Remove Clinical Development Remove FDA Approval Remove Government Remove Small Molecule
article thumbnail

Three trends in the antibody-drug conjugate (ADC) market 

Drug Discovery World

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1.

Marketing 245
article thumbnail

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process. “We Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We For more than 170 years, we have worked to make a difference for all who rely on us.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine

The Pharma Data

In some cases, governments may have regulatory pathways similar to an EUA. Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic.

Vaccine 52
article thumbnail

Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Conversations in Drug Development Trends

Currently Available Pharmacotherapies in the ALS Treatment Armory The battle against ALS has seen the introduction of a limited number of approved pharmacological treatments combined with other essential areas of multidisciplinary care.

article thumbnail

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

The Pharma Data

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. immediately. Source link.

Vaccine 52
article thumbnail

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

The Pharma Data

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. For more than 150 years, we have worked to make a difference for all who rely on us.

Vaccine 52
article thumbnail

Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Evidence of Efficacy in First Interim Analysis from Phase 3 Study

The Pharma Data

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. For more than 150 years, we have worked to make a difference for all who rely on us.

Vaccine 40