FDA leaves biosim trial data off product labels in new guidance

Carly Helfand The FDA is out with new guidance for labeling biosimilar drugs–and it may not make some drugmakers happy. Regulators dismissed pharma's request that ...

UPDATED: A patient in Akashi’s suspended Duchenne MD trial dies

John Carroll A little more than a week after Cambridge, MA-based Akashi Therapeutics suspended its study of a new drug for Duchenne muscular dystrophy after a patient was sent to the ...

UPDATED: OncoMed hits the brakes on PhII pancreatic cancer trial, shares plummet

John Carroll OncoMed slammed the brakes on a Phase II study of the cancer stem cell drug tarextumab, citing worsening response rates in the drug arm for pancreatic cancer, with red ...

Amgen’s Kyprolis wins ‘backbone therapy’ FDA nod after trumping Velcade in trial

Carly Helfand Back in March, Amgen's Kyprolis posted impressive results in a head-to-head trial with Takeda behemoth Velcade–and now, those results have helped it grab an ...

Vasopharm taps investors for €20M to fund PhIII trial of brain injury treatment

Nick Paul Taylor Vasopharm has emerged from talks with investors armed with €20 million ($ 22 million) to hustle its treatment for traumatic brain injury through Phase III. The ...

J&J halts a depression program in the shadow of fatal French trial

Damian Garde In the wake of a disastrous French clinical trial that left one volunteer dead, Johnson & Johnson has voluntarily suspended development of a similar drug until more ...

French drug trial disaster leaves patient dead amid a slew of unanswered questions

Damian Garde The patient left brain-dead in last week's botched drug trial has died, French authorities said, spurring more questions about how a routine Phase I study went awry ...

Botched drug trial leaves one patient ‘brain-dead,’ 5 hospitalized

Damian Garde A botched Phase I trial has left 6 patients in serious condition with one effectively "brain-dead," according to the French government, which has opened an investigation. FierceBiotech ...

Federal judge declines to toss Paxil suicide case, setting GSK up for September trial

Tracy Staton GlaxoSmithKline will have to go to court to fight claims that a generic version of its Paxil antidepressant triggered an Illinois man's suicide. U.S. ...

Cardiorentis raises $60M as PhIII heart failure trial nears completion

Nick Paul Taylor Cardiorentis has raised CHF 60 million ($ 60 million). The investment bolsters the biotech's bank balance at a time when it is nearing the end of a Phase III trial ...

Amgen’s PCSK9 outcomes trial to deliver data sooner than expected

Tracy Staton The wait for outcomes data on Amgen's PCSK9 drug Repatha just got shorter. As CardioBrief reports, top-line results of a study called Fourier will be available in the ...

With Big Pharma backing, eFFECTOR plots solid tumor trial with $40M round

John Carroll More than two years after landing a hefty launch round, San Diego-based eFFECTOR Therapeutics has scooped up a $ 40 million financing from an expanded group of investors, ...
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