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Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.
Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Robots can improve drug discovery and development. Remote-controlled robotic labs.
Ablaze Pharmaceuticals is set to develop a new GPC3-targeted peptide drug candidate for the treatment of liver cancer in China. The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio. The agreement allows Ablaze to clinicallydevelop and commercialise the drug in Greater China.
The Technical University of Denmark (DTU) has announced that an international scientific team has developed a CRISPR-based drug candidate that targets E coli directly and leaves the microbiome intact. The US Food and Drug Administration has granted fast-track designation to SNIPR001, which is currently in clinicaldevelopment.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? Ben Locwin will discuss the potential effects of this draft, along with the pharmacological and toxicological considerations for optimizing doses of prescription drugs. A recent draft from the FDA provides valuable insight.
BioMed X has entered a research partnership with Sanofi to leverage artificial intelligence (AI) for drugdevelopment. This team will focus on creating a versatile computational platform that can precisely forecast the first-in-class drug candidates’ efficacy in virtual patient groups.
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
Biotechnology company Adcentrx Therapeutics has raised $38m in Series A+ financing to advance its pipeline of new antibody-drug conjugate (ADC) therapeutics into clinicaldevelopment. Adcentrx Therapeutics is focused on developing protein conjugate therapeutics to treat cancer and other life-threatening diseases.
Astellas Pharma and Sutro Biopharma have entered a global, strategic partnership and licencing agreement to discover and develop new immunostimulatory antibody-drug conjugates (iADCs). Astellas and Sutro will expedite the development of iADCs for three different biological targets.
Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.
Digital tools must be used in pharma manufacturing to keep pace with drug discovery and clinicaldevelopment Mike.Hammerton Thu, 07/03/2024 - 09:43 Bookmark this
In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drugdevelopment costs, heightened competition and advanced scientific innovations.
The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands.
Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. Shilling was appointed to represent the company on the steering committee of the BGTC.
These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinicaldevelopment goals and corporate culture. At Worldwide, we understand that every program is different, which means every drugdevelopment path forward will be unique.
These daunting figures highlight the necessity for innovative solutions that can accelerate the journey of new drugs from the lab to patients. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research.
Accordingly, the development of non-opioid painkillers is experiencing a surge in activity and despite numerous novel targets receiving high levels of attention, cannabinoids have emerged as strong favourites to replace opioid-related medications. However, along with other painkiller alternatives, doubts have been cast over their efficacy.
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition. Asian, Hispanic, and Native American women are also at higher risk.
This joint service offering, DRIVE™-Biologics, will leverage Abzena’s strength in design and developability, and cell line development through to commercial manufacturing.
Other lines of research look at the genetic overlap between FTD and amyotrophic lateral sclerosis (ALS), which could be used in the development of treatments for both conditions. This is also one of the major challenges that slow the development of effective treatments for FTD, he adds. Do we develop a single treatment for all three?
Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. Rigorous procedures to ensure that drugs are effective and safe.
As novel therapeutics become more complex — and costly — to bring to market, drugdevelopers are looking to unified clinicaldevelopment platforms to streamline operations.
According to GlobalData’s Looking Ahead to 2023 – the Future of Pharma report, five drugs set for approval in 2023 are projected to attain blockbuster status or near-blockbuster status by 2028 with US company dominance. Genmab AS’s epcoritamab presents as the top European drug launch and only oncological therapy.
ImmunoForge has expanded its licence agreement with Duke University in North Carolina, US, to jointly improve research and drugdevelopment opportunities. ImmunoForge chief technology officer Dr Jim Balance pioneered the clinicaldevelopment of peptide drugs genetically fused to ELPs.
Zerion Pharma has entered a partnership with Insud Pharma for the development and marketing of drug products using Zerion Pharma's solubility-boosting Dispersome technology. . Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs.
One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). The initiative reflects the FDA’s recognition of this sector as a growing and increasingly important area of drugdevelopment.
In this episode, Ayesha spoke with Mario Marcondes, MD, PhD, VP Head of ClinicalDevelopment at Nektar Therapeutics , a company focused on the discovery and development of novel therapies for autoimmune disorders and cancer. Dr. Marcondes is a licensed and trained physician, specializing in oncology and immune oncology.
While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drugdevelopers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES.
SOPHiA GENETICS is expanding its collaboration with AstraZeneca to include multimodal approaches for developing cancer drugs. The post SOPHiA GENETICS and AstraZeneca partner for oncology drugsdevelopment appeared first on Pharmaceutical Technology.
By inhibiting this protein, the drug disrupts pathways that contribute to platelet destruction and insufficient production. The drug also reduced the need for emergency rescue therapies by 52 percent and delivered significant improvements in patient-reported fatigue scores.
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.
Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally.
Japan-based Astellas Pharma has entered a partnership with Cullgen to discover and develop multiple targeted protein degraders through the latter’s proprietary uSMITE targeted protein degradation platform, in a deal potentially worth $1.9bn. Astellas could pay Cullgen up to $85m upon using its license option regarding the deal.
GSK has entered a strategic partnership with Wave Life Sciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. The discovery alliance, with a preliminary research period of four years, will aid GSK in progressing up to eight programmes and Wave to develop up to three programmes.
A new CTTI publication , published in Clinical Pharmacology & Therapeutics , reviews current applications of disease progression modeling (DPM) and opportunities to advance the awareness and value of DPM in clinical trials.
The latest development is based on data obtained from an open-label clinical trial of Biktarvy. Merging three therapies, Biktarvy is the smallest available three-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR).
Gildeuretinol is the first and only medicine in clinicaldevelopment to treat Stargardt disease by reducing vitamin A dimerization in the eye, without affecting normal vision. The therapy has also received orphan drug designation and breakthrough therapy designation from the US Food and Drug Administration.
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