The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Remember, some staff may not need protocol-specific training. based sites.

Licensing 52

Licensing Licensing Pharmacy FDA 52

The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.

Licensing 52

Licensing Licensing Pharmaceutical Companies Treatment 52

The Pharma Data

NOVEMBER 18, 2020

. “Based upon our anti-Globo H targeted approaches in cancers of high unmet needs, OBI Pharma is proud to have presentations on the progress of our trial presented at ESMO-Asia 2020 for our novel therapeutic cancer vaccine, OBI-833.” Title: A phase I cohort expansion trial of OBI-833 in non-small cell lung cancer patients.

Vaccine 52

Vaccine Small Molecule Immune Response Hospitals 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.

Clinical Trials 52

Clinical Trials Laboratories Research Laboratories RNA 52

The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. before expanding it into Europe.

Licensing 52

Licensing Licensing Pharmacokinetics Clinical Trials 52

Drug Target Review

FEBRUARY 1, 2024

This can present challenges when attempting to recruit an enriched patient population for clinical trials. We were able to license a molecule from a multi-national pharmaceutical company. Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles.

Therapies 105

Therapies Drug Development Disease Clinical Development 105

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. REGN-COV2 was well tolerated in the trial. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

NOVEMBER 29, 2020

Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs.

FDA 52

FDA Licensing Licensing Pharmaceuticals 52

The Pharma Data

OCTOBER 26, 2020

AR-711 is currently being developed as an inhaled, self-administered treatment for non-hospitalized patients suffering from mild to moderate COVID-19. aeruginosa hospital acquired pneumonia cases worldwide. AR-711 is an in-licensed mAb that is directed against the receptor binding domain of the SARS-Cov 2 virus.

Pharmaceuticals 52

Pharmaceuticals Virus Hospitals Clinical Trials 52

The Pharma Data

AUGUST 16, 2021

Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. adult participants from the Phase 1 trial of the two-dose series. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Vaccine 52

Vaccine FDA Virus Immune Response 52

The Pharma Data

APRIL 4, 2022

The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., today announced that the U.S. A decision on U.S. FDA approval is expected in the second half of this year.

Treatment 52

Treatment FDA Approval Clinical Trials FDA 52

The Pharma Data

OCTOBER 18, 2020

Berk completed his internship, residency, and fellowship in internal medicine, hematology, and medical oncology at the Weill Cornell Medical College and New York Presbyterian Hospital, where he also served as a faculty member. The company’s pipeline was licensed from the Spanish National Cancer Research Centre (CNIO).

Small Molecule 40

Small Molecule Clinical Development Clinical Trials Licensing 40

The Pharma Data

AUGUST 20, 2020

What information has been released about how kits were assessed shows most were tested on small numbers of patients only – just a few dozen, all of whom had been admitted to hospital. “For drug licensing the onus is on the companies to go through clinical trials.

Clinical Trials 52

Clinical Trials Regulations Doctors Government 52

The Pharma Data

OCTOBER 15, 2020

The naxitamab data was presented by Dr. Jaume Mora from SJD Barcelona Children’s Hospital, and the omburtamab data was presented by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center (“MSK”). In addition, bone marrow clearance was observed with complete response in 7 of 9 patients, who had positive bone marrow at trial start.

Licensing 52

Licensing Licensing Production Treatment 52

The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Detailed results from this Phase 3 trial will be published later this year.

FDA 52

FDA Disease Treatment FDA Approval 52

The Pharma Data

MARCH 2, 2021

The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older.

Vaccine 52

Vaccine Clinical Trials FDA Licensing 52

The Pharma Data

MAY 5, 2022

Today, 30-60% of patients with GvHD do not respond to first-line steroid treatment, underscoring the need for new approaches to ensure long-term treatment goals are met,” said Dr. Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany.

Treatment 52

Treatment Disease Therapies Clinical Trials 52

The Pharma Data

JANUARY 5, 2021

RAD011 is a pivotal-trial ready synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases. Acquisition and associated PWS trial costs to be funded from existing operations. Management to host conference call and webcast this morning at 8:15 a.m.

Disease 52

Disease FDA Approval Clinical Trials Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Fourteen newly licensed medicines have been accepted for use on NHS Scotland by the Scottish Medicines Consortium (SMC), bringing a raft of new treatment options for conditions including epilepsy, depression and cancer.

Treatment 52

Treatment Clinical Trials Licensing Licensing 52

The Pharma Data

JANUARY 18, 2021

At the same time, we continue to prepare for the filing of the Biologics License Application with the U.S. million in 2020 despite a very limited access of patients to hospitals due to the COVID-19 crisis. “We Cash position and financing runway. GenSight Biologics’ cash and cash equivalents totaled €37.9

Treatment 40

Treatment Therapies Clinical Trials Marketing 40

The Pharma Data

OCTOBER 19, 2020

Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are among the most common serotypes causing invasive pneumococcal disease in parts of the world, including the U.S., among adults 65 years of age or older. About Pneumococcal Disease.

Vaccine 52

Vaccine Immune Response Disease Clinical Trials 52

The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” . PLYMOUTH MEETING, Pa. ,

DNA 40

DNA Vaccine Clinical Trials Immune Response 40

The Pharma Data

OCTOBER 27, 2020

The study’s objectives are to evaluate the efficacy and safety of NexoBrid compared with the standard-of-care in hospitalized children with severe thermal burns of 1 percent to 30 percent Total Body Surface Area (TBSA). patients during the review of the NexoBrid Biologics License Application (BLA). HHSO100201500035C.

Clinical Trials 40

Clinical Trials Licensing Licensing FDA 40

Agency IQ

JANUARY 4, 2024

Part of the strategic priorities are to increase supervisory and surveillance activities , so the regulator is increasing inspections of clinical trials, hospitals and other economic operators in the devices sector. It is also increasing economic operator inspections. It is also increasing economic operator inspections.

Marketing 40

Marketing Regulations Clinical Trials International 40

The Pharma Data

NOVEMBER 9, 2020

Analysis evaluated 94 confirmed cases of COVID-19 in trial participants. Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints. Pfizer Inc.

Vaccine 40

Vaccine Clinical Trials Trials FDA 40

The Pharma Data

OCTOBER 29, 2020

In the third quarter, we further progressed our LEAD-EXPAND-DIVERSIFY strategy with multiple regulatory approvals, the initiation of new Phase 3 trials and the integration of the Portola team,” said Ludwig Hantson , Ph.D., Chief Executive Officer of Alexion. ” Third Quarter 2020 Financial Highlights.

Clinical Trials 40

Clinical Trials Trials Production Licensing 40

The Pharma Data

DECEMBER 1, 2020

This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, M.D., The Emergency Use Authorization in the U.K.

Vaccine 40

Vaccine Clinical Trials Trials Production 40

Agency IQ

SEPTEMBER 1, 2023

In medical product research, RWD is considered any data captured outside of the confines of a clinical trial, such as claims or electronic health record (EHR) data or records from clinical registries, while RWE is evidence generated from analyzing those data.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

APRIL 8, 2021

The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. .

Hospitals 52

Hospitals FDA Approval Laboratories Treatment 52

The Pharma Data

JANUARY 12, 2021

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials. Yancopoulos , M.D.,

Government 52

Government Hospitals Virus Clinical Trials 52

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies. “We

Clinical Trials 52

Clinical Trials Trials Therapies Licensing 52

The Pharma Data

DECEMBER 2, 2020

This License Agreement represents an important corporate milestone. The License provides EYAM with the exclusive right to develop several proprietary COVID-19 vaccine candidates in a self-amplifying mRNA vaccine platform. EYAM anticipates rapid commencement of animal trials for these COVID-19 vaccine candidates.

Licensing 52

Licensing Licensing Vaccine Virus 52

Codon

FEBRUARY 13, 2024

1 Yet even after more than two decades of research, media hype, and dozens of clinical trials and biotech start-ups that have come and gone, phage therapy has not scaled. No phage-based therapeutic has reached the latter stages of the clinical trial pipeline (where promising results lead to an expanded trial involving thousands of patients).

Therapies 131

Therapies Virus DNA Clinical Trials 131

The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Yancopoulos, M.D.,

Therapies 52

Therapies FDA Clinical Trials Hospitals 52