The Pharma Data

JULY 12, 2021

In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021. This press release features multimedia. View the full release here: [link]. “It About Molnupiravir.

Clinical Trials

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021. About Translate Bio.

Clinical Trials

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. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant.

Vaccine

The Pharma Data

OCTOBER 15, 2020

. ASLAN appoints neurologist Professor Gavin Giovannoni as a scientific advisorto establish clinical development strategy in multiple sclerosis. The company expects to share further details in early 2021. SINGAPORE, Oct. In 2019, ASLAN completed a Phase 2 study testing ASLAN003 in AML.

Pharmaceuticals

The Pharma Data

JANUARY 3, 2021

04, 2021 (GLOBE NEWSWIRE) — TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, announced today that its subsidiary, InspirMed Inc., SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Jan.

Clinical Trials

The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021.

Hospitals

The Pharma Data

OCTOBER 14, 2020

Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. Results from the PRECISION Study Expected in First Half of 2021. Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19, but using bovine parainfluenza as the vector.

Vaccine

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.

Hospitals

The Pharma Data

JANUARY 31, 2021

1, 2021 11:00 UTC. Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead. FOSTER CITY, Calif. & & EMERYVILLE, Calif.–(

Vaccine

The Pharma Data

SEPTEMBER 9, 2020

billion doses by the end of 2021. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies. billion doses by the end of 2021. billion doses by the end of 2021. About the Phase 2/3 Study.

Vaccine

The Pharma Data

JULY 21, 2021

To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately. Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. Pfizer Disclosure Notice.

Vaccine

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. LONDON and BOSTON, Jan. LONDON and BOSTON, Jan.

Science

The Pharma Data

MAY 6, 2021

The information contained in this release is as of May 6, 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. This press release features multimedia. View the full release here: [link]. Pfizer Disclosure Notice.

Vaccine

The Pharma Data

MAY 7, 2021

The information contained in this release is as of May 7, 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. Pfizer Disclosure Notice.

Licensing

The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. immediately, with delivery fulfillment expected to be completed in 2021.

Vaccine

Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

FDA

The Pharma Data

SEPTEMBER 9, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. billion doses by the end of 2021. About Pfizer: Breakthroughs That Change Patients’ Lives.

Vaccine

The Pharma Data

AUGUST 20, 2020

Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021. Jansen, Ph.D.,

Vaccine

Metabolite Tales Blog

JULY 5, 2023

With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. Ayushi Jain and Khalid Mumtaz, 2022. Avicenna J Med 12:154–156. Gangl et al., Clin Cancer Res 27 (12): 3298–3306.

Drugs

Metabolite Tales Blog

JULY 5, 2023

With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. Ayushi Jain and Khalid Mumtaz, 2022. Avicenna J Med 12:154–156. Gangl et al., Clin Cancer Res 27 (12): 3298–3306.

Drugs

The Pharma Data

DECEMBER 15, 2020

Anokion is responsible for preclinical activities and Phase I clinical development of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept. The FDA has set an action date of July 7, 2021. Patient Recruitment.

Disease

Agency IQ

AUGUST 18, 2023

The first implementing act for expert panels came out in 2019 and the panels began evaluating clinical evidence in 2021; these panels evaluate clinical evidence supporting product safety and performance via clinical consultation procedures (for both devices (MDR Article 54) and IVDs (IVDR Article 48(6)).

Science

The Pharma Data

DECEMBER 5, 2020

We are also expanding our odronextamab program with multiple pivotal trials in 2021.” REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

Production

The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4

Science

Drug Target Review

JANUARY 15, 2024

Each T cell expresses a TCR specific for an HLA‑presented peptide signal, and when that signal is detected a T cell expressing the relevant TCR can launch a complex array of immune effector responses that can suppress or destroy tumours or virus-infected cells. The FEBS Journal 288:6159–6173 (2021).

Engineering

The Pharma Data

JANUARY 18, 2021

18, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. © 2021 Sorrento Therapeutics, Inc. SAN DIEGO, Jan.

Clinical Trials

The Pharma Data

NOVEMBER 5, 2020

“Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

Production

The Pharma Data

JANUARY 20, 2021

TSX: CRDL ) ( OTCQX: CRTPF ) is a clinical-stage biotechnology company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease (CVD). Oakville, Ontario–(Newsfile Corp. Cardiol Therapeutics Inc. (

Hospitals

The Pharma Data

JANUARY 18, 2021

19, 2021 06:30 UTC. BT-001 IS AN ONCOLYTIC VIRUS GENERATED WITH TRANSGENE’S INNOVATIVE INVIR.IO oncolytic virus (VVcopTK-RR-), and has been engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent’s proprietary n-CoDeR®/F.I.R.S.T BT-001 is based on the patented Invir.IO

Virus

The Premier Consulting Blog

JUNE 18, 2023

In 2021, the FDA issued draft guidance on Credibility of Computational Modeling & Simulation (CM&S) in Medical Device Submissions. Our goal at Premier Research is to help customers leverage these innovative technologies and accelerate rare disease clinical development with high quality and reduced cost.

Drug Development

The Pharma Data

JANUARY 3, 2021

. The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses. The topline data from the trial is expected to be available in January 2021. NEW YORK and LONDON, Jan.

Clinical Trials

The Pharma Data

APRIL 22, 2023

It involves taking a patient’s own white blood cells, called T-cells, and modifying them so they can identify and target HIV cells to control the virus without medication. The trial is the first-in-human clinical study investigating the duoCAR T-cell therapy for the treatment of HIV. The novel study uses immunotherapy.

Clinical Trials

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. In the U.S.

Hospitals

The Pharma Data

DECEMBER 10, 2020

The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. The trial’s primary endpoints are prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2.

Vaccine

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 Company remains on track to manufacture 500 million to 1 billion doses globally in 2021.

Vaccine

The Pharma Data

NOVEMBER 20, 2020

Eiger’s lead clinical programs target Hepatitis Delta Virus (HDV) infection, the most serious form of human viral hepatitis. Eiger is developing two complementary treatments for HDV. Outside the U.S., Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial.

FDA Approval

The Pharma Data

OCTOBER 15, 2020

The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. The committee is tasked with supporting BeyondSpring’s business development activities related to its lead asset, Plinabulin, and other pipeline assets. BeyondSpring – BeyondSpring Inc.

Pharmaceuticals