Cabozantinib provided a statistically significant and clinically meaningful improvement versus placebo in overall survival at the planned second interim analysis for the population of second-line and third-line patients enrolled in the CELESTIAL study.
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.
Eiger BioPharmaceuticals Inc. will stop development of a drug to treat pulmonary arterial hypertension after it failed in a mid-stage study.
Odonate Therapeutics Inc. announced that it has initiated CONTESSA, a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with locally advanced or metastatic breast cancer.
Shares of Celgene plunged after the company announced Revlimid combined with Biogen’s Rituxan failed in a late-stage study of previously untreated patients with follicular lymphoma.
Shire’s experimental treatment SHP609 to address cognitive impairment in pediatric patients diagnosed with the rare disease known as Hunter syndrome failed a key trial.
Allergan and Gedeon Richter’s drug cariprazine to treat severe bipolar depression in adults met the main goal of a late-stage study.
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.
2017 has shaped up to be a bumper year for drug approvals, with U.S. officials clearing twice as many novel medicines as in 2016, yet returns on research investment at leading pharmaceutical companies are down.
At the American Society of Hematology meeting, Genentech revealed long-term data showing the drug maintains its efficacy over an extended period of time.
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.