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.
For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.
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.
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.
Three times is not the charm. New York-based Ophthotech Corporation announced that its Fovista (pegpleranib) failed yet another Phase III clinical trial.
Sleep may not be controlled only by the brain according to research led by Morehouse School of Medicine
A recently released study from a team led by Morehouse School of Medicine shows that the process controlling sleep may not lie totally in the brain.
Drugmaker Eli Lilly and Co. said its acute migraine drug lasmiditan succeeded in a key late-stage study, setting the stage for U.S. regulatory approval.
U.S. scientists have succeeded in altering the genes of a human embryo to correct a disease-causing mutation, making it possible to prevent the defect from being passed on to future generations.
Merck’s vaunted PD-1 inhibitor Keytruda suffered another setback when it failed to meet endpoints in a Phase III head and neck cancer study.
(Reuters) – European regulators on Friday recommended approving Pfizer Inc and Merck KGaA’s immuno-oncology drug Bavencio to treat a rare type of skin cancer called Merkel cell carcinoma. In May, Bavencio was approved by the U.S. Food and Drug Administration to treat bladder cancer and in March to treat Merkel cell carcinoma. (bit.ly/2vIbPPG) Bavencio, known […]
ZURICH (Reuters) – A European Medicines Agency (EMA) panel recommended on Friday approval of a new Novartis drug to be used against a tough-to-cure form of blood cancer as the Swiss drugmaker makes headway on refreshing its oncology portfolio. The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed Rydapt against acute myeloid leukemia […]
Vertex Pharmaceuticals announced positive efficacy data from its Phase I and Phase II studies of three different triple combination regimens for cystic fibrosis patients,
NKTR-181 shows significantly less abuse potential compared to oxycodone.
The FDA approved Puma Biotechnology’s breast cancer drug Nerlynx (neratinib).
The FDA is tackling a new way to recruit top talent — talent that will fill a “substantial” number of vacant position.
People hoping to lose a few pounds by substituting artificial sweeteners for regular sugar may end up disappointed, suggests a fresh look at past research.
Fueled by a desire for innovation and new medical breakthroughs, the biotech industry continues to enjoy substantial growth due to increased investment in R&D.
FDA placed a clinical hold on three trials studying Merck’s PD-1 inhibitor Keytruda in combination with products developed by Celgene following Merck’s initial reporting of several patient deaths.
Bristol-Myers Squibb announced promising interim data from its Phase III clinical trial of Opdivo 3 mg/kg compared to 10 mg/kg Yervoy in melanoma.
AstraZeneca and Hutchison China MediTech said they had initiated a global late-stage clinical trial of the experimental drug savolitinib in a relatively rare type of kidney cancer.
Alder BioPharmaceuticals’ late-stage study data on its experimental treatment to prevent episodic migraine fell short of investors’ expectation.