Inspire modifies denufosol Phase III trial for Cystic Fibrosis

Inspire Pharmaceuticals have announced modifications to the clinical protocol for TIGER-2, the Company’s ongoing second Phase 3 trial with denufosol tetrasodium for the treatment of cystic fibrosis (CF).

Vanda receive non approvable letter for Iloperidone

Vanda Pharmaceuticals have received a not approvable letter from the US FDA for iloperidone, an atypical antipsychotic under development for schizophrenia. The FDA expressed concern about the efficacy of iloperidone in patients with schizophrenia relative to the active comparator, risperidone (Risperdal(R), Johnson & Johnson), used in prior studies.

NexMed receive non approvable letter for topical alprostadil

NexMed have received a non approvable letter from [...]

Astellas publish series of Beta 3 adrenoceptor agonsits

Astellas have published a series of adrenoceptor Beta 3 agonists

EU gives positive opinion on EpiCepts Ceplene in AML

EpiCept have received a positive opinion from the CHMP for Ceplene (histamine dihydrochloride), for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission.

Ambrilia initiate Phase I/II trial of 3-month goserelin in Prostate cancer

Ambrilia Biopharma have initiated a Phase I/II clinical trial its 3-month formulation of goserelin, in hormone-sensitive prostate cancer patients.

Merck publish series of Neuropeptide Y Y5 Receptor Antagonists

Merck have published a series of selective and orally active neuropeptide Y Y5 receptor antagonists.

Toray publish study on antitussive action of Opioid delta antagonists

Toray have publsihed a structure activity relationship paper on delta opioid receptor antagonist naltrindole derivatives as antitussives.

Targacept initiate Phase IIb of TC-5214 in Major Depressive Disorder

Targacept have initiated a Phase IIb trial of neuronal nicotinic receptor antagonist TC-5214 for the treatment of Major Depressive Disorder

CTP extends duration of action of FSH in Phase III trial

Schering-Plough has successfully completed a Phase III trial of its long-acting fertility hormone corifollitropin alfa (FSH-CTP). The duration of action is expanded by the addition of CTP from Modigene.