Drug Discovery World

SEPTEMBER 4, 2024

The drug was approved by the FDA for Expanded Access, allowing trial participants to continue CS1 treatment when no comparable or satisfactory alternative therapy options are available. The EU OMPD complements the orphan drug designation (ODD) granted by the US FDA in 2020, enhancing the protection and value of CS1 in these major markets.

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BioPharma Drive: Drug Pricing

JULY 24, 2024

Known as SAGE-324, the drug was one of the key assets Biogen gained rights to through a billion-dollar research deal inked back in 2020.

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The Pharma Data

NOVEMBER 9, 2020

Sanofi has halted a global phase 3 trial evaluating its investigational hemophilia drug fitusiran after reports of adverse events. Sanofi halted the study following a recommendation by the trial’s independent? Sanofi halted the study following a recommendation by the trial’s independent?data data monitoring committee.

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Eye on FDA

JANUARY 6, 2021

During 2020, FDA was able to approve 53 – not surpassing the 2018 all time record of 59, but certainly an admirable second place. Notably, the 2020 NME approvals included 22 related to oncology, with 2 new GIST treatments, 3 in breast cancer and 2 approvals in prostate cancer. That, however, was not really the case.

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The Pharma Data

NOVEMBER 13, 2020

A new survey shows one in five cancer patients are far less likely to participate in future clinical trials due to fear of COVID-19 exposure, raising the question of whether enrollment levels that have dropped precipitously since the beginning of the pandemic are likely to recover after the virus is controlled. percent since March 15.

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The Pharma Data

MAY 3, 2021

In its 2020 annual report, the division of the US Food and Drug Administration (FDA) tasked with addressing emerging regulatory issues and developing new tools and approaches for regulatory reviews said it was able to expand its efforts despite the COVID-19 pandemic impacting most of the year. . 2020 was a challenging year.

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

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The Pharma Data

NOVEMBER 12, 2020

13, 2020 10:00 UTC. The DETOUR1 trial is the first-in-man trial of the FDA-designated Breakthrough Device, The Detour System, evaluating the safety and effectiveness of the novel procedure and device system for treating long, complex lesions in the superficial femoral artery (SFA). MILPITAS, Calif.–(

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ProRelix Research

SEPTEMBER 21, 2022

According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, with a death rate of one in six in 2020 (1). The post Cancer Clinical Trials: USA Scenario and Study Designs appeared first on ProRelix Research. Aside from the high […].

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Drug Discovery World

NOVEMBER 16, 2023

Casgevy (exagamglogene autotemcel, or exa-cel) is the first medicine to be licensed that uses gene editing tool CRISPR, for which its inventors were awarded the Nobel Prize in 2020. Trial results for Casgevy The authorisation is based on positive clinical trial data.

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FDA Law Blog: Drug Discovery

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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Olympian Clinical Research

DECEMBER 30, 2020

2020 has been an incredibly difficult year, and we’ve seen firsthand the physical, emotional, and financial struggles that COVID has caused for our patients, our loved ones, and the healthcare industry as a whole over the past several months. 2020 was a year of obstacles, but it was also a year of incredible growth.

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The Pharma Data

NOVEMBER 11, 2020

Moderna has released promising early results from a small phase 1 trial of its experimental personalized cancer vaccine, mRNA-4157, in combination with Merck’s Keytruda (pembrolizumab). The study enrolled 10 patients with human papillomavirus- (HPV) negative head and neck cancer and 17 colorectal cancer patients. drugmaker said.

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The Pharma Data

DECEMBER 14, 2020

The randomized trial of the two-dose vaccine is expected to enroll more than 35,000 participants aged 18 and up at sites throughout Europe and Latin America. Participants will also be monitored in a yearlong study following the trial’s conclusion that will collect additional data to help assess the vaccine’s duration of effectiveness.

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Drug Discovery Today

NOVEMBER 10, 2020

Solna, Sweden, November 10, 2020. Affibody AB (“Affibody”), a clinical stage biopharmaceutical company, today announced the initiation of its 52-week trial investigating the novel bispecific IL-17A inhibitor ABY-035 in patients with psoriatic arthritis (PsA).

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The Pharma Data

NOVEMBER 16, 2020

Inovio announced that it has begun the phase 2 segment of a phase2/3 clinical trial to evaluate INO-4800, its potential coronavirus vaccine funded by the Department of Defense. The phase 2 study, which will enroll 400 participants at 17 U.S. sites, is designed to evaluate the safety, tolerability and immunogenicity of a two-dose regimen.

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Drug Discovery World

DECEMBER 6, 2022

1 Vaccine development was conducted at great pace and within a year of the first infection being reported, the first Covid-19 vaccine to report phase III clinical trial data demonstrated unexpectedly high efficacy and cleared regulatory efficacy criteria with ease. Indeed, few randomised trials of NPIs have been undertaken.

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The Pharma Data

OCTOBER 18, 2020

UK-based contract research organization Open Orphan said it is in advanced negotiations with the British government and other partners for a human challenge trial of a COVID-19 vaccine. Any challenge trial must first be cleared by the Medicines and Healthcare products Regulatory Agency, which oversees the safety of medicines in the UK.

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The Pharma Data

OCTOBER 15, 2020

UK-based contract research organization Open Orphan said it is in advanced negotiations with the British government and other partners for a human challenge trial of a COVID-19 vaccine. Any challenge trial must first be cleared by the Medicines and Healthcare products Regulatory Agency, which oversees the safety of medicines in the UK.

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The Pharma Data

DECEMBER 20, 2020

UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . In October, Scancell signed a manufacturing deal for SN14 with Cobra Biologics, a Cognate BioServices subsidiary, ahead of a planned phase 1 trial in 2021.

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The Pharma Data

NOVEMBER 4, 2020

5, 2020 11:00 UTC. NASDAQ: CNCE) today reported financial results for the third quarter of 2020. Our team has diligently and effectively executed on our plan, and I’m pleased that we have achieved our stated 2020 pipeline milestones. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020.

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Drug Discovery World

JANUARY 24, 2023

Virtual clinical trials ‘Virtual’ and ‘technology’ are concepts which are readily exchanged in this industry, but these are more than just buzzwords. The overall virtual clinical trials market is currently valued at $7.8 In early November 2022, two Alzheimer’s drugs were tested head-to-head in a first-ever virtual clinical trial 3.

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The Pharma Data

NOVEMBER 30, 2020

The UK-based RECOVERY trial, which is evaluating multiple treatments for COVID-19, will add the inexpensive anti-inflammatory drug colchicine to the list of therapies being tested in hospitalized patients.

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The Pharma Data

OCTOBER 22, 2020

The randomized, placebo-controlled trial is being conducted in partnership with the NIH’s National Institute of Allergy and Infectious Diseases and HHS’ Biomedical Advanced Research and Development Authority. Moderna has completed enrollment of 30,000 participants for its phase 3 study evaluating COVID-19 vaccine candidate mRNA-1273.

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The Pharma Data

DECEMBER 17, 2020

COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.

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The Pharma Data

NOVEMBER 29, 2020

AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. An additional trial could further delay AZ’s efforts to earn an EUA in the U.S., James Miessler. Source link.

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The Pharma Data

NOVEMBER 13, 2020

In a Phase 2 trial, SNG001 was given to 48 COVID-19 patients using a nebulizer, while 50 other patients received a placebo. © 2020 HealthDay. Posted: November 2020. “SNG001 reduced the odds of developing severe disease or dying by 79%,” the British researchers wrote in the journal The Lancet Respiratory Medicine. .

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The Pharma Data

OCTOBER 26, 2020

based aTyr Pharma has finalized enrollment for a phase 2 trial to evaluate an investigational anti-inflammatory drug in COVID-19 patients with severe respiratory complications. The double-blind, placebo-controlled trial, which has 32 participants across the U.S., San Diego, Calif.-based Source link.

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The Pharma Data

OCTOBER 22, 2020

COVID-19 Vaccine Trial Enrolls 30,000. 22, 2020 — The first company to start a phase 3 trial of a COVID-19 vaccine reached its target of enrolling 30,000 participants, CNN reported Thursday. ” Moderna is one of four phase 3 trials of vaccines, each involving tens of thousands of people, CNN said. Professional.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Synlogic, Inc. Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced the Company will release its third quarter 2020 financial results before the market opens on Thursday, November 5, 2020. CAMBRIDGE, Mass. ,

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The Pharma Data

DECEMBER 30, 2020

Some people in clinical trials of the Oxford-AstraZeneca vaccine were given the two doses several months apart. © 2020 HealthDay. Posted: December 2020. Regulators said that the first dose of the vaccine had 70% effectiveness in protecting against COVID-19 in the period between the first dose taking effect and a second shot.

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The Pharma Data

OCTOBER 26, 2020

The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has halted a clinical trial evaluating Eli Lilly’s investigational monoclonal antibody, LY-CoV555 (bamlanivimab), in combination with remdesivir for the treatment of COVID-19 patients. The trial was paused earlier this month due to a safety issue. Source link.

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The Pharma Data

OCTOBER 26, 2020

COVID-19 Vaccine Trials. 26, 2020 — Drugmakers AstraZeneca and Johnson & Johnson are ready to resume paused COVID-19 vaccine trials after health scares, CNN reported. The AstraZeneca trial was stopped in early September, and the Johnson & Johnson trial was paused earlier this month. © 2020 HealthDay.

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The Pharma Data

DECEMBER 14, 2020

Researchers with the UK’s multi-armed RECOVERY trial have determined that the widely used antibiotic azithromycin was not beneficial for patients hospitalized with COVID-19 and are discontinuing their evaluation of the drug. Further results from the other arms of the trial are anticipated “over the next couple of months,” Horby said.

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The Pharma Data

DECEMBER 22, 2020

The trial is being conducted in Argentina, Pakistan, Russia, Mexico and Chile. The adenovirus-based vaccine is one of five that China has progressed to phase 3 trials so far. CanSino begun enrollment in September with plans to enroll up to 40,000 adults aged 18 and over, according to ClinicalTrials.gov.

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The Pharma Data

NOVEMBER 30, 2020

Novavax said it will begin a delayed phase 3 trial in the U.S. and Mexico to evaluate its COVID-19 vaccine candidate, NVX-CoV2373, “in the coming weeks” and that its 15,000-person late-stage trial in the UK is now fully enrolled. Source link.

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The Pharma Data

NOVEMBER 10, 2020

Johnson & Johnson (J&J) announced that it has restarted all clinical trials in Europe evaluating its COVID-19 vaccine, Ad26.COV2.S, The clinical trials resuming in Europe this week are phase 2 studies in Germany, the Netherlands and Spain, as well as a phase 1/2 study in Belgium, the company said. . Source link.

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