Vanda Presents Data From Tasimelteon Phase III Studies In Non-24-Hour Disorder

Data presented as a late breaking abstract at SLEEP 2013, the 27th Annual Meeting of Associated Professional Sleep Societies

Vanda Pharmaceuticals Inc. (Vanda) (VNDA) presented additional entrainment and patient-level clinical data at SLEEP 2013, the 27th Annual Meeting of Associated Professional Sleep Societies in Baltimore, from its SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24-Hour Disorder) Phase III studies of tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in totally blind individuals.  Non-24 is a serious, rare and chronic circadian rhythm disorder that affects a majority of totally blind individuals who lack light perception and cannot entrain (synchronize) their master body clock to the 24-hour day.  Currently there is no approved FDA treatment for Non-24.

Read more: Vanda Pharmaceuticals Inc. (Vanda) (VNDA)

Avanir Pharmaceuticals Announces Accelerated Development Path for AVP-786 Following Successful Pre-IND Meeting with FDA

Expedited Development Path will Allow Seamless Integration of AVP-786 into ongoing Clinical Programs

Avanir Pharmaceuticals, Inc. (AVNR) today announced that the U.S. Food and Drug Administration (FDA) has agreed to an expedited development pathway for their next-generation compound, AVP-786, requiring only a limited pre-clinical package as part of the Investigational New Drug (IND) application.  Upon completion of these preclinical studies the company intends to proceed directly into human clinical trials.

Read more: Avanir Pharmaceuticals Inc ( AVNR )

Infinity Reports Updated Phase 1 Data Showing Encouraging Clinical Activity of IPI-145 in B-Cell and T-Cell Lymphomas at ASCO Annual Meeting and Announces Initiation of Phase 2 Clinical Study in Indolent Non-Hodgkin Lymphoma

– Early Data Show that IPI-145 Is Well Tolerated and Has Activity in a Broad Range of B-Cell and T-Cell Lymphomas, with a 68 Percent Response Rate in Indolent Non-Hodgkin Lymphoma –

– Rapid Onset of Clinical Activity Observed, with a Median Time to Response of 1.8 Months –

Infinity Pharmaceuticals, Inc. (INFI) today announced updated Phase 1 data from an ongoing study of IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma in patients with relapsed/refractory lymphoma, a group of potentially fatal hematologic malignancies, or blood cancers.

Read more: Infinity Pharmaceuticals Inc ( INFI )

Flamel Technologies Announces FDA Approval of Bloxiverz

Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Bloxiverz™ (neostigmine methylsulfate), a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Flamel expects to launch Bloxiverz™ in July 2013 in 0.5 and 1.0 mg/mL strengths.

"We are extremely excited and pleased to receive this FDA approval for Bloxiverz™, the first product from the portfolio of Éclat products acquired in March 2012," said Mike Anderson, Chief Executive Officer of Flamel. 

Read more: Flamel Technologies ( FLML )

Clovis Oncology’s Rucaparib Demonstrates Encouraging Results from Ongoing Phase I/II Monotherapy Study in Patients with Solid Tumors

    Objective responses seen in BRCA-mutant ovarian, breast and pancreatic cancer patients
    89% clinical benefit rate in ovarian cancer patients across all doses
    Rucaparib well-tolerated at doses studied
    Consistent therapeutic drug exposures observed with BID dosing
    Phase II dose not yet defined; MTD not yet reached

Clovis Oncology (CLVS) today announced initial findings from an ongoing Phase I/II monotherapy study of rucaparib, the Company’s oral, potent, small molecule poly (ADP-ribose) polymerase (PARP) inhibitor being developed for the treatment of ovarian cancer.

Read more: Clovis Oncology Inc ( CLVS )