The Pharma Data

NOVEMBER 20, 2020

18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. 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. Sanofi, Empowering Life.

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. The information contained in this release is as of May 6, 2021. Pfizer Disclosure Notice.

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The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of July 21, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Manufacturing 52

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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.

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The Pharma Data

NOVEMBER 9, 2020

Analysis evaluated 94 confirmed cases of COVID-19 in trial participants. 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.

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The Pharma Data

AUGUST 20, 2020

Phase 1 trial for the BNT162b2 vaccine candidate, which at 30 ?g The companies are continuing to analyze data from the Phase 1 trials in the U.S. The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. and Germany.

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The Pharma Data

DECEMBER 8, 2020

Recently released interim Phase 1 further indicates that 90 days following the second vaccination, trial participants retained high levels of neutralizing antibodies, suggesting that mRNA-1273 can generate durable neutralizing antibodies across all age groups including in older and elderly adults. Department of Health and Human Services.

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The Pharma Data

DECEMBER 1, 2020

This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, M.D., The Emergency Use Authorization in the U.K.

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Vaccination Vaccine Manufacturing Clinical Trials 40

The Pharma Data

MARCH 4, 2021

Together we generated positive Phase 2 ELEKTRA study data, and as a result, soticlestat is poised to enter two pivotal trials,” said Andy Plump, M.D., Securities and Exchange Commission, available on Takeda’s website at: [link] or at www.sec.gov. “I would like to thank Ovid for their thoughtful and productive collaboration.

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The Pharma Data

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co. LLC, Evercore Group L.L.C.,

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Clinical Trials Clinical Trials Clinical Development Antibody 40

The Pharma Data

DECEMBER 19, 2020

Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. The Moderna COVID-19 vaccine has not been approved or licensed by the FDA, or any other health authority, but it has been authorized for emergency use by the FDA under an EUA.

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Vaccination Vaccine Licensing Licensing 52

Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Disclosure Notice The information contained in this statement is as of January 27, 2023.

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The Pharma Data

OCTOBER 19, 2020

Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are among the most common serotypes causing invasive pneumococcal disease in parts of the world, including the U.S., PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

Pfizer

JULY 26, 2022

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The information contained in this release is as of July 27, 2022. Emergency Use Authorization .

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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. The information contained in this release is as of July 8, 2022. Pfizer Disclosure Notice.

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Pfizer

JULY 8, 2022

The submission included data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. About the Phase 1/2/3 Trial in Children.

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Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 The information contained in this release is as of July 19, 2022. Emergency Use Authorization.

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The Pharma Data

JANUARY 15, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. and Genmab A/S entered into a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. Janssen Biotech, Inc.

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Pfizer

SEPTEMBER 28, 2022

This study is consistent with regulatory guidance and follows the design of the previous Phase 1/2/3 trial to evaluate further options for protection in this age group. . Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus .

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Pfizer

OCTOBER 19, 2022

Today’s recommendation is based on data from a Phase 2/3 randomized, controlled trial that included 4,526 children aged 6 months to less than 5 years. In the trial, children received a third 3-µg dose of the original Pfizer-BioNTech COVID-19 Vaccine at least two months after the second dose at a time when Omicron BA.2 INDICATION.

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Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., For more information, please visit www.PAXLOVID.com. .

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Drugs Licensing Licensing Production 110

The Pharma Data

DECEMBER 17, 2020

Copies of the final prospectus may be obtained, when available, on the SEC’s website, www.sec.gov , or by contacting Aegis Capital Corp., Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy.

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Pfizer

SEPTEMBER 16, 2022

Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus . COMIRNATY® (COVID-19 Vaccine, mRNA) INDICATION. The information contained in this release is as of September 16, 2022. EMERGENCY USE AUTHORIZATION. Pfizer Disclosure Notice.

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Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Disclosure Notice.

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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. The companies are also working together with investigator sites and advocacy partners to raise awareness about the importance of participation in this trial.

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Pfizer

NOVEMBER 23, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., Our Commitment to Access. Disclosure Notice.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. DISCLOSURE NOTICE: The information contained in this release is as of February 23, 2021.

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The Pharma Data

JUNE 18, 2021

The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD), 8,9,10,11,12 and have been associated with high case-fatality rates, 13,14,15,16 antibiotic resistance, 4,17,18 and/or meningitis. IMPORTANT SAFETY INFORMATION.

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Vaccination Vaccine FDA Approval Containment 52

Pfizer

OCTOBER 20, 2022

“With more than 26 million adults over the age of 19 who have been previously vaccinated with PREVNAR 13®, today’s ACIP vote recognizes the importance of helping to protect them against the seven additional serotypes contained in PREVNAR 20®,” said Angela Hwang, President, Global Biopharma Business, Pfizer.

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Vaccination Vaccine Containment Immune Response 40

The Pharma Data

SEPTEMBER 15, 2020

Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. A Phase 3 trial is ongoing. Protease Inhibitor Program. Rare Disease.

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The Pharma Data

JANUARY 12, 2021

Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com. Forward Looking Statements.

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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. The trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted.

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The Pharma Data

JANUARY 6, 2021

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company’s development of a vaccine against the novel coronavirus, and plans for the supply and distribution of the Moderna COVID-19 Vaccine to Member States of the European Union.

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The Pharma Data

MARCH 11, 2021

We are extremely encouraged that the real-world effectiveness data coming from Israel are confirming the high efficacy demonstrated in our Phase 3 clinical trial and showing the significant impact of the vaccine in preventing severe disease and deaths due to COVID-19,” said Luis Jodar, Ph.D., Pfizer Disclosure Notice.

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The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. Global Head, Janssen Research & Development, Johnson & Johnson. John’s wort (Hypericum perforatum).

FDA Approval 52

FDA Approval RNA Drugs Containment 52

Pfizer

NOVEMBER 2, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the advancement of an mRNA-based combination vaccine candidate for influenza and COVID-19 to a Phase 1 trial with the aim to address two severe respiratory diseases with one vaccine. The information contained in this release is as of November 3, 2022. INDICATION.

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