Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Drug Discovery World

SEPTEMBER 26, 2022

Indeed, having a safety profile already established could entice patients to enter clinical trials more readily than with ‘unknown’ compounds. . Remote trials, wearable devices and advancements in genomic sequencing means that clinical data is now more abundant than ever and is only set to grow. . Volume 23 – Issue 4, Fall 2022.

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The Pharma Data

AUGUST 16, 2021

Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinical trial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. Almirall S.A.’s Almirall S.A.’s

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Trials Small Molecule Clinical Trials Immune Response 40

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. CellProthera also appointed the Newcastle Centre for Life’s GMP cell therapy centre to produce the ATMP.”

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Drugs Science Therapies Targeted Protein Degradation 190

The Pharma Data

JULY 21, 2021

Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021.

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Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 4, 2020

. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Small Molecule 52

Drug Discovery World

SEPTEMBER 6, 2022

And whilst clinical trials activity decreased by around 15% compared to 2020, last year still saw a number of regenerative medicines reach the bedside. Last year saw the sector surge, with levels of investment hitting an all-time high at $22.7 billion, compared to $19.9 million price point per dose.

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Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Amanda Conti, AgencyIQ Notably, the increase from FY 2022 was largely driven by biologic products. As a reminder, the U.S. See AgencyIQ’s analysis of these changes here.

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FDA Biosimilars Science Production 52

Agency IQ

NOVEMBER 3, 2023

Synthetic biotics have been engineered to perform a variety of functions: “ Several classes of effectors have been engineered into bacteria, including enzyme pathways that metabolize disease-causing toxins, production of protein effectors, and production of small-molecule effectors,” according to a recent article on the topic.

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Therapies Science FDA Production 40

The Pharma Data

AUGUST 3, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Top-line results from the event-driven confirmatory Phase 3 study comparing LUMAKRAS to docetaxel in patients with KRAS G12C-mutated advanced NSCLC are expected in H1 2022. Tezepelumab.

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Biosimilars Production Treatment FDA 52

New Drug Approvals

DECEMBER 16, 2023

August 2022). PMID 35561315. ^ “Novartis Phase III APPOINT-PNH trial shows investigational oral monotherapy iptacopan improves hemoglobin to near-normal levels, leading to transfusion independence in all treatment-naïve PNH patients” Novartis (Press release). 5 December 2023. . 6 (15): 4450–4460. 2022006960. PMC 9636331.

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FDA Small Molecule FDA Approval Clinical Trials 62

Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals.

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

JANUARY 10, 2021

Development of TransCon CNP is progressing as planned with the recent initiation by VISEN Pharmaceuticals of a second phase 2 trial in patients with achondroplasia, the ACcomplisH China Trial, which provides for dose expansion at an effective dose determined from the ACcomplisH Trial. ?. .

Clinical Trials 40

Clinical Trials Small Molecule Clinical Development Trials 40

Drug Discovery World

AUGUST 4, 2022

The developability gap for small-molecule candidates is generally minimal because there are numerous analytical technologies available for rapidly and cheaply gathering information to generate highly complete descriptions. Volume 23 – Issue 3, Summer 2022. Why biopharma struggles with the developability gap.

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Drug Development Vaccine Production Drugs 130

New Drug Approvals

JULY 10, 2023

1] Zavegepant is an antagonist of the calcitonin gene-related peptide (CGRP) receptor currently in phase 3 trials in an intranasal formulation for the treatment of migraine. The clinical trial is expected to complete in September 2020. Zavegepant is indicated for the acute treatment of migraine with or without aura in adults. [1]

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Clinical Trials Treatment FDA Trials 40

The Pharma Data

SEPTEMBER 15, 2020

Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. A Phase 3 trial is ongoing. Protease Inhibitor Program. Rare Disease.

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The Pharma Data

JUNE 24, 2021

government to purchase at not-for-profit price 200 million doses in 2021 and 300 million in the first half of 2022. The 300 million doses for 2022 will be delivered between January and end of June 2022. government also has the option for additional doses in 2022. government in Pfizer’s U.S. facilities.

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Government Vaccine Clinical Trials Licensing 52

Codon

APRIL 16, 2023

These microbes were engineered to express tumor antigens that could “elicit T cells that were licensed by the commensal immune program but specific for a tumor,” including both CD4+ and CD8+ T cells, according to the study. It turns out that one skin microbe, called S. epidermidis , can actually trigger tumor-specific T cells.

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Engineering DNA RNA Science 52