This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
A study conducted on terminated drug development projects revealed that majority of the drug candidates fail in early drug development phases, due to the problems associated with their pharmacokinetic profiles, ADME ( distribution, metabolism, absorption and excretion ) properties and toxicity-related issues.
dsm-firmenich has announced the launch of CBtru â an advanced formulated cannabidiol (CBD) drug product intermediate designed for oral solid delivery formats.
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.
Furthermore, EDP-323 claims to have a favourable oral bioavailability with good plasma exposure in preclinical species and pharmacokinetic properties and supports once-a-day, oral dosage in humans. We believe this designation will be a valuable component of our clinical and regulatory strategy as we progress EDP-323 in development.”
VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. The water-free formulation of the investigational drug increases residual time on the surface of the eye and improves bioavailability in the target tissues to release the complete potential of cyclosporine A.
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.
While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES.
Jotrol overcomes these barriers using patented micellar technology, enhancing bioavailability and enabling therapeutically effective doses. Conventional resveratrol products often face challenges like poor absorption and significant gastrointestinal side effects.
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The report is a useful read to keep current on a topic of interest at the FDA and in drug development as a whole.
New research reveals the bioavailability of both CBD and THC components of hemp, is higher when delivered in certain oil carriers, and describes how some CBD is converted into THC in the body.
Here are some key approaches with examples: New Formulations One common strategy is to develop and patent new formulations of the existing drug compound to provide benefits like reduced dosing frequency, easier administration, improved bioavailability, or reduced side effects. […] Source
Both have stellar experience and track records in oncology research and development. CellCentric is developing inobrodib, an orally bioavailable drug that is transitioning into Phase II clinical trials in multiple indications.
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.
OR-449 is a first-in-class, orally bioavailable, potent and selective small molecule antagonist of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1). SF-1 is an important transcription factor for adrenal gland growth and development. The company is developing OR-449 to treat ACC in adult and paediatric patients.
The stable gel matrix holds multiple ingredients, offering targeted release and enhanced bioavailability while optimizing patient experience. Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drug delivery, supporting prescription drugs, nutraceuticals, pet care and sports supplements.
The continued high level of interest in small molecules presents multiple opportunities to select a candidate that is ‘developable’, with subsequent rapid progression toward first-in-human (FIH) clinical testing. Therefore, it is vital to choose molecules for pharmaceutical development very carefully.
In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Development and Approval : Small Molecules: The pathway for development and regulatory approval is well-established, with clear guidelines for demonstrating safety and efficacy.
Catale n t has signed an agreement for the acquisition of full-service specialty Contract Development and Manufacturing Organization (CDMO) Metrics Contract Services for $475m from Mayne Pharma. It also has two packaging lines that can accommodate a wide range of development and commercial supply programmes.
Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Proper planning of PK assessments can accelerate the development of both novel drugs and new formulations of previously approved drugs developed via the 505(b)(2) pathway.
C4 Therapeutics has entered an exclusive licensing agreement with Betta Pharmaceuticals to develop and commercialise CFT8919 across the greater China region. It is expected to accelerate the development of CFT8919 in important international markets.
The orally bioavailable small molecule EGFR inhibitor ERAS-801 demonstrated significant central nervous system (CNS) penetration in animal trials. This newly granted status helps Erasca to facilitate the development and review of ERAS-801, thereby accelerating the therapy’s reach to patients.
a clinical-stage biotech company focused on developing next-gen injectable and oral nutrient-stimulated hormone (NuSH) analog peptides for the treatment of obesity, overweight and related conditions, has priced its initial public offering (IPO) at $18.00 Despite this, the drug remains under watch for further development.
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
It might therefore lead to the development of new therapies to treat heart failure. The company stated that the family of drug candidates of SERCA2a activators has similar mechanisms of action to those of istaroxime, a first-in-class dual mechanism therapy.
It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility. Elyxyb is claimed to be the only FDA-approved first-line treatment, ready-to-use solution of celecoxib developed for the indication.
It also aims to contribute to the pharmaceutical sector by facilitating cross-industry partnerships and research-based product development. The centre will primarily offer expert training and troubleshooting. It also has granulation, blending and coating equipment and high-performance liquid chromatography analysis capabilities.
Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and expenses. Biowaiver Eligibility.
million ($2 million) to develop its artificial intelligence-based platform for discovering therapeutic antibodies. The Cardiff, Wales startup is combining machine learning and phage display techniques to model antibody-antigen binding and says it can cut the time it takes to develop a drug candidate. He added. “In
Dieterich has a PhD in synthetic organic chemistry, an MBA from Imperial College London and a wealth of experience in drug development and chemistry, manufacturing and control (CMC) activities. Abzena is a leader in bioconjugation and ADC development. Dr. Dieterich identified two primary hurdles: drug resistance and adverse-events.
It’s been estimated that about 90 percent of new chemical entities or drug molecules currently under development are insoluble. Therefore, techniques and technologies that promote drug solubility and bioavailability are in high demand. KinetiSol uses two machine scales for drug development.
Development of PROTACs (PROteolysis TArgeting Chimeras) has advanced fairly rapidly as excitement grows over their potential to selectively degrade proteins that are involved in various diseases, including cancer. PROTACs are a type of heterobifunctional degrader that offers multiple advantages over traditional small molecules.
Evidence shows that animal models currently dominating bioavailability estimates are poor predictors and human, cell-based multi-organ microphysiological systems (MPS) should be investigated, CN Bio says.
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. 3.1.1: Bioavailability Study Reports. This validation check determines if the submission is uploaded into the FDA’s system, or if it is technically rejected.
As every molecule and development program is unique, there is no single drug substance synthesis and manufacturing solution, so understanding what processes and technologies are available, what strategy is best, and who to partner with is key. . Important considerations for drug substance development. Polymorphic form issues.
Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Developing and manufacturing FDCs factors to consider.
NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, announced … Continue reading → –(BUSINESS WIRE)–Edgewise Therapeutics, Inc.
. “The public believes that pharmaceutical companies should be fairly compensated for developing vaccines, but should be prevented from holding a monopoly on the jabs,” says the Alliance, adding that people “don’t want big pharma to hold monopolies on vaccines that were developed largely with public money.”
Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs).
The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs.
Design validation may be covered by clinical studies, pharmacokinetic/pharmacodynamic or bioequivalence/bioavailability studies, literature, simulated bench testing, and/or anthropometric data and should include endpoints that have the capability of validating device performance. Comments may be submitted by September 30, 2024.
(TWO: 4162) announced today that it has entered into a Collaboration and License Agreement with UK-based Sentinel Oncology Limited for advancing the new drug development of SOL-578 , a Checkpoint Kinase 1 (Chk1) inhibitor, under which PharmaEngine will fund the IND enabling studies for SOL-578. ” said Yufang Hu , Ph.D.,
They also offer enhanced bioavailability, exact dosing and an extended shelf life. Procaps’ deep knowledge of gelatine formulation and scientific expertise in softgel technologies has enabled the development of a range of innovative formulations. The best formulation for the job.
In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the prime reasons that leads to failure in obtaining approval authorization.
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content