Drug Target Review

JULY 12, 2023

We also leverage existing clinical gene expression data from different subsets of molecularly profiled cancer patients, who differ in a certain aspect of disease or response to a particular therapy. We are pleased that to date our lead product candidate has aligned DCI profiles as expected.

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Advarra

JUNE 20, 2023

years , with biotechnology-derived products potentially adding another year or more. cell and gene therapies), with other therapeutic areas then pushing it further. More targeted therapies may change which patients and cancers may benefit, since a given treatment may only impact very specific biomarkers and genetic profiles.

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Drug Target Review

OCTOBER 24, 2023

Live Bacterial Products (LBPs) will provide patients with a desirable, credible, safe and effective treatment option. Microbiotica, a pioneering company that has developed a Discovery Platform that has paved the way for the creation of Live Bacterial Products (LBPs). How does it work and what are the potential benefits?

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. It is approved in the U.S.

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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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LifeSciVC

APRIL 24, 2024

Additionally, for illustrative reasons this is geared towards a single target / product focus vs. broader platform diligence, though many of these mental models will apply for selecting targets and indications for a platform. with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., in liver, in CNS)?

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The Pharma Data

FEBRUARY 25, 2022

The PAS was supported by positive topline data from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment with ABRILADA and its reference product, Humira, both of which were administered with methotrexate in adult patients with moderate to severe rheumatoid arthritis (RA).

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The Pharma Data

MARCH 25, 2022

To date, 170 of the 194 WHO Member States have reported the use of traditional medicine, and their governments have asked for WHO’s support in creating a body of reliable evidence and data on traditional medicine practices and products. May the global centre at Jamnagar help in providing the best healthcare solutions to the world.”.

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The Pharma Data

DECEMBER 15, 2020

16, 2020 (GLOBE NEWSWIRE) — Arecor Limited (“Arecor” or “the Company”), the biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces that Diabetes Care has published data for the Phase I clinical trial of AT247, its ultra-rapid acting insulin product candidate.

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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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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

NOVEMBER 5, 2020

As we had previously indicated, we believe an SVR24 rate of at least 15% would have marked a meaningful first advance in HBV finite therapy, but preliminary results have shown that we will fall short of that mark. ABI-H0731 is a first-generation core inhibitor that is typically administered with NrtI therapy. Assembly Biosciences, Inc.

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The Pharma Data

MARCH 22, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Tominersen, previously IONIS-HTTRx or RG6042, is an investigational antisense therapy designed to reduce the production of all forms of the huntingtin protein (HTT), including its mutated variant, mHTT. said Levi Garraway, M.D.,

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The Pharma Data

APRIL 27, 2021

Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. The review is being conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), which provides a framework for concurrent submission and review of oncology products among international partners.

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The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. 19, 2020 09:00 UTC. SEFA-1024 is one of NST’s three SEFA programs. NST’s lead program, icosabutate, is currently in a phase 2b ‘ICONA’ study for the treatment of NASH.

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The Pharma Data

DECEMBER 13, 2020

About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer. Zai has a strong track record of rapidly progressing the development of innovative product candidates in China and is well on its way to building its commercial platform.

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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. The US Patent and Trademark Office (USPTO) has issued a new patent protecting the product until 2039. Both of these patents protect the respective products until 2039.

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Agency IQ

AUGUST 16, 2024

The road to research on psychedelic products is paved with obstacles. 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. First, nearly all psychedelics are Schedule I drugs under the Controlled Substances Act (CSA).

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The Pharma Data

NOVEMBER 8, 2020

Based on the feedback from our Type A meeting in February, we conducted additional product testing with the goal of addressing the Chemistry, Manufacturing and Controls deficiencies discussed in the CRL.”. Celgene acquired it in 2018 from bluebird bio, who originally developed the therapy.

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Agency IQ

SEPTEMBER 15, 2023

The monographs functioned as rule books for specific classes of OTC drugs, describing active ingredients, doses, indications, labeling and tests requires for covered OTC products to be generally recognized as safe and effective (GRASE). The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. We are initially focused on developing a novel therapy to treat ENPP1 and ABCC6 deficiencies. Food and Drug Administration cleared Investigational New Drug Application. BOSTON, Jan.

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The Pharma Data

OCTOBER 25, 2020

Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. A therapy that quickly and effectively reduces agitation, without causing excessive sedation, is needed to speed up recovery time and improve patient outcomes. BioXcel Therapeutics, Inc.

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The Pharma Data

FEBRUARY 8, 2021

This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. Food and Drug Administration (FDA). 2,3 In the U.S., About Pfizer Oncology.

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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. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. ” In June 2021, AbbVie Inc.

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The Anticancer Fund

APRIL 1, 2022

Top story Inflammatory fibroblasts mediate resistance to neoadjuvant therapy in rectal cancer Published in Cancer Cells Inflammatory cancer-associated fibroblasts (iCAFs) are associated with poor chemoradiotherapy response in rectal cancer. Furthermore, iCAFs are associated with poor prognosis in rectal cancer patients.

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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

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., Please consult the TAKHZYRO Summary Product Characteristics (SmPC) before prescribing.?. Interactions.

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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. Contraindications.

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The Pharma Data

SEPTEMBER 26, 2021

The positive CHMP opinion was supported data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA® (dimethyl fumarate) to determine bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied partially on the well-established long-term safety and efficacy profile of TECFIDERA. for TECFIDERA.

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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

NOVEMBER 9, 2021

product marker for Epclusa contains a BOXED WARNING for the threat of hepatitis B reactivation in HCV/ HBVco-infected cases. The company has transformed the trajectory of many liver diseases through a relentless pursuit of innovation and pioneering access programs to bring meaningful therapies to people around the world.

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The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. who require oxygen therapy due to COVID-19, OR. who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. Breastfeeding.

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The Pharma Data

JULY 23, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. In addition, its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies,” said Levi Garraway, M.D., About Roche’s response to the COVID-19 pandemic.

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Agency IQ

AUGUST 16, 2024

FDA solidifies its advice on dose optimization for oncology products Just over a year after it released the draft guidance, the FDA has finalized its guidance on dose optimization for oncology products. The MTD represents the point at which the serious toxicities outpace the therapeutic benefits of these products.

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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

APRIL 11, 2021

Initiate or adjust anti-hypertensive therapy as appropriate. There are no data on the presence of selpercatinib or its metabolites in human milk or on their effects on the breastfed child or on milk production. ” In May 2020, Lilly’s first-in-class selective RET inhibitor Retevmo received Accelerated Approval from the U.S.

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The Pharma Data

APRIL 16, 2021

For media resources, including product images and fact sheets, please click here. who require oxygen therapy due to COVID-19, OR. who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. Breastfeeding. About bamlanivimab.

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