The Pharma Data

AUGUST 5, 2020

AstraZeneca has signed a licensing deal with UK-based biotech company Redx Pharma for its fibrotic disease candidate RXC006. Redx is also eligible to receive up to $360m in additional payments, dependent on development, regulatory and commercial milestones, as well as tiered royalties on any future sales.

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Drug Discovery World

MARCH 13, 2024

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor. at 16 weeks and 76.2% at 52 weeks). .”

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Pharmaceutical Technology

AUGUST 25, 2022

The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.

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Worldwide Clinical Trials

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide Clinical Trials.

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pharmaphorum

NOVEMBER 10, 2021

Under the terms of the deal, Biohaven would be responsible for further clinical development of Nurtec ODT and the two partners will cooperate on securing approval for the product in ex-US markets. The post Pfizer strikes $1.2bn licensing deal for Biohaven migraine drug appeared first on.

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Pharmaceutical Technology

AUGUST 11, 2022

The proceeds from the business combination will be utilised to advance the pipeline of Disc to clinical trials and offer funding into 2025. Disc focuses on discovering and developing new therapies for patients with serious haematologic ailments. Last year, Disc in-licensed bitopertin from Roche.

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Pharmaceutical Technology

MARCH 23, 2023

The drug is currently licensed in combination with chemotherapy for patients with classical Hodgkin lymphoma, both as frontline therapy and for those at risk of progressing or having progressed following stem cell transplantation. Tivdak, a tissue-factor targeting ADC that was developed in collaboration with Genmab, was approved in 2021.

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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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Drug Discovery World

MARCH 24, 2023

This synergy was demonstrated by the AIPAC Phase IIb trial’s encouraging efficacy and safety, including a over 2.9-month Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA).

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Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

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Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. February 2022.

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Pharmaceutical Technology

MAY 31, 2023

Setanaxib is under clinical development by Calliditas Therapeutics and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Roots Analysis

FEBRUARY 27, 2024

On November 1, 2019, Avacta Group and ADC Therapeutics have announced a collaboration agreement for the development of novel drug candidates. The firm also has the right to obtain exclusive licenses to the Affimer proteins for clinical development and commercialization.

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Pharmaceutical Technology

JUNE 10, 2023

PB-357 is under clinical development by Puma Biotechnology and currently in Phase I for Breast Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

JUNE 10, 2023

PB-357 is under clinical development by Puma Biotechnology and currently in Phase I for Breast Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Drug Discovery World

NOVEMBER 6, 2023

The CDD will sponsor and manage KWF-supported trials. Dr Stephen Nabarro, Interim Director of Cancer Research UK’s Centre for Drug Development, said: “We are delighted to join forces with KWF, who will be invaluable in helping us bring more of the most promising early phase clinical agents into first in human trials.

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Pharmaceutical Technology

AUGUST 4, 2022

P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year. Furthermore, Roche will oversee the late-stage clinical development and worldwide marketing of all products under the alliance.

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Drug Discovery World

JULY 26, 2023

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. The drug, MOv18 IgE, was developed by researchers at King’s College London.

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The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. “We are pleased to work with U.S.

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Pharmaceutical Technology

MARCH 1, 2023

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Cervical Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

MARCH 1, 2023

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Colorectal Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

MARCH 1, 2023

Orvacabtagene autoleucel is under clinical development by Bristol-Myers Squibb and currently in Phase II for Relapsed Multiple Myeloma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

FEBRUARY 24, 2023

ACD-440 is under clinical development by AlzeCure Pharma and currently in Phase I for Neuropathic Pain (Neuralgia). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Drug Discovery World

MARCH 7, 2024

A combined pipeline of therapeutic candidates Akari’s nomacopan is a bispecific recombinant inhibitor of complement C5 and leukotriene B4 (LTB4) being evaluated in a Phase III clinical trial for paediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).

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XTalks

JULY 17, 2023

Phase III Clinical Trials Underpinning the Applications The applications are grounded on two Phase III clinical trials, SPOTLIGHT and GLOW. In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

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Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. It is developed based on MyoKardia's drug discovery platform. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects.

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pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. InnoCare says it will also introduce the restrictions on studies ongoing outside the US.

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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.”

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pharmaphorum

JANUARY 13, 2022

Sanofi has joined a growing list of drugmakers going after alpha-synuclein targeting drugs for Parkinson’s disease, licensing a bispecific antibody from South Korea’s ABL Bio in a deal that could be worth more than $1 billion. An AbbVie antibody called ABBV-0805 successfully cleared a phase 1 trial but seems to have been shelved.

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Drug Discovery World

JUNE 1, 2023

Roberto Iacone, CEO at Alentis Therapeutics, said: “There are huge unmet needs in organ fibrosis and cancer, and this funding enables us to continue with the important work we’re doing in the CLDN1 space and generate clinical data from both our programs.

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Drug Discovery World

FEBRUARY 27, 2023

Under a new agreement, Destiny Pharma and Sebela Pharmaceuticals will co-develop NTCD-M3, Destiny’s lead asset for the prevention of Clostridioides difficile infection (CDI) recurrence.

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XTalks

NOVEMBER 4, 2022

Pfizer announced positive top-line data from a Phase III trial evaluating its respiratory syncytial virus (RSV) prefusion vaccine candidate, RSVpreF (or PF-06928316) for pregnant individuals to help protect their infants from RSV disease after birth. percent efficacy against medically attended RSV-associated lower respiratory tract infection.

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Drug Discovery World

DECEMBER 20, 2022

The positive opinion is based on findings from the pivotal HOPE-B trial, which showed that patients treated with etranacogene dezaparvovec demonstrated durable increases in mean Factor IX activity levels which led to an adjusted annualised bleed rate (ABR) reduction of 64%. . World’s most expensive drug.

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The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Almirall S.A.’s

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Delveinsight

AUGUST 13, 2020

Researchers call out Gilead over the diversity of remdesivir trials. Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. Roche offloads clinical-phase cancer drug to Celleron. Even so, the decision marked the end of the interest of Roche in developing the asset.

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