The Pharma Data

DECEMBER 31, 2020

where he led global clinical development programs including clinical strategy, clinical development, and regulatory affairs. Prior to Taiho, he held the positions of senior vice president of Clinical Oncology and CMO at Geron Corporation. and CMO for Taiho Oncology, Inc. Source link.

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The Pharma Data

DECEMBER 10, 2020

In the study, immunization with the hAd5-COVID-19 vaccine inhibited SARS-CoV-2 virus replication in 100% (10 of 10) of Rhesus macaques, with a drop in viral replication starting on the first day of vaccine administration, and undetectable viral levels as early as three to five days post-challenge in most of the animals.

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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.

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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.

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The Pharma Data

DECEMBER 14, 2020

The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. ” Under the license agreement, the development of ABBV-47D11 will be greatly advanced.

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The Pharma Data

JANUARY 27, 2021

– Second Product Candidate Expected to Enter Clinic in First Half of 2021. We are pleased to be advancing our second therapy into clinical development in our quest to bring transformative medicines to patients who need them,” said Bruce Goldsmith, Ph.D., PHILADELPHIA, Jan. chief executive officer of Passage Bio. “FTD

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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

AUGUST 7, 2020

Most importantly, we are continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinical development. The LY-CoV555 antibodies are infection fighting that can bind to the surface of viruses and prevent the virus infecting cells.

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The Pharma Data

JANUARY 3, 2021

With the COVID-19 pandemic this year redacting the world into a state of panic, TLC aspired to make a difference, and investigated the idea of encapsulating hydroxychloroquine, which has shown antiviral effects toward the SARS-CoV-2 virus, into TLC’s proprietary liposome formulation, using only ~1% of the oral dosage needed.

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Interim analysis from Phase 1/2a First-in-Human trial supports further clinical development of investigational vaccine candidate JNJ-78436735 (also known as Ad26.COV2.S).

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The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. About TNX-1800. 1 Noyce RS, et al.

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The Pharma Data

JANUARY 31, 2021

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. This press release features multimedia. View the full release here: [link]. Terms of the Agreement.

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The Pharma Data

MARCH 11, 2021

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.

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Agency IQ

FEBRUARY 12, 2024

The pilot focused on identifying commonalities across products using Adeno-Associated Virus (AAV) vectors to reduce duplication of efforts across individual therapeutic programs and to encourage the field to move away from the current “one-disease-at-a-time approach.”

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The Pharma Data

JUNE 1, 2022

Under her leadership, Pfizer advanced into clinical development or approval bacterial vaccine programs directed at the prevention of diseases due to Streptococcus pneumoniae, Group B Streptococcus, Neisseria meningitidis, Staphylococcus aureus, and Clostridium difficile.

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The Pharma Data

MAY 7, 2021

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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The Pharma Data

NOVEMBER 19, 2020

This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products. Sosei Heptares has successfully designed three distinct series of compounds with attractive anti-viral drug-like properties and advanced the most promising molecules.

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The Pharma Data

SEPTEMBER 9, 2020

On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study.

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The Pharma Data

JULY 21, 2021

At full operational capacity, the annual production will exceed 100 million finished doses annually. We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022.

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The Pharma Data

APRIL 26, 2022

About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development. 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.

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The Pharma Data

MAY 6, 2021

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Previously natural products have provided the source of up to 90% of macrocyclic drugs, not surprising given that 20% of natural product derived ring systems are macrocyclic [2]. Garcia Jimenez et al.,

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Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Previously natural products have provided the source of 80-90% of macrocyclic drugs, not surprising given that 20% of natural product derived ring systems are macrocyclic. [2] Garcia Jimenez et al.,

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The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8 About Juyou Bio – Technology Co.

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The Pharma Data

DECEMBER 5, 2020

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

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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.

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The Pharma Data

AUGUST 20, 2020

“The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus,” said Kathrin U.

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The Pharma Data

DECEMBER 11, 2020

The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. Vaccination in a pandemic situation is expected to be rapid, and we do not expect that the product will need to be stored at any location for more than 30 days. Secondary endpoints include prevention of severe COVID-19 in those groups.

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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)).

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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. Anti-CD40L Antibody. Patient Recruitment.

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Drug Target Review

JANUARY 15, 2024

This approach has produced a broad range of approved and investigational products. 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.

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The Pharma Data

DECEMBER 27, 2020

. As part of its broad development program, BeiGene expects to work with the NHSA for potential NRDL inclusion in future expanded indications for these medicines. Infections due to hepatitis B virus (HBV) reactivation have occurred. Drug Products with Same Active Ingredient. QARZIBA ® ? Osteonecrosis of the Jaw.

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Codon

MARCH 20, 2023

Point-of-care peptide hormone production enabled by cell-free protein synthesis. Peroxisomal metabolic coupling improves fatty alcohol production from sole methanol in yeast. Optogenetic closed-loop feedback control of the unfolded protein response optimizes protein production. How to build a virus-proof cell. Murakami K.

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The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Product Sales Performance. Total second quarter 2021 product sales increased 21% to $6.2 Total product sales excluding Veklury increased 5% to $5.3 Total product sales excluding Veklury increased 5% to $5.3

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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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Drug Target Review

MAY 22, 2024

We have built a circVec remove-&-replace construct for AATD where we are able to solve both of these issues in one product, expressing the functional wild-type AAT protein from circRNA and removing the mutant form in a sequence-specific and exonucleolytic manner.

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The Pharma Data

OCTOBER 27, 2020

As part of those efforts, it has become increasingly clear that to tackle the pandemic at a global level the development of medicines that can prevent and treat the virus, in addition to the development of vaccines, will be crucial. During the clinical development stage, Molecular Partners will provide clinical supply.

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