Drug Discovery World

NOVEMBER 27, 2023

Vebreltinib is a potent, small molecule, orally bioavailable and highly selective c-Met inhibitor. Apollomics is in active discussion with the US Food and Drug Administration (FDA) regarding a New Drug Application (NDA) for vebreltinib based on clinical data from the SPARTA trial and Avistone’s KUNPENG trial in China.

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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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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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Drug Discovery World

JULY 27, 2022

Biotechnology company Recursion has been granted an Orphan Drug Designation for its potential treatment of the rare disease familial adenomatous polyposis (FAP). . Now, the European Commission has granted REC-4881 Orphan Drug Designation. . As it stands there are no approved therapies for the disease. . Official comments .

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Drug Discovery World

MARCH 3, 2023

Trial design The placebo-controlled, Phase IIa, proof-of-concept trial will evaluate short-term changes in anxiety-related patient reported outcomes in approximately 50 healthy volunteers. The trial will be conducted using a validated clinical model that simulates social anxiety. Chief Medical Officer at PureTech.

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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. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high.

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Drug Discovery World

NOVEMBER 29, 2023

The development of Ketamir-2 is being led by Dr Adam Kaplin, MIRA’s President and Chief Scientific Officer, who served as the Johns Hopkins site Principal Investigator for multi-centre pivotal clinical trials, leading to the approval of an intranasal left-handed ketamine molecule Spravato.

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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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Drug Discovery World

JULY 25, 2023

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects. In addition to describing the ethical framework (eg.

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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

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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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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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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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). Clinical response on the SDS (defined as a total score of ?12)

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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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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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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. Almirall S.A.’s

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The Pharma Data

MARCH 11, 2021

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). 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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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

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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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. 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.

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Drug Discovery World

OCTOBER 25, 2023

Here, she discusses with DDW’s Megan Thomas the impact of AI and ML on the drug discovery process. MT: How does AI and ML accelerate the drug discovery process? JV: A key bottleneck in the research and development of a drug is the lengthy experimentation that is required to gain the confidence to run clinical trials.

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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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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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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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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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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

JULY 30, 2020

Lenti D , under development by bluebird bio , is the company’s investigational cell-based therapy and currently under Phase II/III trial- Starbeam (NCT01896102) in CALD patients, an extension of Starbeam trial (NCT02698579), and the ALD-104 Phase 3 trial (NCT03852498).

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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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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.

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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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Drug Discovery World

FEBRUARY 2, 2023

As of late December 2022, the US Food and Drug Administration (FDA) no longer needs drugs to be tested in animals to receive approval, according to legislation signed by President Joe Biden 1 – the Modernization Act 2.0. may not materially change the current drug approval process at the FDA.

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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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Drug Discovery World

JANUARY 24, 2024

Wigerinck has taken four drugs (Prezista, Olysio, Jyseleca and Rekambys) to market. Fibrocor is on track to complete all IND-enabling work to support IND filing and initiation of clinical trials in 2024. Only a few drugs have received approval for fibrotic diseases like IPF (idiopathic pulmonary fibrosis).

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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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Drug Discovery World

OCTOBER 18, 2022

Enanta Pharmaceuticals, a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, has dosed the first subject in its Phase I clinical trial of EDP-323, a novel, oral L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV). .

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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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