Drug Discovery World

OCTOBER 2, 2023

INAQOVI, developed by Otsuka Pharmaceutical and Astex Pharmaceuticals, is the first oral hypomethylating agent to be licensed in the EEA in this patient population. The post European Commission approves oral treatment for leukaemia appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JUNE 27, 2023

It will be headquartered at the Monash Institute of Pharmaceutical Sciences (MIPS). Together, the three institutions, in collaboration with Therapeutic Innovation Australia (TIA), will guide early-stage projects through the process of identifying drug candidates with potential commercial value. MedChem Australia will fill this gap.

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Drug Discovery World

SEPTEMBER 26, 2022

DDW Editor Reece Armstrong explores the rise of drug repurposing and the benefits and disadvantages it brings to drug discovery and development. . Drug repurposing, the act of finding new clinical targets for both approved and unapproved drugs, has emerged as a viable alternative to traditional drug discovery approaches. .

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Drug Discovery World

AUGUST 23, 2022

The MMA was granted to Otsuka Pharmaceutical and Astex Pharmaceuticals’ oral fixed-dose combination of decitabine and cedazuridine (ASTX727). . The MAA is supported by results from a Phase III clinical trial investigating the pharmacokinetic (PK) exposure equivalence of the novel oral fixed-dose combination versus IV decitabine.

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Drug Discovery World

JANUARY 10, 2024

AIO-001 was exclusively licensed to Aiolos outside of Greater China by Jiangsu Hengrui Pharmaceuticals. Early studies of AIO-001 have shown initial safety, tolerability, pharmacokinetics, and biological activity in healthy volunteers and asthma patients.

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Drug Discovery World

DECEMBER 12, 2023

Exonate, an mRNA therapy company focused on treatments for diabetic complications, has announced that its lead ophthalmology asset, EXN407, has achieved its prespecified endpoints in a Phase Ib/IIa study. During the trial, EXN407 met all safety and pharmacokinetic parameters and displayed encouraging signals of biological activity.

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Alta Sciences

SEPTEMBER 12, 2024

Each preclinical formulation development program has unique formulation goals; whether it be to maximize potency or bioavailability, to change the drug-release timing, to improve safety and stability, or to provide improved handling characteristics. We were required to develop a formulation from the ground up.

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Drug Discovery World

NOVEMBER 29, 2022

The new Clinical Pharmacology degree was launched in 2019 by Professors Emma Baker and Iain Greenwood and aims to take a holistic view of the development of drugs and create graduates that will stand out in the job market. Starting with the drug. Pharmacokinetics: How the body handles drugs.

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DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market.

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Sygnature Discovery

JANUARY 26, 2024

Here at Sygnature Discovery, we offer specialised expertise in early-stage drug formulation. These strategies are tailored to the unique characteristics of each individual Active Pharmaceutical Ingredient (API). These strategies are tailored to the unique characteristics of each individual Active Pharmaceutical Ingredient (API).

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Drug Discovery World

NOVEMBER 20, 2023

Raquel Sanches-Kuiper , Vice President of Science and Applications at Evonetix, and Clare Whitewoods , Marketing Communications Manager at Evonetix, look at the benefits synthetic DNA brings to pharmaceutical development. Eisenstein M., AI-enhanced protein design makes proteins that have never existed. Nature

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Drug Discovery World

JUNE 12, 2023

Then, we move forward with what are called Investigational New Drug enabling studies. Those are the beginning of additional manufacturing, scale of chemistry pharmacokinetics, pharmacology assays, development bioanalytical assays, and then moving forward toxicology work to start the initial clinical trials.

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The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial.

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Drug Target Review

MARCH 6, 2024

Given the relevance of brain metastases in cancer patients, what are the pharmacokinetic properties that enable CNS penetration of LSD1 inhibitors? To date, other LSD1 inhibitors in development have failed to achieve the combination of appropriate pharmacokinetics, required brain penetrance and a reversible mechanism of action.

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The Premier Consulting Blog

APRIL 15, 2024

By William Salminen , Madelyn Huang, & Andrew Emanuel Without concrete guidelines, it can be confusing when determining what nonclinical studies are needed for a Pre-Investigational New Drug application (PIND) meeting. neurotoxicity) that require special assessments.

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. When imaged, the hiPSC showed a stable beating rate.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol). What is the regulatory landscape of medical cannabis?

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New Drug Approvals

DECEMBER 24, 2023

1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] Ionis Pharmaceuticals. “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology.

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Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Listen here. Watch it now. The Altascientist : Issue No.

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Drug Hunter

MAY 18, 2023

Dian Su’s journey from chemistry and proteomics to the DMPK of drug conjugates Following a different path comes naturally to Dian Su, Senior Director of DMPK at Bicycle Therapeutics. Dian eventually made her way to Shanghai, where she encountered a much bigger world while earning degrees in pharmaceutical engineering and medicinal chemistry.

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Drug Target Review

OCTOBER 24, 2023

Microbiotica’s approach differs from traditional pharmaceutical development, offering unique advantages in the field of precision medicine. We also believe that drug development teams should routinely consider the potential modifying effect of the gut microbiome on drug potency and factor it into assessments of PK and PD.

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The Pharma Data

DECEMBER 9, 2020

EDISON, NJ / ACCESSWIRE / December 10, 2020 / Hepion Pharmaceuticals, Inc. ” About Hepion Pharmaceuticals. Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for the treatment of non-alcoholic steatohepatitis (NASH) and other liver diseases.

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New Drug Approvals

SEPTEMBER 10, 2024

“In Vitro Metabolism of Slowly Cleared G Protein–Coupled Receptor 139 Agonist TAK-041 Using Rat, Dog, Monkey, and Human Hepatocyte Models (HepatoPac): Correlation with In Vivo Metabolism” Drug Metabolism and Disposition. X H NMR (500 MHz, DMSO-i¾) δ ppm 1.40 (d, J=6.8 Hz, 3 H), 4.98 (quin, J=7.1 Hz, 1 H); ESI-MS m/z [M+H] + 393.9.

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PPD

OCTOBER 12, 2023

Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required. Parallels between pharmacokinetic (PK) analyses for CGTs and immunotherapies, conducted through PCR-based assays and plate-bound antibody assays, respectively, can inform a successful approach.

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Drug Discovery World

AUGUST 22, 2023

In September 2021, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced the initiation of a pilot programme 1 to provide parallel scientific advice to pharma companies applying for marketing authorisation for generic versions of hybrid products and complex generic drug products.

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The Pharma Data

DECEMBER 28, 2020

Hepion’s lead novel drug candidate, CRV431, is a pan-cyclophilin inhibitor that inhibits multiple forms of cyclophilins. To date, there are no approved drugs to treat NASH. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics.

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The Premier Consulting Blog

JANUARY 31, 2023

Food and Drug Administration (FDA) adopted an addendum to the guidance titled “ S1B(R1) Testing for Carcinogenicity of Pharmaceuticals ,” which had previously been finalized by the International Council for Harmonization (ICH). On November 1, 2022, the U.S. However, the quality and relevance of that data can vary.

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The Pharma Data

NOVEMBER 4, 2020

–( BUSINESS WIRE )– Concert Pharmaceuticals, Inc. Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., 5, 2020 11:00 UTC. .

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The Pharma Data

APRIL 4, 2023

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars.

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Practical Cheminformatics

DECEMBER 7, 2023

A recent editorial by Dean Brown in J Med Chem and follow-up posts by Keith Hornberger and Derek Lowe prompted me to think about how we train computational chemists and cheminformaticians for careers in drug discovery. It is rare for graduate students to be exposed to tasks like optimizing pharmacokinetics or off-target binding.

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The Pharma Data

MARCH 13, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).

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Drug Target Review

JUNE 12, 2023

TEAD proteins are crucial for tumour progression and drug resistance, making them an attractive focus for therapeutic interventions. Leveraging AI-guided structure-based drug design, Insilico’s research and development team generated an impressive portfolio of over 6,000 molecules and identified three highly promising hit series.

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The Pharma Data

JANUARY 26, 2021

. Previous human pharmacokinetic (PK) study showed significantly better PK profile when compared to market leading product. Develops improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental health. UPPSALA, Sweden , Jan. About Orexo.

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New Drug Approvals

OCTOBER 24, 2023

1] Etrasimod was discovered by Arena Pharmaceuticals , with subsequent development by Pfizer. [2] 3] [4] [5] [6] [7] [8] Society and culture Legal status Velsipity was approved by the US Food and Drug Administration (FDA) in October 2023. [1] Food and Drug Administration (FDA). 1] It is taken by mouth. [1] 11] SYN ACS Med.

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Conversations in Drug Development Trends

AUGUST 9, 2024

The team must present data to the IDSMB accurately and promptly, especially when multiple trial arms progress at different rates, demanding comprehensive data management, including safety, pharmacokinetic (PK), or pharmacodynamic (PD) data, and statistical inputs.

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. MacroGenics partnered with Zai Labs, based in Shanghai, China and San Francisco, on the drug.

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Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. One of the core goals of the GDUFA program has been to increase the efficiency of the generic drug review program.

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