Topic:

Clinical Trials

Latest Headlines

Latest Headlines

UPDATED: Biotech upstart Sage sees early efficacy for rare brain seizure drug

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.

UPDATED: Merck's hepatitis C cocktail drug fails a 4-week challenge

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 teams up with Medidata on risk-based monitoring

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.

Sanofi, armed with more strong PhIII dengue data, sets sights on 2015 rollout

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.

Glaxo hep C vaccine delivers promising early results

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.

UPDATED: Nymox blasted as lead drug flops in twin PhIII enlarged prostate studies

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.

Bristol-Myers' nivolumab impresses once again--this time in crucial lung cancer study

Bristol-Myers Squibb's closely watched checkpoint inhibitor nivolumab managed to wow analysts this morning with impressive survival results in a Phase II study of patients with advanced squamous cell non-small cell lung cancer. Of all the patients in the drug arm, 41% were alive at the one-year mark, while investigators tracked an overall response rate of 15%.

Chimerix hammers out an emergency PhII Ebola study for antiviral

Chimerix has outlined plans for a small Phase II study of its powerful antiviral brincidofovir as a counterpunch to Ebola.

Receptos' lead drug scores another promising PhII--this time for ulcerative colitis

San Diego-based Receptos is on a roll. After the markets closed on Monday, the biotech spread the word that its mid-stage trial for lead drug RCP1063 hit its primary endpoint for spurring remissions and clinical responses among patients suffering from ulcerative colitis in the trial. And the results quickly spurred a 37% spike in its share price, which follows a similar surge when the same drug hit its marks in a mid-stage trial for multiple sclerosis back in the summer.

UPDATED: Akebia craters as adverse events cloud positive PhIIb anemia data

Procter & Gamble spinoff Akebia Therapeutics rolled out a batch of promising Phase IIb efficacy data for its experimental anemia drug today, but investors who came in early this year to back the biotech's IPO in the belief that it holds the key to a potential blockbuster were dinged with signs of safety issues.