Pharmaceutical Technology

MAY 8, 2023

The approvals were granted for two Supplemental Applications to covert conditional approval to regular approval, and two Supplemental New Drug Applications to treat Waldenström’s macroglobulinemia (WM), and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients.

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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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Pharmaceutical Technology

NOVEMBER 24, 2022

Understanding how a drug will act in the body, including how it is absorbed, distributed, and eventually eliminated, is a crucial component of drug research. Well-planned ADME investigations are conducted in the early stages of clinical research to generate this important data, which is needed for regulatory submissions.

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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. Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability.

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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. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?

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XTalks

SEPTEMBER 19, 2024

Mobasher Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. It was engineered to have high potency, bioavailability and kinase selectivity that led to improved efficacy and safety in B-cell malignancies.

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XTalks

JUNE 27, 2024

Oral drugs are the most convenient and sought-after form of drug administration. This means they must be digested completely so the active pharmaceutical ingredients (APIs) in the drug can be absorbed by the body. Therefore, techniques and technologies that promote drug solubility and bioavailability are in high demand.

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Camargo

JULY 8, 2021

At Camargo, we have worked with hundreds of investigators who have found new targets for established drugs. It is exciting to find new uses of drugs with known safety because these drugs can reach new groups of patients in a relatively short timeframe.

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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. Yet commercialising a drug is no easy journey, hence why just 10% of new drug candidates succeed in making it to market. One size (never) fits all.

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Roots Analysis

MARCH 2, 2022

However, it is important to highlight that there are still several challenges which need to be addressed in order to develop biologic drugs capable of effectively being administered via the oral route without undergoing significant losses in specificity and / or bioavailability. Oral Protein / Peptide-based Drugs. Web: [link].

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XTalks

FEBRUARY 3, 2023

The US Food and Drug Administration (FDA) has approved the first and only oral drug for the treatment of advanced or metastatic breast cancer in postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) ESR1 mutations. months on elacestrant compared with 1.9

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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. Of those 131 approved FDCs, 98 were oral dosage forms.

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Pharmaceutical Technology

JANUARY 25, 2023

They provide a higher ability to regulate protein levels and can affect the non-enzymatic function of the protein while also providing an alternative to targeting drug-resistant proteins for overcoming tumour drug resistance.

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Roots Analysis

MAY 21, 2024

Over the last decade, one of the major challenges faced by pharmaceutical companies across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility.

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XTalks

JUNE 14, 2023

percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. What Is Dry Eye Disease?

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XTalks

AUGUST 30, 2022

According to an analysis of the 2013 Medical Expenditure Panel Survey, one in six US adults reported taking a psychiatric drug at least once in 2013. CNS drugs treat a range of neurologic and psychiatric disorders, such as psychosis, depression, Parkinson’s disease, multiple sclerosis and epilepsy.

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XTalks

SEPTEMBER 24, 2024

Flatt Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. This feedback is crucial in shaping clinical trials and ensuring new therapies fit seamlessly into existing treatment regimens.

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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.

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Delveinsight

JANUARY 7, 2021

Ikena secures USD 120 Million to advance a growing pipeline of cancer drugs. Ikena Oncology has bagged USD 120 million to develop its expanding pipeline of cancer drugs. The newer side of the pipeline points targeted oncology drugs. Terns raises USD 87 Million for NASH drugs. Medical technology company Hologic Inc.

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XTalks

AUGUST 8, 2024

Antibody-drug conjugates (ADCs) are at the forefront of targeted cancer therapy. They combine the precision of monoclonal antibodies (mAbs) with the potency of cytotoxic drugs to destroy cancer cells, without harming healthy tissue. Abzena is a leader in bioconjugation and ADC development.

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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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pharmaphorum

NOVEMBER 9, 2022

for the purpose of advancing disease-modifying oral medicines for debilitating chronic neurodegenerative disorders, by enabling investigational new drugs (IND) studies. A pre-clinical pipeline of potential first-in-class brain-penetrant small molecule inhibitors of the mitochondrial permeability pore (mPTP) are to be developed.

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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

NOVEMBER 26, 2020

As drug molecules become more complex so do the options to deliver them. 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.”

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XTalks

MAY 23, 2024

XTALKS WEBINAR: Enhancing Efficiency in Early-Phase Oncology Trials: Strategies for Accelerating Data Flow Live and On-Demand: June 24, 2024, at 11am EDT (4pm BST/UK) Register for this webinar today to gain insights into how you can navigate and overcome data flow challenges in early-phase oncology clinical trials.

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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

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) About the COMET -TRD Trial. of patients at Week 6.

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The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e., About Maribavir.

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The Pharma Data

JANUARY 3, 2021

The Company focuses on reducing attrition in clinical trials and on enhancing drug molecules’ formulation performance through its nanoforming services. Nanoform’s shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS).

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Roots Analysis

SEPTEMBER 1, 2023

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. New Drug Formulations as a Blue Ocean Strategy New drug formulations can help improve patient adherence and reduce side effects.

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Delveinsight

SEPTEMBER 8, 2021

The exact cause of SLE is unknown; however, factors such as sunlight and drugs may precipitate the condition, and many studies have revealed a complex genetic basis. The first line of therapy/agents recommended for the Systemic Lupus Erythematosus treatment includes Nonsteroidal anti-inflammatory drugs (NSAIDs) (Naproxen, Celecoxib, etc.),

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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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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. 1-4 The U.S. 1-4 The U.S.

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The Pharma Data

NOVEMBER 19, 2020

20, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces a progress update for its R&D program focused on the design and development of novel drugs targeting the SARS-CoV-2 coronavirus and to treat COVID-19. . TOKYO and CAMBRIDGE, England , Nov. The program was initiated in April 2020.

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The Pharma Data

DECEMBER 8, 2020

The Company’s pipeline consists of two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Forward-Looking Statements.

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Roots Analysis

JANUARY 28, 2024

Pharmaceutical Research: Big data analytics can be applied in various areas of pharmaceutical research, including drug discovery and development, precision medicine , clinical trial optimization, pharmacovigilance and drug safety, supply chain optimization, and real-time monitoring and surveillance.

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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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