CLINSQUARE: CLINICAL RESEARCH COURSES
Thursday, February 6, 2025
CLINSQUARE: Clinical Rsearch Courses by LIFEPRONOW
Home Blog Page 148

Takeda collaborates with MiTest Health to Launch Innovative Disease Risk Prediction Tool to Redefine Crohn’s Disease Management

admin
-
0
Takeda collaborates with MiTest Health to Launch Innovative Disease Risk Prediction Tool to Redefine Crohn’s Disease Management

Dec 14, 2019: Takeda and MiTest Health LLC a pioneering health technology company, announced an exclusive partnership to optimize MiTest’s personalized risk and outcome prediction tool for the widespread use in patients with Crohn’s disease (CD).

The validated tool can help predict a patient’s individual potential risk for CD-related complications based on the clinical, serologic and genetic variables and create a visual report to support informed and shared decision-making with their healthcare providers.

Overwhelming complications from CD – such as fistulas, abscesses, strictures, and intestinal obstruction are common, so far the course of CD is highly variable and difficult to predict.

These validated predictive tool was developed by MiTest in 2014 and validated via analysis of a well-characterized cohort of adult patients with CD and predictive modelling and has been used on a limited basis in clinical settings to date.

Takeda will also provide support in scaling up and operationalizing the tool to be more broadly support providers and patients. https://www.takeda.com/en-us/newsroom/news-releases/2019/takeda-partners-with-mitest-health-to-launch-innovative-disease-risk-prediction-tool/

Horizon Therapeutics first FDA-approved medicine Teprotumumab for the Treatment of Thyroid Eye Disease (TED)

admin
-
0
Horizon Therapeutics first FDA-approved medicine Teprotumumab for the Treatment of Thyroid Eye Disease (TED)

Dec. 16, 2019: Horizon Therapeutics announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) voted collectively about the potential benefits of teprotumumab, a fully human monoclonal antibody (mAb), compensate the potential risks for the treatment of Thyroid Eye Disease (TED).

Thyroid Eye Disease is a rare, serious, progressive and vision-threatening autoimmune disease that is related with proptosis (eye bulging), diplopia (double vision), blurred vision, pain and facial disfigurement that can appreciably impact patient’s quality of life.

“TED can affect patients both physically and emotionally, limiting their ability in order to perform everyday activities like driving, working, reading, sleeping and participating in social activities”.

At present FDA is evaluating a Biologics License Application (BLA) for teprotumumab for the treatment of TED. https://ir.horizontherapeutics.com/news-releases/news-release-details/fda-advisory-committee-votes-unanimously-support-use

U.S. FDA Approved Avadel’s Nouress™ (AV001), a Cysteine Hydrochloride Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)

admin
-
0
U.S. FDA Approved Avadel’s Nouress™ (AV001), a Cysteine Hydrochloride Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)

Dec. 16, 2019: Avadel Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved NouressTM (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal patients requiring total parenteral nutrition (TPN).

Additionally, Avadel announced that the United States Patent and Trademark Office (USPTO) recently issued the United States Patent No. 10,493,051 covering cysteine solutions that includes the approved Nouress product (listed in the Orange Book for Nouress) and is set to expire in March of 2039.

This validates our strategy for developing innovative medicines for the patients. Nouress is the fourth FDA approved product in the sterile injectable hospital business. https://fda.einnews.com/pr_news/504993767/avadel-pharmaceuticals-receives-u-s-fda-approval-for-nouress-av001-a-cysteine-hydrochloride-injection-for-treating-neonate-patients-requiring

FDA approved Salarius’s Seclidemstat by Fast Track Designation for Lead Drug Candidate, in Relapsed or Refractory Ewing Sarcoma

admin
-
0
FDA approved Salarius’s Seclidemstat by Fast Track Designation for Lead Drug Candidate, in Relapsed or Refractory Ewing Sarcoma

Dec. 16, 2019: Salarius Pharmaceuticals announced that its lead investigational drug candidate, Seclidemstat(a potent reversible LSD1 inhibitor), has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Ewing sarcoma for the patients who have relapsed or are refractory to standard-of-care therapy.

Ewing sarcoma is a rare and deadly bone cancer that most often strikes children and young adults, for which there are no targeted therapies approved, Seclidemstat has demonstrated a potential to address this significant unmet need. https://fda.einnews.com/pr_news/504993934/salarius-pharmaceuticals-receives-fda-fast-track-designation-for-lead-drug-candidate-seclidemstat-in-relapsed-or-refractory-ewing-sarcoma

AstraZeneca completed an Agreement with Cheplapharm for rights to Seroquel and Seroquel XR in Europe and Russia

admin
-
0
AstraZeneca completed an Agreement with Cheplapharm for rights to Seroquel and Seroquel XR in Europe and Russia

Dec 16, 2019: AstraZeneca has completed an agreement with Cheplapharm Arzneimittel GmbH (Cheplapharm) to deprive its commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in Europe and Russia.

As per the terms of agreement, AstraZeneca has received a payment of $178m from Cheplapharm,may also receive future sales-contingent payments of up to $61m.

Future payment will be reported in AstraZeneca’s financial statements within the Other Operating Income & Expense in the fourth quarter of 2019.

In the year to 31 December 2018, the cumulative profit before tax referable to Seroquel and Seroquel XR in the relevant territories was $86m.

The deliberation was paid in cash and the profits will be used for general corporate purposes. Seroquel and Seroquel XR are atypical anti-psychotic medicines with antidepressant properties used for the treatment of schizophrenia and bipolar disorder. 

Seroquel XR is also approved in some markets for the major depressive disorder and generalised anxiety disorder.
https://www.astrazeneca.com/media-centre/press-releases/2019/agreement-with-cheplapharm-for-rights-to-seroquel-and-seroquel-xr-in-europe-and-russia-completed-16122019.html

Soligenix initiates phase 1C, double-blind, placebo-controlled, phase 1C trial of RiVax, a lyophilized ricin toxin A-chain subunit vaccine with alum-adjuvant

admin
-
0
Soligenix initiates phase 1C, double-blind, placebo-controlled, phase 1C trial of RiVax, a lyophilized ricin toxin A-chain subunit vaccine with alum-adjuvant

Dec 14, 2019 : Soligenix announced that it has opened the study titled “A phase 1C, double-blind, placebo-controlled, randomised study to evaluate the safety of RiVax, a Lyophilized Ricin Toxin A-Chain subunit vaccine with the Alum-Adjuvant, in healthy, normal adults.” initial safety results from the trial are expected in the second quarter of 2020 with longer-term safety and immunogenicity results from all the way through the 6-month follow-up period expected in the fourth quarter of 2020.

RiVax is the company’s vaccine candidate for the prevention of the death following exposure to a lethal dose of ricin toxin using a unique antigen that is totally devoid of the toxic activity of ricin.

The RiVax antigen has confirmed safety in two previous phase 1 clinical studies. When formulated by using Soligenix’s proprietary heat stabilization technology (ThermoVax), RiVax has demonstrated considerably enhanced thermostability and up to 100% protection in non-human primates (NHPs) in preclinical aerosol challenge models.

RiVax contains a genetically distorted version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule.

A phase 1A clinical trial was conducted with the formulation of RiVax that did not contain an adjuvant. This trial exposed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers.

The adjuvant-free formulation of RiVax induced toxin neutralizing antibodies that lasted up to 127 days after third vaccination in the several individuals. http://www.pharmabiz.com/NewsDetails.aspx?aid=119946&sid=2

ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir DTG 50mg film-coated tablet (FCT) in paediatric HIV patients

admin
-
0
ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir DTG 50mg film-coated tablet (FCT) in paediatric HIV patients

Dec 13, 2019: ViiV Healthcare announced that it has made regulatory submissions to both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in quest of approval of the first-ever 5mg dispersible-tablet (DT) formulation of dolutegravir (DTG), as well as a simplified dosing regimen in order to optimise the use of the existing DTG 50mg film-coated tablet (FCT) in paediatric HIV patients.

Paediatric HIV remains a global issue, with children suspiciously affected by the HIV epidemic. Latest statistics show that there are 1.7 million children living with HIV1, and the majority of AIDS-related deaths among children still occur during the first five years of life.

 Major obstacles keep on for the children, such as the availability of HIV testing, continued mother-to-child transmission, slow initiation of treatment and poor availability of optimised paediatric formulations of antiretrovirals.

These submissions to the EMA and FDA are based on the data from ongoing P10934 and ODYSSEY (PENTA20) studies.

Data to hold the submissions was generated from ViiV Healthcare’s collaborations by means of the U.S. National Institutes of Health (NIH) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) for P1093 and Paediatric European Network for Treatment of AIDS (PENTA) for ODYSSEY.

In order to maintain broad and more affordable access to optimised antiretroviral (ARV) formulations, ViiV Healthcare enables generic companies to manufacture and sell generic versions of paediatric DTG royalty-free in all least-developed, low-income, lower-middle-income and sub-Saharan African countries and also in some upper-middle-income countries through its voluntary licensing policy.

https://viivhealthcare.com/en-gb/media/press-releases/2019/december/viiv-healthcare-files-submissions-to-the-fda-and-ema-for-the-fir/

FDA Approved Amarin’s Vascepa For the cardiovascular problems, Shares Up 5%

admin
-
0
FDA Approved Amarin’s Vascepa For the cardiovascular problems, Shares Up 5%

Dec 13, 2019: Shares of Amarin Corp. jumped 5% on the extended trading session after the company said, it received approval to market its drug Vascepa for. U.S. Food and Drug Administration has approved Amarin’s new indication and label expansion for Vascepa capsules.

Now, it is the first and only drug approved by the FDA as an addition to maximally tolerated statin therapy in order to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with the elevated triglyceride levels and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for the cardiovascular disease. https://fda.einnews.com/article/504835618?lcf=8DWPqPuUsDVNDakfEIxsCA%3D%3D

Trastuzumab deruxtecan (DS-8201), accomplished the tumour response rate of 60.9% in pivotal Phase II HER2-positive metastatic breast cancer trial

admin
-
0
Trastuzumab deruxtecan (DS-8201), accomplished the tumour response rate of 60.9% in pivotal Phase II HER2-positive metastatic breast cancer trial

Dec 11, 2019: AstraZeneca and Daiichi Sankyo presented positive detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody-drug conjugate (ADC) and potential new medicine for the patients with HER2-positive metastatic breast cancer who received two or more prior HER2-targeted regimens. The primary endpoint of objective response rate (ORR) which was confirmed by independent central review found to be 60.9% with trastuzumab deruxtecan monotherapy (5.4mg/kg). About one out of five breast cancers are HER2-positive. Despite recent improvements and approvals of new medicines and there remains significant unmet needs for patients with advanced HER2-positive metastatic breast cancer. This disease remains inoperable with patients eventually progressing after currently available treatments.

HER2 (tyrosine kinase receptor growth-promoting protein) which is found on the surface of some cancer cells that are associated with aggressive disease and poor prognosis in breast cancer patients. https://www.astrazeneca.com/media-centre/press-releases/2019/trastuzumab-deruxtecan-achieved-a-tumour-response-rate-of-60-in-pivotal-phase-ii-her2-positive-metastatic-breast-cancer-trial-11122019.html

First Ever Randomized Phase 3 Clinical Trial (LIBRETTO-431) for the Treatment of Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

admin
-
0
First Ever Randomized Phase 3 Clinical Trial (LIBRETTO-431) for the Treatment of Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

Dec. 11, 2019: Eli Lilly and Company today announced the opening of the LIBRETTO-431 clinical trial for selpercatinib, also known as LOXO-292, for treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC) patients.

Trial participants will be randomized in order to receive either selpercatinib or platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab as initial treatment of their advanced or metastatic RET fusion-positive NSCLC.

“This is an significant milestone in order to further demonstrate the benefit of selpercatinib and also the potential for people living with advanced or metastatic RET fusion-positive non-small cell lung cancer in the first-line setting against the current standard of care”.

Selpercatinib (LOXO-292), is a highly selective and potent, oral investigational new medicine in the clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase.  https://investor.lilly.com/news-releases/news-release-details/lilly-opens-first-ever-randomized-phase-3-clinical-trial

EVENITY® (romosozumab) approved by European Commission (EC) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture

admin
-
0
EVENITY® (romosozumab) approved by European Commission (EC) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture

Dec. 11, 2019: Amgen and UCB announced that the European Commission (EC) has granted marketing authorization for EVENITY® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

EVENITY is a novel bone-builder with a dual effect that can increase bone formation and to a slighter extent reduces bone resorption (or bone loss).

EVENITY is an important step in the management of osteoporosis for physicians who need to treat patients with a medicine that can rapidly increase bone mineral density within 12 months.

The approval received in October 2019 follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The first launches of EVENITY in the European Economic Area (EEA) are planned for the first half of 2020.

EVENITY (romosozumab) is a bone-forming monoclonal antibody, designed to work by inhibiting the activity of sclerostin, which concurrently results in increased bone formation and to a lesser extent decreased bone resorption. https://www.amgen.com/media/news-releases/2019/12/european-commission-approves-evenity-romosozumab-for-the-treatment-of-severe-osteoporosis-in-postmenopausal-women-at-high-risk-of-fracture/

U.S. FDA OKs for Pfizer’s XELJANZ® XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis

admin
-
0
U.S. FDA OKs for Pfizer’s XELJANZ® XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis

Dec 12, 2019: U.S. Food and Drug Administration (FDA) has approved Pfizer’s  XELJANZ ® XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC), after an inadequate response or intolerance to TNF blockers.

Ulcerative colitis is a chronic inflammatory disease  that can significantly affect a patient’s quality of life and be emotionally oppressive due to symptoms, flares and complications.

XELJANZ/XELJANZ XR, indicated for the treatment of adult patients suffering with moderate to severe active UC, who have had an inadequate response or who are intolerant to TNF blockers.

XELJANZ ® (tofacitinib) is approved for adult patients with three indications: moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, active psoriatic arthritis (PsA) after disease modifying antirheumatic drug (DMARD) failure and moderate to severe  active ulcerative colitis (UC) after tumor necrosis factor inhibitor (TNFi) failure. https://www.oaoa.com/news/business/article_0f2d0780-5ba9-5766-b3ff-7a4b0317b5bd.html

1...147148149...156Page 148 of 156

EDITOR PICKS

POPULAR POSTS

POPULAR CATEGORY

ABOUT US

LifeProNow provides guidance and high quality contents to help job seekers to get their dream Job. All the contents are written by experienced folks and peer reviewed by experts.

Contact us: [email protected]

FOLLOW US

© LifeProNow | All Rights Reserved