Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. It enrolled patients (pts) aged ?65

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

JUNE 18, 2021

years of follow-up, median PFS in the IMBRUVICA treatment arm was not reached: the PFS rate for patients treated with single-agent IMBRUVICA was 61 percent compared with only nine percent in patients treated with chlorambucil. to 79 months) were not reached. 1 Additionally, at 6.5 to 83) and CR (range, <0.1

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

MAY 4, 2021

Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Enters Into Contracts to Supply BNT162b2 to Canada and Israel for Periods Beyond 2021; Currently Negotiating Similar Potential Contracts with Multiple Other Countries. First-Quarter 2021 Revenues of $14.6 Billion and Adjusted Diluted EPS (2) to a Range of $3.55

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

JANUARY 22, 2023

While in the US, the therapy is already being prescribed under an expanded access program , the FDA has requested additional data from a randomised, placebo-controlled trial before it will allow Egetis to schedule a PDUFA date. Westerholm highlighted the company’s “robust data” from two different patient cohorts for its approval.

Drugs 317

Drugs Gene Hormones Clinical Trials 317

XTalks

SEPTEMBER 14, 2020

What’s at stake is nothing short of a world full of people who’ll need not one but likely two shots of a vaccine to bring the pandemic to a halt. In the meantime, WHO Director-General, Tedros Ghebreyesus feels that “vaccine nationalism” may prove to be the undoing of the potential to halt the spread of COVID-19.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92