XTalks

JUNE 14, 2023

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. The solution of Vevye does not contain water, anti-microbial preservatives, oils or surfactants.

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Gene Silencing Drug Delivery FDA Approval RNA 97

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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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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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

FDA Approval 52

FDA Approval Hormones Production Drugs 52

The Pharma Data

JANUARY 13, 2021

Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. About the Phase 1/2 Trial for HPN217. HPN217 is covered by a global development and option agreement with AbbVie Inc. NYSE: ABBV).

Drugs 52

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XTalks

OCTOBER 26, 2022

Additionally, the company revealed the latest five-year data from two Phase III studies (Study 1489 and Study 1490) at the 30th International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2022) showing the long-term safety and efficacy profile of Biktarvy in those who switch from a dolutegravir-containing regimen.

Drugs 98

Drugs Containment FDA Approval Marketing 98

pharmaphorum

OCTOBER 2, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5 million with its IPO shortly after the announcement.

Medicine 120

Medicine Life Science FDA Approval Development 120

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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Development Vaccination Vaccine Production 101

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. and globally.”. and Australia.

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The Pharma Data

NOVEMBER 3, 2020

DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial. About DEXTENZA. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

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Clinical Trials Clinical Trials FDA Approval Production 52

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

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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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

Sales 52

Sales Clinical Development Development Containment 52

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.

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Vaccination Vaccine Medicine Clinical Trials 100

Pfizer

NOVEMBER 2, 2022

The first participant has been dosed in a Phase 1 trial evaluating the safety, tolerability, and immunogenicity of a nucleoside-modified RNA (modRNA)-based combination vaccine approach. receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. . COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

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Vaccination Vaccine Clinical Trials Clinical Trials 85

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. INTERCHANGEABILITY. Pfizer Disclosure Notice.

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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. The information contained in this release is as of November 20, 2020.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

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. . 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

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.

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Gene Therapy Drugs Clinical Trials Clinical Trials 40

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

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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The Pharma Data

DECEMBER 10, 2020

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Risks and uncertainties related to this endeavor include, but are not limited to, the company’s beliefs regarding the success, cost, and timing of its development activities and clinical trials.

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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. The information contained in this release is as of December 10, 2020. About the Phase 2/3 Study.

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Vaccination Vaccine Trials Medicine 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

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued.

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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. The information contained in this release is as of December 11, 2020. About the Phase 2/3 Study.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

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.

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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., Obtain a pregnancy test before the start of treatment.

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The Pharma Data

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is also approved in Australia and Canada. IDHIFA is also approved in Australia and Canada.

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Trials FDA Approval Development Clinical Trials 52

The Pharma Data

NOVEMBER 30, 2020

HTL0022562 has already advanced successfully through a rigorous preclinical program and we are confident that the CGRP expertise and resources Biohaven brings will enable the further development of this and other promising CGRP antagonist candidates into human clinical trials. GPCR – G protein-coupled receptors.

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The Pharma Data

SEPTEMBER 1, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). Presentation Topic: Clinical Trials.

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Trials Clinical Trials Clinical Trials Vaccination 52

The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. The granting of an orphan drug designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.

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Drugs FDA Approval Marketing Containment 40

The Pharma Data

OCTOBER 30, 2020

If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. and Roche will develop, manufacture and distribute it outside the U.S. Department of Health and Human Services under OT number: HHSO100201700020C.

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Production Antibody Manufacturing Trials 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. About XELJANZ® (tofacitinib). GASTROINTESTINAL PERFORATIONS. ADVERSE REACTIONS.

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Clinical Trials Clinical Trials Vaccination Vaccine 40

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.

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Antibody Medicine Production Trials 52

The Pharma Data

OCTOBER 29, 2020

Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 trial (BRAVE-AA2) were initiated and are ongoing to assess the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo. 10x ULN were observed in patients in Olumiant clinical trials.

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Dermatology Development Medicine Clinical Trials 52