The Pharma Data

DECEMBER 28, 2020

The AMBITION trial is the first placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. ” About Hepion Pharmaceuticals.

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Drug Discovery World

MAY 15, 2024

Currently in a Phase Ib/IIa study, it is believed to stabilise GAP-junction activity through regulation of connexin-43. In 2019 there were >14.2 million diagnosed cases of diabetic retinopathy in the nine major pharmaceutical markets, expected to grow to >17.7 million by 2029, according to GlobalData. 2019;85(2):347-355.

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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. Drug development and clinical trials: How drugs are discovered and developed as medicines. Providing a broad view.

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). Will this be a viable solution? Clinical trials The draft outlines the requirement for clinical trials in children where a drug is approved in adults for a different disease.

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The Premier Consulting Blog

NOVEMBER 12, 2023

In 2019, the FDA published a discussion paper on a proposed regulatory framework for modification to AI/ML-based software as a medical device (SaMD), which received a significant amount of feedback from stakeholders. FDA Discussions As a result of the feedback received in 2019, the FDA outlined the five-pillar approach to regulating AI/ML.

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The Pharma Data

APRIL 28, 2021

NYSE: PFE) announced today that it has acquired Amplyx Pharmaceuticals, Inc., Fosmanogepix is currently in Phase 2 clinical trials evaluating the safety and efficacy of both intravenous (IV) and oral formulations for the treatment of patients with life-threatening invasive fungal infections caused by molds, yeasts and rare molds (e.g.,

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Tonix Pharmaceuticals Holding Corp.

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The Pharma Data

AUGUST 31, 2020

one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has agreed in principle to supply the Government of Canada with doses of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S. The Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, Source link.

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Drug Discovery World

JULY 11, 2022

These challenges exist across the translation cycle from early research to clinical trials, manufacturing, and ultimately reimbursement. The complexities of sample management can significantly extend the timelines for clinical trials. For regulatory purposes, they may be treated more like a pharmaceutical or a blood product.

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Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his celebrated contributions to the understanding and targeting of pancreas cancer metastasis, including work that has assisted with the development of minnelide, a pro-drug of triptolide for the treatment of pancreas and gastrointestinal cancers that is currently in Phase II clinical trials.

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The Pharma Data

DECEMBER 15, 2020

(hereinafter referred to as: CHIPSCREEN BIOSCIENCES) and ZHEJIANG HISUN PHARMACEUTICAL CO., hereinafter referred to as: HISUN PHARMACEUTICAL) announced that they have reached a strategic cooperation. In September 2019 , the New Drug Application (NDA) of Chiglitazar Sodium was accepted by Center for Drug Evaluation.

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New Drug Approvals

OCTOBER 24, 2023

1] Etrasimod was discovered by Arena Pharmaceuticals , with subsequent development by Pfizer. [2] June 2019). “The Selective Sphingosine 1-Phosphate Receptor Modulator Etrasimod Regulates Lymphocyte Trafficking and Alleviates Experimental Colitis” J Pharmacol Exp Ther. 1] It is taken by mouth. [1] 11] SYN ACS Med.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. August 05, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. New Brunswick, N.J., Learn more at www.jnj.com.

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and around the world.

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The Pharma Data

JANUARY 19, 2021

Prior to joining Ipsen, Gwenan was the Global Head of Pharma Communications and Patient Advocacy at Novartis Pharmaceuticals. billion in 2019, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen also has a well-established Consumer Healthcare business.

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The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial). and a disease control rate (DCR) of 86.2%

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The Pharma Data

AUGUST 16, 2020

Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. We thank the NMOSD community, including patients and investigators who participated in ENSPRYNG clinical trials.”. Chief Medical Officer and Head of Global Product Development. “We

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Agency IQ

JULY 21, 2023

released both a coordinated plan on artificial intelligence (AI) and a proposal for a regulation. The plan is intended to “work hand in hand with the Proposal for a Regulation on Artificial Intelligence,” which is the Artificial Intelligence Act (AIA). The risk of using AI and ML in early phase clinical trials might be low.

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. 5, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. NEW BRUNSWICK, N.J., Follow us at @JNJNews.

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The Pharma Data

APRIL 19, 2022

The Maryland site joins Kite’s existing manufacturing facilities in Southern California and Amsterdam, Netherlands to form the largest, dedicated in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Bayer Animal Health. Genentech. ,

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Learn more at Learn more at www.jnj.com.

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The Pharma Data

MARCH 25, 2021

Along with the scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP), national regulators in countries participating in the EU-M4all procedure will conduct their own assessments to determine if national marketing authorizations for TAK-003 are granted. About the Phase 3 TIDES (DEN-301) Trial.

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The Pharma Data

APRIL 27, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that that the U.S. The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial , which is evaluating the safety and efficacy of oral mobocertinib in patients with mNSCLC. In 2019, the U.S. About the Phase 1/2 Trial.

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The Pharma Data

AUGUST 24, 2020

TGF-beta is a key cytokine that regulates various cell processes, including regulation of the immune system. In contrast, TGF-beta 2 is a positive regulator of hematopoiesis and normal cardiac function, and blockade of TGF-beta 2 is therefore undesirable. AVID200 neutralizes TGF-beta 1 and -beta 3 with picomolar potency.

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The Pharma Data

MAY 15, 2023

Before joining Nestlé he served as CFO at Takeda Pharmaceuticals, one of the largest publicly listed companies in Japan, between 2013 and 2015, and CFO at Millicom, a NASDAQ listed global mobile phone operator based in Luxembourg, between 2008 and 2013. François-Xavier Roger, Chief Financial Officer of Nestlé S.A.,

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The Pharma Data

JANUARY 3, 2021

In 2021 Nanoform targets “at least 12 new non-GMP 1 (pre-clinical) customer projects and at least one new GMP (clinical) customer project” The company reported 2 non-GMP customer projects in 2019 and 7 non-GMP customer projects in Q1-Q3/2020. 3 Active Pharmaceutical Ingredient. over 90 percent gross margin.

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. 6] ERLEADA ® is being studied in five Phase 3 registrational clinical trials. About the Janssen Pharmaceutical Companies of Johnson & Johnson. ERLEADA ® received U.S. All rights reserved.

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The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. billion during 2019-2023 (Technavio 2019). billion during 2019-2023 (Technavio 2019). Toronto, Ontario–(Newsfile Corp.

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The Pharma Data

NOVEMBER 24, 2020

Lynparza is the first biomarker-selected targeted treatment option approved in Canada , based on the Phase III PROfound trial of men with Homologous Recombination Repair mutated (HRRm) mCRPC. Approximately 32 patients from 12 Canadian centres have participated in the PROfound trial to date.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. since Q4 2019. and CHICAGO , Oct.

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The Pharma Data

NOVEMBER 4, 2020

4, 2020– Caelum Biosciences and Alexion Pharmaceuticals, Inc. In 2019, Caelum entered a collaboration agreement with Alexion under which Alexion acquired a minority equity interest in Caelum and an exclusive option to acquire the remaining equity in the company based on Phase 3 CAEL-101 data.

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The Pharma Data

JANUARY 24, 2021

We are grateful to our collaborators who worked with us on these vaccine candidates and to the volunteers in the trials,” said Dr. Dean Y. Molnupiravir is currently being evaluated in Phase 2/3 clinical trials in both the hospital and out-patient settings. Li, president, Merck Research Laboratories. “We About Merck.

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