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.
DynPort’s clinical stage recombinant Yersinia pestis rF1V plague vaccine to benefit from FDA Orphan Drug Designation FALLS CHURCH, Va., March 8, 2017 /PRNewswire/ — CSRA Inc. (NYSE: CSRA) today announced that […]
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.
Lonza is hosting a free 60-minute webinar on March 21, 2017, titled “Hepatocytes in the Drug Development Pipeline.”
TrialScope, the global leader in clinical trial transparency and compliance solutions, announced the launch of the Trial Results Summaries Portal. Through the publicly accessible website, clinical trial sponsors can inform and educate trial participants and the general public about trial results through a non-promotional and unbiased venue.
Proof-of-concept study in first-line mRCC (a type of kidney cancer) shows that Tecentriq and Avastin can be combined with a manageable safety profile.
Celgene Corporation announced that its phase III SUNBEAM trial, evaluating the efficacy and safety of ozanimod – an investigational oral, selective S1P 1 and 5 receptor modulator – in patients with relapsing multiple sclerosis (RMS), met the primary endpoint in reducing annualized relapse rate (ARR), compared to weekly interferon (IFN) β-1a (Avonex).
AstraZeneca announced positive results from its Phase III OlympiAD trial comparing LYNPARZA (olaparib) tablets (300mg twice daily) to physician’s choice of a standard of care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2 mutations.
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.
The New Jersey Rare Disease Alliance will hold its annual Rare Disease Day commemoration on February 27 at the New Jersey Business and Industry Association (NJBIA).