Since the disappointment of the Phase III MYSTIC trial failure earlier this year,...
- AstraZeneca’s Imfinzi looks to maintenance setting in advanced NSCLC to reverse fortunes
- MiMedx to initiate Phase IIb trial of AmnioFix for osteoarthritis
- Why are over half of newly-approved cancer drugs failing to deliver?
- Anacetrapib failure marks the death of the CETP class of cholesterol-lowering therapies
- Fulfilling the main unmet needs in prostate cancer will open the way for new ones
AstraZeneca’s Imfinzi looks to maintenance setting in advanced NSCLC to reverse fortunes
Since the disappointment of the Phase III MYSTIC trial failure earlier this year, AstraZeneca has redirected its efforts in non-small cell lung cancer to gaining approval in the second-line and maintenance settings.
MiMedx to initiate Phase IIb trial of AmnioFix for osteoarthritis
Biopharmaceutical firm MiMedx Group has obtained approval from the US Food and Drug Administration (FDA) for the initiation of its investigational new drug (IND) Phase IIb clinical trial of AmnioFix Injectable in patients with osteoarthritis of the knee.
Why are over half of newly-approved cancer drugs failing to deliver?
A recent study has found that only 43% of cancer drugs recently approved in Europe allowed patients to live longer, or improved their quality of life.
Anacetrapib failure marks the death of the CETP class of cholesterol-lowering therapies
Merck & Co recently decided not to apply for regulatory approval of anacetrapib, one of the last-standing drugs from the doomed cholesteryl ester transfer protein (CETP) class of cholesterol-lowering therapies.
Fiasp (insulin aspart) for the Treatment of Type 1 and Type 2 Diabetes
Discovered and developed by Novo Nordisk, Fiasp® (insulin aspart) is a fast-acting insulin analogue indicated for the treatment of adults with Type 1 and Type 2 diabetes.
Orphan Drug Designation for Argenx’s ARGX-113—Hopeful News for Myasthenia Gravis Community
On September 25, the FDA granted Orphan Drug Designation for Argenx’s lead clinical-stage product candidate, ARGX-113, for the treatment of myasthenia gravis (MG). The designation, which came one month after the EMA approval of the first complement-based therapy, Soliris, for the treatment of refractory generalized MG, is deemed welcoming and important news to the myasthenia gravis community, given the limited effective and sustainable treatments for this rare disease. ARGX-113 is also the second biologic that was granted the Orphan Drug Designation for the MG indication, and what makes this pipeline drug so attractive is that it targets a broader MG patient population, generalized MG (gMG), in comparison with Soliris’ smaller refractory gMG group, which is a clear bonus over its biologic competitor.
With $62M BARDA Contract Secured, the Future for Summit’s Ridinilazole Looks Bright
After being recently awarded a contract worth $62M from the US government’s Biomedical Advanced Research and Development Authority (BARDA), Summit Therapeutics has achieved a significant step toward initiating its clinical research program just seven months after outlining plans for Phase III trials for its developmental Clostridium difficile antibiotic, ridinilazole. With this news, the company looks well-positioned to kick-off its Phase III trials in H1 2018, thus securing ridinilazole’s position as the second most advanced developmental antibiotic for CDIs, behind Actelion’s cadazolid.
Kura Oncology may hold hope for mutant HRAS head and neck cancer patients
Kura Oncology Inc., a clinical-stage biopharma company focused on the development of precision medicines, has announced positive top-line results from a Phase 2 trial for its lead candidate, tipifarnib, in patients with HRAS-mutant relapsed or refractory squamous cell head and neck cancer (HNSCC).
Fulfilling the main unmet needs in prostate cancer will open the way for new ones
Among the current unmet needs in prostate cancer, the lack of therapeutic options for non-metastatic castration-resistant prostate cancer (nmCRPC) patients and the need to delay the onset of castration-resistant disease in metastatic hormone-naïve prostate cancer (mHNPC) are two of the most pressing ones.
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