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Ibutamoren mesylate is under clinicaldevelopment by Lumos Pharma and currently in Phase II for Growth Hormone Deficiency. According to GlobalData, Phase II drugs for Growth Hormone Deficiency have a 63% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. It is administered orally.
Two phase 3 trials of Merck & Co’s Keytruda in metastatic castration-resistant prostate cancer (CRPC) and advanced liver cancer have ended in failure, proving once again that cancer immunotherapy studies can be a hit-and-miss affair. The post Keytruda fluffs its lines in prostate, liver cancer trials appeared first on.
(LAI-287 + semaglutide) is under clinicaldevelopment by Novo Nordisk and currently in Phase III for Type 2 Diabetes. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
Ibutamoren mesylate is under clinicaldevelopment by Lumos Pharma and currently in Phase I for Turner Syndrome. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. It is administered orally.
The approvals include Keytruda plus chemotherapy as neoadjuvant treatment and then continued as a single agent for adjuvant treatment post-surgery in hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients. This approval is based on KEYNOTE-564 trial data.
Amgen announced positive results from a Phase II clinicaltrial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. The trial included 465 participants who were either obese or overweight.
With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinicaldevelopment pipeline and are expected to play a crucial role in the future of healthcare. Whether you’re considering a new study or need support with an ongoing trial, we’re here to partner with you.
Amgen announced positive results from a Phase II clinicaltrial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. The trial included 465 participants who were either obese or overweight. “We
On October 14th, Amolyt Pharma announced the first dosing in its Phase I trial of AZP-3601 in healthy subjects, a momentous occasion capping off years of hard work in pre-clinicaldevelopment. The drug aims to walk the biological tightrope in the management of hypoparathyroidism, a rare disease c.
Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinicaltrials. In CV clinicaltrials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.
At the beginning of this year, KaNDy completed a phase 2b trial of its first-in-class drug NT-814, showing activity against symptoms of the menopause such as hot flashes and night sweats. A phase 3 trial is expected to begin in 2021 and the company says that the compound could generate peak sales of more than a billion euros globally.
Buparlisib hydrochloride is under clinicaldevelopment by Adlai Nortye Biopharma and currently in Phase II for Mantle Cell Lymphoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
Rezvilutamide is under clinicaldevelopment by Jiangsu Hengrui Medicine and currently in Phase I for Liver Failure (Hepatic Insufficiency). Attributes of the drug, company and its clinicaltrials play a fundamental role in drug-specific PTSR and likelihood of approval.
Rezvilutamide is under clinicaldevelopment by Jiangsu Hengrui Medicine and currently in Phase III for Prostate Cancer. Attributes of the drug, company and its clinicaltrials play a fundamental role in drug-specific PTSR and likelihood of approval. Rezvilutamide overview Rezvilutamide is an antineoplastic agent.
Among these, rare pediatric diseases present unique challenges and opportunities for rare disease drug development. Pediatric growth hormone deficiency (PGHD) is one such condition, affecting a child’s growth and development. How does this stance influence your decision-making and the company’s approach to drug development?
Ecubectedin is a small molecule commercialized by Pharma Mar, with a leading Phase II program in Hormone Sensitive Breast Cancer. According to Globaldata, it is involved in 5 clinicaltrials, which are ongoing. It is administered through intravenous route. The drug candidate is a marine-derived compound.
Enzalutamide is under clinicaldevelopment by Pfizer and currently in Phase I for Relapsed Multiple Myeloma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. The findings were made via Lilly’s SURPASS phase 3 global clinicaldevelopment programme, which comprised studies ranging from 40 to 52 weeks.
These gut hormones are released in response to nutrient intake and play a crucial role in the incretin effect, which enhances insulin secretion. Participants were selected based on their prediabetic status, and the trial compared tirzepatide with a placebo.
Sym-021 is under clinicaldevelopment by Les Laboratoires Servier and currently in Phase I for Solid Tumor. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
(Lopinavir + ritonavir) is under clinicaldevelopment by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
(Lopinavir + ritonavir) is under clinicaldevelopment by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
Its lead candidate in clinicaldevelopment is VLS-101, an antibody-drug conjugate (ADC) targeting ROR1 that is being tested in a phase 1 and a phase 2 clinicaltrial for patients with blood cancer and solid tumours, respectively. The transaction is expected to close at the end of 2020.
Enzalutamide is under clinicaldevelopment by Pfizer and currently in Phase I for Myelofibrosis. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
Enzalutamide is under clinicaldevelopment by Pfizer and currently in Phase I for Relapsed Chronic Lymphocytic Leukemia (CLL). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
Prostate cancer has proved an elusive target for cancer immunotherapies, and Merck & Co’s checkpoint inhibitor Keytruda is the latest to fall short in the disease in a phase 3 trial. It remains ongoing with updated results due in the coming months.
Data presented at ENDO 2021 demonstrate clinically relevant weight loss, without weight regain, in people treated with semaglutide 2.4 Bagsværd, Denmark, 23 March 2021 – New results from the STEP phase 3a clinicaltrial programme demonstrated weight loss with investigational treatment of once-weekly subcutaneous semaglutide 2.4
According to Globaldata, it is involved in 24 clinicaltrials, of which 19 were completed, 2 are ongoing, 1 is planned, and 2 were terminated. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinicaldevelopment failing to progress.
Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. All patients in the trial received a HER2 test, and the results were centrally confirmed. The data will be presented at a forthcoming medical meeting and shared with global health authorities.
For example, pediatric growth hormone deficiency (PGHD) affects approximately one in 3,500 to one in 10,000 children. Existing therapeutic options for PGHD consist of injectable formulations of recombinant human growth hormone (rhGH), administered subcutaneously either on a daily or weekly basis.
KEYTRUDA Now Approved for the Treatment of Patients With PD-L1-Positive, Hormone Receptor-Negative and HER2-Negative, Inoperable or Recurrent Breast Cancer. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck Research Laboratories.
AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.
Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. Earlier clinical evidence showcased administration of the therapy resulted in a statistically significant and dose-proportional increase in body weight.
The buildup in adrenal glands leads to the insufficient hormonal response, thus leading to several of the symptoms such as deficiency of steroid hormones (mainly cortisol and aldosterone), impaired cortisol secretion, and others that are harbingers of the disease. The disorder can occur at any stage of life and vary with severity.
The American Society of Clinical Oncology (ASCO) annual conference was one of the highlights of the year in cancer research and the fact it was held virtually did not distract from some stunning clinical lung cancer trial results presented by AstraZeneca. months, compared with 6.7 months in patients treated with chemotherapy.
If successful, this trial could pave the way for a New Drug Application (NDA) submission. Enveric is set to file an Investigational New Drug (IND) application by the third quarter of 2025, with plans to start clinicaldevelopment by the end of the year.
.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.
The positive CHMP opinion is based on results from the STEP phase 3a clinicaltrial programme. Across the trials in people with obesity or overweight without type 2 diabetes, an average weight loss of 17-18% 1 sustained over 68 weeks was reported for those treated with Wegovy. About Wegovy ( s e maglutide 2.4
By the end of the year, we expect to have five independent TransCon product candidates in clinicaldevelopment leveraging TransCon technologies through our algorithm for product innovation. Pipeline Updates.
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(NYSE: PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. Chief Scientific Officer for Oncology Research and Development at Pfizer.
The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(
The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints. had fatal outcomes.
At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients.
The findings bolster the idea, which is currently under investigation in at least three clinicaltrials, that when it comes to treating resistant breast cancer, two drugs may be better than one.
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