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

JANUARY 17, 2023

Orphagen Pharmaceuticals has received a rare pediatric disease designation (RPDD) for OR-449 from the US Food and Drug Administration (FDA) to treat paediatric adrenocortical carcinoma (ACC). Orphagen Pharmaceuticals CEO Scott Thacher said: “We are gratified that OR-449 has received an RPDD from the FDA.

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Pharmaceutical Technology

MAY 2, 2023

Erasca has received the US Food and Drug Administration’s (FDA) fast track designation (FTD) for ERAS-801 to treat adults with glioblastoma (GBM) with epidermal growth factor receptor (EGFR) gene alterations. A team of three cancer researchers, Michael Jung, Timothy Cloughesy and David Nathanson, designed and developed ERAS-801.

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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

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

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

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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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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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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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. The post Grünenthal takes non-opioid pain drug resiniferatoxin into phase 3 appeared first on.

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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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pharmaphorum

JANUARY 16, 2023

The bi-weekly intramuscular shot – which was also approved in China in 2021 – will enter a crowded market for long-acing injectable (LAI) schizophrenia therapies in the US and have to take on heavyweight competition, including drugs that require less frequent dosing.

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Delveinsight

AUGUST 25, 2020

Novartis’s Spartalizumab Combo Fails To Meet The Primary Goal In The Melanoma Trial. The results announced that the spartalizumab combo stumbled in the trial and failed to hit the primary endpoint of investigator-assessed progression-free survival in melanoma.

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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

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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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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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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Drug Discovery World

DECEMBER 16, 2022

The proceeds from the financing will support the ongoing multiple-ascending dose trial of STC-15 and further facilitate Storm as we advance our pipeline of products.” . The post Biotech company raises $30M to target RNA modifying enzymes appeared first on Drug Discovery World (DDW).

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pharmaphorum

JULY 22, 2021

Pfizer has pledged a whopping $1 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. billion in backloaded milestone payments.

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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. Incentive Programs. Clinical Safety and Efficacy.

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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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Camargo

SEPTEMBER 30, 2021

The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. This blog post offers advice for avoiding major pitfalls during the drug development process. Overview of a Drug Development Program.

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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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The Pharma Data

MARCH 8, 2021

Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related. This program included assays such as Big Blue and PIG-a designed to provide a robust measure of a drug or chemical’s ability to induce mutations in vivo. About Molnupiravir.

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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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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. Ofev (Nintedanib) Approval History.

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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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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

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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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

OCTOBER 9, 2021

Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.

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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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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). . The trial

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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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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

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 £16 million Series A financing – led by Omega Funds – has been announced by the innovative neuroscience company NRG Therapeutics Ltd.,

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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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