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

John Carroll 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 ...

Muscular dystrophy drug from GlaxoSmithKline, Prosensa fails PhIII

John Carroll GlaxoSmithKline and Prosensa today conceded defeat in the Phase III study for drisapersen, one of two closely-watched therapies for Duchenne muscular dystrophy which had ...

Under FDA priority review, Mallinckrodt’s pain med succeeds in PhIII

Ryan McBride Mallinckrodt has rolled out upbeat data from a Phase III study of its experimental pain drug MNK-795 for quelling acute pain in patients after surgeries to remove their ...

In big setback, GlaxoSmithKline’s cancer immunotherapy MAGE-A3 flunks PhIII goal

John Carroll GlaxoSmithKline experienced a major R&D setback today, reporting that its targeted cancer immunotherapy MAGE-A3 failed its first co-primary endpoint in a Phase III ...

Otonomy banks $46M VC round for PhIII programs on inner-ear drugs

John Carroll When venture investor Jay Lichter developed an inner-ear affliction known as Ménière's disease, the available treatment was so crude and unreliable, ...

ESC spotlight: Daiichi trumpets edoxaban PhIII; Isis drug shines; Novartis upbeat on serelaxin

John Carroll The European Society of Cardiology meeting in Amsterdam produced some notable data for a slate of closely-watched heart drugs over the long weekend. FierceBiotech News

Teva scraps depression program for Nuvigil after latest PhIII flop

John Carroll Teva ($ TEVA) today announced that it will dump its depression program for Nuvigil (armodafinil) after the treatment failed its latest Phase III test in a comparison against ...

Low-profile Epirus lays claim to a PhIII success for Remicade biosimilar

John Carroll A low-profile startup in Boston backed by some marquee venture groups has posted positive data from a Phase III study of its biosimilar of Remicade, a blockbuster rheumatoid ...

Argos turns to unusual players for $42.5M needed to fund PhIII cancer study

John Carroll With a Phase III cancer immunotherapy study under way, Durham, NC-based Argos Therapeutics today put in place its fifth fundraising, banking $ 42.5 million from a big ...

GlaxoSmithKline ponders future of Crohn’s disease drug after PhIII flop

John Carroll One of GlaxoSmithKline's late-stage assets for Crohn's disease has failed a Phase III study, pushing the pharma giant to suspend patient recruitment in the ambitious ...

Questions on MannKind’s inhaled insulin PhIII data cloud Afrezza’s future

John Carroll Early yesterday MannKind's Phase III data for Afrezza looked like a big hit with investors. But after a second look at the trial results, analysts' enthusiasm–and ...

MannKind soars after inhaled Afrezza delivers positive PhIII results

John Carroll After being dogged by regulatory setbacks and demands for new trials, MannKind says it gathered clearly positive late-stage data on its inhaled insulin Afrezza from a pair ...
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