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Bioavailability Development Drugs 
Pharmaceutical Technology
FEBRUARY 23, 2023
Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).
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Pharmaceutical Technology
AUGUST 30, 2022
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.
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Outsourcing Pharma
JULY 9, 2024
dsm-firmenich has announced the launch of CBtru â an advanced formulated cannabidiol (CBD) drug product intermediate designed for oral solid delivery formats.
Pharmaceutical Technology
SEPTEMBER 23, 2022
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.
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Pharmaceutical Technology
JANUARY 13, 2025
Nano milling is a vital technique for developing fine particle-sized drug formulations and improving bioavailability of water-soluble APIs.
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Pharmaceutical Technology
JUNE 9, 2023
Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. to treat the signs and symptoms of dry eye disease.
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Drug Patent Watch
JUNE 17, 2024
Pharmaceutical companies employ various strategies to extend the commercial life and patent protection of successful drugs.
105 
Roots Analysis
FEBRUARY 15, 2023
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.
Outsourcing Pharma
JUNE 14, 2021
With bioavailability challenges a frequent frustration for drug developers, one research outfit suggests a technique that could reduce the headaches.
XTalks
DECEMBER 4, 2024
Jotrol overcomes these barriers using patented micellar technology, enhancing bioavailability and enabling therapeutically effective doses. The company has secured Orphan Drug designations for Friedreich’s ataxia, offering benefits like market exclusivity and eligibility for Priority Review vouchers.
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XTalks
JANUARY 30, 2025
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.
Camargo
JULY 8, 2021
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. At Camargo, we have worked with hundreds of investigators who have found new targets for established drugs.
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Cloudbyz
MARCH 5, 2024
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.
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Pharmaceutical Technology
AUGUST 3, 2022
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. Yet commercialising a drug is no easy journey, hence why just 10% of new drug candidates succeed in making it to market.
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Pharma Mirror
APRIL 8, 2022
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.
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Pharmaceutical Technology
FEBRUARY 13, 2023
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.
130 
Pharmaceutical Technology
JANUARY 17, 2023
Orphagen Pharmaceuticals has received a rare pediatric disease designation (RPDD) for OR-449 from the US Food and Drug Administration (FDA) to treat paediatric adrenocortical carcinoma (ACC). SF-1 is an important transcription factor for adrenal gland growth and development.
147 
XTalks
FEBRUARY 5, 2025
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.
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Pharmaceutical Technology
JUNE 26, 2022
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.
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Camargo
FEBRUARY 10, 2021
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. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. that could arise from that same population.
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Pharmaceutical Technology
NOVEMBER 24, 2022
Understanding how a drug will act in the body, including how it is absorbed, distributed, and eventually eliminated, is a crucial component of drug research. ADME studies require the use of a radiolabeled version of the investigational drug. ADME studies require the use of a radiolabeled version of the investigational drug.
130 
Pharmaceutical Technology
JUNE 13, 2023
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 might therefore lead to the development of new therapies to treat heart failure.
130 
Pharmaceutical Technology
AUGUST 10, 2022
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.
147 
FDA Law Blog
JULY 23, 2024
Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.
105 
Pharmaceutical Technology
FEBRUARY 13, 2023
Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility.
Camargo
DECEMBER 22, 2021
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. Why Conduct a Portfolio Analysis?
169 
XTalks
DECEMBER 5, 2022
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
Pharmaceutical Technology
MAY 2, 2023
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.
130 
Pharmaceutical Technology
APRIL 20, 2023
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.
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pharmaphorum
MARCH 16, 2021
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
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XTalks
JUNE 27, 2024
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.
Pharmaceutical Technology
OCTOBER 25, 2022
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. Of those 131 approved FDCs, 98 were oral dosage forms.
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pharmaphorum
FEBRUARY 25, 2021
Chiesi and Protalix have built the case for their long-acting enzyme replacement therapy (ERT) for Fabry disease PRX-102, as the FDA’s review of the drug continues towards a decision due by 27 April. . The post Switch data back Chiesi/Protalix long-acting Fabry drug appeared first on.
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Pharmaceutical Technology
JANUARY 25, 2023
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.
130 
Roots Analysis
MARCH 2, 2022
Interestingly, recent advances in this domain have led to the development of several treatment strategies that, according to developers, exhibit the necessary capabilities to overcome challenges posed by traditional oral protein formulations and peptide-based therapies. Oral Protein / Peptide-based Drugs.
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Roots Analysis
MARCH 1, 2022
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.
Pharmaceutical Technology
JUNE 14, 2023
The number of high-potency drug approvals has increased over the last decade, driven by the increasing use of APIs (Active Pharmaceutical Ingredients) in the pipeline and among marketed drugs. Furthermore, the number of marketed high potency APIs (HPAPIs) tends to increase over time as more HPAPIs in development gain approval.
130 
Camargo
AUGUST 22, 2021
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.
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Pharmaceutical Technology
FEBRUARY 3, 2023
In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.
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The Pharma Data
JANUARY 7, 2021
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.
XTalks
JUNE 14, 2023
percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. 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. What Is Dry Eye Disease?
pharmaphorum
AUGUST 19, 2022
Grünenthal has moved its painkiller resiniferatoxin into phase 3 trials in patients with osteoarthritis, hoping to find an option that sidesteps the side effects and addictive potential of opioid drugs. The post Grünenthal takes non-opioid pain drug resiniferatoxin into phase 3 appeared first on.
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pharmaphorum
JANUARY 16, 2023
The bi-weekly intramuscular shot – which was also approved in China in 2021 – will enter a crowded market for long-acing injectable (LAI) schizophrenia therapies in the US and have to take on heavyweight competition, including drugs that require less frequent dosing.
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The Pharma Data
DECEMBER 1, 2020
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.,
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