Clinical Trials

Latest Headlines

Latest Headlines

Amgen, Cytokinetics say that oral omecamtiv mecarbil looks positive in PhII heart study

A little more than two years ago Amgen and its partner Cytokinetics were hit by a backlash as their IV version of the heart drug omecamtiv mecarbil failed a key Phase IIb trial for heart disease. A follow-up study of an oral version of the drug, though, proved positive, the partners announced over the weekend, opening up a potential path forward into late-stage studies.

Bavarian Nordic announces PhI data for new cancer vaccine candidate

Bavarian Nordic makes most of its money from its smallpox business, but it is working to expand its reach with moves in the cancer vaccine arena. Toward that end, the Danish company announced on Tuesday the results from a National Cancer Institute-sponsored Phase I study of its new cancer vaccine candidate, MVA-BN Brachyury.

GSK forms Keytruda combo trial pact as it plots path to 20 filings by 2020

GlaxoSmithKline has struck a deal to trial its anti-OX40 monoclonal antibody in combination with Merck's Keytruda. The Phase I study is part of a slate of programs that GSK is hoping will support filings for up to 20 new drug approvals in the coming years, the success rate of which will go a long way to deciding whether the company can bounce back from its recent travails.

AstraZeneca's olaparib looks promising for a targeted set of prostate cancer patients

Scientists in the U.K. say that AstraZeneca's drug olaparib, approved by the FDA late last year to treat ovarian cancer and sold as Lynparza, has demonstrated distinct signs of efficacy in a small and very targeted group of prostate cancer patients who share a distinct type of genetic mutation.

The top 10 biopharma pipeline disasters of 2015

Drug R&D is a tough business. The odds are almost always against success, and the price to be paid for being wrong is cruelly high. That said, it did seem a little harder than usual this year to...

Macrocure on the ropes after its latest crushing failure in regenerative medicine

Israeli biotech Macrocure posted another clinical failure for its blood cell-derived regenerative medicine, a final blow that has management pondering how to move forward with what cash the company has left.

Intercept's much-hyped NASH drug misses the mark in Phase II

Intercept Pharmaceuticals' new drug for the pervasive liver disease NASH came up short in a Phase II trial in Japan, seeding some worries about an ongoing late-stage study designed to support future FDA approval.

GSK reports PhIII success for shingles jab, will file for approval in late 2016

Merck's Zostavax is the only shingles vaccine approved in the U.S. and EU, but it may not be for long. Based on results from two Phase III trials involving more than 16,000 older adults, GlaxoSmithKline plans to submit a regulatory filing for its shingles candidate, dubbed Shingrix, in North America, Japan and the EU in the second half of 2016.

GlaxoSmithKline's cardio R&D group records another big PhIII flop

More than a year after its second big Phase III program for darapladib also turned out to be a bust, GlaxoSmithKline is reporting today that losmapimod--cited by CEO Andrew Witty as a top late-stage program--failed to measure up in the first leg of a clinical marathon. And it's not planning to fund step two.

Merck's star oncology drug posts mixed results in a lung cancer trial

Merck's immuno-oncology treatment Keytruda met just one of its two goals in a late-stage lung cancer trial, a rare clinical hiccup as it works to keep pace with rival Bristol-Myers Squibb and fortify its position as more contenders move toward the market.