FDA clamps down on stem cell ‘bad actors’

StemGenex warned as FDA clamps down on stem cell ‘bad actors’

StemGenex warned as FDA clamps down on stem cell ‘bad actors’

byDan Stanton, Editorial director

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