Drug Discovery World

SEPTEMBER 16, 2022

W here globally is innovation occurring and what factors – industry, regulatory, and academia – are helping developers get their products to market? Here, DDW Editor Reece Armstrong explores the global hubs of innovation for cell and gene therapies. The UK stands as one of the key markets for cell and gene therapies.

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The Pharma Data

OCTOBER 26, 2020

(Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the U.S. Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process.

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Drug Discovery World

OCTOBER 16, 2023

Dr Salako says there are some clear fields of work associated with different areas, which include: Hertfordshire as a cell and gene therapy hub, with a number of companies in this space clustered around Stevenage. billion in funding. billion in funding. Northern Ireland “Northern Ireland is a medtech super-hub,” says Saleko.

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The Pharma Data

APRIL 27, 2022

We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”. About Novartis Novartis is reimagining medicine to improve and extend people’s lives.

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Drug Discovery World

SEPTEMBER 14, 2023

joined Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla.

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pharmaphorum

SEPTEMBER 29, 2020

As of 2018, there were over 1,100 cancer therapies in development, and as of 2020, 362 of them were cell and gene therapies. Many novel therapies have been successfully developed through such partnerships.

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The Pharma Data

OCTOBER 27, 2020

Orphan Drug designation affords Passage Bio the potential for certain benefits, including up to seven years of market exclusivity, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees. About PBKR03. More information is available at www.passagebio.com.

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pharmaphorum

NOVEMBER 12, 2020

UCB has made a new foray into the gene therapy space, buying fellow Belgium-based company Handl to get control of its adeno-associated virus (AAV) capsid delivery platform and two research programmes in neurodegenerative diseases.

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The Pharma Data

NOVEMBER 3, 2020

According to the FDA, the purpose of Fast Track designation is to get important new drugs to patients earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA).

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Pharmaceutical Technology

AUGUST 26, 2008

As understanding of biological systems has forged ahead, pharmaceutical companies have made increasing use of biotechnology in discovering and manufacturing new medicines. ” Today most big pharmaceutical companies are pursuing biotechnology either in house or by using an in-licensing strategy.

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FDA Law Blog

SEPTEMBER 20, 2021

We have seen first-hand the difficult task faced by CBER review staff to keep up with the flood of innovative cell and gene therapy products, as well as the taxing influx of COVID-19 pandemic related applications requiring review resources in both Centers. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

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The Pharma Data

DECEMBER 9, 2020

The Chinese biopharmaceutical industry is growing in leaps and bounds, but there is still a huge unmet need when it comes to getting patients access to the breakthrough therapeutic modalities and platforms like RNAi, cell and gene therapy and others. A solution could be at hand with Overland Pharmaceuticals.

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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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The Pharma Data

JANUARY 27, 2021

Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for PBFT02, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of patients with Frontotemporal Dementia (FTD) with granulin (GRN) mutations. chief executive officer of Passage Bio. “FTD

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Drug Discovery World

JULY 13, 2023

In a statement, the company at fault claimed the problem was caused by an issue at its medicines manufacturing unit. There are various schemes in force that allow patients access to unlicensed medicines that are in the late stages of clinical development (i.e., What are the risks?

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Drug Discovery World

OCTOBER 2, 2023

With fully closed and automated devices, therapy manufacturing will hopefully be able to break the next barrier in patient access to generate safe products in record time. Even so, the licensing approvals over the past six years have relied on development visions established 20 years ago.

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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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XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. every eight weeks for the 90 mg dose, according to the manufacturer. 2022 Revenue: Pfizer reported an annual revenue of $100.33 billion, a 42.74

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The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need. NYSE: PFE) today announced the U.S.

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Pfizer

SEPTEMBER 28, 2022

1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. 5-adapted bivalent vaccine, and preclinical data from the companies’ Omicron BA.4/BA.5-adapted

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Pfizer

OCTOBER 19, 2022

Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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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. Key updates include: Data from the Phase 1b DMD gene therapy program, including data from an additional nine boys, who were all administered the high dose of the investigational therapy.

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The Pharma Data

OCTOBER 15, 2020

Mukul Agarwal, former vice president of Corporate Development, at Forty Seven, Inc., Axovant – Kristin Vuori was named to the board of directors at Axovant Gene Therapies Ltd. Before joining MaxCyte, Meeks served as vice president of Business Development at Synpromics, which is now part of AskBio. Additionally, Parag V.

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). The therapy received approval based on positive Phase III trial (NCT02773849) results.

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Pharmaceutical Technology

MAY 26, 2023

Tripling its production capacity, Touchlight can now manufacture 8kg plasmid DNA, a key component for mRNA gene therapies and vaccines. As per the company, dbDNA is suitable for rapid, scalable manufacture of GMP DNA and can incorporate gene sequences of sizes ranging from 500bp to 20kb, which are typically unstable as pDNA.

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