The Pharma Data

NOVEMBER 23, 2020

At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In Mr. Berkien is currently a board member of the Nordic Pharma Licensing Group.

Clinical Trials 52

Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

The Pharma Data

MARCH 1, 2022

” The lead molecule, SDI-118, is a small molecule currently in Phase 1b studies, which is being evaluated to target nerve terminals to enhance synaptic efficiency. It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Source link: [link].

Small Molecule 52

Small Molecule Licensing Licensing Disease 52

The Pharma Data

NOVEMBER 18, 2021

— Gilead Exercises Options to Arcus’s Anti-TIGIT Program (Domvanalimab and AB308), Etrumadenant (A2a/A2b Adenosine Receptor Antagonist) and Quemliclustat (Small Molecule CD73 Inhibitor) — — Arcus to Receive Option Payments Totaling $725 million — Gilead Lores,Inc. Nasdaq GILD) and Arcus Biosciences,Inc.

Research 52

Research Clinical Development Small Molecule Packaging 52

The Pharma Data

OCTOBER 14, 2020

Read-through therapeutic development is focused on extending mRNA half-life and increasing protein synthesis by enabling the cytoplasmic ribosome to read through premature stop codons to produce full-length proteins. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis.

Pharmaceuticals 52

Pharmaceuticals RNA Small Molecule Protein Production 52

The Pharma Data

DECEMBER 2, 2020

HZI – Germany’s Helmholtz Centre for Infection Research (HZI) secured two awards worth up to $15 million from CARB-X to develop non-traditional approaches against antibiotic-resistant pathogens. The goal is to develop a first-in-class treatment for Staphylococcus aureus infections and thereby prevent exacerbation of pneumonia.

Licensing 52

Licensing Licensing DNA Vaccine 52

The Pharma Data

OCTOBER 26, 2020

The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus ( S.

Pharmaceuticals 52

Pharmaceuticals Virus Hospitals Clinical Trials 52

Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling. Any CMC changes (e.g.,

Biosimilars 40

Biosimilars Science FDA Production 40

The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Pipeline Updates. •. ?.

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

The Pharma Data

JANUARY 13, 2021

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

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. Small Molecule Inhibitors. Oral, Small Molecules.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

OCTOBER 14, 2020

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. 1 Noyce RS, et al. 2018) PLoS One. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.

Vaccine 40

Vaccine Pharmaceuticals Small Molecule Virus 40

The Pharma Data

APRIL 27, 2021

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 8, 2020

It is estimated that there will potentially be 13 million moderate-to-severe acne patients treated with oral antibiotics in the urban Chinese population by 2028, which represents a significant opportunity to launch an innovative product whose clinical development is largely de-risked.

Licensing 52

Licensing Licensing Production Treatment 52

The Pharma Data

NOVEMBER 5, 2020

Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. Prior to that, Taveras was vice president of Small Molecule Drug Discovery and CMC Development at Biogen Idec, and Alantos Pharmaceuticals, which was acquired by Amgen in 2007.

Analytical Chemistry 40

Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

The Pharma Data

JANUARY 18, 2021

for the treatment of post-herpetic neuralgia.

Clinical Trials 40

Clinical Trials Small Molecule Trials Therapies 40

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

SEPTEMBER 9, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

The Pharma Data

SEPTEMBER 9, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine Clinical Trials RNA Trials 52

The Pharma Data

AUGUST 20, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 52

The Pharma Data

NOVEMBER 9, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 40

Vaccine Clinical Trials Trials FDA 40

The Pharma Data

SEPTEMBER 15, 2020

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Pfizer is leading further development of vupanorsen, with a focus on cardiovascular risk reduction, and plans to initiate a Phase 2b dose-ranging study in the coming weeks.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

The Pharma Data

DECEMBER 12, 2020

AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. The FcRn extends the half-life and hence the availability of pathogenic immunoglobulin G (IgG) antibodies.

Regulations 75

Regulations International Disease Small Molecule 75

Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. other regulatory submissions, the anticipated timing of regulatory submissions (including the anticipated timing of filing of a Biologics License Application in the U.S.),

Vaccine 52

Vaccine Clinical Trials Trials Licensing 52

The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 22, 2020

In parallel, Cytokinetics plans to conduct commercial readiness assessments and to evaluate potential partnering opportunities, including co-promotion options in North America as well as licensing in other territories. Cytokinetics will have no trailing royalty payment obligations to Amgen for either omecamtiv mecarbil or AMG 594.

Clinical Trials 52

Clinical Trials Licensing Licensing Trials 52

The Pharma Data

DECEMBER 10, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

NOVEMBER 20, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine FDA Clinical Trials Trials 52

The Pharma Data

OCTOBER 26, 2020

billion related to certain license and collaboration agreements, and certain other items. Companies enter into exclusive license and co-development agreement to accelerate global reach of Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor for the treatment of HER-2 positive cancers.

Vaccine 40

Vaccine Trials Treatment Production 40

The Pharma Data

NOVEMBER 4, 2020

License and research and development revenue. Research and development. . 2019. Revenue: . . . . . . . .

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Treatment 52

The Pharma Data

DECEMBER 1, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 40

Vaccine Clinical Trials Trials Production 40

The Pharma Data

DECEMBER 27, 2020

Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Tislelizumab is not approved for use outside of China.

Production 52

Production Therapies Treatment Drugs 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52