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.

Packaging 147

Packaging Packaging Bioavailability Manufacturing 147

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.

Development 246

Development Drugs Bioavailability In-Vivo 246

Pharmaceutical Technology

MAY 31, 2023

CFT8919 is an orally bioavailable BiDAC degrader designed to exhibit potent and selective activity against EGFR L858R in patients with non-small cell lung cancer (NSCLC). C4T can also earn up to $357m in milestone payments and receive low to mid-double-digit percentage royalties on net sales of the product in greater China.

In-Vivo 130

In-Vivo Bioavailability In-Vitro Licensing 130

Pharmaceutical Technology

MARCH 21, 2023

So far, the FDA has approved just one CBD product, a prescription drug designed to treat seizures associated with Lennox Gastaut syndrome (LGS) [i]. Just before the Covid-19 pandemic, there were 60 ongoing clinical trials with cannabis-based products, with the majority being tested for pain or psychosis.

Production 243

Production Bioavailability Pharmacy Clinical Trials 243

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

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

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

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. One of the most significant benefits of PDFs is their ease of administration.

Manufacturing 52

Manufacturing Development Compliance Production 52

Outsourcing Pharma

AUGUST 8, 2022

The pharmaceutical company has forged a partnership with the nanotechnology specialist to use nanoparticle tech and formulation to advance its products.

Bioavailability 52

Bioavailability Branding Medicine Production 52

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

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

Bioavailability 97

Bioavailability FDA Approval Trials Drugs 97

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

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.

Bioavailability 130

Bioavailability Clinical Trials Clinical Trials Protein 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

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

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

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.

Drug Delivery 105

Drug Delivery Drugs Bioequivalency Production 105

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.

Manufacturing 130

Manufacturing Production Packaging Packaging 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.

Development 130

Development Production Manufacturing Bioavailability 130

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

XTalks

JUNE 27, 2024

Therefore, techniques and technologies that promote drug solubility and bioavailability are in high demand. Their focus is on improving drug solubility and bioavailability with powerful amorphous dispersion technologies, such as KinetiSol for poorly soluble compounds.

Bioavailability 59

Bioavailability Manufacturing Drugs Development 59

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.

Containment 190

Containment Bioavailability Cosmetics Packaging 190

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

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

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

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.

Bioavailability 52

Bioavailability Production Manufacturing 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

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 Drugs Clinical Trials 130

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.

Development 97

Development Drugs Immune Response Manufacturing 97

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

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

JULY 8, 2021

As required by components of the 21 st Century Cures Act and the FDA Reauthorization Act, the FDA has sought to promote Patient-Focused Drug Development considerations into regulatory decision making, including product application approvals. FDA Publishes Draft Guidance on Adverse Drug Experience Reporting for INDs and BA/BE Studies .

Development 130

Development Bioequivalency Gene Expression Drugs 130

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

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].

Protein 52

Protein Drugs Drug Delivery Drug Delivery Systems 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

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

They indicate that the potential benefits over current protein and RNA-based approaches are “potency, selectivity, oral bioavailability, tissue distribution and central nervous system penetration.”. It has state-of-the-art proprietary assays to identify ligands that bind specifically to the structural pockets in many RNA molecules.

RNA 52

RNA Protein Bioavailability DNA 52