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).

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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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Pharmaceutical Technology

NOVEMBER 24, 2022

The ADME study results form an important part of the Investigational New Drug (IND) approval process in the US and for the submission of a national Clinical Trial Authorization (CTA) in the EU. How does your unique Synthesis-to-Clinic® offering streamline the drug development process?

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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. More FDC products flowing into pharma pipelines.

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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. If clinical trials prove successful, that same process should then be scaled to commercial manufacturing.

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Pharmaceutical Technology

FEBRUARY 13, 2023

By associating molecular properties with in-silico absorption, distribution, metabolism, excretion, and toxicity (ADMET) models, we can significantly increase the robustness of candidate selection, which subsequently reduces the failure rate during clinical trials.

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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.

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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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Camargo

JULY 8, 2021

Researchers at the University of Southern California in conjunction with the National Cancer Institute are currently conducting a Phase II clinical trial of the MAOI phenelzine in prostate cancer patients and have announced in an interim study publication that it has thus far demonstrated efficacy. .

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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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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. Clinical Research Landscape of Oral Peptide and Protein-based Therapeutics. Over 40 oral drug delivery technologies have been designed so far.

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Delveinsight

JANUARY 7, 2021

The immunotherapy pipeline is led by an in-licensed EP4 antagonist that Ikena is testing combined with Keytruda in phase 1b/2 colorectal and non-small cell lung cancer clinical trials. Eli Lilly backed Terns Pharmaceuticals now has two NASH candidates in clinical trials. IND-enabling studies are underway.

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The Pharma Data

DECEMBER 1, 2020

The SDS is a patient-rated scale that was designed to assess functioning in work, social life, and family life, and is among the most commonly used functional impairment scales in depression clinical trials. Clinical response on the SDS (defined as a total score of ?12) 12) after treatment with AXS-05 was achieved by 37.1%

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The Pharma Data

MARCH 11, 2021

Lilly will present findings from a post-hoc safety analysis of the Phase 1/2 LIBRETTO-001 trial, the largest clinical trial in patients with RET -altered cancers. LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial. Session Type: Clinical Trials Plenary Session.

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The Pharma Data

JANUARY 20, 2021

21, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX: CALTX) (NASDAQ: CALT) today announced that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

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The Pharma Data

JANUARY 3, 2021

to have in place 25 operating production lines of which 5 to 10 are expected to be GMP production lines. The Company focuses on reducing attrition in clinical trials and on enhancing drug molecules’ formulation performance through its nanoforming services. over 90 percent gross margin.

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The Pharma Data

NOVEMBER 26, 2020

There are significant challenges in drug development in this space and we look forward to working closely with pharma and biotech partners to discover how we can add value to their programs, provide patient benefit and competitive product differentiation.” ” Prof.

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XTalks

AUGUST 30, 2022

Global sales of over-the-counter and prescription products related to central nervous system (CNS) disease added up to $86 billion in 2019. Also, traditional preclinical models may not accurately reflect the possible efficacy of compounds moving into Phase I trials, particularly with compounds that have new mechanisms of action.

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The Pharma Data

NOVEMBER 19, 2020

These compounds have demonstrated high potency in inhibiting the activity of the M pro protease as well as promising oral bioavailability and blood plasma levels in animal studies. This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products.

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The Pharma Data

NOVEMBER 22, 2020

About EZEPROGIND (AZP2006): Alzprotect is developing a drug candidate, EZEPROGIND, whose mode of action, acting on Progranulin secretion, is clearly different from other products developed in the past 15 years by the pharmaceutical industry. EZEPROGIND, which is kicking off phase 2a trials, is a bioavailable neurotrophic inducer.

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Roots Analysis

SEPTEMBER 1, 2023

The strategy involves creating an entirely new demand for products or services, transcending the constraints of existing demand. The platform utilizes electronic health records (EHRs) to generate real-world datasets that can be used to identify outcomes for those typically underrepresented or not represented in clinical trials.

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Delveinsight

JULY 30, 2020

Another player in the race to advance ALD market size is Minoryx Therapeutics who recently announced the beginning of the registration-enabling Phase 2 NEXUS trial to evaluate the safety and efficacy of leriglitazone in pediatric patients with early-stage cerebral ALD (cALD), the acute form of X-linked adrenoleukodystrophy (X-ALD).

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XTalks

FEBRUARY 3, 2023

Aditya Bardia, MD, MPH, director of Breast Cancer Research at Mass General Cancer Center, associate professor at the Medicine Department at Harvard Medical School and principal investigator for the EMERALD trial, in the same press release statement. Mutations in the ESR1 , however, have contributed to the rise of endocrine resistance.

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FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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XTalks

MAY 23, 2024

Companies specializing in dermatology and skincare have developed a range of products aimed at protecting the skin from harmful UV rays. These include broad-spectrum sunscreens, protective clothing and innovative skincare products developed using antioxidants and other protective agents.

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XTalks

AUGUST 8, 2024

At least 13 ADCs have been approved by the US Food and Drug Administration (FDA) to treat a wide range of cancers cancers, including breast cancer, B-cell lymphoma, urothelial cancers and more, and there is an acceleration ADC entering Phase III clinical trials.

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FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). population demographics.

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The Pharma Data

DECEMBER 3, 2020

Maribavir, an orally bioavailable anti-CMV compound, is the only antiviral agent presently in Phase 3 development for the treatment of post-transplant patients with CMV in SOT or HSCT. 4, 2020 11:00 UTC. About Maribavir. Maribavir is an investigational treatment that has not been approved for use by the U.S.

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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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