Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Takeda's norovirus vaccine misses endpoint in early-phase trial

When Takeda bought LigoCyte Pharmaceuticals last year, it hitched the near-term fate of its nascent vaccine unit to a jab for the vomiting and diarrhea bug, norovirus. This week, exactly one year after moving to buy LigoCyte, Takeda revealed the vaccine missed its primary endpoint in an early-phase trial.

Shutdown halts NIH drug trials as researchers hit brakes on preclinical research

The National Institutes of Health normally enrolls about 200 patients a week in ongoing trials of experimental therapies. Now, with about 73% of NIH staff sitting at home, the agency can't begin any new studies, forcing researchers to turn patients away.

Quintiles looks to biomarkers to speed up cancer trials

Quintiles, the world's largest CRO, has launched a study to determine whether preprofiling cancer patients for key biomarkers can ease trial enrollment and speed drug development.

NIH expands vaccine clinical trial network

Over their 50-year history, the National Institutes of Health's (NIH) Vaccine and Treatment Evaluation Units (VTEUs) have shaped immunization policy by stepping up when industry can't--or won't--run trials. This week, NIH reiterated its belief in the model by expanding its network.

AstraZeneca CEO celebrates 1st anniversary with promising lung cancer data

The promising early results on AstraZeneca's lung cancer drug AZD9291 won't convince anyone that the troubled company is on the turnaround trail, but it's a step in the right direction in what CEO Pascal Soriot promises will be a slow but steady reversal of its misfortunes.

Quintiles jumps into personalized medicine for cancer trials

Quintiles has kicked off a study to determine whether early genomic profiling of cancer patients can help inform physician decisions and match the right participant with the right study, a method the CRO said could speed up the development process of personalized drugs.

Achillion shares crushed in a rout as hep C blockbuster hopes fade

After the market closed on Friday, Achillion spread the word that the FDA is maintaining its clinical hold related to its once-hot hepatitis C drug sovaprevir, while distributing some unimpressive data on its combination approach.

Relypsa pitches $126M IPO as lead CKD drug nears moment of PhIII truth

Just weeks away from reporting key endpoint data from a Phase III trial of its lead therapy, Relypsa has mapped out plans to go public, shooting for a $126.5 million payday to help complete a prospective transformative leap into marketing.

Roche's new round of lung cancer data keeps spotlight on immunotherapies

Researchers have posted early-stage data demonstrating that Roche's PD-L1 drug MPDL3280A--which takes the blinders off the immune system to spur an attack on cancer--scored a hopeful 26% response rate among a small group of non-small cell lung cancer patients who smoked.

Nektar Therapeutics shares crash on PhII pain drug trial flop

Shares of Nektar Therapeutics took a nasty plunge Thursday evening after the biotech failed to convince investors that the Phase II flop of a top pain drug didn't tarnish the program's promise.