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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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 If successful, Phase III trials are expected to follow shortly thereafter.

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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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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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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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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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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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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. Clinical Pharmacology. Clinical Safety and Efficacy.

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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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XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics? During the webinar, Dr. Vornov discussed a few developments in targeted CNS delivery, which are summarized below.

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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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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. A trial summary dataset (ts.xpt) containing the study start date in YYYY-MM-DD format is present. Validation Code.

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The Pharma Data

MARCH 8, 2021

We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Molnupiravir.

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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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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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XTalks

JUNE 14, 2023

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. “The Attendees will understand best practices for novel drug delivery design and development. What Is Dry Eye Disease?

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The Pharma Data

DECEMBER 1, 2020

NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the open-label Phase 2 COMET-TRD trial of AXS-05 in patients with treatment resistant depression (TRD). AXS-05 was well tolerated in the COMET trial.

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Pharmaceutical Technology

MAY 10, 2023

Within the pharmaceutical industry, it is critical to measure particle size as it influences surface area and porosity, impacting a drug’s bioavailability, effectiveness, and shelf life. Particle size is monitored in quality control as well as the development of active pharmaceutical ingredients (APIs).

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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. Oral Protein / Peptide-based Drugs.

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. About Molnupiravir.

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pharmaphorum

FEBRUARY 25, 2021

Earlier this month Chiesi and Protalix reported results from another trial called BRIDGE which showed a decrease in patients with moderately or fast progressing kidney disease following the switch from Replagal.

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pharmaphorum

AUGUST 19, 2022

Grünenthal has moved its painkiller resiniferatoxin into phase 3 trials in patients with osteoarthritis, hoping to find an option that sidesteps the side effects and addictive potential of opioid drugs. Along with knee osteoarthritis, Grünenthal also plans to test resiniferatoxin in other joints affected by the condition.

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XTalks

SEPTEMBER 24, 2024

CDKL5 deficiency disorder (CDD) is a rare genetic condition caused by mutations in the CDKL5 gene, which is essential for brain development and function. a company dedicated to developing innovative treatments for seizure disorders. At the forefront of addressing these challenges is Marinus Pharmaceuticals, Inc.,

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XTalks

OCTOBER 2, 2024

If successful, this trial could pave the way for a New Drug Application (NDA) submission. With positive outcomes in preclinical models, EB-003 has confirmed oral bioavailability, adding to its therapeutic potential. This development highlights a growing interest in neuroplastogens as alternative mental health treatments.

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pharmaphorum

JANUARY 29, 2021

Lilly is paying $20 million upfront for exclusive rights to AK1780, a P2X7 receptor antagonist in early-stage clinical development for neuroinflammatory pain conditions, outside Japan and China. While tanezumab is an antibody and has to be delivered by subcutaneous injection, AK1780 is orally bioavailable.

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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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The Pharma Data

AUGUST 16, 2021

Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinical trial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. vice president of immunology development at Lilly.

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The Pharma Data

DECEMBER 29, 2020

Cybin is developing technologies and delivery systems, aiming to improve bioavailability, to potentially achieve the desired medicinal effects of psychedelics at low dosage levels. The new delivery systems are expected to be studied through clinical trials to confirm safety and efficacy.

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pharmaphorum

JANUARY 16, 2023

They include a once-monthly form of paliperidone called LY03010 that has shown comparable bioavailability with Johnson & Johnson’s Invega Sustenna in a pivotal trial and has a slightly simpler regimen in the induction therapy stage.

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Delveinsight

JANUARY 7, 2021

Ikena Oncology has bagged USD 120 million to develop its expanding pipeline of cancer drugs. 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. IND-enabling studies are underway.

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pharmaphorum

NOVEMBER 9, 2022

A pre-clinical pipeline of potential first-in-class brain-penetrant small molecule inhibitors of the mitochondrial permeability pore (mPTP) are to be developed. A £16 million Series A financing – led by Omega Funds – has been announced by the innovative neuroscience company NRG Therapeutics Ltd., It has been supporting NRG’s work since 2019.

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Delveinsight

FEBRUARY 16, 2021

The drug is the first and only therapy that is developed and approved to protect bone marrow (myeloprotection), which is injected prior to treatment with chemotherapy, asserts the US oncology drug developer, G1. Maribavir is an orally bioavailable anti-CMV compound.

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Delveinsight

AUGUST 10, 2020

Boehringer Ingelheim is worth mentioning here, as it is presenting key posters and studies on Ofev’s SENSCIS Trial and INBUILD Trial. Nintedanib is an orally bioavailable, small-molecule tyrosine kinase inhibitor (TKI) developed for the treatment of IPF and SSc-ILD. Ofev (Nintedanib) Facts.

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Delveinsight

JULY 30, 2020

Key pharma players such as Bluebird Bio , Minoryx Therapeutics , MedDay Pharmaceuticals , Magenta Therapeutics , and others are proactively focusing on developing therapies to address the unmet needs prevailing in the ALD market. The pharma players are evaluating their pipeline candidates in different stages of clinical development.

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The Pharma Data

NOVEMBER 26, 2020

This novel nanoparticle formation technology provides hope for improving the possibilities and probabilities of developing better medicines for patients and it expands Nanoform’s reach into the growing biological market. ” Prof. ” Prof. Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 562 1806.

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