The Pharma Data

DECEMBER 13, 2020

Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. BOSTON–( BUSINESS WIRE )– Gamida Cell Ltd. Food and Drug Administration (FDA) on Friday, December 11, 2020.

Licensing 52

Licensing Licensing Clinical Trials FDA 52

Drug Discovery World

FEBRUARY 28, 2024

Using IgE to treat cancer In the UK, a Cancer Research UK-funded clinical trial has shown, for the first time, that a new class of antibody could benefit cancer patients whose existing treatments have stopped working. “Cancer shredding could hold potential not only for glioblastoma, but possibly for other hypermutated tumours.”

Drug Development 162

Drug Development Research Clinical Trials Drugs 162

Drug Discovery World

JANUARY 31, 2023

But first, there is the urgency of getting the new drug application (NDA) or biologics license application (BLA) filing into the hands of the respective regulatory authorities. Over the last decade, many pharmaceutical companies have undertaken internal ‘harmonisation’ projects.

Production 246

Production Engineering Pharmaceutical Companies Clinical Trials 246

Drug Discovery World

OCTOBER 16, 2023

A company within this ecosystem is STORM Therapeutics, a clinical stage biotechnology company creating novel small molecule therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. billion in funding.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

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 62

FDA Approval FDA International Clinical Trials 62

The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. We look forward to working on this new collaboration with Biohaven, a world leader in the clinical development of CGRP-targeted therapies.”

Small Molecule 40

Small Molecule Licensing Licensing Clinical Trials 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

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

Drug Discovery World

APRIL 20, 2023

Biological mechanisms Given its prevalence and potential economic, societal and patient burden, post-Covid cognitive impairment seems an important target for treatment, be that through existing rehabilitations services, or digital, drug or biologic therapies. New therapeutics of course depend on an understanding of biological mechanisms.

Drug Development 246

Drug Development Clinical Trials Drugs Virus 246

The Pharma Data

AUGUST 17, 2020

In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. Dragonfly received U.S. About Bristol Myers Squibb.

Licensing 52

Licensing Licensing Production Clinical Trials 52

Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. Significantly, in January 2023, the FDA finalised a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds without running afoul of federal law 2.

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care).

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China. 1 Kratz et al.,

Licensing 52

Licensing Licensing Pharmaceutical Companies Treatment 52

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. LUND, Sweden , Nov. About BioInvent.

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

New Drug Approvals

DECEMBER 24, 2023

1] Society and culture Names Eplontersen is the international nonproprietary name. [9] 1] Society and culture Names Eplontersen is the international nonproprietary name. [9] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85” WHO Drug Information. 12 (1): 267–287.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

The Pharma Data

DECEMBER 1, 2020

NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the open-label Phase 2 COMET-TRD trial of AXS-05 in patients with treatment resistant depression (TRD). AXS-05 was well tolerated in the COMET trial.

Treatment 52

Treatment Trials Clinical Trials Therapies 52

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. Additional trials (e.g., Join the club.

Small Molecule 139

Small Molecule Trials Therapies Disease 139

The Pharma Data

DECEMBER 9, 2020

The Chinese biopharmaceutical industry is growing in leaps and bounds, but there is still a huge unmet need when it comes to getting patients access to the breakthrough therapeutic modalities and platforms like RNAi, cell and gene therapy and others. A solution could be at hand with Overland Pharmaceuticals.

Therapies 52

Therapies International Disease Research 52

Drug Discovery World

JULY 16, 2024

Here, regulatory affairs teams are able to pre-empt agency queries in their initial submissions and/or when trying to provide consistent replies to questions globally – thereby increasing their chances of new products or clinical trials, or changes thereto, being accepted quickly, and first time.

Science 130

Science Production Marketing Compliance 130

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 International Licensing Licensing 40

New Drug Approvals

SEPTEMBER 10, 2024

5] Society and culture Names Deuruxolitinib is the international nonproprietary name [6] and the United States Adopted Name. [7] 5] Society and culture Names Deuruxolitinib is the international nonproprietary name [6] and the United States Adopted Name. [7] -(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-, (.beta.r)-D8-ruxolitinib

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

JANUARY 12, 2021

JTX-4014 demonstrated a 17% durable overall response rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor naïve patients, which excluded all tumor types for which PD-(L)1 inhibitors were approved. In this Phase 1 trial, JTX-4014 was shown to have an acceptable safety profile.

Clinical Trials 52

Clinical Trials Therapies Trials Science 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 Pharmaceuticals Therapies Production 49

The Pharma Data

APRIL 27, 2022

About Tislelizumab Novartis is evaluating tislelizumab, a uniquely designed anti-PD-1 monoclonal antibody, in a global clinical development program consisting of 14 pivotal clinical trials across a broad array of solid tumors, with more than 8,800 patients enrolled to date in 35 countries.

Treatment 52

Treatment Clinical Development FDA Therapies 52

Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

FDA 40

FDA Trials Regulations Therapies 40

The Pharma Data

NOVEMBER 22, 2020

Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. Blum, Cytokinetics’ President and Chief Executive Officer. Terms of Termination.

Clinical Trials 52

Clinical Trials Licensing Licensing Trials 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. Small-molecule inhibitors of the MDM2-p53 protein-protein interaction (MDM2 inhibitors) in clinical trials for cancer treatment.

Licensing 40

Licensing Licensing Small Molecule Clinical Trials 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. BioInvent International AB (publ) Co.

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. Wainberg, M.D.,

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

MAY 5, 2022

Novartis today announced the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies. GvHD occurs when donor cells see the recipient’s healthy cells as foreign and attack them.

Treatment 52

Treatment Disease Therapies Clinical Trials 52

The Pharma Data

JUNE 7, 2023

Dostarlimab also was recently granted Breakthrough Therapy designation for this potential new indication. The sBLA is based on the prespecified interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial.

FDA 40

FDA Trials Treatment Licensing 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.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 23, 2020

“In the last months, Ultimovacs has strengthened its corporate and clinical development position having launched multiple mid-stage clinical trials and established a solid financial runway. Mr. Berkien is currently a board member of the Nordic Pharma Licensing Group. For further information, please see www.ultimovacs.com.

Clinical Trials 52

Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

The Pharma Data

JANUARY 27, 2021

Based on these results, we will now move to identify the recommended Phase II dose for the Phase IIa part of the trial and look forward to further evaluating the exciting potential of BI-1206 to bring much needed innovation to lymphoma patients,” said Martin Welschof, Ph.D, (Nasdaq: CASI), a U.S. CEO of BioInvent.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

New Drug Approvals

OCTOBER 24, 2023

This approval was based on favorable results obtained from Pfizer’s Elevate UC Phase III registrational program, consisting of the Elevate UC 52 and Elevate UC 12 clinical trials, that investigates the efficacy of a 2-mg daily dose regimen of etrasimod, with a 32% and 26% remission rate observed in UC 52 and UC 12 trials respectively.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

JULY 22, 2021

ARV-471 is currently in a Phase 2 dose expansion clinical trial for the treatment of patients with estrogen receptor (ER) positive / human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer. The estrogen receptor is a well-known disease driver in most breast cancers.

Targeted Protein Degradation 52

Targeted Protein Degradation Therapies Clinical Trials Treatment 52

Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

Therapies 40

Therapies Science FDA Production 40