Kalydeco in R117H patients? As AdComm nears, Vertex drug faces doubts

Carly Helfand Vertex' orphan drug Kalydeco boasts a comparatively small patient pool that the drugmaker is trying to swell, with an eye on adding cystic fibrosis patients with the ...

Peg cancer drug prices to effectiveness, ’60 Minutes’ interviewee suggests

Tracy Staton On "60 Minutes," Dr. Peter Bach and Leonard Saltz deliver some sound bites that might get the general public talking–and politicians, too. FiercePharma ...

Alcobra says its ADHD drug works–as long as you don’t compare it to placebo

Damian Garde Alcobra is touting the benefits of its in-development ADHD treatment, saying the drug provided a statistically significant benefit over placebo–but only after the ...

NICE nixes Roche’s new leukemia drug Gazyvaro despite discount offer

Arlene Weintraub Roche just can't win with the U.K.'s drug price watchdog, the National Institute for Health and Care Excellence (NICE). In August, the agency decided the company's ...

Ascension hospitals bar Genentech reps after cancer drug distribution switch

Tracy Staton One hospital chain has struck back at Roche's Genentech unit for switching its top 3 cancer treatments to specialty distributors. Ascension Health, a Roman Catholic-based ...

Boehringer pairs its lung cancer drug with a vaccine in $600M tie-up with CureVac

John Carroll FierceBiotech News

Biota tanks as its flu drug comes up empty in Phase II

Damian Garde Biota Pharmaceuticals' slow trip downward continued Friday as the company disclosed that its its lead program, a flu treatment called laninamivir octanoate, failed ...

Lilly, Boehringer win FDA approval for once-rejected diabetes drug

Damian Garde After a manufacturing issue scuttled their first attempt, Eli Lilly and Boehringer Ingelheim have won the FDA's blessing to market their new diabetes drug, a late entrant ...

Keryx touts its kidney drug with an FDA decision around the corner

Damian Garde Keryx Biopharmaceuticals' in-development Zerenex helped reduce dangerous buildups of phosphorus in patients on kidney dialysis, meeting its goals in a Phase III study ...

Amgen’s kidney dialysis drug clears its first Phase III hurdle

Damian Garde Amgen's in-development treatment for patients on kidney dialysis met its primary and secondary goals in a late-stage trial, step one in the drug's three-part Phase ...

Concert’s spasticity drug gets out from under an FDA hold

Damian Garde The FDA has lifted a partial clinical hold on Concert Pharmaceuticals' treatment for spasticity, allowing the biotech to resume dosing in a Phase I trial. FierceBiotech ...

Boehringer’s lung drug wins FDA ‘breakthrough’ tag

Damian Garde Boehringer Ingelheim's treatment for a rare and deadly lung disease picked up the FDA's coveted breakthrough therapy designation, a mark that guarantees a speedy ...
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