The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.

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XTalks

APRIL 24, 2023

According to Dr. 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.

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The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. Sosei Heptares will now conduct a full internal review to determine a strategy for the further development and re-partnering of the program. . ” About the License Agreement. TOKYO and CAMBRIDGE, England , Jan.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval. PharmaDrug Inc.

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The Pharma Data

JANUARY 27, 2021

. A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. ET ) to discuss the results and next steps in clinical development of BI-1206.

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Drug Discovery World

MARCH 29, 2023

An example of the current disparity, drawn from data from the European Federation of Pharmaceutical Industries and Associations (EFPIA), can be seen in Romania, Poland or Bulgaria, where a recently approved medicine will take more than 800 days on average before it becomes publicly available compared with Germany, where that figure is 133 days 3.

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. NEW YORK and LONDON, Jan.

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The Pharma Data

NOVEMBER 3, 2020

Nasdaq:LOGC) (LogicBio), a company dedicated to extending the reach of genetic medicine with pioneering targeted delivery platforms, announced today the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). LEXINGTON, Mass.,

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. The European Medicines Agency has also granted orphan drug designation to INZ-701 for the treatment of ENPP1 deficiency. Food and Drug Administration cleared Investigational New Drug Application.

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Pfizer

FEBRUARY 16, 2023

The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. 2-4 About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development.

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The Pharma Data

APRIL 27, 2021

(the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. Interactions with other medicinal products or concomitant administration of COMIRNATY® with other vaccines has not been studied.

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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. is immunocompromised or are on a medicine that affects the immune system. has a fever.

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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. About Pneumococcal Disease.

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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. have a fever.

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The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

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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. are immunocompromised or are on a medicine that affects the immune system. NEW YORK and MAINZ, GERMANY, SEPT 16, 2022 — Pfizer Inc.

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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. are immunocompromised or are on a medicine that affects the immune system. have a fever.

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The Pharma Data

DECEMBER 14, 2020

NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases (“the Company”), today announced the pricing of an underwritten public offering of 6,320,000 shares of common stock at a public offering price of $43.50 NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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The Pharma Data

JANUARY 14, 2021

Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. Wainberg, M.D.,

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Pfizer

DECEMBER 8, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron sublineages BA.4/BA.5, are immunocompromised or are on a medicine that affects the immune system. COMIRNATY® (COVID-19 Vaccine, mRNA).

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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The Pharma Data

DECEMBER 12, 2020

We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.” ” Ludwig Hantson , Ph.D., Strategic rationale.

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Pfizer

JULY 8, 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. is immunocompromised or is on a medicine that affects the immune system. has a fever.

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The Pharma Data

JANUARY 18, 2021

In-licensed from Merck KGaA, Darmstadt, Germany , atacicept has been studied previously in autoimmune diseases and shown to reduce autoantibodies in a dose-dependent fashion with once-weekly subcutaneous dosing and has a well-established and acceptable clinical safety profile. For more information please visit: www.veratx.com.

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The Pharma Data

JANUARY 13, 2021

Complete approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials. . Our 5,000+ employees in China, the United States, Australia, Europe, and elsewhere are committed to expediting the development of a diverse pipeline of novel therapeutics. About BeiGene.

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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. 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 May 6, 2021.

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The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S.

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The Pharma Data

NOVEMBER 22, 2020

In parallel, Cytokinetics plans to conduct commercial readiness assessments and to evaluate potential partnering opportunities, including co-promotion options in North America as well as licensing in other territories. Cytokinetics will have no trailing royalty payment obligations to Amgen for either omecamtiv mecarbil or AMG 594.

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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. 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 21, 2021.

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The Pharma Data

NOVEMBER 20, 2020

As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”. The information contained in this release is as of November 20, 2020. Pfizer Disclosure Notice.

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Pfizer

OCTOBER 19, 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. are immunocompromised or are on a medicine that affects the immune system. The information contained in this release is as of October 19, 2022. Wednesday, October 19, 2022 - 11:45am.

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The Pharma Data

DECEMBER 1, 2020

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. Pfizer has a 171-year track record of researching, developing, manufacturing and delivering innovative medicines and vaccines to patients in need. 2, 2020 07:05 UTC.

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The Pharma Data

OCTOBER 29, 2020

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . The data underscore Lilly’s commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA). INDIANAPOLIS , Oct.

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The Pharma Data

SEPTEMBER 9, 2020

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 September 7, 2020. Pfizer Disclosure Notice. For more information, please visit www.BioNTech.de.

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