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This, coupled with small pharma companies being unable to acquire or access containment capabilities in-house, means that the demand for innovative specialized small molecule capabilities remains high. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.
VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1%
In 2020, the US Food and Drug Administration (FDA) issued a Guidance for Industry recommending that sponsors include plans for developing age-appropriate formulations of drug products in instances where adult formulations may not be suitable for paediatric patients. Dosing flexibility is another prominent advantage provided by PDFs.
The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drug development. This is where the process development stage, which directly follows the drug discovery and early formulation work, can make or break a drug’s success.
Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective.
Clinical-stage biotech company PureTech Health has announced it has developed a new oral CBD therapeutic candidate with improved bioavailability and tolerability, which could expand use of the CBD prodrug in a wide range of indications and age groups. Jazz bought out Epidiolex developer GW Pharmaceuticals for the drug in a whopping $7.2
To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. The FDA also issued the Study Data Technical Conformance Guide , which contains detailed information on how to meet the requirements contained in the DSC.
Few contract development and manufacturing organizations (CDMOs) are able to provide radiolabeling services as part of a fully integrated pharmaceutical development program. How does your unique Synthesis-to-Clinic® offering streamline the drug development process?
Softgel capsules, containing a liquid, paste or emulsion active ingredient, are trusted and favoured by many patients. They also offer enhanced bioavailability, exact dosing and an extended shelf life. Compared to traditional hard capsules or granules, they are easier to swallow and more attractive in appearance.
After five years of research and development, the brand found a way to transform saved grain from brewing into nutrient-rich, barley-based proteins and fibers that have a variety of applications in the food and beverage industry. EverGrain’s UFA Certification. Related: Will Pecan Milk Find Success in the Crowded Plant-Based Dairy Space?
Sheppard, MD, MMSc, FACS, professor of ophthalmology at Eastern Virginia Medical School, and mid-atlantic medical director for Eye Care Partners and investigator in the development program. Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology.
Within the pharmaceutical industry, it is critical to measure particle size as it influences surface area and porosity, impacting a drug’s bioavailability, effectiveness, and shelf life. Particle size is monitored in quality control as well as the development of active pharmaceutical ingredients (APIs).
Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. Of 2,787 small molecule API CMOs analysed by GlobalData in 2021, only a third offered containment capabilities, and only 256 facilities (9%) featured controlled substance capabilities.
Cybin is developing technologies and delivery systems, aiming to improve bioavailability, to potentially achieve the desired medicinal effects of psychedelics at low dosage levels. Cybin is a life sciences company advancing psychedelic pharmaceutical treatments for various psychiatric and neurological conditions.
Structure-based design approach has identified potent compounds for further development as oral treatments for SARS-CoV-2 infection and related human coronaviruses.
This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products.
This novel nanoparticle formation technology provides hope for improving the possibilities and probabilities of developing better medicines for patients and it expands Nanoform’s reach into the growing biological market. ” Prof. ” Prof. Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 562 1806.
Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. About Calliditas. Forward-Looking Statements.
Nanoform works together with pharma and biotech partners globally to provide hope for patients in developing new and improved medicines utilizing Nanoform’s platform technologies. The Company focuses on reducing attrition in clinical trials and on enhancing drug molecules’ formulation performance through its nanoforming services.
CycPeptMPDB, a novel database – created by Tokyo Tech researchers – focused on the membrane permeability of cyclic peptides, could accelerate the development of drugs based on these promising compounds. To build the database, they gathered data from previously published papers and pharmaceutical patents.
Development of oral biosensor and contract development & manufacturing.
Psychedelic transdermal and sublingual drug formulation development.
Vektor will position itself for commercial manufacturing, pipeline development and drug formulations for critical mental health conditions.
The strong results from this Phase 1 readout reinforce our view that LYT-100 has the potential to offer a tolerability and bioavailability profile that could be highly differentiated at the same exposure levels as pirfenidone,” said Daphne Zohar, co-founder and chief executive officer of PureTech. About PureTech Health.
More recently, in April 2022, the agency issued draft guidance recommending sponsors to develop Diversity Action Plans to improve the enrollment of racial and ethnic populations in clinical trials. Now, FDORA makes these plans mandatory for most drug and device studies.
We designed KB-0742 to be an orally bioavailable CDK9 inhibitor with a differentiated selectivity profile,” said Norbert Bischofberger, Ph.D., We look forward to advancing clinical development of KB-0742 to establish the dose, safety and efficacy of this investigational therapy as a potential treatment for MYC-amplified tumors.”.
Achieving the primary endpoint of the SOLSTICE trial is an exciting new development in the search for a treatment for transplant recipients with refractory/resistant CMV infection. No new safety signals were identified and maribavir was associated with lower incidence of neutropenia compared to IAT. About Maribavir.
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