The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

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The Pharma Data

NOVEMBER 20, 2020

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. as well as Europe, Latin America, and South Africa. About the Study.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. www.sec.gov. www.sec.gov.

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The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

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The Pharma Data

JANUARY 20, 2021

Chimerix intends to use the net proceeds from the proposed offering to fund the clinical development of its product candidates, commercial pre-launch activities and general corporate purposes. The offering is expected to close on or about January 25, 2021. Jefferies and Cowen are acting as joint bookrunning managers for the offering.

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Clinical Trials Clinical Trials Trials Sales 52

The Pharma Data

NOVEMBER 9, 2020

Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints. Pfizer Inc. The data will be discussed with regulatory authorities worldwide. “I

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The Pharma Data

DECEMBER 10, 2020

The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About the Phase 2/3 Study.

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The Pharma Data

JULY 21, 2021

In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever 3 (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).

Manufacturing 52

Manufacturing Vaccination Vaccine Clinical Trials 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech appreciate the continued participation of the approximately 44,000 trial volunteers and remain committed to the companies’ pledge to always make their safety and well-being the companies’ top priority. About the Phase 2/3 Study. Germany, Turkey, South Africa, Brazil and Argentina.

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The Pharma Data

MAY 6, 2021

Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTech.

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The Pharma Data

APRIL 27, 2021

Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTech. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.

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The Pharma Data

AUGUST 20, 2020

The Phase 2/3 trial enrollment to date has exceeded 11,000 participants with a second dose underway. Pfizer and BioNTech are committed to decreasing health disparities in underrepresented populations through the clinical trial process. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

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The Pharma Data

JANUARY 3, 2021

The product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release.

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The Pharma Data

DECEMBER 1, 2020

Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech is able to produce mRNA for commercial supply after having already produced the vaccine candidate doses for the clinical trials. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTech.

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The Pharma Data

JULY 21, 2021

“This announcement reflects another important regulatory milestone in the development of this medicine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Obtain a pregnancy test before the start of treatment.

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The Pharma Data

NOVEMBER 29, 2020

(NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive interim efficacy results, as well as additional safety and immunogenicity data, for its prophylactic Cytomegalovirus (CMV) vaccine candidate HB-101. 1 Gilbert C and Boivin G.

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The Pharma Data

DECEMBER 2, 2020

We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. Pfizer Inc.: Breakthroughs that change patients’ lives. Source: Pfizer Inc. . Posted: December 2020.

Containment 52

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The Pharma Data

JANUARY 20, 2021

INOVIO intends to use the net proceeds from this offering for the development of its clinical pipeline, including clinical development expenses relating to INO-4800 and research and development expenses, and for general corporate purposes, including working capital and general and administrative expenses.

DNA 40

DNA Containment Immune Response Sales 40

The Pharma Data

JANUARY 12, 2021

The FDA Fast Track program is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Previously, LBS announced positive topline data from a Phase 2, randomized, double-blind, placebo-controlled, study that enrolled 120 adult open-heart surgery patients.

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The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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The Pharma Data

JULY 21, 2021

Islatravir (MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation in clinical trials for the treatment of HIV-1 infection in combination with other antiretrovirals, including the ILLUMINATE clinical trials program for once-daily treatment. KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

OCTOBER 25, 2020

BTI’s drug re-innovation approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices.

Trials 52

Trials Production FDA Approval Development 52

The Pharma Data

JANUARY 20, 2021

We are pleased to offer a meaningful new treatment option for appropriate patients with symptomatic chronic heart failure,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Obtain a pregnancy test before the start of treatment.

FDA Approval 52

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Pfizer

JULY 8, 2022

Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc. have completed a primary series.

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Pfizer

JULY 26, 2022

Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTech. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

Pfizer

JULY 8, 2022

The Phase 1/2/3 trial has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, Spain and Brazil from more than 90 clinical trial sites. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTech.

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Pfizer

JULY 19, 2022

Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. 1 subvariant, including a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine, based on the BA.1 About BioNTech.

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Pfizer

SEPTEMBER 28, 2022

Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. 5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age, initiation of a Phase 1/2/3 study to evaluate the safety, tolerability and immunogenicity of different doses and dosing regimens of the companies’ Omicron BA.4/BA.5-adapted

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Pfizer

OCTOBER 19, 2022

The Phase 1/2/3 trial ( NCT04816643 ) has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, Spain and Brazil from more than 90 clinical trial sites. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTech.

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The Pharma Data

SEPTEMBER 9, 2020

The study is an event-driven trial. Pfizer and BioNTech are committed to decreasing health disparities in underrepresented populations through the clinical trial process. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTech.

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Pfizer

SEPTEMBER 16, 2022

Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTech. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.

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The Pharma Data

FEBRUARY 25, 2021

7 In clinical trials, the safety and immunogenicity of TicoVac was assessed across two age groups (1-15 years of age and 16-65 years of age). 8,9 Clinical studies demonstrated that TicoVac was well-tolerated with no unexpected adverse events or vaccine-related serious adverse events observed. “If approved in the U.S.,

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Pfizer

OCTOBER 28, 2022

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in rheumatoid arthritis (RA) patients, and prescribed to more than 362,000 adult patients (the majority of whom were RA patients) worldwide since 2012. About XELJANZ® (tofacitinib). GASTROINTESTINAL PERFORATIONS. ADVERSE REACTIONS.

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Clinical Trials Clinical Trials Vaccination Vaccine 40

The Pharma Data

JUNE 16, 2021

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012. XELJANZ ® (tofacitinib) is approved in the U.S. See Limitations of Use below. GASTROINTESTINAL PERFORATIONS.

Medicine 40

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The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus.

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The Pharma Data

SEPTEMBER 15, 2020

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. 1 (646) 592-3157.

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