The Pharma Data

JANUARY 13, 2021

Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

NOVEMBER 4, 2020

–( BUSINESS WIRE )– Concert Pharmaceuticals, Inc. President and Chief Executive Officer of Concert Pharmaceuticals. Both of our clinical candidates represent important opportunities for new medicines that we hope will have a meaningful impact on the lives of patients.”. 5, 2020 11:00 UTC. LEXINGTON, Mass.–(

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Treatment 52

The Pharma Data

DECEMBER 14, 2020

This grant will support Alume’s clinical development of its novel nerve illumination technology in surgery. Alume is a biotechnology company founded in 2017 that is developing nerve-targeted pharmaceutical agents for surgical and therapeutic use. View original content to download multimedia: [link].

Clinical Trials 52

Clinical Trials Trials Clinical Development Pharmaceuticals 52

The Pharma Data

DECEMBER 28, 2020

She most recently comes from a position as Senior Medical Director at Ferring Pharmaceuticals in Copenhagen. Dr Reimer will replace Dr Charlotte Russel and be overall medically responsible for Alligator’s drug development candidates, with an emphasis on bringing mitazalimab and ATOR-1017 into Phase II efficacy studies.

Clinical Development 40

Clinical Development Doctors Drug Development International 40

The Pharma Data

JANUARY 6, 2021

He continues: “With the green light granted by the FDA to continue our clinical research, we are one step closer to offering psoriasis patients a novel, improved oral treatment option and thereby enhancing their quality of life. The following files are available for download: View original content: [link]. Source link.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

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. View original content to download multimedia: [link].

Therapies 52

Therapies Clinical Trials Science Laboratories 52

Metabolite Tales Blog

NOVEMBER 17, 2022

Figure 3: Roquinimex (linomide) Clinical development of both laquinimod and roquinimex was halted due to serious cardiovascular events. Studies in non-clinical species raised no obvious red flags of this clinical outcome. Teva Pharmaceuticals licensed laquinimod from Active Biotech. This was unexpected.

International 52

International Licensing Licensing Treatment 52

Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

Clinical Trials 52

Clinical Trials Trials FDA Drug Development 52

The Pharma Data

JANUARY 27, 2021

“Our commitment to supporting clinical research sites with strategic flexible resources has been increasingly important over the past 12 months in particular. View original content to download multimedia: [link]. VERONA, Italy , Jan. ” About CROMSOURCE. For more information, visit www.cromsource.com. Logo – [link].

Clinical Research 40

Clinical Research Clinical Trials International Clinical Development 40

The Pharma Data

JANUARY 20, 2021

” “Dynacure is a leader in rare disease drug development, as evidenced by its lead product candidate DYN101, which is in clinical development for the treatment of Myotubular and Centronuclear Myopathies for which there are no FDA or EMA approved therapeutics,” said Ms. ” Ms. Previously, Ms.

Treatment 40

Treatment Pharmaceuticals Drug Development Science 40

The Pharma Data

NOVEMBER 25, 2020

technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering. The following files are available for download: View original content: [link].

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Pharma Data

DECEMBER 8, 2020

technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the company’s own clinical development pipeline or for additional licensing and partnering. The following files are available for download: View original content: [link].

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. Dr. Liu shared his over 30 years of R&D experience in drug development both in the global pharmaceutical companies and world renowned scientific research institutions.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

The Pharma Data

OCTOBER 18, 2020

Oncopeptides plans to initiate clinical development of OPD5 with an open-label phase 1, dose escalation study on safety and tolerability of OPD5 as a myeloablative regimen followed by Autologous Stem Cell Transplantation in patients with relapsed refractory multiple myeloma. About Oncopeptides. SOURCE Oncopeptides AB.

FDA 40

FDA Drugs Pharmaceutical Companies Treatment 40

The Pharma Data

JANUARY 19, 2021

BioInvent’s management team will also give an update on the ongoing Phase I/IIa trial of BI-1206 in combination with rituximab and BioInvent’s partner CASI Pharmaceuticals (NASDAQ: CASI) will provide an update on the development plan and potential for BI-1206 in China. The Company’s validated, proprietary F.I.R.S.T

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. View original content to download multimedia: [link]. NEW YORK , Jan. Media Contact: mindmed@150bond.com. .

Clinical Trials 52

Clinical Trials FDA Trials 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

JANUARY 14, 2021

Clinical Development – Pipeline Review. The following files are available for download: View original content: [link]. . 3:40pm. Setanaxib – Applications in Oncology. Professor Gareth Thomas. .

Clinical Trials 40

Clinical Trials Disease Hospitals International 40

The Pharma Data

JANUARY 17, 2021

“This result provides a foundation for a clinical development program using higher doses of setanaxib across a variety of orphan indications. The following files are available for download: View original content: [link]. Significant improvement in fatigue was also achieved. ”, said CEO Renée Aguiar-Lucander.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40

The Pharma Data

JANUARY 25, 2021

“ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. but with a healthcare system that is still developing. This information was brought to you by Cision [link].

Clinical Development 40

Clinical Development Licensing Licensing Production 40

The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa.

FDA Approval 40

FDA Approval FDA Treatment Clinical Trials 40

The Pharma Data

JANUARY 4, 2021

The term “orphan drugs” refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. Any of these intentions may alter in light of future development. View original content to download multimedia: [link].

FDA 40

FDA Therapies Drugs Treatment 40

The Pharma Data

DECEMBER 20, 2020

BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene. “This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. BT-001 is our fourth program in clinical development. The Company’s validated, proprietary F.I.R.S.T

Virus 40

Virus Trials Clinical Trials Clinical Development 40

Codon

MARCH 24, 2024

” Even today, the company’s profile on the Flagship Pioneering website knocks the size of “pharmaceutical factories,” which “can run to 800,000 square feet or more,” and touts the beauty of cells as factories, with messenger RNA as their “foreman.” The real cost is clinical development.

Engineering 87

Engineering Vaccine Production RNA 87

The Pharma Data

DECEMBER 15, 2020

The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project. Diamyd Medical develops therapies for type 1 diabetes. About Diamyd Medical. Source link.

Drug Development 40

Drug Development Clinical Trials Trials Vaccine 40

The Pharma Data

DECEMBER 2, 2020

The new plant will as a first priority produce recombinant GAD65, the active pharmaceutical ingredient in the therapeutic diabetes vaccine Diamyd ® currently in late-stage clinical development. The following files are available for download: View original content: [link]. SOURCE Diamyd Medical AB. Source link.

Production 40

Production Vaccine Therapies Laboratories 40

The Pharma Data

JUNE 26, 2021

FDA Letter of Authorisation and Fact Sheets for patients and health care professionals are available for download with the latest information on this EUA. The extensive Actemra/RoActemra RA IV clinical development programme included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries.

Treatment 40

Treatment FDA Clinical Trials Virus 40

The Pharma Data

OCTOBER 29, 2020

vice president of immunology development at Lilly. “The results of this study underscore baricitinib’s potential in alopecia areata, and we look forward to continuing the clinical development program for baricitinib in hopes of becoming the first FDA approved treatment option for adults with AA.” J Rheumatol.

Therapies 52

Therapies Treatment Disease Clinical Trials 52