The Pharma Data

DECEMBER 20, 2020

21, 2020 (GLOBE NEWSWIRE) — Shanghai Haini Pharmaceutical Co., They are one of the top pharmaceutical firms in China and are considered a market leader in the antibiotics space. About YRPG Yangtze River Pharmaceutical Group (YRPG) was founded in 1971, which is headquartered in Taizhou, China.

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The Pharma Data

NOVEMBER 18, 2021

Altay Therapeutics, RADD Pharmaceuticals, Rubik Therapeutics, VastBiome and Waypoint Bio to receive free year of lab bench use and other amenities at prominent bioscience incubators. RADD Pharmaceuticals is concentrated on preliminarily undrugged cancer targets. Rubik Rectifiers,co-founded by Murray Robinson,Ph.D.,

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Molecular Biology Pharmaceuticals Laboratories Clinical Development 52

The Pharma Data

JANUARY 21, 2021

Caggiano joins Evolve Biologics after most recently serving as CEO of Dendreon Pharmaceuticals LLC. Among his earlier leadership roles in the biotech, pharmaceutical and medical device industries, Caggiano directed the divestiture of Allergan’s LAP-BAND to Apollo Endosurgery in 2013. Abbott Laboratories and TAP Pharmaceuticals.

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Laboratories Pharmaceuticals Engineering Clinical Development 52

New Drug Approvals

AUGUST 21, 2023

4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 7] A one-year trial did not demonstrate a significant benefit on lung density in moderate-to-severe emphysema secondary to severe α(1)-antitrypsin deficiency. [8] 1 January 2013.

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

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Packaging FDA Trials Regulations 52

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder.

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

MARCH 28, 2022

Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc. This Phase 1 study was a randomized, placebo-controlled, dose-escalating trial to evaluate BIIB078 administered intrathecally to adults (n=106) with C9orf72-associated ALS. About Ionis Pharmaceuticals, Inc. Biogen Inc.

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The Pharma Data

SEPTEMBER 7, 2020

New pivotal data from ASCLEPIOS trials evaluating the efficacy and safety of Kesimpta in a subgroup of treatment-naïve RMS patients will be presented for the first time 1 . In this extended analysis, Kesimpta showed a safety profile that remains consistent with data reported in the Phase II and III clinical trials 5.

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Drug Target Review

SEPTEMBER 26, 2023

This shift occurred following implementation of the Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative in 2013 and extensive testing of hiPSC-cardiomyocytes with known proarrhythmic drugs. Within the field of drug safety hiPSC-cardiomyocytes are now routinely used for early identification of cardiac liabilities in drug discovery.

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Drug Target Review

APRIL 8, 2024

Identifying patients who are at high risk for relapse would likely help us isolate those high risk group of patients for more innovative clinical trials. He is the Principal Investigator for the NCI funded ALCHEMIST trial to study the role of erlotinib in patients with early-stage EGFR mutated lung cancer.

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Hospitals Therapies Clinical Trials Molecular Biology 52

Drug Target Review

OCTOBER 8, 2024

2013 Aug 20;109(4):934–42. Immuno-PET Using Anticarcinoembryonic Antigen Bispecific Antibody and 68 Ga-Labeled Peptide in Metastatic Medullary Thyroid Carcinoma: Clinical Optimization of the Pretargeting Parameters in a First-in-Human Trial. British Journal of Cancer. Journal of Nuclear Medicine. 2016 May 26;57(10):1505–11.

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Pharmacokinetics Engineering Treatment Science 52

The Pharma Data

DECEMBER 15, 2020

months that we observed in this trial. These positive efficacy results across all endpoints give us a high degree of confidence in their repeatability in a randomized trial and we plan to meet with the regulatory authorities in order to agree on the fastest pathway forward in this indication. Kenilworth, N.J. , Kenilworth, N.J. ,

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LifeSciVC

OCTOBER 13, 2022

At the same time, there are more gene therapies in development overall than antibodies, with 39 Phase 3 trials ongoing and several companies expected to file for approvals over the next 12 months. Revenue opportunities like this have never existed in the history of the pharmaceutical world — until now. million price.

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DrugBank

AUGUST 15, 2024

To effectively navigate this ecosystem and expedite the development of new therapies, collaboration between the pharmaceutical industry and academia is proving increasingly vital. This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks.

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Drug Target Review

OCTOBER 26, 2023

Many biotechnology start-ups, leveraging AI and high-throughput experiments, play a pivotal role in revolutionising gene therapy, while some traditional pharmaceutical giants have also displayed strong interest in this AI-driven AAV design approach. Molecular therapy 21 , 109-118 (2013). Russell S, et al. Wang D, Tai PW, Gao G.

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Codon

APRIL 9, 2024

After confirming they experienced no side effects, Tu and her colleagues carried out the first clinical trial on human patients in Hainan between August and October 1972, which continued to demonstrate qinghao extract’s high efficacy. only issued “the strongest ‘black box’ warning” against the drug in 2013.

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New Drug Approvals

SEPTEMBER 29, 2024

Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. A Phase 2/3 trial (GAIN) evaluating a 48-week course of COR388 in 643 people with mild to moderate AD began in April 2019. This trial involves 93 sites in the U.S. Periodontitis has been linked epidemiologically to cognitive impairment, and P. and Europe.

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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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Agency IQ

AUGUST 9, 2024

This draft guideline, which was open for public comments from September 15, 2023, through March 31, 2024, aims to modernize its set of criteria for developing medicines to treat depression since the guideline has not been updated since 2013. See AgencyIQ’s analysis on EMA’s draft guidance on clinical trials to treat depression ].

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The Pharma Data

JANUARY 13, 2021

Ensifentrine has been well tolerated in clinical trials involving more than 1,300 people. Lancet Respir Med 2013. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 subjects to date. About the study. Patient Population: 45 hospitalized patients with COVID-19. . Franciosi LG, et al.,

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Hospitals Clinical Trials Therapies Treatment 52

The Pharma Data

FEBRUARY 22, 2022

In 2013, she was appointed Finance Director of the Artémis Group. He is co-founder and non-executive board member of the Hartwig Medical Foundation (large scale DNA analyses) and is a board member of the Center for Personalized Cancer Treatment and leads several innovative precision oncology clinical trials.

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Clinical Trials DNA Science Clinical Development 52

The Pharma Data

AUGUST 30, 2021

The approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the DAPA-CKD Phase III trial. In 2013, AstraZeneca K.K. AZKK), a subsidiary in Japan of AstraZeneca, entered into an agreement with Ono Pharmaceutical Co., The trial was conducted in 21 countries. Ono) for Forxiga.

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Treatment Trials Disease Clinical Trials 52

New Drug Approvals

JULY 10, 2023

1] Zavegepant is an antagonist of the calcitonin gene-related peptide (CGRP) receptor currently in phase 3 trials in an intranasal formulation for the treatment of migraine. The clinical trial is expected to complete in September 2020. Zavegepant is indicated for the acute treatment of migraine with or without aura in adults. [1]

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Clinical Trials Treatment FDA Trials 40

LifeSciVC

APRIL 27, 2023

BMS had just begun Phase 3 trials of their agent, which was likely to be successful — as we now know it was. That funding enabled the two Phase 2b trials of our TYK2 program, one in psoriasis and one in psoriatic arthritis. The initial interactions with BMS were pragmatic and sensible.

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Small Molecule Computational Chemistry Engineering Clinical Development 40

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

Science 40

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The Pharma Data

NOVEMBER 4, 2020

Reaffirmed c linical trial results from study of VASCEPA in China are expected by year end 2020 : Assuming positive results from this study conducted by Amarin’s commercial partner for VASCEPA in China, regulatory submission in China could follow promptly thereafter. commercial team. “In About Amarin.

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Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

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FDA Science Biosimilars Regulations 40

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.

Treatment 52

Treatment DNA Trials Therapies 52

Codon

DECEMBER 12, 2024

A drug called thalidomide, initially made by a West German pharmaceutical company called Chemie Grünenthal, was manufactured and given to patients as a mixture containing both enantiomers. In 2013, it became the only international treaty to have been ratified by every country on the planet.

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Drug Target Review

JANUARY 16, 2025

Phase III trials for MK-0616 commenced in the second half of 2023. Their collaborative work continues to drive advancements in computational methods, offering new solutions to the intricate problems of preclinical pharmaceutical discovery through innovative predictive modelling techniques. Drug Discovery Today , 18(13-14):659666, 2013.

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Drug Development Small Molecule Drugs FDA Approval 52

New Drug Approvals

APRIL 21, 2025

2013 Jun 11;110(24):9992-7. Epub 2013 May 28 PATENT [link] Chemical Synthesis Methyl 3-(3-bromopropoxy)-4-fluorobenzoate (Compound 2) To a solution of methyl 4-fluoro-3-hydroxybenzoate 1 (3.0 June 2013). Acoramidis AG-10 1446711-81-4 AG10 Acorami 292.30 It is taken by mouth. [1] Proc Natl Acad Sci U S A. doi: 10.1073/pnas.1300761110.

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FDA Law Blog: Biosimilars

MARCH 31, 2025

2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful. Constitution protects the right to a jury trial in federal court. Under the Seventh Amendment and Jarkesy , a jury trial must be provided on liability before civil monetary penalties that are legal in nature can be assessed.

Biosimilars 64

Biosimilars Licensing Licensing Production 64

FDA Law Blog: Biosimilars

APRIL 2, 2025

2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful. Consitution protects the right to a jury trial in federal court. Under the Seventh Amendment and Jarkesy , a jury trial must be provided on liability before civil monetary penalties that are legal in nature can be assessed.

Biosimilars 59

Biosimilars Licensing Licensing Production 59

FDA Law Blog: Biosimilars

DECEMBER 3, 2024

2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful. Then, in a follow-on action in court to impose civil penalties, the liability findings made by the ALJ are treated as “conclusive” and a judge—not a jury—assesses penalties in a bench trial. Supreme Court declined to hold, in FTC v.

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NIH Director's Blog: Drug Discovery

JANUARY 13, 2015

In collaboration with colleagues from Germany, England, and NovoBiotic Pharmaceuticals (Cambridge, MA), Lewis’s team used the iChip approach to study 10,000 different species of soil bacteria. More safety and efficacy testing is needed in animal models to lay the groundwork for possible human clinical trials, perhaps within a couple of years.

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Clinical Trials Laboratories Disease Drugs 52

Codon

FEBRUARY 23, 2025

In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. If a permanent freeze goes into effect, researchers estimate there could be 8.7

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Clinical Trials Virus Vaccine DNA 74

Drug & Device Law

FEBRUARY 22, 2024

In particular, plaintiffs trying to force clinical trial sponsors to continue providing free drug after the end of the trial—something clinical trial participants are told is not a guaranty—have floundered. 2d 952 (S.D. Ohio 2007), but has generally failed to expand that foothold since.

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