The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Disclaimer. About Sandoz.

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.

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The Pharma Data

JANUARY 25, 2021

agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. The company is conducting a Phase 3 trial in status epilepticus. Marinus and Ceribell, Inc. RADNOR, Pa.–( –( BUSINESS WIRE )– Marinus Pharmaceuticals, Inc. Forward-Looking Statements.

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.

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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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pharmaphorum

DECEMBER 2, 2021

In September, it reported a fourth patient death in a clinical trial of its AT132 (resamirigene bilparvovec) gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), possibly linked to liver side effects. Those safety issues have hit Astellas’ aspirations in gene therapy directly.

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The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Disclaimer. About Sandoz.

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The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. For more information about the COVE study, click here. mRNA-1273 currently is not approved for use by any regulatory body.

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The Pharma Data

OCTOBER 28, 2020

We appreciate the confidence of the MHLW in Moderna and mRNA-1273, which we hope will help address the pandemic, especially given the encouraging data we have recently published together with the NIH related to the clinical trial in the elderly and older adult population,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. Vaccine doses for Europe would be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. billion doses by the end of 2021.

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Pfizer

AUGUST 3, 2022

We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures. Learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

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The Pharma Data

JANUARY 3, 2021

TLC19 Hydroxychloroquine Liposome Inhalation Suspension was thus incubated, with Phase I clinical trial currently taking place in Taiwan and Australia. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Cautionary Note on Forward-Looking Statements.

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Pfizer

SEPTEMBER 28, 2022

1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted 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 . 5-adapted bivalent vaccine. Pfizer Disclosure Notice.

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The Pharma Data

DECEMBER 10, 2020

“We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement.

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XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

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Pfizer

NOVEMBER 2, 2022

The vaccine candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development , and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

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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. Manufacturing and Delivery Capabilities. About the Study.

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Pfizer

JULY 26, 2022

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. The information contained in this release is as of July 27, 2022. Pfizer Disclosure Notice.

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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

DECEMBER 8, 2022

Pfizer and BioNTech previously announced the start of a Phase 1 trial to examine the safety, tolerability, and immunogenicity of their combined influenza and COVID-19 candidate vaccine among healthy adults. . The information contained in this release is as of December 9, 2022. COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

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The Pharma Data

NOVEMBER 3, 2020

According to the FDA, the purpose of Fast Track designation is to get important new drugs to patients earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need. Commenting on the announcement, Daniel Gruskin, M.D., LogicBio is headquartered in Lexington, Mass.

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Pfizer

JULY 19, 2022

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. The information contained in this release is as of July 19, 2022. Pfizer Disclosure Notice.

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Delveinsight

JULY 29, 2020

The Government of India in order to contain the spread of novel coronavirus rolled out several guidelines and precautionary measures. Several pharma and biotech companies are developing and manufacturing safe and effective vaccines to fight coronavirus. The first part of Phase-1 trials commenced at PGIMS, Rohtak on July 17.

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The Pharma Data

JANUARY 21, 2021

.–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial.

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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Delveinsight

JULY 27, 2021

a biotechnology (clinical stage immuno-oncology) company from California publicized the design of its new XPro therapy in Phase 2 clinical trials. Also information about their biomarker Phase 1b trial indicated improvement in white matter (myelinated axons) that degrades in AD patients. INmune Bio Inc. ,

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The Pharma Data

JANUARY 13, 2021

The magnitude of change in blood AEC was consistent with the eosinophil depletion seen in previous clinical trials of dexpramipexole in other indications. In the EXHALE trial, eosinophil depletion in blood by oral dexpramipexole correlated with clinically important improvement in lung function as measured by pre-bronchodilator FEV1.

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

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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. Manufacturing and Delivery Capabilities. About the Phase 2/3 Study. Pfizer is leveraging three of its U.S.

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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.

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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. Pfizer Disclosure Notice.

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The Pharma Data

DECEMBER 1, 2020

In the trial, BNT162b2 was generally well tolerated with no serious safety concerns reported by the Data Monitoring Committee to date. Today’s decision also is based on a review of Pfizer’s and BioNTech’s Chemistry, Manufacturing and Control (CMC) data for BNT162b2. Manufacturing and Delivery Capabilities.

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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. About AstraZeneca. AstraZeneca.

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The Pharma Data

DECEMBER 14, 2020

Both ublituximab and umbralisib, or the combination of which is referred to as “U2”, are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis.

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The Pharma Data

JANUARY 19, 2021

Dr. Jerkeman is the coordinator of several ongoing clinical trials in diffuse large B-cell lymphoma and mantle cell lymphoma. An additional preclinical programs in solid tumors is expected to enter clinical trials in Q1 2021. The Company’s validated, proprietary F.I.R.S.T

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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. The information contained in this release is as of November 9, 2020. Pfizer Inc. billion doses in 2021.

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