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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.
(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.
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.
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.
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.
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.
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.
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.
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.
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.
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. percent in the 68-week STEP-1 clinicaltrial.
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. Astellas in August last year announced it is beginning pivotal phase 3 clinicaltrials for fezolinetant, which could be considered a competitor although it only works against the NK3 receptor.
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?
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.
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. percent in the 68-week STEP-1 clinicaltrial.
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.
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.
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.
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.
These gut hormones are released in response to nutrient intake and play a crucial role in the incretin effect, which enhances insulin secretion. It’s the first and only approved dual agonist targeting both the GIP and GLP-1 receptors.
KEYTRUDA Now Approved for the Treatment of Patients With PD-L1-Positive, Hormone Receptor-Negative and HER2-Negative, Inoperable or Recurrent Breast Cancer. KEYTRUDA Approved for the Treatment of Patients With PD-L1-Positive, Hormone Receptor-Negative and HER2-Negative, Inoperable or Recurrent 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.
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.
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.
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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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.
(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.
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
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
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.
Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program.
The company’s menopause drug NT-814 is heading for phase 3 development in 2021 following a mid-stage trial readout. NT-814 is a non-hormonal drug that works on the neurokinin (NK) 1,3 receptor antagonist, thus treating the vasomotor symptoms associated with the menopause.
Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses in adults with type 2 diabetes after 40 weeks of treatment in Eli Lilly and Company’s (NYSE: LLY) SURPASS-1 monotherapy clinicaltrial evaluating the efficacy and safety of tirzepatide compared to placebo. mg, 5 mg and 7.5
The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells.
The new hub will focus on centralising things like clinicaldevelopment strategy, clinical operations, and regulatory approval strategy – not necessarily drug development itself. How big pharma tackles rare diseases.
FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomized, controlled trials (HARMONY CTP and HARMONY 1) from the clinicaldevelopment program for WAKIX. WAKIX may reduce the effectiveness of hormonal contraceptives. Adverse Reactions.
In recent years, the landscape of women’s health clinicaltrials has begun to shift. Beth Tulip, Senior Executive Director of ClinicalTrial Management at Medpace, also participated and shared key operational strategies for women’s health clinicaltrials.
Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinicaltrials across all phases, including Phase 3, in a variety of tumor types. Thyroiditis can present with or without endocrinopathy.
Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinicaltrials across all phases, including Phase 3, in a variety of tumor types. Thyroiditis can present with or without endocrinopathy.
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