Drug Discovery World

MAY 6, 2024

In 2022, the continent held a 22.4% 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. Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery.

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Drug Discovery World

OCTOBER 4, 2022

million in 2022 to 12.7 Recent reports suggest global market value is forecasted to grow to $25-$40 billion before the end of this decade, driven primarily by the introduction of disease-modifying therapies with accompanying biomarkers for early diagnosis, coupled with the demographic rise in the number of patients.” .

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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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. Northern Ireland “Northern Ireland is a medtech super-hub,” says Saleko.

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The Pharma Data

APRIL 27, 2023

It is also an off-the-shelf therapy, meaning that people do not have to wait for cell collection and genetic engineering before starting treatment, which could be particularly important for patients who are at a high-risk of their disease progressing. “New Roche’s Chief Medical Officer and Head of Global Product Development.

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Drug Target Review

JUNE 3, 2024

Results from these preclinical studies were published in the peer-reviewed publication, Journal of Immunology in August 2022 as a “Top Read” article. Notably, we anticipate initiating the first clinical study of CNP-103 in late 2024, on the heels of our Series A announced earlier this year on January 30.

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The Pharma Data

NOVEMBER 25, 2020

Under the agreement, which may generate revenue for BioInvent of up to SEK 30 million , BioInvent will provide process development, scale-up, supply of material for toxicological studies and clinical grade material in 1000L scale for use in phase I and II clinical trials. About BioInvent.

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Drug Discovery World

MARCH 29, 2023

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

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LifeSciVC

JANUARY 16, 2024

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Just in time for new years’ reflections and resolutions, this year’s JPM felt like a refreshing burst of enthusiasm for a sector that has seen its challenges in 2022 and 2023 but also some green shoots. Join the club.

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Drug Discovery World

SEPTEMBER 16, 2022

Here, DDW Editor Reece Armstrong explores the global hubs of innovation for cell and gene therapies. Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. .

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The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022.

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The Pharma Data

APRIL 4, 2022

The target action date for the FDA decision on this investigational use is August 3, 2022. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Regulatory filings around the world are also planned in 2022. In September 2020, the U.S.

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The Pharma Data

APRIL 19, 2022

tumour response rate If approved, Enhertu to provide patients with a much-needed targeted therapy option. Enhertu is a HER2 – directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. Based on pivotal DESTINY-Lung01 results showing AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a 54.9%

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The Pharma Data

JULY 22, 2021

This should significantly enhance and accelerate the development and potential commercialization of ARV-471 while also advancing Arvinas’ strategy of building a global, integrated biopharmaceutical company,” said John Houston, Ph.D., Chief Scientific Officer for Oncology Research and Development at Pfizer.

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Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

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Drug Discovery World

FEBRUARY 22, 2023

Sustained and durable effect The European Commission’s decision follows the CHMP’s positive opinion in December 2022, based on findings from the pivotal HOPE-B trial, the largest gene therapy trial in haemophilia B to date. The treatment was approved by the US Food and Drug Administration in November 2022.

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The Pharma Data

MAY 15, 2023

Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). 1,2 Vabysmo’s safety profile was consistent with previous trials. Review by other regulatory authorities is ongoing.

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Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

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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. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

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Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

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LifeSciVC

SEPTEMBER 15, 2022

By Joshua Brumm, CEO of Dyne Therapeutics, as part of the From The Trenches feature of LifeSciVC By all accounts, 2022 did not start according to plan for the biotech industry. Given the complex nature of global clinical development, the strong foothold of our strategic plans positioned our team to overcome these obstacles.

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The Pharma Data

NOVEMBER 11, 2020

Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval of a biologics license application (BLA) for a rare pediatric disease product application may be eligible for a voucher which can be redeemed to obtain priority review for a subsequent marketing application for a different product.

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., The Company expects to report topline results from the THRIVE-AA1 trial in 2022.

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The Pharma Data

MARCH 20, 2023

2,3 These data are among a Zolgensma data set being presented during the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, which also include, in part, real-world evidence data from the RESTORE registry. 3 The majority of patients in LT-002 (70.4%, 57/81) never received add-on therapy (76.2%

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The Pharma Data

JANUARY 27, 2021

. – Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies. “We

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Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

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The Pharma Data

DECEMBER 2, 2020

Onivyde, in combination with fluorouracil and leucovorin, was previously approved for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. based Horizon Discovery Group granted a license to China’s Sanyou Biopharmaceuticals Co. in Mainland China.

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The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Pipeline Updates. •. ?.

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Drug Discovery World

OCTOBER 10, 2022

The pharmaceutical industry is highly dependent on the productivity of its research and development expenditure to source innovative solutions for the discovery of the next generation of new drugs. Volume 23 – Issue 4, Fall 2022 . References: . Schlander et al. PharmacoEconomics 39:1243–1269 . Scannell et al. Marek et al.

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The Pharma Data

APRIL 26, 2022

AstraZeneca’s Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US, supporting the indication of a single priming dose of the anti-CTLA4 antibody added to Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 0.93; p=0.0035).4

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The Pharma Data

SEPTEMBER 15, 2020

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

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The Pharma Data

AUGUST 10, 2021

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of March 28, 2022. The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

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