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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.
Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations. You have the oversight you need.
“Following encouraging data from our Phase IIa clinical trial in patients with obesity, this financing enables us to advance development of HU6 and a pipeline of controlled metabolic accelerators to address a range of cardio-metabolic conditions.”.
Clinicaldevelopment organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies.
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. Lab-specific industrial co-bots can carry out both complex and repetitive tasks such as liquid handling.
Hookipa Pharma and Roche have signed a strategic partnership and licence agreement for developing HB-700 and another undisclosed arenaviral immunotherapy. Under the deal, Hookipa will carry out research and initial clinicaldevelopment through Phase Ib for HB-700 to treat KRAS-mutated cancers.
German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinicaldevelopment? Explore the limitations of what we know about prescription drug dosing The future of Clinical Research April 12, 2023 at 11:00 am PDT, 2:00 pm EDT, 7:00 pm GMT
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. It can potentially enhance the anti-cancer effect.
Ablaze Pharmaceuticals is set to develop a new GPC3-targeted peptide drug candidate for the treatment of liver cancer in China. The agreement allows Ablaze to clinicallydevelop and commercialise the drug in Greater China. The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio.
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.
C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. The deal has been signed to develop the C4X NRF2 Activator programme for these ailments. This includes an upfront payment of $2m from AstraZeneca.
Chinook Therapeutics and Ionis Pharmaceuticals have entered a partnership to develop an antisense oligonucleotide (ASO) therapy to treat a rare, severe chronic kidney disease. The collaboration aims to discover, develop and commercialise an ASO therapy.
BioMed X has entered a research partnership with Sanofi to leverage artificial intelligence (AI) for drug development. The companies will jointly create a virtual patient engine for the drug candidates’ clinical translation. The companies will select a varied group of skilled researchers for the project.
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.
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.
However, the current MS pipeline offers new hope for PPMS patients, with three late-stage agents currently in development. Nonetheless, the increased focus on the development of PPMS treatment is a welcome game-changer for patients.
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 drug development path forward will be unique.
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?
As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinicaldevelopment platforms to streamline operations.
The deal gives Biohaven global rights for the development of BHV-8000, excluding regions of China. We look forward to advancing BHV-8000 into clinicaldevelopment and uncovering the potential of neuroimmunomodulation for severe neurological disorders in desperate need of novel treatment options.”
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