The Pharma Data

OCTOBER 14, 2020

15, 2020 /PRNewswire/ — Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. CARLSBAD, Calif. ,

Therapies 52

Therapies Clinical Trials Science Laboratories 52

FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

Therapies 59

Therapies FDA Production Regulations 59

The Pharma Data

JUNE 2, 2023

Gilead and Kite Oncology Demonstrate Growing Hematology Pipeline and Strength of Leading Cell Therapy Portfolio at EHA FOSTER CITY, Calif. & Other data include efficacy and safety information, healthcare resource use in patients with AML and MDS, and proof-of-concept of magrolimab on calreticulin in myelofibrosis CD34-positive cells.

Therapies 52

Therapies Clinical Development Treatment Trials 52

The Pharma Data

MARCH 29, 2022

Boehringer Ingelheim and Veeva Systems (NYSE: VEEV) today announce Boehringer Ingelheim’s selection of Veeva Development Cloud to drive end-to-end processes and seamless information sharing enterprise wide for greater speed in the delivery of innovative therapies. About Boehringer Ingelheim.

Therapies 52

Therapies Clinical Development Pharmaceutical Companies Research 52

The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. . ” About Ascletis.

Clinical Development 40

Clinical Development Disease Clinical Trials Therapies 40

The Pharma Data

JANUARY 27, 2021

. – Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies. “We

Therapies 52

Therapies Clinical Trials Treatment FDA 52

The Premier Consulting Blog

MARCH 7, 2024

The FDA’s January 2020 guidance, Chemistry, Manufacturing and Control (CMC) [1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics.

Production 52

Production Therapies DNA Virus 52

The Pharma Data

JULY 8, 2021

The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Please see the full Prescribing Information.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

PPD

OCTOBER 16, 2023

There has been continuous growth in the variety and volume of available health care data, and newer applications for use of real-world data (RWD) and real-world evidence (RWE) to enhance the speed of patient access to new therapies. Consent development: Informed consent is the most important step in the tokenization process.

Clinical Trials 98

Clinical Trials Trials Research Therapies 98

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

The Pharma Data

JANUARY 12, 2021

Working alongside KSQ will facilitate smart drug discovery and development of what we hope will be transformative new therapies for patients with intractable forms of cancer.”. KSQ and Takeda can collaborate on IND-enabling activities, with clinical development led by Takeda to explore multiple modalities.

Therapies 52

Therapies Immune Response Research Clinical Development 52

The Pharma Data

JUNE 2, 2022

New multi-program collaboration to develop allogeneic TCR-T/CAR-T programs brings together Immatics’ allogeneic gamma delta T cell therapy platform ACTallo ® with Bristol Myers Squibb’s technologies and oncology drug development expertise. Executive Vice President, Research & Early Development, Bristol Myers Squibb. “We

Therapies 52

Therapies Production Clinical Development Engineering 52

Drug Target Review

JUNE 6, 2023

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. For the last several years, the field has worked to unlock the potential of IO therapies for additional tumour types, and has explored options beyond checkpoint inhibitors.

Engineering 98

Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

The Pharma Data

JANUARY 17, 2021

“We are very pleased that EMA has acknowledged the potential Tessa’s CD30 CAR-T therapy holds for patients with Hodgkin Lymphoma” said Jeffrey H. These results were published in Journal of Clinical Oncology ( Ramos et al., BEDMINSTER, N.J. and SINGAPORE , Jan. Buchalter , President and CEO of Tessa Therapeutics.

Therapies 40

Therapies Clinical Development Treatment Trials 40

DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.

Drug Development 73

Drug Development Clinical Trials Drugs Therapies 73

The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly.

Therapies 52

Therapies FDA Hospitals FDA Approval 52

The Pharma Data

DECEMBER 13, 2020

NRG1 fusions are a rare genetic mutation that are increasingly recognized as a driver of multiple tumor malignancies, and an actionable target for HER3 targeted therapy. Up to 1% of all solid tumors harbor NRG1 fusions, therefore, it is important to identify this patient population and develop therapies that can treat them. [1].

Clinical Development 40

Clinical Development Clinical Trials Therapies Trials 40

The Pharma Data

DECEMBER 2, 2020

Based on the Phase 2 study findings to date, marstacimab may have the potential to offer improved bleed control via subcutaneous injection and potentially eliminate the need for prophylactic factor replacement, providing an enhanced treatment option compared to factor replacement therapy.”. About Pfizer Rare Disease. Pfizer Inc.:

Therapies 52

Therapies Treatment Disease Clinical Trials 52

Drug Target Review

OCTOBER 1, 2024

At the beginning of my career, during my scholarship, I worked for two years at a research institute where I set up a research project focused on the study of metronomic oral therapies for patients with metastatic breast cancer (BC). That paper, of which I was in the authorship, remains a current point of reference for that therapy usage.

Doctors 97

Doctors Therapies Science Pharma Companies 97

Drug Target Review

APRIL 3, 2024

I am currently working as Chief Scientific Officer at CatalYm, where we translate the latest scientific findings into clinical applications. Our company has identified a new role for Growth Differentiation Factor 15 (GDF-15) as a potent local immunosuppressor mediating cancer resistance to therapy.

Science 105

Science Clinical Development Treatment DNA 105

The Pharma Data

JANUARY 17, 2021

LONDON–( BUSINESS WIRE )– Ixaka Ltd , an integrated cell and gene therapy company focused on the natural power of the body to cure disease, launches today. The new business will continue to develop Ixaka’s proprietary technologies – concentrated multi-cell therapies (MCTs) and targeted nanoparticle (TNP) therapeutics.

Therapies 40

Therapies Clinical Trials Disease Immune Response 40

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). For more information, please visit: www.harbourbiomed.com. CAMBRIDGE, Mass.

Therapies 40

Therapies Treatment International Licensing 40

Drug Target Review

MAY 7, 2024

Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. For instance, AI algorithms could facilitate patient-trial matching, encompassing medical records, genetic information, demographics, and personal preferences.

Disease 59

Disease Clinical Trials Clinical Pharmacology Trials 59

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster.

Drug Development 98

Drug Development Clinical Trials Drugs Clinical Research 98

Drug Target Review

JANUARY 15, 2024

CD8+ T cells are a type of lymphocyte that specialises in scanning information presented by HLA Class I. About the author Daniel Kavanagh, PhD, RAC Senior Scientific Advisor, Gene Therapies, Vaccines and Biologics at WCG Dr Kavanagh engages with sponsors, CROs and research institutions on topics related to human gene transfer research.

Engineering 110

Engineering DNA Virus Immune Response 110

The Pharma Data

JUNE 30, 2021

Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause. Food and Drug Administration (FDA) whereby the trial design, clinical endpoints and statistical analysis were agreed in advance with the Agency. “The View the full release here: [link].

Therapies 52

Therapies Treatment Virus Vaccine 52

LifeSciVC

MAY 9, 2024

These connections provide all-too-important ‘reasons to believe’ for further investment and movement into earlier lines of therapy. However, despite this long winter, new approaches, ranging from CD3 bi-specifics, to cell therapies, to cancer vaccines, and more recent novel intracellular mechanisms have started to turn the tide.

Immune Response 76

Immune Response Vaccine Therapies Clinical Development 76

The Pharma Data

SEPTEMBER 16, 2020

executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept. PDT , David M.

Clinical Development 52

Clinical Development Therapies Disease Research 52

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.”

FDA 40

FDA Therapies Clinical Trials Disease 40

Drug Target Review

JULY 18, 2024

However, what has really helped the sensitivity is using a tumour-informed approach where mutations found when sequencing the patient’s own tumour are part of the design. How is leveraging liquid biopsy leading to innovative trial designs in oncology and ultimately our ability to develop new drugs in the adjuvant setting?

Drug Development 59

Drug Development Clinical Trials Drugs Vaccine 59

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

Disease 52

Disease Trials Treatment Clinical Trials 52

LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). Human and mouse genetics can inform not only efficacy but also safety.

Production 114

Production Small Molecule Regulations Trials 114

Drug Target Review

MAY 1, 2024

The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development. T-DM1, for example, is approved in patients with HER2-positive breast cancer and residual invasive cancer following neoadjuvant therapy.

Drugs 69

Drugs FDA Approval Organic Chemistry Small Molecule 69

The Pharma Data

JANUARY 20, 2021

In order to do so, the DSMC may review unblinded study information (on a patient level or treatment group level) during the conduct of the trial. For more information about Cardiol Therapeutics, please visit cardiolrx.com. About Cardiol Therapeutics. Cardiol Therapeutics Inc. ( alone exceeding $30 billion.

Hospitals 52

Hospitals Trials International Clinical Trials 52

The Pharma Data

NOVEMBER 25, 2020

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 two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. About BioInvent.

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need. Visit FDA’s website for more information.

Disease 52

Disease FDA Treatment Clinical Trials 52

The Pharma Data

MARCH 2, 2021

This new collaboration builds on the positive experience from previous partnerships with Gubra and combines Gubra’s proprietary streaMLine platform and expertise in obesity and peptide chemistry with Boehringer Ingelheim’s expertise in lead optimization and clinical development. Financial terms of the new agreement are not disclosed.

Treatment 52

Treatment Bioinformatics Clinical Development Therapies 52