Author Archive

SCMP FDA Approval + updates for HALO CYTR ISIS CVM AMRN OPK PBTH AFFY TZYM CLVS

Apr 24, 2013 No Comments

Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced the initiation of a Phase 2 multicenter, randomized clinical trial evaluating PEGPH20 as a first-line therapy for patients with stage IV metastatic pancreatic cancer. Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) announced that FDA approved its supplemental new drug application (sNDA) for AMITIZA (lubiprostone) (24 mcg twice daily) for the […]

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FDA Calendar – Glossary

Apr 21, 2013 2 Comments

A glossary of key terms used in the FDA Calendar is now available. This page is aimed at novice investors wanting to familiarise themselves with some of the key language used in the calendar. The glossary covers definitions regarding clinical trials, new PDUFA guidelines and other FDA related information. Readers can access the glossary under […]

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News updates for SNTS ACHN SRPT ACOR CCXI NKTR SYN AGN GTXI DRRX

Apr 17, 2013 No Comments

Allergan, Inc. (NYSE: AGN) announced that the FDA has issued a Complete Response Letter (CRL) for LEVADEX (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults. The main issues cited in the CRL were already identified by the FDA in prior discussions with Allergan. Based on Allergan’s current understanding of the FDA’s CRL, the company estimates that the next FDA action will […]

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News updates for BRLX MRK SGYP SSH

Apr 11, 2013 No Comments

BioLineRx (NASDAQ:BLRX; TASE:BLRX) announced that it will soon commence a Phase 2a trial for BL-8040, for the treatment of Acute Myeloid Leukemia (AML), with partial results expected in 4Q 2013 and final data due in 2H 2014. Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) announced that it has commenced an underwritten public offering of its common stock. […]

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AZN RIGL report mixed Phase 3 fostamatinib data. ARIA ASTM updates + INSV reverse split vote May

Apr 05, 2013 No Comments

InSite Vision Incorporated (OTCBB: INSV) will hold a meeting on Wednesday, May 29, 2013, where shareholders will vote to give permission for the company to effect a reverse split. ARIAD Pharmaceuticals, Inc.(NASDAQ: ARIA) provided an update on its progress noting that its Phase 3 EPIC trial of Iclusig, in patients with newly diagnosed CML, should have interim analysis available […]

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MRK Adcom meeting set for suvorexant + VRX ups offer for OMPI

Apr 04, 2013 No Comments

Merck & Co., Inc.(NYSE:MRK) – On May 22, 2013, the Peripheral and Central Nervous System Drugs Advisory Committee of the FDA will discuss the NDA of suvorexant tablets for insomnia. Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) announced that it has  increased its offer to acquire Obagi Medical Products, Inc. (NASDAQ: OMPI) from $19.75 to $24.00 per share in cash.

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News updates for INO NVAX CYTK ITMN NLNK

Apr 03, 2013 No Comments

Inovio Pharmaceuticals, Inc. (NYSE MKT: INO)  announced that preliminary data released  by its collaborator ChronTech AS of their open label Phase 2 trial of ChronVac-C, in patients with hepatitis C virus (HCV) infection, do not show a statistically significant difference  between treatment outcomes of the vaccinated and non-vaccinated groups. Novavax, Inc. (Nasdaq: NVAX) announced positive top-line […]

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MDVN interim PREVAIL trial data due 2013. BMRN files BLA for Vimizim + GNBT

Apr 01, 2013 No Comments

Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503)  announced that they intend to conduct  interim analysis for the Phase 3 PREVAIL trial, evaluating XTANDI (enzalutamide) capsules in men with metastatic castration-resistant prostate cancer (mCRPC) who have not yet received chemotherapy, sometime in 2013. BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced that it has filed a Biologics License Application […]

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DVAX ATM offering. FDA approval for JNJ’s INVOKANA + INO

Mar 31, 2013 No Comments

Dynavax Technologies Corporation (NASDAQ: DVAX) entered into an At Market Issuance Sales Agreement with MLV & Co. LLC where it may offer and sell common stock having aggregate sales proceeds of up to $50,000,000 from time to time through MLV as the sales agent. Janssen Pharmaceuticals, Inc. (NYSE:JNJ) announced the FDA has approved INVOKANA (canagliflozin) for […]

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APPA issued CRL. ALIM refiles NDA. JNJ files simeprevir NDA + updates for PRAN GENT BIOD RPRX CTIC

Mar 29, 2013 No Comments

Alimera Sciences, Inc. (NASDAQ: ALIM) said in a filing that it has submitted a response to the second CRL to the FDA in 1Q 2013, for  ILUVIEN in the treatment of ocular disease. Alimera is partnered with pSivida Corp. (NASDAQ:PSDV). A.P. Pharma, Inc. (OTCBB: APPA.OB) announced that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application […]

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ASTM stops Phase 3 REVIVE trial. NDA filings for IGXT POZN. BIIB FDA approval + updates for NBIX ZGNX ARRY NAVB CPRX KBIO

Mar 27, 2013 No Comments

Aastrom Biosciences, Inc. (Nasdaq:ASTM) announced that it will stop enrollment and end the Phase 3 REVIVE clinical trial of  ixmyelocel-T in patients with critical limb ischemia (CLI) due to an inability to secure a partner, and challenges with enrollment. The company will  now focus its resources on its Phase 2b trial of ixmyelocel-T, for the treatment […]

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