The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 Senior Vice President and Head of Global Clinical Development at Regeneron. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. There was a 1.08

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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.

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The Pharma Data

JULY 12, 2021

The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021.

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The Pharma Data

OCTOBER 15, 2020

ASLAN believes ASLAN003 has the potential to bethe most potent oral inhibitor of DHODH currently in development for autoimmune disease, more than 30 times more potent at inhibiting the DHODH enzyme than teriflunomide. The company expects to share further details in early 2021. SINGAPORE, Oct.

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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.”

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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.

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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.

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The Pharma Data

MAY 26, 2023

since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent with the EUA. 1) “Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern. .” More than 11.6

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The Pharma Data

JANUARY 13, 2021

GMP Production of TNX-1500 is Expected to be Available in the Third Quarter of 2021. 14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. WO 2021/001458 A1. Lederman added, “We believe the development risk of TNX-1500 is mitigated by previous clinical data and extensive preclinical science with ruplizumab.

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The Pharma Data

JANUARY 3, 2021

The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), Santa Casa de Misericórdia de Santos Hospital (Santos, Brazil) and INTRIALS, a world-class, full-service Latin American CRO based in São Paulo, Brazil. NEW YORK and LONDON, Jan. Dr. .

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The Pharma Data

JUNE 26, 2021

. “Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalisations from severe forms of the disease,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development.

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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.

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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. Have diabetes.

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The Pharma Data

APRIL 27, 2021

All doses expected to be delivered in 2021. NEW YORK and MAINZ, GERMANY, April 19, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021.

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The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. This patient population is at significant risk of developing cardiovascular complications, which are frequently fatal, during their illness.

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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. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain.

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The Pharma Data

APRIL 29, 2022

These results, however, were not statistically significant and, as such, the primary endpoint of reducing the risk of confirmed and symptomatic COVID-19 infection in adults who had been exposed to the virus through a household contact was not met. Additional details on the study are available on clinicaltrials.gov (NCT05047601).

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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. cardiovascular disease, OR. In the U.S.

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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. CEO and Co-founder of BioNTech. “We

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The Pharma Data

APRIL 7, 2022

announced today that the companies have entered into a definitive agreement under which Pfizer will acquire ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV).

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The Pharma Data

MAY 7, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The information contained in this release is as of May 7, 2021. AUTHORIZED USE IN THE U.S.:

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The Pharma Data

MAY 6, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The information contained in this release is as of May 6, 2021. This press release features multimedia.

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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. About BioNTech.

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The Pharma Data

NOVEMBER 20, 2020

Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Progeria and Progeroid Laminopathies are separate and distinct ultra-rare, genetic, premature aging diseases that accelerate mortality in young patients. PALO ALTO, Calif.,

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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.

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Metabolite Tales Blog

JULY 5, 2023

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Gangl et al.,

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Metabolite Tales Blog

JULY 5, 2023

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Gangl et al.,

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Drug Discovery World

AUGUST 21, 2023

Diana Spencer investigates therapies in clinical development for triple-negative breast cancer and asks what future treatments might look like. TVEC is a modified herpes simplex 1 virus that includes coding sequences for the protein GM-CSF, which can stimulate the immune system. The results showed that 45.9%

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The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.

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Drug Discovery World

JUNE 26, 2023

Now, there are many mRNA-based therapeutics in clinical development and mRNA cancer vaccines have been promised by 2030. In rare diseases, Moderna has several mRNA therapeutics in clinical development, including one in Phase II, a treatment for Propionic acidemia (PA), for which the company recently announced encouraging trial results.

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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.

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The Pharma Data

DECEMBER 5, 2020

57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative. 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.

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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.,

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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).

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The Pharma Data

FEBRUARY 25, 2021

In line with Priority Review designation, the FDA will target an action within six months of the application submission date, 3 with the anticipated Prescription Drug User Fee Act (PDUFA) action date expected for August 2021. 5 To date, ticks infected with the TBE virus have been identified in more than 35 countries across Europe and Asia.

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The Pharma Data

DECEMBER 10, 2020

These pivotal data demonstrate that our COVID-19 vaccine candidate is highly effective in preventing COVID-19 disease and is generally well-tolerated. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. Secondary endpoints include prevention of severe COVID-19 in those groups.

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The Pharma Data

OCTOBER 26, 2020

V590 — a SARS-CoV-2 vaccine candidate in development in collaboration with the International AIDS Vaccine Initiative (IAVI) that uses a recombinant vesicular stomatitis virus (rVSV) platform, the same platform used for Merck’s approved Ebola Zaire virus vaccine, will enter Phase 1 development shortly.

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