Martin's tenure has seen the company build blockbuster revenue from its HIV franchise while creating a new standard of care in the hepatitis C arena.
San Diego startup CURx has paid an undisclosed sum to license an antiobitic developed by Gilead, planning to launch a Phase III trial on the drug to treat lung infections in cystic fibrosis patients.
In an interview with Bloomberg, COO John Milligan says the big biotech outfit--which is expected to generate megablockbuster revenue from the newly approved Sovaldi for hep C--is pondering a head-to-head study to determine whether Letairis is better or worse than Actelion's recently approved lung drug Opsumit.
Right on schedule, Gilead Sciences has submitted its combination hepatitis C treatment for FDA approval, inching toward the era of interferon-free treatment and widening its lead on rival AbbVie.
Gilead unveiled a package of stellar late-stage cure rates for its closely-watched hepatitis C combination of the newly approved "nuke" Sovaldi (sofosbuvir) and the NS5A inhibitor ledipasvir, putting it on a short path to the FDA with a new drug application planned for the first quarter of the coming year.
Carl June and the Novartis/Penn team weren't the only players to grab the spotlight at the global gathering of hematology experts at the big American Society of Hematology meeting in New Orleans. Several companies touted new data for their therapies over the weekend, and FierceBiotech focused on a roundup of the news related to some top contenders in the field.
The FDA has stamped its approval on sofosbuvir for hepatitis C, perhaps one of the most anticipated new drugs of the year. Gilead's therapy, which will be marketed as Sovaldi, will open the door to a new generation of treatments that don't require interferon--freeing patients from an arduous regimen tied to a host of nasty side effects.
As Gilead nears a virtually guaranteed FDA approval for the hepatitis C-fighting sofosbuvir, the biotech is facing intellectual property challenges from a bevy of competitors, most recently Idenix Pharmaceuticals, which claims the blockbuster hopeful infringes on its patents.
Gilead Sciences is sprinting toward FDA approval with the promising idelalisib, a targeted cancer therapy that met all its Phase III endpoints, giving the company another boost in the competitive landscape for chronic lymphocytic leukemia treatments.
Gilead's sofosbuvir appears headed for a quick if not early approval from the FDA, which would set it firmly on a path to a megablockbuster market, with a wide variety of analysts estimating peak annual sales at $5 billion-plus.