pharmaphorum

SEPTEMBER 8, 2022

This year, Novartis’ deal-making in the area paid off when it received US FDA approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for previously-treated patients with PSMA-positive metastatic castration-resistant prostate cancer. The copper pairing provides significant supply and manufacturing advantages.

Manufacturing 105

Manufacturing Development Drugs Antibody 105

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.

Development 101

Development Vaccination Vaccine Production 101

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. INTERCHANGEABILITY.

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FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

OCTOBER 25, 2020

SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test. SQI intends to submit RALI- fast for EUA to FDA in late Q1 2021. About SQI Diagnostics.

Development 52

Development Antibody Clinical Development FDA Approval 52

XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

NOVEMBER 20, 2020

The BNT162b2 vaccine candidate is not currently approved for distribution anywhere in the world. Both collaborators are committed to developing this novel vaccine with preclinical and clinical data at the forefront of all their decision making. Manufacturing and Delivery Capabilities. Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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.

Drugs 52

Drugs Containment Development Sales 52

The Pharma Data

DECEMBER 10, 2020

agreed to share equally the costs of development, manufacturing, marketing and commercialization of the products each is developing related to COVID-19, including the hAd5 vaccine candidate. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

DECEMBER 11, 2020

Manufacturing and Delivery Capabilities. Pfizer and BioNTech continue to work in collaboration with governments and Ministries of Health around the world that will distribute the vaccine, subject to country authorization or approval and terms of supply agreements, to help ensure it can reach those most in need as quickly as possible.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JULY 21, 2021

Food and Drug Administration (FDA) approved VERQUVO in the U.S. the product label for VERQUVO contains a boxed warning that indicates that VERQUVO should not be administered to pregnant females because it may cause fetal harm. In the U.S.,

Production 52

Production Medicine Containment Development 52

The Pharma Data

OCTOBER 30, 2020

REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. and Roche will develop, manufacture and distribute it outside the U.S.

Production 52

Production Antibody Manufacturing Trials 52

The Pharma Data

NOVEMBER 9, 2020

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. The information contained in this release is as of November 9, 2020.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 40

The Pharma Data

DECEMBER 10, 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 December 10, 2020. Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

OCTOBER 27, 2020

Orphan Drug designation affords Passage Bio the potential for certain benefits, including up to seven years of market exclusivity, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees. More information is available at www.passagebio.com.

Gene Therapy 40

Gene Therapy Drugs Clinical Trials Clinical Trials 40

The Pharma Data

DECEMBER 27, 2020

Our work began modestly, but we hit our stride in 2020 and reached important clinical, manufacturing, and business milestones this year, which created substantial value and advanced us toward our ultimate goal. Our goal of building Lineage into the preeminent cell therapy company is ambitious but attainable.

Manufacturing 52

Manufacturing Production Development Clinical Trials 52

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” and Roche will develop, manufacture and distribute it outside of the U.S.

Antibody 52

Antibody Medicine Production Trials 52

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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Gene Therapy Gene Trials Clinical Trials 264

The Pharma Data

NOVEMBER 30, 2020

Under the agreement, Biohaven will receive exclusive global rights to develop, manufacture and commercialize a portfolio of novel, small-molecule CGRP receptor antagonists discovered by Sosei Heptares for the treatment of CGRP-mediated disorders. . TOKYO and CAMBRIDGE, England , Dec. GPCR – G protein-coupled receptors.

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Licensing Licensing Production Development 40

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. Even more interestingly, now there are drugs that have FDA approval that were conducted by decentralized clinical trials.

Life Science 98

Life Science Clinical Trials Clinical Trials Trials 98

XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. Pfizer Inc.

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Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

OCTOBER 28, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. and Roche will develop, manufacture and distribute it outside the U.S. Under an agreement with the U.S.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). Updates from the clinical pipeline include: Dupixent ® (dupilumab). Corporate and Business Development Update. government.

Sales 52

Sales Production Manufacturing Antibody 52

Pharmaceutical Technology

MARCH 2, 2023

Pembrolizumab is under clinical development by Merck and currently in Phase III for Bile Duct Cancer (Cholangiocarcinoma). GlobalData’s report assesses how Pembrolizumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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FDA Approval Containment Development Genome 100

The Pharma Data

JANUARY 15, 2021

Enhertu is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicityEnhertu. mg/kg) is also approved in the U.S. About the Enhertu Clinical Development Program. Daiichi Sankyo is responsible for manufacturing and supply of Enhertu and datopotamab deruxtecan. Indications.

Medicine 52

Medicine Trials Antibody HR 52

Pfizer

JULY 26, 2022

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use. INTERCHANGEABILITY.

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Vaccination Vaccine Protein Immune Response 111

The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

Antibody 40

Antibody Production Trials Medicine 40

Pfizer

JULY 19, 2022

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use. INTERCHANGEABILITY.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

Pfizer

JULY 8, 2022

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use. INTERCHANGEABILITY.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 In May, the FDA approved GSK’s Arexvy as the first RSV vaccine, which was shortly followed by the approval of Pfizer’s RSV vaccine Abrysvo.

Vaccination 105

Vaccination Vaccine RNA Manufacturing 105

XTalks

JANUARY 19, 2024

Radiobiological and Clinical Considerations from CRO and Emerging Biotech Radiopharmaceuticals are medicinal formulations containing radioisotopes that are used in the field of nuclear medicine primarily for the diagnosis and treatment of various diseases, particularly cancer. In addition, the cascades can also contain beta emissions.

DNA 66

DNA Radiology FDA Approval Development 66

The Pharma Data

OCTOBER 25, 2020

FDA approval. The company has introduced Oxbryta® (voxelotor), the first FDA-approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of red blood cell sickling in SCD. These forward-looking statements are based on GBT’s current expectations and actual results could differ materially.

Medicine 52

Medicine Development Containment FDA Approval 52

The Pharma Data

NOVEMBER 30, 2020

I would again like to thank our partners at NIH, NIAID, BARDA and Operation Warp Speed who have helped us advance the clinical development of mRNA-1273. Finally, I want to thank the Moderna team and our suppliers and partners for their tireless work on the research, development and manufacturing of our vaccine.

Vaccination 52

Vaccination Vaccine Medicine Clinical Trials 52

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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Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

OCTOBER 26, 2020

Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. Transgene has an ongoing Invir.IO Disclaimer.

Vaccination 52

Vaccination Vaccine Trials Containment 52

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. In addition to receiving regulatory approval in the U.S.,

Clinical Trials 40

Clinical Trials Clinical Trials Vaccination Vaccine 40

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, receipt of the most recent booster dose with any authorized or approved monovalent* COVID-19 vaccine . INDICATION.

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Vaccination Vaccine Clinical Trials Clinical Trials 81