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. Dosing flexibility is another prominent advantage provided by PDFs.

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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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XTalks

DECEMBER 4, 2024

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.

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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. The report is a useful read to keep current on a topic of interest at the FDA and in drug development as a whole.

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BioPharma Reporter

JUNE 22, 2023

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.

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Drug Patent Watch

JUNE 17, 2024

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

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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

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. 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.

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Pharmaceutical Technology

JANUARY 17, 2023

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.

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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.

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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. Development and Approval : Small Molecules: The pathway for development and regulatory approval is well-established, with clear guidelines for demonstrating safety and efficacy.

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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.

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Packaging Packaging Bioavailability Manufacturing 147

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. 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.

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Pharmaceutical Technology

MAY 31, 2023

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.

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In-Vivo Bioavailability In-Vitro Licensing 130

Pharmaceutical Technology

MAY 2, 2023

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.

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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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Hormones Bioavailability Clinical Trials Clinical Trials 59

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

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Pharmaceutical Technology

JUNE 13, 2023

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.

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Pharmaceutical Technology

NOVEMBER 24, 2022

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?

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Pharmaceutical Technology

FEBRUARY 13, 2023

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.

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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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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. Biowaiver Eligibility.

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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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Antibody Bioavailability Engineer Drugs 101

XTalks

JUNE 27, 2024

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.

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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.

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Outsourcing Pharma

JANUARY 24, 2023

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.

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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

JUNE 26, 2022

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.

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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. Developing and manufacturing FDCs factors to consider.

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BioTech 365

MARCH 25, 2021

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.

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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.

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FDA Law Blog

JULY 23, 2024

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.

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Pharmaceutical Technology

JUNE 14, 2023

Furthermore, the number of marketed high potency APIs (HPAPIs) tends to increase over time as more HPAPIs in development gain approval. Challenges for micronization Micronization has become an increasingly significant process in the pharmaceutical industry and is necessary to produce APIs with better solubility and improved bioavailability.

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Pharmaceutical Technology

DECEMBER 19, 2022

A major challenge in the top-down approach is the development of an efficient size reduction process by using a highly performant mill. Nanomilling, in which the particles are ground in a suspension, allows for highly concentrated conditions, as well as precise process control, which are both required for a high yield.

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Pharmaceutical Technology

FEBRUARY 3, 2023

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.

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Pharmaceutical Technology

AUGUST 22, 2022

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.

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XTalks

FEBRUARY 25, 2022

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?

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