Regulations

thumbnail
Facilities & Capacity
IRA matches BIOSECURE in driving CDMO sector in IndiaIRA matches BIOSECURE in driving CDMO sector in India

While much talk at CPHI Milan centered on the potential impact of BIOSECURE, other US policies – particularly the Inflation Reduction Act (IRA) – are proving a boon for Indian CDMOs.

byDan Stanton, Editorial director
Nov 13, 2024
|
1 Min Read
thumbnail
Facilities & Capacity
BIOSECURE: China’s loss could be India’s gainBIOSECURE: China’s loss could be India’s gain
byDan Stanton
Nov 4, 2024
1 Min Read
thumbnail
Regulations
Surviving BIOSECURE: US companies must prepare to avoid disruptionSurviving BIOSECURE: US companies must prepare to avoid disruption
byJosh Abbott
Oct 23, 2024
1 Min Read
thumbnail
Regulations
Letter urges FTC to block Novo’s $16.5bn Catalent purchaseLetter urges FTC to block Novo’s $16.5bn Catalent purchase
byJosh Abbott
Oct 18, 2024
1 Min Read
thumbnail
Regulations
Size matters when navigating BIOSECURE, says consultantSize matters when navigating BIOSECURE, says consultant
byDan Stanton
Oct 14, 2024
1 Min Read
thumbnail
Global Markets
White House OSTP: ‘Whether Harris or Trump, biomanufacturing is bipartisan’‘Whether Harris or Trump, biomanufacturing is bipartisan’
byDan Stanton
Sep 30, 2024
1 Min Read
Regulations
FDA inspector exposes most common regulatory violations at BWB
FDA inspector exposes most common regulatory violations
Sep 27, 2024
|
1 Min Read
byJosh Abbott, Editor, BioProcess Insider
Regulations
BIOSECURE Act passes through US House
BIOSECURE Act passes through US House
Sep 11, 2024
|
1 Min Read
byJosh Abbott, Editor, BioProcess Insider
Bioprocess Insider
Ensuring a healthy future for AI in biomanufacturing
Ensuring a healthy future for AI in biomanufacturing
Aug 7, 2024
|
1 Min Read
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?
Jul 17, 2024
|
1 Min Read
byJosh Abbott, Editor, BioProcess Insider
Global Markets
US Speaker vows Congress will vote on BIOSECURE in 2024
US Speaker vows Congress will vote on BIOSECURE in 2024
Jul 15, 2024
|
1 Min Read
byRichard Daverman
Regulations
US FDA finds issues at Aurobindo injectables facility
US FDA finds issues at Aurobindo injectables facility
Jul 3, 2024
|
1 Min Read
byShreeyashi Ojha, Reporter
Facilities & Capacity
Biocon expanded plant approved to make Avastin biosimilar
Biocon expanded plant approved to make Avastin biosimilar
Jul 3, 2024
|
1 Min Read
byShreeyashi Ojha, Reporter
Global Markets
BIO-more-SECURE? Act left out of 2025 US Defense Bill
BIO-more-SECURE? Act left out of 2025 US Defense Bill
Jun 14, 2024
|
1 Min Read
byDan Stanton, Editorial director
Regulations
FDA advisors unanimously back Lilly’s Alzheimer's drug
FDA advisors unanimously back Lilly’s Alzheimer's drug
Jun 11, 2024
|
1 Min Read
byMillie Nelson, Editor
Regulations
US FDA grants GSK RSV vax label expansion
US FDA grants GSK RSV vax label expansion
Jun 10, 2024
|
1 Min Read
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
May 22, 2024
byRoger Lias
Global Markets
US looks to 2032 as cut-off from Chinese biomanufacturing reliance
US looks to 2032 as cut-off from Chinese biomanufacturing reliance
May 13, 2024
|
1 Min Read
byDan Stanton, Editorial director
Regulations
Pfizer wins approval for $3.5m hemophilia B gene therapy
Pfizer wins approval for $3.5m hemophilia B gene therapy
Apr 29, 2024
|
1 Min Read
byDan Stanton, Editorial director
Regulations
Orchard $4.25m gene therapy approval a boon for AGC Bio
Orchard $4.25m gene therapy approval a boon for AGC Bio
Mar 21, 2024
|
1 Min Read
byShreeyashi Ojha, Dan Stanton
Global Markets
BIO switches gears, cuts links with WuXi AppTec
BIO switches gears, cuts links with WuXi AppTec
Mar 15, 2024
|
1 Min Read
byRichard Daverman
logo in a gray background |
Regulations
Sterile Filtration Process Control: Meeting Regulatory Expectations
Sterile Filtration Process Control: Meeting Regulatory Expectations
Mar 6, 2024
byLibby Russell
Regulations
EMA selects candidates for pilot scheme to advance ATMPs
EMA selects candidates for pilot scheme to advance ATMPs
Feb 23, 2024
|
1 Min Read
byShreeyashi Ojha, Reporter
Regulations
Iovance: Price and time could hinder Amtagvi rollout
Iovance: Price and time could hinder Amtagvi rollout
Feb 21, 2024
|
1 Min Read
byMillie Nelson, Editor
Regulations
Iovance wins FDA approval for solid tumor cell therapy
Iovance wins FDA approval for solid tumor cell therapy
Feb 19, 2024
|
1 Min Read
byMillie Nelson, Editor
Regulations
The Impact of ICH Q5A R2 on the Biopharmaceutical Market
The Impact of ICH Q5A R2 on the Biopharmaceutical Market
Feb 14, 2024
byBPI Contributor
Regulations
Aduhelm: Biogen calls a day on controversial Alzheimer’s mAb
Aduhelm: Biogen calls a day on controversial Alzheimer’s mAb
Feb 1, 2024
|
1 Min Read
byMillie Nelson, Editor
Global Markets
WuXi Bio shares drop as US BIOSECURE bill targets China biotech
WuXi Bio shares drop as US BIOSECURE bill targets China biotech
Jan 29, 2024
|
1 Min Read
byDan Stanton, Editorial director
Regulations
Insider’s out? Evotec ‘immediately’ reported ex-CEO share trading
Insider’s out? Evotec ‘immediately’ reported ex-CEO share trading
Jan 25, 2024
|
1 Min Read
byDan Stanton, Editorial director
Regulations
Patient advocate slams FDA decision for CAR-T warning labels
Patient advocate slams FDA decision for CAR-T warning labels
Jan 24, 2024
|
1 Min Read
byMillie Nelson, Editor
FDA
Regulations
Astellas: CDMO issues cause FDA to reject gastric cancer mAb
Astellas: CDMO issues cause FDA to reject gastric cancer mAb
Jan 12, 2024
|
1 Min Read
byDan Stanton, Editorial director
Nobel Prize
Regulations
Bayh-Dole Act nurtures medical innovation, says Nobel Prize winning mRNA researcher
Bayh-Dole Act nurtures medical innovation, says Nobel Prize winning mRNA researcher
Jan 3, 2024
|
1 Min Read
Funding
Regulations
Bluebird seeks $150m funding to support gene therapy launch
Bluebird seeks $150m funding to support gene therapy launch
Dec 21, 2023
|
1 Min Read
byShreeyashi Ojha, Reporter
FDA Approved
Regulations
Bluebird bio receives US FDA nod for sickle cell therapy
Bluebird bio receives US FDA nod for sickle cell therapy
Dec 11, 2023
|
1 Min Read
byShreeyashi Ojha, Reporter
Approved
Regulations
Vertex/CRISPR win FDA approval for gene therapy Casgevy
Vertex/CRISPR win FDA approval for gene therapy Casgevy
Dec 11, 2023
|
1 Min Read
byMillie Nelson, Editor

Webinars

Ask the Expert webcasts
ATE Webcasts
Register Now: Evaluation of a New Multimodal Anion Exchange Resin for Emerging Biotherapeutic Process Challenges
Register Now: Evaluation of a New Multimodal Anion Exchange Resin for Emerging Biotherapeutic Process Challenges
Ask the Expert webcasts
ATE Webcasts
Register Now: Linking mAb Product Quality Profile Changes to Your Bioprocess: Case Study of Dynamic Glucose Level Control in CHO Process Improves Product Quality
Register Now: Linking mAb Product Quality Profile Changes to Your Bioprocess: Case Study of Dynamic Glucose Level Control in CHO Process Improves Product Quality
Ask the Expert webcasts
ATE Webcasts
Register Now: Navigating Biopharma Commercialization: The Interplay of Regulatory Affairs, Process Development, and Manufacturing to Ensure Drug Quality
Register Now: Navigating Biopharma Commercialization: The Interplay of Regulatory Affairs, Process Development, and Manufacturing to Ensure Drug Quality
Insider News
See all
Dec 2 - Dec 5, 2024
The European Cell and Gene Therapy Congress for Groundbreaking Manufacturing, Commercialisation & Analytical Strategies: World renowned leaders share the latest process development, analytical and market access strategies to improve manufacturing scalability, quality and cost to propel your CGT programmes to commercial success
Learn More

Innovative Technology

Thermo Fisher White Paper
Sponsored Content
Peptones: A Powerful Tool for Manufacturing Complex Protein Therapies
Peptones: A Powerful Tool for Manufacturing Complex Protein Therapies

Nov 21, 2024

Thermo Fisher WP
Sponsored Content
Efficient-Pro Medium and Feed 1 Enable Rapid and Seamless Upstream Process Development and Scale-Up for CHO-K1 Cells
Efficient-Pro Medium and Feed 1 Enable Rapid and Seamless Upstream Process Development and Scale-Up for CHO-K1 Cells

Nov 21, 2024

Emerson white paper
Sponsored Content
Sustainability in Life Sciences: Actionable Solutions for Improving Energy Efficiency
Sustainability in Life Sciences: Actionable Solutions for Improving Energy Efficiency

Nov 12, 2024