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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.
According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.
Despite the market size for B-cell non-Hodgkin’s lymphoma (NHL) being at least five times that of ALL, NHL has a smaller pipeline of cell therapies. The total market for cell therapies in oncology is projected to exceed $37bn worldwide by 2028.
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.
As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinicaldevelopment platforms to streamline operations.
Oren Cohen, MD, FIDSA CMO & President of Clinical Pharmacology Fortrea Fortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, market access solutions and other enabling services.
Phase III trials: In these advanced stages, focused on confirming efficacy and monitoring side effects in larger populations, DHTs may support market authorization and label claims. This approach can speed up development and improve data quality, potentially leading to more effective and personalized therapies.
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.
Gilead Sciences has entered an agreement with Everest Medicines to acquire complete rights to develop and market Trodelvy (sacituzumab govitecan) in Greater China, Singapore, South Korea, Philippines, Vietnam, Thailand, Indonesia, Mongolia and Malaysia.
Astellas and Sutro will expedite the development of iADCs for three different biological targets. Sutro will oversee the research and preclinical research to detect candidate compounds and subsequently Astellas will carry out the clinicaldevelopment. Furthermore, the company is entitled to get up to $422.5m
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.
Health economics and outcomes research (HEOR) and market access strategies play a critical role in ensuring that newly approved therapies are made available to patients. Professionals in these roles are facing new challenges when it comes to negotiating coverage for many of the new, innovative treatments that are coming to market.
There have recently, however, been some notable developments towards improving the care of bronchiectasis patients. These include the ongoing clinicaldevelopment of AstraZeneca’s Fasenra (benralizumab), Insmed’s brensocatib and Novartis’ icenticaftor (QBW251).
While Eli Lilly and Novo Nordisk currently dominate the GLP-1 receptor agonist space, there are more than 50 candidates in clinicaldevelopment for obesity and type 2 diabetes, according to analytics firm GlobalData.
The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).
A Marketing Authorization Application has been submitted to the European Medicines Agency (EMA), with a decision anticipated in 2025. Patient advocacy groups, including the Amyloidosis Support Groups led by Muriel Finkel, highlight the transformative impact of Attruby on the lives of those with ATTR-CM.
In 2022, Pfizer acquired the drug, with the promise of accelerating clinicaldevelopment via new, differentiated, and best-in-class approaches, enhancing optimism for further drug development. Currently, Jazz Pharmaceuticals’s nabiximols is the only cannabinoid approved for pain, receiving approval in Israel, in August 2010.
Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. Laurus Labs will be responsible for launching these products in India and emerging markets.
In the clinicaldevelopment programme, 1,944 epilepsy patients received cenobamate treatment. In December last year, Endo subsidiary Endo Ventures and SK Biopharmaceuticals entered a licencing agreement under which Endo Ventures received exclusive rights for marketing cenobamate in Canada.
Belsomra’s first-to-market advantage in the US hasn’t however translated into big annual sales, which have stayed planted just over the $300 million mark since 2019. The class as a whole is, however, trying to break into a low-cost generic market, and almost inevitably is facing pushback from payers.
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.
Biotechnology company Enveda Biosciences has raised $51m in equity financing in a Series B1 round to advance several drug candidates to clinicaldevelopment. Enveda Biosciences intends to use the additional financing to advance several candidates derived from its drug discovery platform to clinicaldevelopment in 2023 and 2024.
Additionally, over a 176-week period, weekly injections of tirzepatide (marketed as Zepbound and Mounjaro) using pooled doses of 5 mg, 10 mg and 15 mg, significantly reduced the risk of disease progression to type 2 diabetes by 94 percent compared with placebo in adult prediabetes patients who were obese or overweight.
While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options. However, the current MS pipeline offers new hope for PPMS patients, with three late-stage agents currently in development.
Daiichi Sankyo has stepped up its efforts to bring a Japanese COVID-19 vaccine to patients, starting a new clinical trial of its mRNA-based candidate DS-5670 that focuses on its use as a booster dose. The Japanese group says it hopes to complete clinicaldevelopment of the vaccine and bring it to market in Japan before the end of the year.
government has provided Moderna with nearly $10 billion in taxpayer money for research and development and the purchase of 500 million doses of this mRNA COVID-19 vaccine. This includes almost the entire cost of clinicaldevelopment. SUMMARY: The U.S. Additionally, Moderna used patents and non-exclusive rights that the U.S.
After more than a decade of research and clinicaldevelopment, and through the perseverance of clinicians, patients and their families, the approval of Zynteglo marks a watershed moment for the field of gene therapy.”. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
Ben Beckley, Global Lead at EmerGENE explores the market challenges holding back Cell and Gene Therapy (C>) from taking its place as an established treatment area. Some 3,366 treatments are currently in preclinical and clinicaldevelopment[1]. Some 3,366 treatments are currently in preclinical and clinicaldevelopment[1].
Currently, the company is working with various regulatory agencies to explore the potential to further advance ASC10’s clinicaldevelopment. In preclinical studies, ASC10-A showed to possess robust cellular antiviral activity against wildtype SARS-CoV-2 virus as well as Omicron and Delta variants.
The pharmaceutical industry is increasingly relying on artificial intelligence to power its drug discovery and development efforts, and its spend in this area has created a multibillion-dollar market for AI technologies. billion, according to the report.
Chinese biopharmaceutical company, Hutchmed Limited, has announced today (Friday September 29) that it has taken a step towards bringing a colon and rectum cancer drug to a third market.
Both McKinsey (2014) and Deloitte (2022) emphasize that market access strategy and execution – a life sciences company’s ability to demonstrate clinical and economic evidence, negotiate with healthcare access stakeholders, and enable affordable and timely product fulfillment for appropriate patients – are critical to a drug’s success or failure.
These strategic deals have reshaped the competitive landscape, spurred innovation and enabled companies to diversify their product offerings, expand into new markets and enhance operational efficiencies. The deal was valued at approximately $25 billion and strengthened Abbotts presence in the cardiovascular devices market.
Experience with severe mental health disorders in close friends and family gave Sam Clark the drive to found Terran Biosciences to explore new approaches to therapeutics in neuropsychiatry.
It’s illegal in most countries including the US and UK but Small Pharma is convinced of its potential as a therapeutic medicine for depression and has already begun clinicaldevelopment. The post Small Pharma stock market launch funds DMT-based depression drug trial appeared first on.
NKGen CEO Paul Song said: “The team at Graf fully understands and appreciates our novel NK cell therapy platform technology and our overall mission to help patients in real clinical need, especially those with neurodegenerative diseases. “We We believe that the business combination represents a key step in our overall growth strategy. “We
The initial phase of the expansion will see the installation of two 2,000-liter single-use bioreactors within new, purpose-built manufacturing suites and associated investments to support early-phase clinicaldevelopment as well as late-stage and commercial tech transfers.
VLA15 is the only vaccine for Lyme disease in clinicaldevelopment, according to GlobalData, the parent company of Pharmaceutical Technology. In the last 20 years, this is the biggest buzz in the vaccine market for Lyme disease,” said Yale School of Medicine associate professor Sukanya Narasimhan, PhD, about the Phase III VLA15 trial.
Under the deal, GSK will obtain an exclusive licence for the development and marketing of tebipenem pivoxil HBr in all countries. Since 2009, Meiji has marketed tebipenem HBr in Japan. Known as Orapenem, it is marketed for the treatment of paediatric infections limited to pneumonia, otitis media and sinusitis.
This approach will support its manufacturer partners throughout the pharmaceutical development and marketing processes. This latest development will progress various AmerisourceBergen’s strategic imperatives and bolster its position to gain substantial growth prospects in the biopharma market.
FivepHusion has collaborated with Treehill Partners and Syneos Health to strategically progress development and commercialisation of its chemotherapeutic formulation Deflexifol in markets across the globe. Syneos will support the commercialisation and clinicaldevelopment capabilities of FivepHusion.
Phesi, a global provider of patient-centric data analytics, has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.
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.
The Advantages of Midsize CROs In contrast to large CROs, midsize CROs like Worldwide Clinical Trials offer a unique value proposition to the market. To gain deeper insights into this pivotal shift and how it can benefit your clinicaldevelopment strategy, we invite you to download our full industry survey report.
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