Amgen and its Big Pharma partner AstraZeneca have roped in another round of promising Phase III plaque psoriasis data for their IL-17 blockbuster contender brodalumab, which beat Johnson & Johnson's big earner Stelara in a head-to-head study.
Shares of Threshold Pharmaceuticals jumped about 10% this morning on news that the FDA is granting fast-track status to TH-302, the company's sole therapy now in a pair of late-stage cancer studies.
Regeneron and its close partner Sanofi have cleared the final mid-stage hurdle for dupilumab in asthma patients, with several doses hitting the trial endpoint both for a subset of patients as well as the broad population. And the ambitious development team at Regeneron now plans to hustle into a pivotal late-stage program as they continue to make swift progress with a drug that promises to tackle a trio of conditions that share a core inflammatory trigger.
ArQule's badly battered shares managed a quick surge this morning on news that the biotech's lead drug tivantinib scored a positive outcome in a Phase II metastatic prostate cancer study.
Sage Therapeutics has successfully resolved a rare seizure disorder among the majority of patients in its small but closely watched Phase I/II study, adding more promising outcomes to the early evidence that helped inspire one of this year's most successful biotech IPOs. In the data update out Monday morning investigators say the 73% overall response rate in their study is also being mirrored among a small group of patients who are receiving the drug on an emergency-use basis.
After sending out signals that it might be running into trouble with a short-duration study of a new triple combination drug for its hepatitis C regimen, Merck investigators hailed the clear success of an 8-week test but confirmed analysts' fears in a batch of 4-week data released at the meeting of the American Association for the Study of Liver Diseases.
PPD has expanded its relationship with eClinical outfit Medidata, combining technologies in risk-based monitoring to help sponsors use real-time safety data to make decisions on clinical trials.
Expanded results from Sanofi's Latin American Phase III dengue vaccine trial are here, and the pharma giant says they confirm the high efficacy against severe dengue and the reduction in hospitalization the jab posted in its first Phase III study. And with these in tow, the company says it could have the vaccine to market by the second half of next year.
Next-generation hepatitis C drugs may be breaking revenue records now, but eventually a vaccine to prevent the disease could cut into the cash cows' market share. That candidate might come from GlaxoSmithKline, whose hepatitis C vaccine just passed an early test, generating strong and broad immune responses not seen before against the transmissible liver disease.
Nymox Pharmaceutical is headed for a bruising opening this morning after putting out word on Sunday that both their late-stage studies of their lead drug flopped as a treatment for enlarged prostate. Partnered with Italy's Recordati, the biotech put out a brief statement blaming the failure on an unexpectedly high placebo response.