AMRN Adcom meeting date set. CCXI data on track for 3Q. Offering news for PGNX RPRX BIOD.

Jun 19, 2013 No Comments

Amarin Corporation plc (Nasdaq:AMRN) announced that the FDA will convene an advisory committee on October 16, 2013 for the  Supplemental New Drug Application (sNDA) for the use of Vascepa in the treatment of adult patients with high triglycerides with mixed dyslipidemia. The PDUFA date is December 20, 2013. ChemoCentryx, Inc. (Nasdaq:CCXI) announced that it has completed the target enrollment of 270 […]

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CYTK Phase 2b data due Sept. BIOD and OGXI offering news + ICPT EXAS

Jun 19, 2013 No Comments

Biodel Inc. (Nasdaq:BIOD) announced that it is offering to sell shares of its common stock in an underwritten public offering. Cytokinetics Incorporated (NASDAQ:CYTK) announced that results from the Phase 2b ATOMIC-AHF trial of omecamtiv mecarbil  in patients with left ventricular systolic dysfunction who are hospitalized with acute heart failure, will be presented at the European Society of Cardiology (ESC) […]

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SNTS IGXT PDUFA dates set. MNKD on track for summer data release. FOLD NDA filing delayed + ICPT RPRX EXAS offerings

Jun 18, 2013 No Comments

Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) announced that the FDA has set a PDUFA date of  April 16, 2014 for RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). The companies indicated that they will most likely be required to appear before the  Blood Products Advisory Committee prior to the PDUFA […]

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News updates for CEMP ECTE SNSS AMGN LLY EPZM XOMA

Jun 14, 2013 No Comments

Cempra, Inc. (Nasdaq: CEMP) announced its intention to offer and sell shares of its common stock in an underwritten public offering. Echo Therapeutics, Inc. (Nasdaq: ECTE) announced the pricing of a previously announced underwritten public offering of 4,025,000 shares of its common stock, offered at a price to the public of $2.70 per share, for gross proceeds […]

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OHRP uplist to NASDAQ. AMGN meets Phase 3 ovarian endpoint. ANAC $45m loan facility

Jun 13, 2013 No Comments

Ohr Pharmaceutical, Inc. (OTCQB: OHRPD) announced that it will list on the NASDAQ Capital Market on June 13 under the ticker symbol, OHRP. The company is currently enrolling patients in a Phase 2 trial of Squalamine Eye Drops for wet-AMD (age-related macular degeneration). Its other Phase 2 candidate is OHR/AVR118 for the treatment of cancer […]

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SLXP and PGNX set to appear before Adcom + BOTA ARIA NBY CERS updates

Jun 12, 2013 No Comments

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals (NASDAQ:PGNX) announced that the FDA will hold an Advisory Committee meeting regarding the Supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, for opioid-induced constipation, or OIC, in patients with chronic pain. A date has yet to be set. Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) announced that it has commenced dosing in a Phase 2 clinical […]

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DVAX requires more safety data. AVEO CRL. CLVS offering. BDSI NDA due mid summer + SGEN EXAS AZN updates

Jun 11, 2013 No Comments

Dynavax Technologies Corporation (NASDAQ: DVAX) reported that following a meeting with the FDA regarding its Biologic License Application (BLA) for HEPLISAV,an adult hepatitis B vaccine, additional safety data would be required before they refile their BLA. This would most likely necessitate the need for a new trial. Clovis Oncology (NASDAQ:CLVS) announced that it has commenced an underwritten […]

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ECTE reverse split. BIOD glucagon update. BLRX commences Phase 2 AML enrolment.

Jun 06, 2013 No Comments

Echo Therapeutics, Inc. (Nasdaq: ECTE) announced that a 1-for-10 reverse split of its common stock will be effective prior to the market opening on Friday, June 7, 2013. Biodel Inc. (Nasdaq:BIOD) announced that it intends to initiate a pivotal trial of its glucagon rescue device to treat severe hypoglycemia in 2H 2014, with a NDA filing in […]

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CELG Approval for REVLIMID + updates for BMRN IDRA ZGNX OPK PBTH RCPT MELA

Jun 05, 2013 No Comments

Celgene Corporation (NASDAQ: CELG) announced the FDA approved the supplemental new drug application (sNDA) for REVLIMID (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced that it has initiated the Phase 3 program (165-301) for PEG-PAL (PEGylated […]

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