NeurogesX Submit NDA for NGX-4010 for Treatment of Postherpetic Neuralgia (PHN)

NeurogesX have submitted a new drug application (NDA) with the U.S. FDAS for NGX-4010 Dermal Capsaicin Patch for the management of pain due to postherpetic neuralgia (PHN).

ProStrakan receive FDA approval for Sancuso

ProStrakan Group has received FDA approval for Sancuso, it’s transdermal granisetron patch for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Takeda withdraw MAA for ramelteon in Europe

Takeda has withdrawn its Marketing Authorization Application for melatonin agonist ramelteon in Europe. This follows the receipt of a negative opinion recommending the refusal of a marketing authorization for ramelteon in May 2008 and subsequent a re-examination of the CHMP opinion in June 2008.

FDA Acute Chemotherapy-induced Nausea and Vomiting

Eisai and Helsinn have announced that the US FDA has approved a new oral formulation of ALOXI (palonosetron hydrochloride) for the prevention of chemotherapy-induced nausea and vomiting (CINV).

KeyNeurotek receive EMEA Orphan Drug Designation for KN38-7271 in TBI

KeyNeurotek Pharmaceuticals have received Orphan Drug Designation for its lead cannabinoid agonist compound KN38-7271 for the treatment of moderate and severe closed traumatic brain injury from EMEA

Tracleer (bosentan) approved in EU for Pulmonary Arterial Hypertension

Actelion Ltd have announced today that its endothelin receptor antagonist Tracleer (bosentan) has been approved in the EU for the treatment of patients with mildly symptomatic pulmonary arterial hypertension (PAH)

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.

FDA approves first generic risperidone

The FDA has approved the first generic versions of Risperdal (risperidone) tablets, manufactured by Teva.

United Therapeutics submit Treprostinil NDA for pulmonary arterial hypertension (PAH)

United Therapeutics have submitted a NDA to the U.S. FDA the approval of an inhaled formulation of treprostinil in the treatment of pulmonary arterial hypertension (PAH)

Bosentan receives positive EU opinion for treatment of patients with mildly symptomatic WHO Functional Class II pulmonary arterial hypertension

Actelion have announced that Bosentan (Tracleer) has received a positive EU opinion for treatment of patients with mildly symptomatic WHO Functional Class II pulmonary arterial hypertension (PAH)