Author Archive

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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ZIOP fails Phase 3 palifosfamide for soft tissue sarcoma + APPY BDSI updates

Mar 27, 2013 No Comments

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) announced that its Phase 3 trial of palifosfamide (ZIO-201) for the treatment of metastatic soft tissue sarcoma in the first-line setting (PICASSO 3) did not meet its primary endpoint of progression-free survival (PFS) and will discontinue further development. Venaxis, Inc. (Nasdaq: APPY) provided an update of its appendicitis test, APPY1, noting that it hopes to complete […]

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UTHR issued CRL. VNDA NDA due mid-year. TSRX meets endpoints.

Mar 26, 2013 No Comments

United Therapeutics Corporation (NASDAQ: UTHR) announced that it received a second complete response letter declining to approve its new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension (PAH). Vanda Pharmaceuticals Inc.(Vanda) (NASDAQ:VNDA) announced that as a result of its pre-NDA meeting with the FDA, it intends to […]

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CHMP offers MAA opinions for BIIB ARIA GENT GILD BAX HALO ISIS

Mar 23, 2013 No Comments

Isis Pharmaceuticals Inc.(NASDAQ: ISIS) announced that following Genzyme’s request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its previous position and has maintained a negative opinion regarding the marketing authorization application (MAA) for KYNAMRO (mipomersen) as a treatment for patients with Homozygous Familial Hypercholesterolaemia (HoFH). Baxter International Inc. (NYSE: BAX) and Halozyme […]

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FDA Panel recommends approval of Probuphine. ENTA IPO. ALIM NDA refiling due this month + updates for ANAC AEZS KYTH

Mar 22, 2013 No Comments

 Titan Pharmaceuticals, Inc. (OTCBB:TTNP) announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) members voted for approval (10 positive votes, 4 negative votes and 1 abstention) of Probuphine for the maintenance treatment of adult patients with opioid dependence. The PDUFA date is April 30, 2013. – Alimera Sciences, Inc. […]

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THRX GSK Adcom rescheduled. BLRX failure. ANAC data due Thur + TTPH CCXI AMGN BIIB RMTI VRX OMPI CSII

Mar 21, 2013 No Comments

GSK and Theravance, Inc. (NASDAQ: THRX) – On April 17, 2013 the FDA Pulmonary-Allergy Drugs Advisory Committee will discuss the new drug application (NDA) for fluticasone furoate and vilanterol dry powder inhaler (proposed trade name BREO ELLIPTA), sponsored by GlaxoSmithKline plc (GSK), for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic […]

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NPSP regains Gattex rights for $80m. CSII offering + IGXT BDSI updates

Mar 20, 2013 No Comments

Cardiovascular Systems, Inc.  (Nasdaq: CSII) announced that it intends to offer and sell shares of its common stock in an underwritten public offering. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) and Takeda Pharmaceutical Company Limited announced that NPS has re-gained the full worldwide rights to teduglutide (Gattex in US, Revestive in Europe) and PTH 1-84 (Natpara in US, Preotact in Europe). Gattex is […]

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AFFY reduces workforce. SGEN files sBLA + updates for MACK AGN CYTK MELA INCY INSM NVAX INO RMTI ICPT OMER

Mar 19, 2013 No Comments

Affymax, Inc. (Nasdaq: AFFY) announced in a filing that it will reduce its workforce by approximately 230 employees (or 75%) following the recall of OMONTYS.  The company is considering all possible alternatives, including further restructuring activities, wind-down of operations or even bankruptcy proceedings. If they are unable to rapidly identify and rectify the causes of the safety concerns […]

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NVS receives Breakthrough Therapy designation. CYTK reverse split vote May + CSII CUR updates

Mar 16, 2013 No Comments

Novartis (NYSE:NVS) announced that LDK378 has received Breakthrough Therapy designation by the FDA for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who had progressed during treatment with, or were intolerant to, crizotinib. Breakthrough Therapy designation is intended to expedite the development and review of drugs that treat serious […]

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