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 […].

Clinical Trials 52

Clinical Trials Trials Research 52

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Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices.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.

Clinical Trials 59

Clinical Trials Trials FDA Production 59

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.

Clinical Research 52

Clinical Research Trials Research Clinical Trials 52

Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. Most NMEs approved so far this year relied on one pivotal trial.

Clinical Trials 52

Clinical Trials Trials Science FDA 52

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).

Trials 100

Trials 100

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.

Vaccine 52

Vaccine Trials Immune Response RNA 52

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.

Vaccine 52

Vaccine Trials Research 52

FDA Law Blog: Drug Discovery

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

Clinical Trials 64

Clinical Trials Trials FDA Drug Development 64

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.

Vaccine 52

Vaccine Trials Clinical Trials Research 52

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.

Vaccine 52

Vaccine Trials Government Production 52

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.

Vaccine 52

Vaccine Trials Government Production 52

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.

Clinical Trials 52

Clinical Trials Vaccine Pharma Companies Trials 52

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.

Treatment 52

Treatment Trials Hospitals Therapies 52

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.

Vaccine 52

Vaccine Trials FDA Clinical Trials 52

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.

Vaccine 52

Vaccine Trials Disease Research 52

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.

Vaccine 52

Vaccine Trials FDA Marketing 52

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.

Trials 52

Trials Drug Trials Drugs Research 52

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.

Vaccine 52

Vaccine Trials Government Drugs 52

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.

Trials 52

Trials Clinical Trials FDA Treatment 52

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.

Vaccine 52

Vaccine Trials Research 52

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.

Trials 52

Trials Hospitals Treatment FDA 52

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.

Vaccine 52

Vaccine Trials Pharmacy Research 52

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.

Vaccine 40

Vaccine Trials Clinical Trials Virus 40

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. ,

Clinical Trials 52

Clinical Trials Clinical Development Trials Engineering 52

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. .

Vaccine 52

Vaccine Virus Disease Trials 52

The Pharma Data

DECEMBER 10, 2020

Moderna has started dosing adolescent participants in a phase 2/3 trial evaluating vaccine candidate mRNA-1273, planning to enroll 3,000 U.S. volunteers aged 12 to 17.

Vaccine 52

Vaccine Trials Research 52

The Pharma Data

DECEMBER 20, 2020

Oxford University released new trial data last week that raises further questions about the most effective dosing regimen for Oxford’s COVID-19 vaccine candidate, AZD1222, that is being co-developed with AstraZeneca and how it came to pass that two different dosing regimens were pursued. Efficacy was not measured in the phase 1/2 trials.

Vaccine 52

Vaccine Trials Regulations FDA 52

The Pharma Data

DECEMBER 9, 2020

The University of Oxford has attempted to clarify the dosing error it and AstraZeneca (AZ) made in a clinical trial assessing COVID-19 vaccine AZD1222, following divergent reports between the two of what exactly transpired. AZ has not responded to a request to confirm this account. percent ( DID , Dec. Jason Scott. Source link.

Vaccine 52

Vaccine Trials Clinical Trials Regulations 52

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.

Vaccine 52

Vaccine Pharmacy Clinical Trials Packaging 52

Quanticate

MAY 3, 2020

This article has been updated in May 2020 to reflect the recent guidance by European Medicines Agency and other regulatory bodies on remote monitoring due to the recent coronavirus disease (COVID-19) pandemic. With this increase comes the enhanced pressure of effectively monitoring these trials.

Clinical Trials 52

Clinical Trials Trials Disease FDA 52

The Pharma Data

OCTOBER 20, 2020

20, 2020 — British scientists are infecting healthy volunteers with COVID-19, in hopes of speeding up vaccine development, TheWashington Post reported Tuesday. Led by scientists at Imperial College London, people in this challenge trial will be guaranteed treatment if they become ill. © 2020 HealthDay. TUESDAY, Oct.

Trials 52

Trials Vaccine Virus Pharmaceutical Companies 52

The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. NASDAQ:ALXN) today announced financial results for the third quarter of 2020. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24 , a 16 percent increase versus the third quarter of 2019. ” Third Quarter 2020 Financial Highlights. . in the prior year.

Clinical Trials 40

Clinical Trials Trials Production Licensing 40

The Pharma Data

NOVEMBER 3, 2020

million for an initial trial of SCB-2019 in Australia that enrolled 150 participants. Earlier this year, CEPI provided $3.5 Preliminary phase 1 data demonstrated SCB-2019 produced neutralizing antibodies to the coronavirus, CEPI said. Jason Scott.

Vaccine 52

Vaccine Trials Licensing Licensing 52

The Pharma Data

DECEMBER 8, 2020

The FDA has issued a clinical hold on Bellicum Pharmaceuticals for its ongoing phase 1/2 trial evaluating CAR-T therapy BPX-601 in patients who received prior treatment for metastatic pancreatic or prostate cancer, following the death of a trial participant. The Houston, Tex., The Houston, Tex., Source link.

Trials 52

Trials Drug Trials FDA Drugs 52

The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. Conference Call Information : Date : Thursday, November 5, 2020. Company management to host a webcast and conference call to provide a business update and review financial results at 4:30 p.m. WALTHAM, Mass., Time : 4:30 p.m. Domestic Dial-in Number : (866) 913-8546.

Pharmaceuticals 52

Pharmaceuticals RNA Small Molecule Protein Production 52

The Pharma Data

OCTOBER 15, 2020

More than a month has passed since AstraZeneca’s phase 3 COVID-19 vaccine trial was paused due to a potential adverse event, but few solid details have emerged from ongoing safety reviews by the FDA and the UK drugmaker. The vaccine trial, which has resumed in other countries but remains halted in the U.S., The length of time the U.S.

Vaccine 52

Vaccine Trials FDA Licensing 52

The Pharma Data

OCTOBER 26, 2020

British drugmaker Evgen Pharma has won approval to start a late-stage clinical trial in the UK to evaluate its respiratory treatment, SFX-01, for COVID-19 patients.

Trials 52

Trials Clinical Trials Treatment Research 52