Versartis Inc. said the company’s experimental human growth hormone somavaratan failed to meet endpoints in a critical Phase III trial.
R&D success and M&A activity loom as large swing factors for the bio sector in 2017 with the regulatory arena potentially at its most amenable for years.
Nearly two decades ago, the promise of precision medicine began making its mark on the pages of medical journals – along with speculation that “therapy with the right drug at the right dose in the right patient” – would define the future of medical treatment.
There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.
Positive Phase III data were reported for Alnylam’s RNA interference treatment for hereditary ATTR amyloidosis with polyneuropathy.
Nabriva Therapeutics’ experimental antibiotic lefamulin for CABP met the main goal of a late-stage study.
Pfizer Inc. and Astellas Pharma Inc. said their drug to treat a type of prostate cancer met the main goal of improving overall survival in a late-stage trial.
Amicus Therapeutics terminated a late-stage wound-treatment therapeutic after it failed to meet primary and secondary endpoints in a Phase III trial.
Vertex Pharmaceuticals reportedly terminated a long-acting trial combining a recently acquired therapy with the company’s cystic fibrosis drug Kalydeco.
Sage Therapeutics Inc.’s shares tumbled 23 percent after its drug to treat a life-threatening seizure disorder failed to meet the main goal of a key trial.
London-listed drugmaker Shire successfully tested a new medicine that prevents attacks in patients with hereditary angioedema (HAE).
AbbVie announced positive top-line results from its Phase III clinical trial of upadacitinib (ABT-494) in moderate-to-severe rheumatoid arthritis patients.
The pharma landscape has significantly evolved in the last decade, especially when it comes to clinical trials.
Bristol-Myers Squibb’s immunotherapy drug Opdivo is a better and safer option than its older medicine Yervoy for treating melanoma patients who have had surgery to remove disease, researchers reported.
Two AstraZeneca drugs tackling lung cancer in different ways delivered impressive clinical results on Saturday, helping the British group offset July 2017’s big clinical trial setback in the disease.
French cell therapy specialist Cellectis, which is developing a gene-modified cancer treatment, was forced to suspend testing following a patient death.
Otonomy Inc. suspended developing its drug for Meniere’s disease, a chronic disorder of the inner ear, after it failed a late-stage trial.
An anti-inflammatory drug developed for cardiac patients has an exciting, yet unintended side effect – possible prevention of lung cancer.
Hearing impairment is already linked to a heightened risk of cognitive decline in old age, and a new study suggests that impaired vision may carry the same risk.
A Phase 3 study evaluating Ultragenyx Pharmaceuticals’ aceneuramic acid extended release in patients with GNE Myopathy did not achieve its primary endpoint.
Positive results were announced from Novo Nordisk’s SUSTAIN 7 Phase III trial comparing once-weekly semaglutide against Lilly’s Trulicity for type 2 diabetes.
Bristol-Myers Squibb released mixed top-line results from its Phase III CheckMate-214 clinical trial of Opdivo in combination with Yervoy for advanced or metastatic RCC.
Lexicon Pharmaceuticals Inc. announced additional positive data from the pivotal Phase 3 inTandem2 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor.