Pipeline updates for CLDX and OGXI. PCYC offering + JNJ files canagliflozin MAA

Mar 08, 2013 No Comments

Janssen-Cilag International NV (Janssen) today announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat adult patients with type 2 diabetes. Pharmacyclics, Inc. (NASDAQ: PCYC) announced that it has commenced an underwritten registered public offering of […]

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THRX GSK Adcom meeting postponed. AMAG PDUFA date set + updates for POZN ZIOP ZLCS

Mar 07, 2013 No Comments

Theravance, Inc. (NASDAQ:THRX) announceD that the FDA notified GlaxoSmithKline plc (GSK) that the March 7, 2013 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting has been postponed due to forecasted adverse weather conditions.  The FDA is working to reschedule the meeting in a timely manner.  The new drug application (NDA) for fluticasone furoate and vilanterol dry powder inhaler (proposed trade […]

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ABIO reverse split. NRIFF receives CRL. Updates for RIGL INFI NYMX TRGT VPHM NWBO.

Mar 05, 2013 No Comments

Targacept, Inc. (NASDAQ: TRGT) announced that AstraZeneca will return all rights to the alpha4beta2 modulator TC-1734 (also known as AZD3480), which is currently in a Phase 2b clinical trial in mild to moderate Alzheimer’s disease. It will also give up the option to license any alpha7 NNR modulator that was developed by Targacept for a cognitive disorder or schizophrenia Nuvo […]

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DEPO gets hit with negative Adcom vote. BIIB NDA accepted. ACRX releases Phase 3 data.

Mar 05, 2013 No Comments

Depomed, Inc.(Nasdaq: DEPO) announced that the Reproductive Health Drugs Advisory Committee (RHDAC) of the FDA voted 2-12 against approval for SEFELSA. Biogen Idec (NASDAQ: BIIB) announced today that the FDA has accepted its Biologics License Application (BLA) for rFIXFc for the treatment of hemophilia B and granted the company a standard review timeline. The company issued a press […]

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Updates for ANX TSRO CERS CYTR CEMP DRRX NLNK ENMD ANAC NVAX PTN CTIC

Mar 02, 2013 No Comments

DURECT Corporation (Nasdaq: DRRX) provided an update noting that Pfizer is targeting a meeting with the FDA in late March to discuss their proposed resubmission plan for REMOXY. Durect also intends to submit a new drug application (NDA) for Posidur under 505(b)(2) with the FDA near the end of 1Q 2013. Repros Therapeutics Inc. (Nasdaq: RPRX) announced that it will meet with […]

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ATRS PDUFA date set for OTREXUP. Updates for ANIK and ECYT

Feb 27, 2013 No Comments

Antares Pharma, Inc. (NASDAQ: ATRS) announced that the New Drug Application (NDA) for OTREXUP, for the subcutaneous delivery of methotrexate (MTX) using Medi-Jet technology, has been accepted by the FDA. OTREXUP is being developed for self-administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.The PDUFA date isOctober 14, 2013. Anika Therapeutics, Inc. (Nasdaq: ANIK) […]

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Adcom dates set for TTNP DCTH AVEO. PDUFA delay for ZGNX. AMRN files sNDA + DVAX TSRO DRTX DNDN ARIA CBST IPXL NKTR ISIS

Feb 26, 2013 No Comments

Delcath Systems, Inc (NASDAQ: DCTH) – The Oncologic Drugs Advisory Committee will discuss the new drug application of the Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System, for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver, during the afternoon session on May 2, 2013. Titan Pharmaceuticals, Inc (TTNP) – The Psychopharmacologic Drugs Advisory Committee will discuss new […]

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Weekly summary – AFFY QLTI RPRX CRIS CHTP CELG AEZS ONCY ACHN GTXI CLSN SYN IMMU VVUS GENT ITMN NPSP IMGN

Feb 24, 2013 No Comments

Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited (Takeda) have decided to recall all lots of OMONTYS (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of […]

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UTHR THRX PDUFA dates set. ACRX pipeline update. ONCY offering. CRTX takeover + EXAS ISIS news

Feb 19, 2013 No Comments

GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc.(NASDAQ: THRX) announced that the New Drug Application (NDA) for the  once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the FDA. The PDUFA date is 18 December 2013. United Therapeutics Corporation (NASDAQ: UTHR) announced last week that the FDA has set a PDUFA date […]

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