Drug Discovery World

JULY 2, 2024

In another example, university of Basel spin-off T3 Pharma reached Phase I development of a cancer therapy that harnesses the natural behaviours of live bacteria before being acquired by Boehringer Ingelheim for $509m at the end of 2023. Biopôle Lausanne has been created to provide a focus for life sciences activity in the region.

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Drug Discovery World

JANUARY 5, 2023

CANbridge Pharmaceuticals has exercised its option to secure the exclusive global rights to develop, manufacture and commercialise a novel gene therapy to treat spinal muscular atrophy (SMA) from UMass Chan Medical School. . It also exhibited much less liver toxicity when administered intravenously. . “The

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Drug Discovery World

OCTOBER 4, 2022

million in 2022 to 12.7 While AD remains a huge area of opportunity for drug developers, we believe that the rare neurodegenerative disease space, specifically rare tauopathies, is a sector that is in critical need for better diagnosis and effective therapeutics. Diseases such as PSP and FTD have no licensed and available treatments.

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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

FEBRUARY 12, 2024

5 Reliability of animal testing Even the few drugs that go on to be licensed for use in the general population can have unexpected and serious adverse effects once they are prescribed in large numbers. Drug discovery and development tomorrow – Changing the mindset. Clinical Development Success Rates 2006-2015.;

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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. The Company’s validated, proprietary F.I.R.S.T

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The Pharma Data

APRIL 27, 2023

Food and Drug Administration (FDA) accepted Genentech’s Biologics License Application and granted priority review for glofitamab for the treatment of people with R/R large B-cell lymphoma. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme.

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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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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

JUNE 7, 2022

We look forward to continuing our collaboration with Lilly and advancing in our clinical program, aiming to obtain approval in the European Union,” stated Karl Ziegelbauer, Ph.D., With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Almirall S.A.’s ’s Chief Scientific Officer.

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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. Regulatory filings around the world are also planned in 2022. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

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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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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). By Holly N.

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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

APRIL 19, 2022

1 The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is during the third quarter of 2022. The safety profile of the most common adverse events with Enhertu in DESTINY-Lung01 was consistent with previous clinical trials with no new safety concerns identified.

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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

OCTOBER 16, 2023

Dr Tralau-Stewart says: “Indeed, many academic institutions have established new ways of supporting the discovery pipeline, providing tech transfer offices to support licensing, and entrepreneurship and start-up support through fundraising, accelerators, and incubators.

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The Pharma Data

JULY 22, 2021

“Building on Pfizer’s established leadership position in breast cancer science and CDK 4/6 inhibition, we are excited to work with Arvinas to maximize ARV-471, the first PROTAC for breast cancer with encouraging early clinical data and a potential novel hormonal therapy backbone for HR+ breast cancer,” said Jeff Settleman, Ph.D.,

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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.

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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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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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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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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

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

The Company expects to report topline results from the THRIVE-AA1 trial in 2022. License and research and development revenue. Research and development. CTP-543 THRIVE-AA2 Phase 3 Trial Planned for First Half of 2021. 2019.

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Drug Discovery World

SEPTEMBER 16, 2022

Globally, the pipeline for therapies in this sector has continued to grow over the years, and in 2021, there were just under 2,500 cell and gene therapies in some stage of clinical development. . The UK stands as one of the key markets for cell and gene therapies. Neelam Patel, CEO of London cluster organisation, MedCity. .

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The Pharma Data

MARCH 20, 2023

All 18 children in LT-002 who were treated with one-time investigational OAV101 IT, were alive, free from permanent ventilation and continued to show incremental gains in motor function as of the May 2022 data cut-off. 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

DECEMBER 2, 2020

GENFIT – France’s GENFIT announced the conclusion of the partial buyback of GENFIT’s 6,081,081 convertible bonds maturing in October 2022. Vivlion holds an exclusive license to Goethe University of Frankfurt’s proprietary 3Cs technology for the production of next generation 3Cs CRISPR/Cas gRNA libraries. in Mainland China.

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Drug Discovery World

OCTOBER 10, 2022

In early-stage clinical development, cognition offers a means to translate target engagement from preclinical to human studies, look for early signs of brain safety and/or efficacy, and hence support decision-making. Volume 23 – Issue 4, Fall 2022 . References: . Schlander et al. PharmacoEconomics 39:1243–1269 . Marek et al.

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Advarra

AUGUST 10, 2023

The pace has since increased: 2022 and 2023 each saw three approvals issued. Operation Warp Speed for Rare Diseases looks to accelerate both drug development and approval. This will aid clinical development and preparation for investigational new drug (IND) and biologics license application (BLA) submissions.

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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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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

JANUARY 27, 2021

We are pleased to be advancing our second therapy into clinical development in our quest to bring transformative medicines to patients who need them,” said Bruce Goldsmith, Ph.D., We are excited to investigate the potential of PBFT02 as a treatment for FTD-GRN as we initiate our clinical development program in the coming months.”.

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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. Three of the nine boys were dosed with gene therapy product that was manufactured using the commercial manufacturing process developed at Pfizer’s facility in Sanford, North Carolina.

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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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