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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.
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.
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.
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.
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 division of infectious diseases at Weill Cornell Medicine carried out the work in collaboration with JAFRAL and JMI Laboratories.
But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. Although a high number of cell and gene therapies are in early-stage development, a new wave of approvals could be on its way. Securing the supply chain. The industry is moving at an unprecedented speed.
BioMed X has entered a research partnership with Sanofi to leverage artificial intelligence (AI) for drug development. The partnership intends to address a 90% failure rate of new therapy candidates in clinicaldevelopment, which is a key bottleneck of the pharmaceutical industry.
Vectura Group plc, an industry leading inhalation CDMO, today announced it has signed an agreement with Incannex Healthcare Limited, an Australian cannabinoid medicinesdevelopment company, to provide pre-clinicaldevelopment services for IHL-216A, Incannex’s proprietary inhaled drug product for the treatment of traumatic brain injury (TBI).
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.
July 19, 2022, New York—Insilico Medicine, a clinical-stage end-to-end artificial intelligence (AI) driven drug discovery company, has appointed Dr. Sujata Rao as Senior Vice President (SVP) with responsibility for the global clinicaldevelopment strategy of Insilico Medicine’s therapeutic programs.
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.
Our discussion delved into the potential of DHTs to reshape how clinical trials are conducted, making them not only faster and less costly but also more patient-centric and reflective of real-world outcomes. This approach can speed up development and improve data quality, potentially leading to more effective and personalized therapies.
This joint service offering, DRIVE™-Biologics, will leverage Abzena’s strength in design and developability, and cell line development through to commercial manufacturing.
CAR-T Cell Therapy is under clinicaldevelopment by Shanghai Unicar-Therapy Bio-Medicine Technology and currently in Phase II for Diffuse Large B-Cell Lymphoma.
Gemini Therapeutics has signed a definitive agreement to merge with Disc Medicine in an all-stock deal to create a clinical-stage biopharmaceutical company. The merged company is expected to be named Disc Medicine, which will have corporate headquarters in Watertown, Massachusetts, US.
Stephanie Manson Brown, VP & Head of ClinicalDevelopment & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement of aesthetic medicine. She was honored as a 2023 Healthcare Business Women’s (HBA) Luminary.
RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore. Topic sponsors are not involved in the creation of editorial content.
Cognizant and Boehringer Ingelheim are collaborating on an integrated cloud platform to enhance the speed and quality of medicinal therapy development. Cognizant will leverage the Veeva Development Cloud platform to help Boehringer Ingelheim to merge medicinaldevelopment processes and data into a connected technology ecosystem.
Bayer has entered a strategic collaboration agreement with biotechnology company Bicycle Therapeutics to discover, develop, manufacture and commercialise Bicycle’s radioconjugates for a number of oncology targets. Bicycle will receive an upfront payment of $45m and up to $1.7bn as potential development and commercially based milestone fees.
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). Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies.
A Marketing Authorization Application has been submitted to the European Medicines Agency (EMA), with a decision anticipated in 2025. BridgeBio is also working to address gaps in ATTR-CM diagnosis through its TRACE-AI Network Study , a collaboration with the Cardiovascular Data Science Lab (CarDS Lab) at the Yale School of Medicine.
Trastuzumab rezetecan is under clinicaldevelopment by Jiangsu Hengrui Medicine and currently in Phase I for Transitional Cell Carcinoma (Urothelial Cell Carcinoma).
Trastuzumab rezetecan is under clinicaldevelopment by Jiangsu Hengrui Medicine and currently in Phase I for Transitional Cell Carcinoma (Urothelial Cell Carcinoma).
In the US, African American women are more likely to develop lupus than white or Caucasian women. In a 29 March press release, the FDA stated that Lupus ABC will bring voices together in a centralised forum to define challenges in drug development and analyse potential approaches to help advance therapies.
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.
GSK expects that the BELLUS Health acquisition will boost its speciality medicines and respiratory pipeline. Camlipixant is being assessed in the CALM Phase III clinicaldevelopment programme, with anticipated regulatory approval and launch in 2026. There are no approved medicines for the disease in the EU and the US.
Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies. Roche and Poseida will also partner in a research programme for creating and developing next-generation features and enhancements for allogeneic CAR-T therapies.
Lacerta Therapeutics has entered a new licensing and research partnership agreement with Eli Lilly and Company subsidiary, Prevail Therapeutics, to discover and develop adeno-associated virus (AAV) capsids for treating central nervous system (CNS) diseases. . Topic sponsors are not involved in the creation of editorial content.
HanAll Biopharma and Daewoong Pharmaceutical have entered into a co-development deal with NurrOn Pharmaceuticals to develop therapy for Parkinson’s disease (PD) and other neurodegenerative disorders. Nurr1 is a class of proteins important for the development and maintenance of dopamine in the brain.
Indonesia has granted Emergency Use Authorization (EUA) for the patent-free Covid-19 vaccine, IndoVac, developed by the Texas Children’s Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine, US. PT Bio Farma will manufacture 20 million doses of the vaccine this year.
Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. Under the deal, the companies will leverage MacroGenics’ DART platform to develop MGD024 as well as two further bispecific research programmes.
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.
UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinicaldevelopment of its psilocybin-based therapies. The post Beckley Psytech raises $80m for psychedelic meds development appeared first on.
Regeneron Pharmaceuticals has entered a collaboration and licensing agreement with CytomX Therapeutics for developing conditionally-activated bispecific cancer therapies. This collaboration will use Regeneron’s Veloci-Bi bispecific antibody development platform and CytomX's Probody therapeutic platform.
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. Led by Bain Capital Life Sciences, the financing round has also seen participation from Sofinnova Investments, TCGX and Wellington Management.
percent platelet response in a study published in The New England Journal of Medicine. The LUNA 3 study enrolled 202 adults with persistent or chronic ITP and severely low platelet counts, averaging just 15,000 per microliter well below the normal range of 150,000 to 450,000 per microliter.
Pfizer has entered a research partnership and exclusive licence agreement with Clear Creek Bio to progress new SARS-CoV-2 papain-like protease (PLpro) inhibitors’ discovery and development for the oral treatment of Covid-19. On entering the clinic, Pfizer will solely handle the development and marketing works of the candidate.
The approval is based on comprehensive data from the clinicaldevelopment programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.
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 drugs development appeared first on Pharmaceutical Technology.
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