Topic:

Clinical Trials

Latest Headlines

Latest Headlines

GlaxoSmithKline shutters lung cancer vaccine study on latest MAGE-A3 setback

Just days after announcing that investigators had red-flagged a high-profile Phase III study of the cancer vaccine MAGE-A3 after failing to hit two primary endpoints for non-small cell lung cancer, GlaxoSmithKline has decided to bring a last-stab effort to find a subpopulation of patients who could benefit from the therapy to a halt. GSK says it was not possible to find a genetically defined group of patients who responded.

Danish trial results show stem cells improve failing hearts

Results from a clinical trial of 59 patients with chronic ischemic heart disease and severe heart failure found that a new stem cell treatment improved heart pump function compared to the placebo group.

UPDATED: GlaxoSmithKline's darapladib team finds hope in a PhIII bomb

No matter how badly a drug fails in Phase III, investigators and the companies that employ them often bend over backward to highlight any positive sign of efficacy, no matter how weak the signal. And GlaxoSmithKline's team at the American College of Cardiology meeting over the weekend was in full spin mode with their heart drug darapladib.

Parexel eyes Asian trials with Singapore expansion

Parexel is stretching its global network of clinical trial supply operations with a new distribution center in Singapore, bringing the facility online to better support studies across the globe.

J&J trumpets early success for 3-month Invega Sustenna PhIII schizophrenia trial

J&J wrapped a Phase III study of a 3-month formulation of Invega Sustenna early after an independent monitoring group called it on positive efficacy data. That's good news for J&J as well as Alkermes, which provided their NanoCrystal delivery tech for the new-and-improved therapy.

Geron sinks as liver risks plague another imetelstat trial

A week after the FDA put a halt to Geron's in-house studies of the cancer drug imetelstat over toxicity concerns, the agency stepped in on a Mayo Clinic-run trial of the same treatment, citing familiar dangers and imposing a partial clinical hold.

GlaxoSmithKline's cancer vaccine MAGE-A3 suffers its second PhIII flop

Once a top Phase III program at the pharma giant, MAGE-A3 failed to hit a pair of primary endpoints for non-small cell lung cancer, its second failure since the melanoma flop that occurred in the first hurdle of the study reported last fall.

A renal cancer study fails and stock plunges, but Bionomics stays upbeat

If you take some time with Bionomics' release on the Phase II study of their lead cancer drug you'll see that the trial failed, with progression-free survival for a combo use of the therapy with Afinitor tracking closely to the same PFS rate for renal cancer as a control arm which was treated with Afinitor only. The investment community apparently managed to accomplish the heavy lifting, though, pushing shares for the Australian penny stock company down 30% after the data drop.

Upbeat review of PhII DMD trial earns Prosensa a big boost to shares

After the markets closed last night, Prosensa issued an upbeat self-assessment of its 48-week extension data from a Phase II study of its lead drug drisapersen for Duchenne muscular dystrophy.

Intercept scores a PhIII win for lead drug following Friday night frights

On Friday night Intercept Pharmaceuticals managed to rattle investors with a 10-K filing flagging a collection of serious cardiac adverse events recorded in a study of its lead drug OCA. But come Sunday morning, the biotech balanced out that bitter taste with an announcement that its Phase III trial had ended with positive data, setting up a regulatory filing for approval.