This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Science Daily: Pharmacology News
MAY 17, 2024
An HIV vaccine candidate triggered low levels of an elusive type of broadly neutralizing HIV antibodies among a small group of people enrolled in a 2019 clinical trial.
340 
BioPharma Drive: Drug Pricing
SEPTEMBER 26, 2024
The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S.
280
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
ProRelix Research
JUNE 6, 2023
Being the second most populous country in the world with skilled labor and good infrastructure, India is a favorable destination for clinical trials for a wide variety of diseases.
BioPharma Drive: Drug Pricing
AUGUST 28, 2023
The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression.
246 
Creative Biolabs
JANUARY 15, 2020
Drug Name Trade Name Company Approval Date 1 PrabotulinmtoxinA Jeuveau Evolus 2019/2/1 2 Caplacizumab-yhdp Cablivi Ablynx 2019/2/6 3 Triclabendazole Egaten Novartis 2019/2/13 4 Brexanolone Zulress Sage Therapeutics 2019/3/19 5 Solriamfetol Sunosi Jazz Pharmaceuticals 2019/3/20 6 Siponimod Mayzent Novartis 2019/3/26 7 Romosozumab-aqqg Evenity Amgen (..)
Conversations in Drug Development Trends
AUGUST 23, 2023
Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.
96 
Antidote
JULY 29, 2022
In 2019 alone, research and development spending totaled $186 billion for the global pharmaceutical industry. Between 2009 and 2018, U.S. biopharmaceutical companies spent about $1 billion per drug according to an analysis published in JAMA , and other studies have found that it can cost up to $2.8 billion to bring a new therapy to market.
SCIENMAG: Medicine & Health
JULY 14, 2023
billion in project funding for phased clinical trials involving drugs approved by the FDA from 2010-2019, according to a new study from Bentley University’s Center for Integration of Science and Industry. BENTLEY UNIVERSITY Credit: Bentley University BENTLEY UNIVERSITY The U.S. National Institutes of Health (NIH) contributed $8.1
The Pharma Data
MAY 27, 2022
billion in Medicare funds in 2019 on drugs whose clinical benefits have yet to be confirmed by the Food and Drug Administration, a new study led by researchers from the Johns Hopkins Bloomberg School of Public Health suggests. billion on 36 of these drugs across 55 indications in 2019. federal government spent an estimated $1.8
The Pharma Data
AUGUST 14, 2020
Clinical trial programme resumes after safety concerns. Novo Nordisk is set to resume the phase 3 clinical trials of concizumab in haemophilia A and B, with or without inhibitors, following a previous safety scare. The trials are expect to enrol approximately 293 patients from 32 countries.
52 
The Pharma Data
NOVEMBER 9, 2020
Almost two-thirds of participants in clinical trials to support U.S. drug approvals from 2015 to 2019 were outside the U.S., the FDA’s Center for Drug Evaluation and Research (CDER) said in a new report unveiled yesterday. Source link.
The Pharma Data
NOVEMBER 3, 2020
The agreement will fund Clover’s coronavirus spike protein-targeting vaccine candidate, SCB-2019, through licensing in China and distribution by COVAX, the World Health Organization-backed initiative aimed at supplying 2 billion doses of COVID-19 vaccines globally by the end of 2021 that CEPI is running. Earlier this year, CEPI provided $3.5
52 
Alta Sciences
MARCH 4, 2025
We are the leading organization in conducting substance abuse clinical trials, with principal investigators who collectively bring over 50 years of experience in the field of substance abuse, and with a team of physicians who have extensive expertise in identifying participants for substance abuse studies. Tags Clinical Trials Weight 16
Drug Target Review
NOVEMBER 1, 2023
2 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. 1-5 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. Andrew McCarthy Andrew is a Team Leader at EMBL Grenoble since 2007.
134 
FDA Law Blog: Biosimilars
JANUARY 15, 2024
FDA published a June 2019 guidance , which stated that manufacturers would not need to perform long-term studies or submit long-term data in PMTAs. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. FDA also directed manufacturers to produce detailed marketing plans.
115 
The Pharma Data
DECEMBER 5, 2020
.–(BUSINESS WIRE) December 5, 2020 — Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced new clinical data from its Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RAR?)
FDA Law Blog: Biosimilars
MAY 13, 2024
FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”
111 
The Pharma Data
AUGUST 28, 2020
The Phase 1 trial will be conducted by MindMed later this year and will be the first to investigate what happens when you mix the two drugs to work as a therapy. Coaster420. Researchers are set to investigate a combined dose of LSD and MDMA to treat patients undergoing psychotherapy.
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.
The Pharma Data
SEPTEMBER 8, 2020
Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS).
The Pharma Data
AUGUST 7, 2020
The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19. Dr. Francis S.
The Pharma Data
SEPTEMBER 12, 2020
Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.
52 
Drug Target Review
NOVEMBER 17, 2023
Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. CAR-NK cell trials only commenced in 2017 and most are still recruiting patients.
118 
The Pharma Data
MAY 31, 2022
the completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease (PD). Ph1 clinical trial is to evaluate the safety, tolerability, and?preliminary?efficacy?of The company was fully acquired by Bayer in 2019. AG, announced?the
52 
The Pharma Data
JANUARY 19, 2021
The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple- ascending dose (MAD) cohorts, respectively. This press release is provided “as is” without any representation or warranty of any kind. Source link.
The Pharma Data
NOVEMBER 5, 2020
Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.
52 
The Pharma Data
SEPTEMBER 25, 2020
Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. The full set of results will be published once the complete Phase 1/2a trial data are available.
The Pharma Data
DECEMBER 14, 2020
Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use. The Phase II SBIR grant is a follow-on 2–year award that will support testing of Alume’s fluorescent nerve targeting agent in an ongoing Phase 1/2 clinical trial in patients undergoing Head and Neck Surgery.
The Pharma Data
SEPTEMBER 23, 2020
September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. NEW BRUNSWICK, N.J., In the U.S.,
The Pharma Data
JANUARY 17, 2021
Aruvant has chosen Lonza to help develop and manufacture ARU-1801 for its upcoming pivotal trial. As we advance our gene therapy through clinical trials, this partnership signifies a critical milestone in the development pathway.” Once complete, Lonza will deliver cGMP material supply for the pivotal clinical trial.
52 
The Pharma Data
SEPTEMBER 29, 2020
. Sosei Heptares has received a $5m milestone payment from its strategic alliance partner Pfizer after the first subject in a clinical trial was dosed with a new drug candidate from the collaboration between the two companies.
FDA Law Blog: Drug Discovery
OCTOBER 2, 2023
Just as the original 1962 efficacy standard makes scientific judgment central to a determination of substantial evidence, the 1997 amendment makes scientific judgment central to a determination of what constitutes sufficient confirmatory evidence to substantiate a single adequate and well-controlled trial.
64 
The Pharma Data
JANUARY 31, 2021
Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.
52 
PLOS: DNA Science
OCTOBER 19, 2023
Last week DNA Science covered a setback in a clinical trial of a gene therapy for Duchenne muscular dystrophy (DMD). The two conditions and the therapeutic approaches differ, but their clinical trials illustrate the importance of selecting patients whose characteristics suggest that they are the most likely to respond.
105 
The Pharma Data
DECEMBER 1, 2020
(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the open-label Phase 2 COMET-TRD trial of AXS-05 in patients with treatment resistant depression (TRD). AXS-05 was well tolerated in the COMET trial.
52 
Agency IQ
APRIL 19, 2024
Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). set specific standards and expectations for discrete components of clinical trials (e.g.,
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.”. in July 2019, who have recently initiated a Phase 1 study with their formulation.
The Pharma Data
DECEMBER 20, 2020
Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. The primary objective of the trial is to evaluate the safety and tolerability of SAD and MAD of ALS-4 administered orally to healthy subjects.
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.
52 
The Pharma Data
NOVEMBER 4, 2020
. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.
Drug Target Review
MAY 18, 2023
Tedesco Distinguished Chair of Paediatric Haematology and Oncology, are collaborating as co-principal investigators on a new clinical trial, which has been awarded a $2.3 The trial represents an early-stage effort to determine the viability of this approach. million grant from the National Heart, Lung and Blood Institute.
80 
Eye on FDA
JULY 5, 2022
The most obvious impact is that of COVID-19 to recruiting and maintaining clinical trials. And then there is the fact that a number of clinical trials were being conducted either in Russian or in Ukraine prior to the outbreak of the war. This is not to say that the balance of the year might not make up for the slow first half.
The Pharma Data
SEPTEMBER 2, 2020
NICE concluded that clinical trial evidence shows that, for people with untreated advanced RCC, Bavencio plus axitinib increases how long people live without their disease getting worse compared with sunitinib, while early data also suggest the therapy increases survival. Source link.
Perficient: Drug Development
AUGUST 2, 2023
SVS is designed to work with a command line in the background and also provides an interactive interface in Visual Studio 2019. For learning purposes, you can request a trial license as well. Note: Sitecore TDS trial version is valid for 30 days. It provides all the features required for the serialization.
52
Expert insights. Personalized for you.
We have resent the email to
Are you sure you want to cancel your subscriptions?
Let's personalize your content