NASDAQ instructs AFFY to delist. DEPO CRL. ONTY trial failure. VNDA files NDA. MNKD data due this summer + CLSN OMER AEGR news

Jun 01, 2013 No Comments

Affymax (NASDAQ: AFFY) was notified by NASDAQ that it has determined the company is operating as a public shell and no longer has an operating business. As a result, NASDAQ have requested that the company delist from NASDAQ before trading on June 6, 2013. The  company intends to list on the OTC Bulletin Board. Vanda […]

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ENDP receives CRL, expects to resubmit 3Q. BMRN Vimizim PDUFA set + IDIX EXEL initiate Phase 2 and 3 trials

May 31, 2013 No Comments

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced that the FDA has assigned a PDUFA date of February 28, 2014 for the Biologics License Application (BLA) for Vimizim (BMN-110, elosulfase alfa), for the treatment of patients with the rare lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), also called Morquio A Syndrome. While a priority review was granted,  the FDA […]

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POZN PDUFA date set. RMTI data due July. GSK Approval + updates for ANAC PCRX TRGT

May 30, 2013 No Comments

POZEN Inc. (NASDAQ: POZN) announced that the FDA has set a PDFUA date of  January 24, 2014 for PA32540/PA8140, for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. Rockwell Medical (NASDAQ: RMTI) announced that it has completed patient dosing of its CRUISE-1 Phase 3 efficacy study for SFP (Soluble Ferric Pyrophosphate) for the treatment […]

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VRX receives CRL for efinaconazole. TGTX to uplist to NASDAQ. OMTH buyout. GNVC liquidation

May 29, 2013 No Comments

Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced that it has received a Complete Response Letter (CRL)  from the FDA regarding its New Drug Application (NDA) for efinaconazole for the treatment of onychomycosis.  The FDA mentioned there were only issues related to the Chemistry, Manufacturing and Controls (CMC) related areas of the container closure apparatus. No […]

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AVEO MAA won’t be pursued. CELG granted priority review. Offering details for APPY APRI ALXA + MRK OGXI LPTN MACK updates

May 24, 2013 No Comments

AVEO Pharmaceuticals, Inc. (Nasdaq: AVEO) announced in a SEC filing that is was informed by its partner, Astellas Pharma Inc. that they will no longer submit a Marketing Authorization Application to the European Medicines Agency for tivozanib for the treatment of patients with advanced renal cell carcinoma. Astellas also informed AVEO that it does not […]

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FDA requires RPRX to initiate Phase 2b trial for Proellex-V. APRI offering

May 22, 2013 No Comments

Repros Therapeutics Inc. (Nasdaq:RPRX) announced that the FDA has recommended initiating a Phase 2b trial Proellex-V, in the treatment of uterine fibroids, prior to a Phase 3 trial. The company had previously indicated that they had hoped to initiate a Phase 3 trial during 3Q 2013. An NDA submission is expected in 2016. Apricus Biosciences, Inc. (Nasdaq: APRI) […]

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AEZS ATM agreement. AMAG – Rienso recall. ACRX NDA due 3Q + IRWD NPSP BIIB GILD

May 21, 2013 No Comments

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced the pricing of an underwritten public offering of 10,500,000 shares at a price of $13.00 per share for gross proceeds of $136.5 million. Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) announced that it has entered into an “At Market” Issuance (“ATM”) Sales Agreement, with MLV & Co. LLC (“MLV”), where it may, from […]

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XNPT trial failure. Offering news for NPSP IRWD + GEVA PPHM ABBV updates

May 21, 2013 No Comments

XenoPort, Inc. (Nasdaq: XNPT) announced that it failed to meet the endpoints of its pivotal Phase 3 clinical trial of arbaclofen placarbil (AP) for the treatment of patients with spasticity due to multiple sclerosis (MS). NPS Pharmaceuticals, Inc.(NASDAQ: NPSP), today announced that it has commenced an underwritten public offering of 6,000,000 shares of its common stock. […]

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QRXPY Adcom meeting set. BLRX ATM. SNY myelofibrosis data. ETRM obesity PMA to be filed 2Q

May 18, 2013 No Comments

RxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced that the FDA has set 17 July 2013 as the date of the Advisory Committee meeting to consider its resubmitted MOXDUO New Drug Application (NDA). The PDUFA date is 26 August 2013. Sanofi (EURONEXT: SAN and NYSE: SNY) announced that in its pivotal Phase 3 JAKARTA trial of its […]

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