Regulations

Flags with the World Health Organization logo

Gates' impact on global health and biologics manufacturing to increase Gates' impact on global health and biologics manufacturing to increase

Decisions from the Trump administration could make billionaire Bill Gates the biggest player in global health, with potential downstream impacts on manufacturing.

bySøren Hough, Editor, Drug Modalities at Tides Global

Jan 28, 2025

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1 Min Read

The Framingham biomanufactuiring facility near Boston has received a US FDA warning letter

Facilities & Capacity

FDA cites contamination concerns in warning to Sanofi MA plant FDA cites contamination concerns in warning to Sanofi MA plant

Jan 22, 2025

1 Min Read

A US flag juxtaposed with a symbolic representation of the department of commerce

Department of Commerce cracks down on biotechnology exports Department of Commerce cracks down on biotechnology exports

Jan 17, 2025

1 Min Read

Image of two researchers looking into microscopes

Facilities & Capacity

Aragen $100m PE boost to bolster CDMO ambition in India and beyond Aragen $100m PE boost to bolster CDMO ambition in India and beyond

Jan 15, 2025

1 Min Read

Novo Catalent deal clears regulatory hurdles Novo Catalent deal clears regulatory hurdles

byShreeyashi Ojha

Dec 16, 2024

1 Min Read

Vaccine makers sanguine amid threat from US health nominees RFK Jr. and Dr. Oz Vaccine makers sanguine amid threat from RFK Jr. and Dr. Oz

Nov 27, 2024

1 Min Read

Facilities & Capacity

IRA matches BIOSECURE in driving CDMO sector in India

IRA matches BIOSECURE in driving CDMO sector in India

byDan Stanton, Editorial director

Facilities & Capacity

BIOSECURE: China’s loss could be India’s gain

BIOSECURE: China’s loss could be India’s gain

byDan Stanton, Editorial director

Surviving BIOSECURE: US companies must prepare to avoid disruption

Surviving BIOSECURE: US companies must prepare to avoid disruption

byJosh Abbott, Editor, BioProcess Insider

Letter urges FTC to block Novo’s $16.5bn Catalent purchase

Letter urges FTC to block Novo’s $16.5bn Catalent purchase

byJosh Abbott, Editor, BioProcess Insider

Size matters when navigating BIOSECURE, says consultant

Size matters when navigating BIOSECURE, says consultant

byDan Stanton, Editorial director

White House OSTP: ‘Whether Harris or Trump, biomanufacturing is bipartisan’

‘Whether Harris or Trump, biomanufacturing is bipartisan’

byDan Stanton, Editorial director

FDA inspector exposes most common regulatory violations at BWB

FDA inspector exposes most common regulatory violations

byJosh Abbott, Editor, BioProcess Insider

BIOSECURE Act passes through US House

BIOSECURE Act passes through US House

byJosh Abbott, Editor, BioProcess Insider

Bioprocess Insider

Ensuring a healthy future for AI in biomanufacturing

Ensuring a healthy future for AI in biomanufacturing

byJosh Abbott, Editor, BioProcess Insider

Bioprocess Insider

AI is stronger and faster. But is it better?

AI is stronger and faster. But is it better?

byJosh Abbott, Editor, BioProcess Insider

US Speaker vows Congress will vote on BIOSECURE in 2024

US Speaker vows Congress will vote on BIOSECURE in 2024

byRichard Daverman

US FDA finds issues at Aurobindo injectables facility

US FDA finds issues at Aurobindo injectables facility

byShreeyashi Ojha, Reporter

Facilities & Capacity

Biocon expanded plant approved to make Avastin biosimilar

Biocon expanded plant approved to make Avastin biosimilar

byShreeyashi Ojha, Reporter

BIO-more-SECURE? Act left out of 2025 US Defense Bill

BIO-more-SECURE? Act left out of 2025 US Defense Bill

byDan Stanton, Editorial director

FDA advisors unanimously back Lilly’s Alzheimer's drug

FDA advisors unanimously back Lilly’s Alzheimer's drug

byMillie Nelson, Editor

US FDA grants GSK RSV vax label expansion

US FDA grants GSK RSV vax label expansion

byMillie Nelson, Editor

Outsourcing — India's Burgeoning Biologics CDMO Marketplace eBook Cover

Sponsored Content

eBook: Outsourcing — India's Burgeoning Biologics CDMO Marketplace

eBook: Outsourcing — India's Burgeoning Biologics CDMO Marketplace

US looks to 2032 as cut-off from Chinese biomanufacturing reliance

US looks to 2032 as cut-off from Chinese biomanufacturing reliance

byDan Stanton, Editorial director

Pfizer wins approval for $3.5m hemophilia B gene therapy

Pfizer wins approval for $3.5m hemophilia B gene therapy

byDan Stanton, Editorial director

Orchard $4.25m gene therapy approval a boon for AGC Bio

Orchard $4.25m gene therapy approval a boon for AGC Bio

byShreeyashi Ojha, Dan Stanton

BIO switches gears, cuts links with WuXi AppTec

BIO switches gears, cuts links with WuXi AppTec

byRichard Daverman

Sterile Filtration Process Control: Meeting Regulatory Expectations

Sterile Filtration Process Control: Meeting Regulatory Expectations

byLibby Russell

EMA selects candidates for pilot scheme to advance ATMPs

EMA selects candidates for pilot scheme to advance ATMPs

byShreeyashi Ojha, Reporter

Iovance: Price and time could hinder Amtagvi rollout

Iovance: Price and time could hinder Amtagvi rollout

byMillie Nelson, Editor

Iovance wins FDA approval for solid tumor cell therapy

Iovance wins FDA approval for solid tumor cell therapy

byMillie Nelson, Editor

The Impact of ICH Q5A R2 on the Biopharmaceutical Market

The Impact of ICH Q5A R2 on the Biopharmaceutical Market

byBPI Contributor

Aduhelm: Biogen calls a day on controversial Alzheimer’s mAb

Aduhelm: Biogen calls a day on controversial Alzheimer’s mAb

byMillie Nelson, Editor

WuXi Bio shares drop as US BIOSECURE bill targets China biotech

WuXi Bio shares drop as US BIOSECURE bill targets China biotech

byDan Stanton, Editorial director

Insider’s out? Evotec ‘immediately’ reported ex-CEO share trading

Insider’s out? Evotec ‘immediately’ reported ex-CEO share trading

byDan Stanton, Editorial director

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