XTalks

DECEMBER 4, 2024

Conventional resveratrol products often face challenges like poor absorption and significant gastrointestinal side effects. Jotrol overcomes these barriers using patented micellar technology, enhancing bioavailability and enabling therapeutically effective doses.

Bioavailability 111

Bioavailability Genetic Disease Marketing RNA 111

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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Development Production Manufacturing Bioavailability 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.

Packaging 147

Packaging Packaging Bioavailability Manufacturing 147

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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Development Bioequivalency Gene Expression Drugs 130

Pharmaceutical Technology

DECEMBER 19, 2022

The second is the “top-down” approach during which an initial micrometre-sized product is processed to reduce its size down into the nano-range using bead milling. A major challenge in the top-down approach is the development of an efficient size reduction process by using a highly performant mill.

Production 130

Production Bioavailability Biohazard Biohazard 130

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.

In-Vivo 130

In-Vivo Bioavailability In-Vitro Licensing 130

Camargo

DECEMBER 22, 2021

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Each product is unique, and so is the associated development strategy. Why Conduct a Portfolio Analysis?

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

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.

Development 130

Development In-Vivo Drugs Clinical Trials 130

XTalks

FEBRUARY 25, 2022

EverGrain Ingredients, a barley protein and fiber solutions company, recently received certification from the Upcycled Food Association (UFA) for its entire portfolio of products. The brand saw a unique opportunity to extract the excess barley to meet the global demand for sustainable, plant-based products. Barley Milk.

Production 98

Production Protein Branding Bioavailability 98

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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Drug Delivery Systems FDA Approval Bioavailability Drug Delivery 130

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. The production process is often less complex compared to biologics.

Development 97

Development Drugs Immune Response Manufacturing 97

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?

Bioavailability 130

Bioavailability Manufacturing Drugs Production 130

Pharmaceutical Technology

JUNE 13, 2023

It might therefore lead to the development of new therapies to treat heart failure. Windtree Therapeutics noted that these product candidates are intended to be both oral and IV therapies. Dual mechanism SERCA2a activators work by inhibiting the Na+/K+ pump [an enzyme found in the membrane of all animal cells] and activating SERCA2a.

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Bioavailability Protein Drugs Development 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.

Bioavailability 130

Bioavailability Manufacturing Scientist Development 130

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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Bioavailability FDA Approval Trials Drugs 97

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. More FDC products flowing into pharma pipelines.

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Manufacturing Production Packaging Packaging 130

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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Manufacturing Drugs Production Development 130

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.

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Drug Delivery Drugs Bioequivalency Production 105

Pharmaceutical Technology

FEBRUARY 3, 2023

There are a number of reasons why OSD forms dominate the market, not least because they are simple to administer, and it is easy to differentiate one OSD product from another. Developing a good SOP entails understanding all the application requirements at every manufacturing stage, and providing operators with procedures that they can follow.

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Contamination Manufacturing Containment Production 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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Containment Bioavailability Cosmetics Packaging 190

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.

Bioavailability 59

Bioavailability Manufacturing Drugs Development 59

Pharmaceutical Technology

JUNE 14, 2023

According to GlobalData’s Drugs database, 97% of marketed drugs are small molecule products and analysis shows an increased CMO appetite for specialized capabilities, with controlled substance and containment facilities highly sought after [i].

Containment 130

Containment Manufacturing Contract Manufacturing Bioavailability 130

Pharmaceutical Technology

AUGUST 22, 2022

When it comes to pharmaceutical, nutritional or cosmeceutical dosing, some of the most crucial parameters are safety, product effectiveness and patient adherence. They also offer enhanced bioavailability, exact dosing and an extended shelf life. The best formulation for the job.

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Compliance Bioavailability Containment Branding 130

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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Bioavailability Production Manufacturing Drugs 52

XTalks

JUNE 14, 2023

Novaliq, a biopharmaceutical company specializing in ocular therapeutics, recently announced that their product Vevye (cyclosporine ophthalmic solution) 0.1 Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology. What Is Dry Eye Disease?

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Gene Silencing Drug Delivery FDA Approval RNA 97

Pharmaceutical Technology

APRIL 12, 2023

Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. Best practices for ensuring API quality control One of the biggest factors in efficient API manufacturing resulting in a safe product is the control process.

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Manufacturing Production Containment Contamination 130

Pharmaceutical Technology

MAY 10, 2023

Microparticles can be present as a contamination of products such as pharmaceuticals and electronics, or as an air pollutant. Alternatively, they can come as a product component of formulations such as cleaning agents and polymers.

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Contamination Filler Bioavailability Production 130

The Pharma Data

NOVEMBER 19, 2020

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.

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Development Bioavailability Production Drugs 40

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. Pipeline Overview of Oral Peptide and Protein-based Therapeutics.

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Protein Drugs Drug Delivery Drug Delivery Systems 52

pharmaphorum

JANUARY 16, 2023

Rykindo is something of a pathfinder product for Luye Pharma, however, and will allow the Chinese company to build a commercial presence in the US antipsychotics market as it brings forward its own pipeline of longer-acting candidates for schizophrenia and bipolar disorder.

FDA Approval 52

FDA Approval Drugs Bioavailability Marketing 52

The Pharma Data

JANUARY 27, 2021

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.

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Drugs Manufacturing Drug Delivery Production 52

pharmaphorum

AUGUST 19, 2022

.” Grünenthal already sells a topical capsaicin product called Qutenza for post-shingles nerve pain and diabetic nerve pain affecting the feet, and recently started a phase 3 trial that aims to extend its indications to include post-surgical neuropathic pain.

Drugs 52

Drugs Bioavailability Trials Clinical Development 52

The Pharma Data

JANUARY 5, 2021

Targeting RNA is believed to be a way to develop therapeutics for so-called undruggable proteins. This collaboration with Genentech unites our RNA therapeutics leadership with their global reach and broad expertise to accelerate development of this important new class of medicines.”. Most Read Today. Source link.

RNA 52

RNA Protein Bioavailability DNA 52

XTalks

OCTOBER 2, 2024

Despite increasing awareness, mental health issues like depression and anxiety continue to impact productivity and overall well-being in professional settings. With positive outcomes in preclinical models, EB-003 has confirmed oral bioavailability, adding to its therapeutic potential.

Research 52

Research Bioavailability Trials Hormones 52

Delveinsight

FEBRUARY 16, 2021

With damages to the bone marrow, the production and normal functioning of red blood cells, white blood cells, and platelets get hampered. Maribavir is an orally bioavailable anti-CMV compound. Chemotherapy drugs while killing cancer cells also damages normal tissues. The bone marrow is particularly vulnerable in this case.

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Marketing Protein Bioavailability Drugs 52

Delveinsight

JANUARY 7, 2021

Ikena Oncology has bagged USD 120 million to develop its expanding pipeline of cancer drugs. Under the terms of the deal, Ribometrix and Genentech, a member of the Roche Group, will collaborate on discovering and preclinical development of programs. Genentech will be accountable for further development and commercialization.

RNA 52

RNA Clinical Trials Clinical Trials Bioavailability 52

Roots Analysis

SEPTEMBER 1, 2023

The strategy involves creating an entirely new demand for products or services, transcending the constraints of existing demand. Blue Ocean Strategy Example: Pear Therapeutics has developed a digital therapeutic called reSET, which is used to treat substance use disorder.

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Drug Delivery Marketing Drug Delivery Systems Drugs 52