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.
Both have stellar experience and track records in oncology research and development. CellCentric is developing inobrodib, an orally bioavailabledrug that is transitioning into Phase II clinical trials in multiple indications.
Understanding how a drug will act in the body, including how it is absorbed, distributed, and eventually eliminated, is a crucial component of drugresearch. Well-planned ADME investigations are conducted in the early stages of clinical research to generate this important data, which is needed for regulatory submissions.
Situated at the hub of the country’s northeastern pharmaceutical corridor, the new facility is staffed by research, application and formulation specialists. It also aims to contribute to the pharmaceutical sector by facilitating cross-industry partnerships and research-based product development.
Erasca has received the US Food and Drug Administration’s (FDA) fast track designation (FTD) for ERAS-801 to treat adults with glioblastoma (GBM) with epidermal growth factor receptor (EGFR) gene alterations. A team of three cancer researchers, Michael Jung, Timothy Cloughesy and David Nathanson, designed and developed ERAS-801.
Drug substance plays a key part in ensuring a drug program achieves its major milestones, keeps to budget and delivers on its corporate goals. To increase the likelihood of clinical success, drug developers must identify challenges and potential red flags early on in the candidate selection stage. Polymorphic form issues.
In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability.
Pfizer has pledged a whopping $1 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. billion in backloaded milestone payments.
At Camargo, we have worked with hundreds of investigators who have found new targets for established drugs. It is exciting to find new uses of drugs with known safety because these drugs can reach new groups of patients in a relatively short timeframe. ” .
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. Pediatric Research Equity Act (PREA) Requirements.
Oral drugs are the most convenient and sought-after form of drug administration. This means they must be digested completely so the active pharmaceutical ingredients (APIs) in the drug can be absorbed by the body. Therefore, techniques and technologies that promote drug solubility and bioavailability are in high demand.
They provide a higher ability to regulate protein levels and can affect the non-enzymatic function of the protein while also providing an alternative to targeting drug-resistant proteins for overcoming tumour drug resistance.
However, there is a high level of attrition during the pharmaceutical research and development process, which is an indicator of the vast number of potential drug substances considered for progression. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?
Recognized with Fast Track designation from the US Food and Drug Administration (FDA), fasedienol could become a much-needed treatment option for the 30 million Americans affected by SAD. If successful, this trial could pave the way for a New Drug Application (NDA) submission.
Over the last decade, one of the major challenges faced by pharmaceutical companies across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility.
Interestingly, over the past few years, drug developers focused on non-respiratory diseases have also shifted their attention towards intranasal drug formulations. This can be attributed to ease of delivery, increased bioavailability and by-pass of first-pass metabolism offered by this type of route of administration.
However, it is important to highlight that there are still several challenges which need to be addressed in order to develop biologic drugs capable of effectively being administered via the oral route without undergoing significant losses in specificity and / or bioavailability. Oral Protein / Peptide-based Drugs. Web: [link].
.
The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. The number of biopharmaceutical products show a considerable growth accounting for nearly a quarter of the new molecular entities approved in 2017.
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. That is why, in recent years, cyclic peptides have become a very active research area.
Over the last decade, one of the major challenges faced by pharmaceutical players across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Our Social Media Platform. Web: [link]. LinkedIn: [link].
Owing to their unique size and physicochemical properties ( surface roughness, surface area, surface energy, crystal structure and shape ), nanoparticles can be widely used as a contrasting agent in medical imaging, a vesicle to cross the blood-brain barrier and a carrier for targeted delivery of genes / drugs, proteins, vaccines and antibiotics.
Construction of commercial drug manufacturing facility in Germany.
Psychedelic transdermal and sublingual drug formulation development.
Vektor will position itself for commercial manufacturing, pipeline development and drug formulations for critical mental health conditions.
Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. Session Category: Clinical Research (Excluding Trials). Portfolio Highlights.
Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. According to an analysis of the 2013 Medical Expenditure Panel Survey, one in six US adults reported taking a psychiatric drug at least once in 2013.
Nintedanib is an orally bioavailable, small-molecule tyrosine kinase inhibitor (TKI) developed for the treatment of IPF and SSc-ILD. In August 2016, nintedanib gained Orphan drug Designation from European Commission to treat systemic sclerosis. Ofev (Nintedanib) Facts. Ofev (Nintedanib) Approval History. In March 2020, The U.S.
The US Food and Drug Administration (FDA) has approved the first and only oral drug for the treatment of advanced or metastatic breast cancer in postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) ESR1 mutations. months on elacestrant compared with 1.9
US drugmaker Eli Lilly – still waiting for an FDA decision on one non-opioid pain drug – has just added another to its pipeline via a licensing agreement with Japan’s Asahi Kasei worth up to $410 million. While tanezumab is an antibody and has to be delivered by subcutaneous injection, AK1780 is orally bioavailable.
The drug, Spartalizumab, is an experimental monoclonal antibody designed as immunotherapy to target the human programmed death-1 (PD-1) receptor. The drug uses an optimized salt form of niclosamide, which is a safe oral drug and is in use for decades as an anthelmintic drug.
Alzprotect co-owns or has an exclusive worldwide license from the French National Institute of Health and Medical research (Inserm) and the University of Lille (France) on a total of 58 patents related to Ezeprogind in 39 countries. The company employs 8 people and is supported by BPI France, the National Research Agency and Eurasanté.
Genesis is progressing both an internal drug pipeline, as well as select external partnerships, to create transformative therapies for patients. We are united in our view that drug discovery and development must raise its success rate. Most recently, Genesis announced a multi-target partnership with Genentech. Feinberg, Ph.D.,
Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. While SLV213 can be dosed orally or intravenously, Selva is first advancing it as an oral drug candidate for COVID-19. About SLV213.
for the purpose of advancing disease-modifying oral medicines for debilitating chronic neurodegenerative disorders, by enabling investigational new drugs (IND) studies. A £16 million Series A financing – led by Omega Funds – has been announced by the innovative neuroscience company NRG Therapeutics Ltd.,
Chemotherapy drugs while killing cancer cells also damages normal tissues. The drug is the first and only therapy that is developed and approved to protect bone marrow (myeloprotection), which is injected prior to treatment with chemotherapy, asserts the US oncology drug developer, G1.
Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related. This program included assays such as Big Blue and PIG-a designed to provide a robust measure of a drug or chemical’s ability to induce mutations in vivo. “We
Ikena secures USD 120 Million to advance a growing pipeline of cancer drugs. Ikena Oncology has bagged USD 120 million to develop its expanding pipeline of cancer drugs. The newer side of the pipeline points targeted oncology drugs. Terns raises USD 87 Million for NASH drugs. IND-enabling studies are underway.
“It continues to be critically important to advance potential antiviral treatments to address the devastating impact of COVID-19 globally,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “If About Molnupiravir.
Drugs such as pembrolizumab (Merck’s Keytruda) and nivolumab (Bristol Myers Squibb’s Opdivo) have revolutionized the treatment options for skin cancer. Ongoing research on molecular diagnostics and AI-powered diagnostic tools has helped enhance the early detection and treatment of skin cancer, promising improved patient outcomes.
Real World Data and Blue Ocean Strategy Real-world data is particularly useful for researchers, as it provides valuable insights from patient data and knowledge that can impact many decision-making processes. New Drug Formulations as a Blue Ocean Strategy New drug formulations can help improve patient adherence and reduce side effects.
Given the evident benefits of biologics over small molecule drugs (including high efficacy, target specificity and favorable safety profiles), the biopharmaceutical market is poised to witness continued and consistent growth over the next several years. Biopharmaceutical excipients can range from simple inert entities to complex compounds.
In addition, acquired drug resistance has been reported in patients after treatment with approved TRK protein inhibitors. Hence, Cullgen’s TRK degraders could offer patients a new therapeutic approach to treat TRK-mediated cancer diseases with reduced drug resistance. “We
With no cure currently available, managing symptoms and improving the quality of life for patients remain critical goals for medical research and treatment. This magazine immerses you in a world where industry leaders, patient advocates and top researchers converge to provide the most insightful perspectives on clinical trials.
Spun out of CEO and co-founder Evan Feinberg’s breakthrough artificial Intelligence (AI) research at Stanford University’s Pande Lab , Genesis Therapeutics is applying the resulting influential PotentialNet neural network algorithm to unify AI and biotech against a range of diseases with unmet needs. Genesis Therapeutics.
The exact cause of SLE is unknown; however, factors such as sunlight and drugs may precipitate the condition, and many studies have revealed a complex genetic basis. The first line of therapy/agents recommended for the Systemic Lupus Erythematosus treatment includes Nonsteroidal anti-inflammatory drugs (NSAIDs) (Naproxen, Celecoxib, etc.),
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