The Pharma Data

JULY 6, 2021

New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented. Sanofi’s two marketed extended half-life factor replacement therapies shifted a two-decades-old treatment paradigm when launched in 2014.

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Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Watch it now. The Altascientist : Issue No.

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Drug Target Review

JULY 1, 2024

Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies? The global pain management market is projected to reach about $87 billion by 2025, driven by rising chronic diseases, an ageing population and more surgical procedures. South Rampart Pharma, Inc.

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PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.

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The Pharma Data

NOVEMBER 11, 2020

We now have compelling data showing SLV213 has potent antiviral activity against SARS-CoV-2 as well as data on the safety, tolerability, and pharmacokinetics and pharmacodynamics of SLV213 in several preclinical model systems, including nonhuman primates,” said Felix Frueh, Ph.D., Cofounder and Chief Scientific Officer of Selva Therapeutics.

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DrugBank

APRIL 3, 2025

This increases costs and delays the introduction of potentially life-saving therapies. These studies typically include in vitro assays to evaluate cytotoxicity and in vivo models to study pharmacokinetics, pharmacodynamics, and toxicological profiles. Preclinical studies form the backbone of early safety assessment.

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Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

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The Pharma Data

JUNE 28, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurrence of blood clots with standard anticoagulation therapy which requires injections, dietary restrictions, and regular laboratory monitoring. Xarelto is marketed outside the U.S. Study The randomized, open-label phase III EINSTEIN-Jr.

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The Pharma Data

DECEMBER 27, 2020

phase I trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers – FGF19 and C4) of ASC42 in healthy subjects. Phase I Trial. This trial also investigates the food effect on ASC42 exposure.

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The Pharma Data

AUGUST 9, 2021

Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative,” said Levi Garraway, M.D., Safety outcomes were consistent with those seen in previous trials. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

DECEMBER 29, 2020

Of the 22 patients enrolled in the BRIDGE study, the majority of treatment emergent adverse events were mild or moderate in severity, with two patients (9.1%) withdrawing from the therapy due to hypersensitivity reaction that was resolved. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea.

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The Pharma Data

JANUARY 17, 2021

Syngeneic tumor animal models play a critical role because they use standard inbred mice that have a competent immune system, which is required to evaluate immune-modulating therapies. Because the Jh mouse cannot produce ADA, there is no neutralizing or pharmacokinetic impact on the therapeutic or anaphylaxis risk.

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The Pharma Data

AUGUST 19, 2021

3] While MET inhibitors have recently received accelerated approval in this setting in some regions, the vast majority of patients eventually acquire resistance to these therapies, thus underscoring the need for new treatment options. [4] METex14 mutations are found in approximately three percent of patients with NSCLC. [2] 4] , [5] , [6].

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Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

APRIL 11, 2023

Bayer is advancing its oncology R&D efforts in three scientific areas that have the potential to address unmet needs in cancer patients: next-generation Immuno-Oncology, Targeted Radionuclide Therapies and Precision Molecular Oncology. Data from all three areas of scientific focus will be showcased during this year’s meeting.

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The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.

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Hospitals Pharmacokinetics Treatment Trials 52

New Drug Approvals

APRIL 18, 2025

2] The US Food and Drug Administration (FDA) granted the application for crinecerfont fast track , breakthrough therapy , orphan drug , and priority review designations. [2] New Drug Therapy Approvals 2024 (PDF). 2] In the first trial, 122 adults received crinecerfont twice daily and 60 received placebo twice daily for 24 weeks. [2]

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FDA FDA Approval Drugs Trials 62

The Pharma Data

NOVEMBER 26, 2020

Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas.

Disease 52

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML. About CG-806.

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The Pharma Data

APRIL 11, 2021

Retevmo (marketed as Retsevmo ® outside the U.S.) Initiate or adjust anti-hypertensive therapy as appropriate. Use of Retevmo for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 12 years and older.

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Research Treatment Therapies Trials 52

The Pharma Data

JULY 27, 2021

Each of these three investigational therapies uses a different approach to treat a highly prevalent disease for which new treatment options are very much needed. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

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Production Clinical Trials Government Disease 52

The Pharma Data

AUGUST 29, 2020

Oral, investigational complement factor B inhibitor LNP023 substantially improved hematological response as add-on therapy to eculizumab. To date, after at least six months of stable LNP023 add-on therapy, and at the investigators’ discretion, seven patients (70%) have discontinued eculizumab and remained on LNP023 as monotherapy.

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The Pharma Data

DECEMBER 15, 2020

The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. The secondary outcome involves pharmacokinetic endpoints. 2 g/dl on three consecutive available visits during the 24-week treatment period, with the response not being attributed to rescue therapy.

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The Pharma Data

JULY 11, 2021

For more than a decade, we’ve listened to the HAE community to further understand the need for long-term, preventive targeted therapies and have committed our resources to developing treatment options,” said Neil Inhaber, M.D., percent of patients (n=116) and the most common being injection-site pain. TAKHZYRO Safety Information for Europe.

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Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

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The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days. ” About Hepion Pharmaceuticals.

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The Pharma Data

JULY 22, 2021

1 The pharmacokinetics (PK) of VWF:ristocetin cofactor (VWF:RCo) and FVIII pharmacodynamics (PD) [PB0917] were also studied and presented at the congress. 15 Treatment regimens typically include on-demand and/or regular prophylactic infusions of factor replacement therapy to control or prevent the risk of bleeding.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The committee also made recommendations regarding pharmacokinetic and safety assessments. hours, the drug is no longer physiologically active.

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The Pharma Data

DECEMBER 5, 2020

” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 Multiple myeloma is not curable despite treatment advances.

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The Pharma Data

JANUARY 10, 2021

The company submitted its Marketing Authorisation Application (MAA) to the EMA in September 2020 and anticipates receiving MAA approval for lonapegsomatropin for use in pediatric GHD in the fourth quarter of 2021. If approved on the PDUFA date, Ascendis anticipates commercial launch in the third quarter of 2021. ?.

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The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. Currently no curative or specific therapies are available. The Phase 2b trial is expected to begin during the second half of 2021.

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Trials Disease Treatment Pharmacokinetics 40

The Pharma Data

NOVEMBER 4, 2020

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., Unrealized gain (loss) on marketable equity securities.

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The Pharma Data

OCTOBER 27, 2020

The decrease in Adcirca revenues was driven by continued erosion of market share due to generic competition. Sales and marketing. In October 2020 , we completed a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. .

FDA 40

FDA Production Licensing Licensing 40

Alta Sciences

DECEMBER 31, 2024

Listen to the audiobook or download the PDF below, to learn more about: key factors to consider in drug development (age, biological sex, genetics, DDIs); examples of common DDI involving the cytochrome P450 enzyme system; and drug interactions and guidance for marketed drugs. The Altascientist, Issue 7, pg.

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The Pharma Data

JULY 21, 2021

In the ongoing Phase 2a (NCT04003103) randomized, double-blind, parallel assignment, placebo-controlled, multicenter trial in adults at low-risk for acquiring HIV-1 infection, participants were randomly assigned (2:2:1) to one of three oral once-monthly therapy groups: islatravir 60 mg, islatravir 120 mg or placebo.

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Clinical Trials Pharmacokinetics Trials International 52

The Pharma Data

MARCH 25, 2021

With more than six years of patient experience, a positive benefit-risk profile, strong clinical data and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.”. The analysis also showed the two-year OS rate was 78.3%

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