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. . The finished product dosage form, clinical development and the final products’ marketing and sales across the globe will be handled by Insud. .

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Development Drugs Bioavailability Production 130

Pharmaceutical Technology

FEBRUARY 13, 2023

It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility. Scilex president and CEO Jaisim Shah said: “We are very pleased to announce the addition of Elyxyb to our current portfolio of two FDA-approved commercial non-opioid pain products. “We

Drug Delivery Systems 130

Drug Delivery Systems FDA Approval Bioavailability Drug Delivery 130

Pharmaceutical Technology

MAY 18, 2023

It delivers sustained BTK protein inhibition by optimising bioavailability, half-life and selectivity. Brukinsa is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor that will be used to treat chronic lymphocytic leukaemia (CLL) in adult patients.

Bioavailability 130

Bioavailability Protein Production 130

Pharmaceutical Technology

AUGUST 10, 2022

The takeover of Metrics will bolster the expertise of Catalent in the development of integrated oral solid formulation, production and packaging to aid customers in streamlining and expediting their programmes. It will also aid in expanding the capacity of Catalent to manage highly potent compounds.

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Packaging Packaging Bioavailability Manufacturing 147

Pharmaceutical Technology

JUNE 13, 2023

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.

Bioavailability 130

Bioavailability Protein Drugs 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. Meanwhile, net product sales of Epidiolex grew by 22 percent to $196.2

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Bioavailability FDA Approval Trials Drugs 97

Pharmaceutical Technology

MAY 8, 2023

The China National Medical Products Administration (NMPA) has granted approval for BeiGene’s four applications for Brukinsa (zanubrutinib). The small molecule Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa has been specially designed for delivering sustained BTK protein inhibition by optimising bioavailability, half-life, and selectivity.

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Bioavailability Clinical Trials Clinical Trials Protein 130

Pharmaceutical Technology

NOVEMBER 24, 2022

At Quotient Sciences, our state-of-the-art facilities follow cGMP guidelines for the production of 14 C-labeled pharmaceuticals for human investigations and are accredited by the UK Medicines and Healthcare products Regulatory Agency (MHRA). How does your unique Synthesis-to-Clinic® offering streamline the drug development process?

Bioavailability 130

Bioavailability Manufacturing Drugs Production 130

Pharmaceutical Technology

JANUARY 20, 2023

BeiGene has received marketing authorisations for Brukinsa (zanubrutinib) in Great Britain from the Medicines and Healthcare products Regulatory Agency (MHRA) to treat chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL).

Marketing 130

Marketing Bioavailability Trials Clinical Trials 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 facility complements the company’s current pharma innovation centres in France and Singapore, and intends to improve the patient experience with modern oral dosage forms.

Bioavailability 130

Bioavailability Manufacturing Scientist Development 130

Roots Analysis

MAY 21, 2024

In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the main causes of drug failure in obtaining approval authorization.

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Drug Delivery Drugs Gene Therapy Bioavailability 40

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 23, 2023

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably.

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Development Drugs Bioavailability In-Vivo 246

Pharmaceutical Technology

SEPTEMBER 23, 2022

Current treatment options for DES are dominated by a mix of prescription and over-the-counter (OTC) products. GlobalData anticipates CyclASol to be positioned as the superior cyclosporine due to its favorable tolerability profile and better bioavailability, with the potential to capture market share from other cyclosporine-based therapies.

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Development Drugs Clinical Trials Clinical Trials 147

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

The Pharma Data

JANUARY 7, 2021

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.

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Bioavailability Production Manufacturing Drugs 52

Roots Analysis

FEBRUARY 20, 2022

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. Nanoparticles Contract Manufacturing.

Contract Manufacturing 52

Contract Manufacturing Bioavailability Manufacturing Drug Delivery Systems 52

Drug Discovery World

NOVEMBER 27, 2023

The Chinese National Medical Products Administration (NMPA) has granted conditional approval to Apollomics’ partner Avistone Biotechnology to commercialise vebreltinib (APL-101) in China for MET exon 14 skipping non-small cell lung cancer (NSCLC).

Bioavailability 52

Bioavailability Clinical Trials Clinical Trials Trials 52

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. Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated.

Contamination 130

Contamination Manufacturing Containment Production 130

Pharmaceutical Technology

AUGUST 3, 2022

During this stage, a team of lab technicians must identify the best way to manufacture the active pharmaceutical ingredient (API) into a suitable dosage form for pilot production. This is an exact science as the generation of too-fine or not-fine-enough powder will have a huge impact on the end-product.

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Development Production Manufacturing Bioavailability 130

Drug Discovery World

DECEMBER 16, 2022

The proceeds from the financing will support the ongoing multiple-ascending dose trial of STC-15 and further facilitate Storm as we advance our pipeline of products.” . Initial results are anticipated to be presented in 2023. .

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RNA Immune Response Bioavailability Development 52

Cloudbyz

MARCH 5, 2024

The difference between biologics vs small molecules in pharma drug development In pharmaceutical drug development, biologics and small molecules represent two distinct categories of medicinal products, each with their own unique characteristics, development processes, and mechanisms of action.

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Development Drugs Manufacturing Immune Response 78

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]. This is achieved via a controlled vacuum.

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.

Compliance 130

Compliance Bioavailability Containment Branding 130

Drug Discovery World

DECEMBER 7, 2022

However, developing and bringing new small molecule products to market is fraught with challenges, and the failure rate remains high, driven primarily by later-stage efficacy, safety, and solubility concerns. While a candidate molecule’s chemical structure is a critical determinant of such characteristics, it isn’t the only one.

Bioavailability 52

Bioavailability Manufacturing Production Development 52

Drug Discovery World

AUGUST 9, 2023

The discovery of a second, more stable polymorphic form of Ritonavir (form II) within the originally formulated drug product (form I) resulted in a reduction in bioavailability that led to the product’s withdrawal. The post CCDC AIDS research wins AAPS pharma award appeared first on Drug Discovery World (DDW).

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Research Bioavailability Scientist Drugs 52

Pharmaceutical Technology

APRIL 12, 2023

Containment and controlled substance capabilities are defining and necessary features for these manufacturing facilities, but not all contract manufacturers have the specialist equipment and capabilities required for high potency small molecule API production. After that, the risks to product quality can be identified, quantified, and rated.

Manufacturing 130

Manufacturing Production Containment Contamination 130

Pharmaceutical Technology

JUNE 26, 2022

Placing traditionally siloed drug substance and drug product development activities within a single organization that also has commercial manufacturing capabilities accelerates clinical development and builds in quality and robustness of supply. Integrated drug substance and drug product services. Polymorphic form issues.

Manufacturing 130

Manufacturing Drugs Production Development 130

Pharmaceutical Technology

FEBRUARY 13, 2023

Quotient Sciences was asked to select the best candidate based on material science and oral bioavailability considerations. We select the appropriate salt or physical form to optimize a molecule for both manufacturability and downstream product performance.

Development 130

Development In-Vivo Clinical Trials Clinical Trials 130

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.

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Gene Silencing Drug Delivery FDA Approval RNA 97

The Pharma Data

DECEMBER 3, 2020

SOL-578 is a best-in-class checkpoint kinase 1 (Chk1) inhibitor featuring high kinase selectivity and oral bioavailability which targets the DNA Damage Response (DDR) network. We believe that PharmaEngine can accelerate the development of this product based on our successful experience with a liposomal irinotecan, Onivyde®.”

Licensing 52

Licensing Licensing Bioavailability DNA 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

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.

Contamination 130

Contamination Filler Bioavailability Production 130

Camargo

SEPTEMBER 30, 2021

Drug product formulation should be as simple as possible, but carefully executed to account for the characteristics of the intended administration route and dosing regimen and to facilitate successful manufacturing, storage, shipping, and compliance in the clinic and eventually on the market. CMC Considerations. Unstable intermediates.

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Development Research Manufacturing In-Vivo 201

Camargo

AUGUST 22, 2021

A final binding guidance published April 2017, Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications required that electronic submissions be formatted according to eCTD submission standards and defined technical rejection criteria.

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Containment Bioavailability Cosmetics Packaging 190

Roots Analysis

MARCH 2, 2022

One of the key objectives behind the aforementioned developments is to overcome issues related to high costs associated with the design and production of such pharmacological interventions. Over 40 oral drug delivery technologies have been designed so far. For further information on this domain, check out the report –. Web: [link].

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Protein Drug Delivery Drugs Drug Delivery Systems 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