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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Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1.

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Pharmaceutical Technology

MARCH 23, 2023

Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio. Seagen will maintain its operations in the Seattle area and will leverage Pfizer’s protein-engineering capabilities to develop next-generation biologics.

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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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pharmaphorum

MAY 4, 2022

Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. The limits of animal models in drug discovery are well known. Beyond testing.

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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

MAY 31, 2023

Setanaxib is under clinical development by Calliditas Therapeutics and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). GlobalData’s report assesses how Setanaxib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

Clinical Trials 100

Clinical Trials Clinical Trials Production Licensing 100

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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Drug Discovery World

JANUARY 15, 2024

Amgen and NVIDIA Amgen has announced plans to advance drug discovery using NVIDIA’s DGX SuperPOD-powered insights from human datasets. Chiesi and Oak Hill Bio Chiesi Group and Oak Hill Bio have entered a collaboration to develop OHB-607, a clinical-stage investigational drug candidate to treat complications of extremely premature birth.

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Drug Discovery World

MAY 6, 2024

In this article, DDW’s Diana Spencer highlights several prominent hotspots that are taking the lead on advancing European drug discovery and development. billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1.

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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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Pharmaceutical Technology

JUNE 10, 2023

PB-357 is under clinical development by Puma Biotechnology and currently in Phase I for Breast Cancer. According to GlobalData, Phase I drugs for Breast Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is administered through oral route.

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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. According to GlobalData, Phase I drugs for Breast Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is administered through oral route.

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Clinical Trials Clinical Trials Licensing Licensing 100

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. Despite the interest, there have already been some failures in the alpha-synuclein category.

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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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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.

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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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Drug Discovery World

FEBRUARY 28, 2024

Lu Rahman selects some of the year’s interesting and noteworthy advances in cancer research drug discovery and development. As always, a year within cancer drug discovery and development brings with it significant breakthroughs, and 2023 has been no exception. Research into new cancer drugs remain strong.

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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. Official comments .

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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. According to GlobalData, Phase I drugs for Cervical Cancer have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is administered through intravenous route.

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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. According to GlobalData, Phase I drugs for Colorectal Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is administered through intravenous route.

Protein 100

Protein Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

FEBRUARY 24, 2023

ACD-440 is under clinical development by AlzeCure Pharma and currently in Phase I for Neuropathic Pain (Neuralgia). According to GlobalData, Phase I drugs for Neuropathic Pain (Neuralgia) have a 77% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. Buy the report here.

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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. The post Companies agree up to $570m deal for C difficile drug appeared first on Drug Discovery World (DDW).

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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. According to GlobalData, Phase II drugs for Relapsed Multiple Myeloma have a 38% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. Buy the report here.

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pharmaphorum

AUGUST 11, 2020

Bayer is to buy UK-based KaNDy Therapeutics in a deal worth more than $800 million, adding the biotech’s menopause drug to its women’s health pipeline. At the beginning of this year, KaNDy completed a phase 2b trial of its first-in-class drug NT-814, showing activity against symptoms of the menopause such as hot flashes and night sweats.

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Drug Discovery World

MARCH 7, 2024

Following closing, the company will have an expanded pipeline that contains multiple assets spanning early and late development stages. The merged pipeline features an antibody-drug conjugate (ADC) toolkit with novel payload and linker technologies.

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pharmaphorum

DECEMBER 21, 2021

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. Novartis licensed rights to tislelizumab for $650 million upfront and up to $1.55 billion, providing a partner for its PD-1 agent Opdivo (nivolumab).

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Drug Discovery World

NOVEMBER 6, 2023

Under the partnership, KWF intends to provide funding to enable the development of select early phase clinical programmes through Cancer Research UK’s Centre for Drug Development (CDD). The CDD will sponsor and manage KWF-supported trials. Collaboration with like-minded organisations is essential to what we do.

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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. The data hint approved COVID-19 drugs will be used extensively in Black, Latinx, and Native Americans. F2G raises USD 60.8 F2G has raised USD 60.8

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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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XTalks

JULY 17, 2023

In a significant development, Astellas Pharma announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had accepted their applications for Priority Review and Marketing Authorization respectively for zolbetuximab. In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive

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Drug Discovery World

OCTOBER 16, 2023

The United Kingdom has established itself as a hub for drug discovery expertise worldwide. There is a range of reasons why this area has become focal point for drug discovery, one of which is the fact that it encompasses the University of Oxford and the University of Cambridge, two of the oldest and most prestigious universities in the world.

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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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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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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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pharmaphorum

NOVEMBER 19, 2021

Gilead Sciences has forged closer ties to its cancer drug partner Arcus Biosciences , although a licensing deal doesn’t go as far as the takeover that some market commentators have been predicting. The post Gilead foregoes buyout, but pledges $725m to Arcus’ cancer drugs appeared first on.

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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. Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. Vlad Coric , M.D.,

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