The Pharma Data

NOVEMBER 19, 2020

The Company is also aiming to leverage the highly conserved structure of the SARS-CoV-2 M pro protease as a basis for the design of novel oral small molecules against predicted future variants of SARS-CoV-2 and other related human viruses.

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Conversations in Drug Development Trends

MAY 30, 2024

Differences in regulatory sentiments and industry sponsors’ subsequent clinical development strategies historically restricted access based on geography. was withdrawn, rendering it unapproved for patient use, based on negative review comments by the Committee for Medicinal Products for Human Use. The MAA file in the E.U.

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The Premier Consulting Blog

JULY 9, 2023

During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. Global regulatory agencies, including the U.S. ICH Q3A and ICH Q3B outline expectations for reporting, identifying, and qualifying (i.e.,

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Fierce BioTech

AUGUST 25, 2023

In this webinar, Alcami experts will share their experience in partnering with biopharma clients to meet their specific project needs, be it early phase clinical development or late phase or commercial products, small molecules, biologics or advanced modalities.

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The Pharma Data

JANUARY 13, 2021

Knopp Biosciences is a privately held drug discovery and development company focused on delivering breakthrough treatments for immunological and neurological diseases of high unmet need. Knopp’s clinical-stage oral small molecule, dexpramipexole, is in Phase 2 clinical trials in moderate-to-severe eosinophilic asthma.

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Nvidia Developer: Drug Discovery

MARCH 21, 2023

New supercomputing-scale large language models (LLMs) that understand biology and chemistry text are helping scientists understand proteins, small molecules, DNA, and biomedical text. These state-of-the-art AI models help generate de novo proteins and molecules and predict the 3D structures of proteins.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. and reduce the overall clinical pharmacology program.

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The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. About LX9211.

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The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. Xofigo is currently under further evaluation in a broad clinical development program in prostate cancer and beyond.

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The Pharma Data

MAY 31, 2022

We look forward to continuing our collaboration with Biogen and the Parkinson’s community in our unified goal to develop BIIB122 as a potential treatment option for people and families living with Parkinson’s disease.”. BIIB122 is an investigational small molecule inhibitor of LRRK2 that was discovered and developed by Denali.

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The Pharma Data

OCTOBER 14, 2020

As a consequence, patients with premature stop codon diseases have reduced or eliminated protein production from the mutation bearing allele accounting for some of the most severe phenotypes in these genetic diseases. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis.

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The Pharma Data

APRIL 6, 2021

The new data reaffirm Bayer’s continued efforts to demonstrate the clinical impact a precision medicine approach can have on patients. While local labels might differ, the product is approved for adult and pediatric patients with solid tumors that harbor a NTRK gene fusion and have no satisfactory alternative treatments.

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The Pharma Data

SEPTEMBER 25, 2020

Monte Rosa Therapeutics has raised $96m in Series B financing to support further develop of its pipeline of small-molecule protein degraders. ICR and Cancer Research UK spinout closes Series B financing. Source link.

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The Pharma Data

DECEMBER 17, 2020

He previously served as vice president, for drug device industrialization at AbbVie, where he led product scale-up and industrialization projects for drug-device combinations. Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs.

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The Pharma Data

DECEMBER 21, 2020

Program focused on identifying small molecules that target a GPCR for degradation as potential therapeutic agents for gastrointestinal disorders. The principle of TPD is to use small molecules to commit the target protein into the E3 ligase-mediated degradation pathway thereby eliminating or reducing its activity.

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The Pharma Data

FEBRUARY 21, 2022

We are excited to see our efforts crystalize in our latest product launches, which include two potential blockbusters, as well as a late-stage portfolio with at least another blockbuster opportunity.”. Bayer is committed to drive sustainable development and generate a positive impact with its businesses.

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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. 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.

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The Pharma Data

FEBRUARY 22, 2021

(Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly. About Rigel.

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The Pharma Data

JANUARY 10, 2021

(Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, today announced it has submitted an Investigational New Drug (IND) application with the U.S. Chief Scientific Officer, IDEAYA Biosciences.

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The Pharma Data

JUNE 26, 2021

BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer and is fully owned by BioNTech.

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The Pharma Data

MARCH 13, 2022

In particular, we’re hopeful that we can accelerate clinical development of etrasimod successfully to have a positive impact on those living with these debilitating diseases.”. Arena has previously indicated that it expected the results of the Phase 3 ELEVATE-UC trial of etrasimod in ulcerative colitis during the first quarter of 2022.

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The Pharma Data

JANUARY 7, 2021

Galecto has an exciting pipeline of product candidates within fibrosis and cancer and a lead candidate in phase 2 for Idiopathic pulmonary fibrosis (IPF). Before that, Dr. Prener was Global Therapeutic Area Head of Hematology and Vice President, Clinical Research Hematology at Baxalta. a gene therapy company focused on eye diseases.

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The Pharma Data

JANUARY 19, 2021

Other products include SY-2101, a novel oral form of arsenic trioxide for acute promyelocytic leukemia, and SY-5609, a highly selective and potent oral CDK7 inhibitor for solid tumors. Ortho Clinical Diagnostics Holdings – Ortho launched its IPO of ordinary shares on January 19. This is planned to raise about $25 million.

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The Pharma Data

NOVEMBER 10, 2020

11, 2020 (GLOBE NEWSWIRE) — Calithera Biosciences, Inc. , (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, today announced its participation at two upcoming healthcare investor conferences in November.

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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. 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. CHATHAM, N.J., Holding Corp.

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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.

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The Pharma Data

JANUARY 7, 2021

Oncoceutics’ lead product candidate, ONC201, has been shown in clinical testing to selectively induce cell death in multiple cancer types. ONC201 is currently in a registrational clinical trial for recurrent H3 K27M-mutant glioma and a confirmatory response rate assessment is expected in 2021. Oncoceutics, Inc.

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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.

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The Pharma Data

JANUARY 11, 2021

is a publicly-traded biopharmaceutical company founded upon developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a primary commercial focus on the U.S. 3D, together with its portfolio company’s management, pursues the same goal of increasing value for all stakeholders.

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Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? However, even the most innovative in vitro assays still present major limitations when it comes to fully understanding and assessing the risks of a product. Pivotal (i.e.,

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The Pharma Data

JANUARY 10, 2021

10, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, will provide an update on Vision 3×3 and the company’s 2021 key milestones at the 39 th Annual J.P. COPENHAGEN, Denmark, Jan.

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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.

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Alta Sciences

APRIL 17, 2024

Our preclinical and bioanalytical experts have extensive experience in leading-edge technologies to support sponsors in the advancement of their gene therapy products. Gene Therapy resources Watch our on-demand webinar, “ Nonclinical Safety Assessment for Gene Therapy Products ”. Asia, and Europe.

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The Pharma Data

JANUARY 18, 2021

for the treatment of post-herpetic neuralgia. This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc.

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Codon

MARCH 20, 2023

Point-of-care peptide hormone production enabled by cell-free protein synthesis. Marine biofilm engineered to produce current in response to small molecules. Peroxisomal metabolic coupling improves fatty alcohol production from sole methanol in yeast. A swapped genetic code prevents viral infections and gene transfer.

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The Pharma Data

JANUARY 3, 2021

The product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release.

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The Pharma Data

OCTOBER 14, 2020

Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, which can be manufactured on conventional cell culturing systems, with the potential for mass scale production. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. 1 Noyce RS, et al. 2018) PLoS One.

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