Merck & Co.’s Keytruda came up short in a pivotal study as a second-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma.
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.
At the American Society of Hematology meeting, Genentech revealed long-term data showing the drug maintains its efficacy over an extended period of time.
The DUO study showed statistically significant PFS improvement for duvelisib versus standard of care treatment ofatumumab.
Eli Lilly & Co.’s Cyramza met the main study goal but failed to improve survival rates in a late-stage trial for gastric cancer.
Pfizer’s talazoparib for advanced breast cancer was demonstrated to be superior to chemotherapy in a late-stage study.
Roche scientists may have discovered why some tumors resist new immunotherapy drugs as well as a possible means of turning the tables to incite a T-cell attack.
Sage Therapeutics Inc.’s drug to treat patients with moderate to severe depression met the main goal in a mid-stage study.
Sanofi’s Toujeo met the primary study objective in the first large head-to-head clinical trial, called BRIGHT study, comparing Toujeo with insulin degludec.
Sanofi SA ended development of an experimental vaccine for Clostridium difficile infection.
Bristol-Myers Squibb announced that the company’s Phase III trial pitting Opdivo against chemotherapy drug docetaxel in treating certain lung cancer patients was stopped early after meeting key endpoints.
Amgen unveiled results from a late-stage study that shows the company’s Phase III drug Aimovig reduced monthly migraine attacks in half.
Germany’s Merck KGaA suffered a setback in the development of the company’s key cancer immunotherapy Bavencio, which failed in a trial to prolong lives in gastric cancer patients when compared with standard chemotherapy.
Ardelyx decided to shutter development of RDX7675 – an experimental medicine for hyperkalemia – including the onset-of-action trial and Phase III studies.
Cytokinetics Inc. will stop developing one of its treatments for ALS – which afflicts Stephen Hawking – after the drug failed in a late-stage trial, sending the company’s shares tumbling about 35 percent.
Roche shares were lifted by two clinical trial wins for its new cancer and hemophilia drugs, potential blockbusters that the Swiss drugmaker is counting on to offset shrinking revenue from older medicines.
Argos Therapeutics announced positive interim data for the company’s kidney cancer drug Rocapuldencel-T from a Phase III clinical trial.
U.S. researchers have used nanotechnology plus the powerful CRISPR-Cas9 gene editing tool to turn off a key cholesterol-related gene in mouse liver cells.
Otonomy announced the success of its AVERTS-2 Phase III clinical trial of Otividex in patients with Meniere’s disease.
Sage Therapeutics Inc.’s postpartum depression drug succeeded in two late-stage studies, paving the way for it to bring to market the first FDA-approved treatment for the disorder.
J&J’s blockbuster psoriasis drug Stelara led to a significant reduction in disease activity in patients with systemic lupus compared with a placebo in a mid-stage clinical trial.