The Pharma Data

JANUARY 27, 2021

HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG). CAMBRIDGE, Mass. ROTTERDAM, Netherlands and SUZHOU, China , Jan. ” he added.

Therapies 40

Therapies Treatment International Licensing 40

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. GPCR – G protein-coupled receptors.

Small Molecule 40

Small Molecule Licensing Licensing Treatment 40

The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s (NYSE: LLY) investigational antibody therapy for Alzheimer’s disease (AD).

Therapies 40

Therapies Disease Treatment FDA Approval 40

LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. recent announcements from Merck and Sanofi for obesity and broader metabolic disease). Join the club.

Small Molecule 138

Small Molecule Trials Therapies Disease 138

The Pharma Data

DECEMBER 13, 2020

RLY-1971 has the potential to serve as a backbone for combination therapy across numerous solid tumors and therefore represents an encouraging approach for cancer patients,” said Sanjiv Patel, M.D., To access the live call, please dial 1 (833) 540-1168 (domestic) or 1 (929) 517-0359 (international) and refer to conference ID 8792127.

Licensing 40

Licensing Licensing Clinical Trials Small Molecule 40

The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. BioInvent International AB (publ).

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

LifeSciVC

APRIL 24, 2024

Suggested resources for this first pass genetics diligence include OMIM, GWAS Catalog, DisGeNET, OpenTargets, Genebass, and the International Mouse Phenotyping Consortium. with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., in liver, in CNS)? with antibodies), or correction (e.g.,

Production 114

Production Small Molecule Regulations Trials 114

Codon

JULY 27, 2023

But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. It’s called Roctavian and it’s only available for people who don’t have antibodies against AAV5, which is the viral vector used to deliver the gene therapy. From Moazami et al.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. It’s called Roctavian and it’s only available for people who don’t have antibodies against AAV5, which is the viral vector used to deliver the gene therapy. From Moazami et al.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

SEPTEMBER 29, 2024

It suggested that, in the future, certain classes of drugs, specifically genetic therapies, could be screened entirely virtually via models of life. At best, the corporations with the best models released weak versions to the public under non-commercial licenses. Of particular interest was how genetic therapies were delivered.

Engineering 138

Engineering Virus DNA Therapies 138

The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — The members of the Nomination Committee for BioInvent International AB :s (publ) (“BioInvent) Annual General Meeting in 2021 have now been appointed. Proposals to the Nomination Committee can be sent to Stefan Ericsson , by mail: BioInvent International AB (publ).), BioInvent International AB (publ).

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

The Pharma Data

JANUARY 21, 2021

–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial. 22, 2021 12:00 UTC. HENDERSON, Nev.–(

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 29, 2020

1 Meanwhile, these MDM2 inhibitors present some challenges, including dose-limiting hematological toxicities, thus the urgent need to develop new generation of MDM2-targeting therapies in the treatment of cancer. SUZHOU, China and ROCKVILLE, Md. , 29, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), Shaomeng Wang, Ph.D., Aguilar, A.;

Licensing 40

Licensing Licensing Small Molecule Clinical Trials 40

The Pharma Data

JANUARY 12, 2021

is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. About Jounce Therapeutics Jounce Therapeutics, Inc.

Clinical Trials 52

Clinical Trials Therapies Trials Science 52

Drug Target Review

APRIL 9, 2024

Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy. These compounds were later licensed to the pharmaceutical industry for clinical development. More recently, the group has expanded to other areas such as mechanisms of drug resistance and neurodegenerative diseases.

RNA 64

RNA Cell Biology Clinical Development DNA 64

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson Disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death.

Disease 52

Disease FDA Treatment Clinical Trials 52

The Pharma Data

SEPTEMBER 25, 2020

The approval relates to patients for whom conventional therapies for the prevention of structural joint damage have not been effective. Gilead’s Japanese branch will hold the commercial license as well as handle supply of the product in Japan, while Eisai will be responsible for distributing it in the country for RA. “RA

Licensing 40

Licensing Licensing International Treatment 40

The Pharma Data

APRIL 27, 2022

Novartis four distinct therapeutic platforms (immunotherapy, radioligand therapy, cell and gene therapy, targeted therapy) offer a unique opportunity to study tislelizumab in differentiated, potentially synergistic combinations across our pipeline and portfolio of market compounds.

Treatment 52

Treatment Clinical Development Therapies Clinical Trials 52

New Drug Approvals

DECEMBER 24, 2023

1] Society and culture Names Eplontersen is the international nonproprietary name. [9] “Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy. 12 (1): 267–287. doi : 10.1007/s40120-022-00414-z.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

The Pharma Data

NOVEMBER 23, 2020

During his tenure at Nuevolution, Mr. Berkien contributed to a number of corporate achievements including supporting the company’s successful listing onto Nasdaq OMX Stockholm, executing a program out-licensing deal with Almirall as well as drug discovery collaborations with Janssen Biotech and Amgen.

Clinical Trials 52

Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

Drug Target Review

OCTOBER 10, 2024

Developing cell therapies exclusively with healthy donor material introduces substantial risks that can hinder clinical translation and jeopardise the entire program. Diseased cells are likely to be more fragile or less abundant, making it difficult to obtain enough for therapy.

Therapies 52

Therapies Immune Response Clinical Trials Disease 52

Drug Target Review

NOVEMBER 22, 2023

Whilst TGF-β is an attractive target for cancer therapy because of its critical role in promoting tumor aggressiveness, immune escape and resistance to therapy, activation of alternative resistance pathways has hindered drug development attempts in the past.

Licensing 52

Licensing Licensing Small Molecule Therapies 52

The Pharma Data

JANUARY 27, 2021

A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. (Nasdaq: CASI), a U.S. About BioInvent.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

New Drug Approvals

SEPTEMBER 6, 2024

2 History Efficacy was evaluated in MARIPOSA (NCT04487080), a randomized, active-controlled, multicenter trial of 1074 participants with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic non-small cell lung cancer and no prior systemic therapy for advanced disease. [2] 20 August 2024.

FDA Approval 48

FDA Approval FDA International Clinical Trials 48

The Pharma Data

JANUARY 17, 2021

The study enrolled 5,050 patients who received either vericiguat or placebo in combination with available heart failure therapies. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co. Myelosuppression happens when radiation damages internal organs, including bone marrow.

FDA 52

FDA Small Molecule Immune Response Hospitals 52

The Pharma Data

OCTOBER 20, 2020

We look forward to successful commercialization and licensing of TLC’s programs across the globe under Mr. Bliss’s leadership, as well as to creating benefit and bringing value for all of TLC’s stakeholders.”. Earlier in his career, he ran business-development functions at Amgen and Baxter.

Licensing 40

Licensing Licensing Pharmaceutical Companies Clinical Trials 40

The Pharma Data

JULY 22, 2021

We share Pfizer’s deep commitment to people with breast cancer and are thrilled to partner with them to develop this potentially best-in-class therapy. Endocrine therapy is a backbone of ER+ breast cancer treatment and is used as monotherapy or as combination therapy as a standard of care across treatment settings.

Targeted Protein Degradation 52

Targeted Protein Degradation Therapies Clinical Trials Treatment 52

The Pharma Data

JANUARY 19, 2021

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with three ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. LUND, Sweden , Jan.

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

PPD

MAY 7, 2024

This harmonization aims to enhance the efficient use of resources, reduce duplication in HTA submissions and address inequities in patient access to innovative therapies. However, challenges persist, including limited early engagement opportunities and the absence of a requirement for consolidated advice engagement.

Regulations 52

Regulations Pharmaceutical Companies International Pharmaceuticals 52

The Premier Consulting Blog

NOVEMBER 20, 2024

This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. Note that pre-approval inspections for biologics are referred to as pre-licensing inspections (PLI).

Small Molecule 52

Small Molecule Drugs FDA Production 52

The Pharma Data

NOVEMBER 26, 2020

27, 2020 /PRNewswire/ — BioInvent International AB ‘s (publ) (“BioInvent”) (OMXS: BINV) Extraordinary General Meeting (the “EGM”) today resolved to approve the Board of Directors’ resolution on a directed issue of 29,395,311 new shares and 14,697,655 new warrants to CASI Pharmaceuticals Inc.

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. RayzeBio is also funneling cash into expanding its HQ in San Diego with plans to further develop internal R&D. .

RNA 52

RNA Therapies Disease Protein Expression 52

Drug Target Review

JUNE 3, 2024

Could you explain the development of CNP-108 for T cell immunogenicity in gene therapy, and how it induces the immune system to build a tolerance to gene therapy treatments? It was published by Pfizer and Sarepta that the T cell component is responsible for toxicity in humans within gene therapy trials.

Disease 49

Disease Therapies Pharmaceuticals Clinical Trials 49

The Pharma Data

AUGUST 19, 2021

The application will be reviewed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) under the centralized licensing procedure for all 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. Additional data from the CAPELLA study will be presented at a future scientific conference.

Marketing 52

Marketing Treatment FDA FDA Approval 52

The Pharma Data

NOVEMBER 18, 2020

Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan. Its mission is to develop and license novel therapeutic agents for unmet medical needs against cancer targets such as Globo Series (including Globo H, SSEA-3 and SSEA-4), AKR1C3, and other promising targets. Presenter: Ching-Liang Ho MD, et.al.

Vaccine 52

Vaccine Small Molecule Immune Response Hospitals 52

New Drug Approvals

OCTOBER 24, 2023

1] [9] [10] Names Etrasimod is the international nonproprietary name. [11] “Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies” Lancet. 11] SYN ACS Med. “Velsipity (etrasimod) tablets, for oral use” (PDF). .

FDA 57

FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

OCTOBER 18, 2020

Dr. Berk most recently has served as a consultant to several companies developing oncology therapies. Dr. Berk completed his internship, residency, and fellowship in internal medicine, hematology, and medical oncology at the Weill Cornell Medical College and New York Presbyterian Hospital, where he also served as a faculty member.

Small Molecule 40

Small Molecule Clinical Development Clinical Trials Licensing 40