MAPP receives CRL. ISTA buyout. RPTP NDA filing this week. APPA NDA mid-2012 + ASTX VVUS ARNA CLVS NBIX news

Mar 26, 2012 No Comments by

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced it received a Complete Response letter for LEVADEX. The FDA noted that the company will need to address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The FDA also noted that it had requested the company to provide information of […]

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CHTP positive Adcom vote. PDUFA date issued for IPXL + LGND YMI SGMO CLDX ISTA EXAS QLTI news

Feb 24, 2012 No Comments by

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 7-4 with 1 abstention and 1 non-vote to recommend approval of NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine […]

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CRIS FDA Approval. CTIC withdraws NDA + ISTA DRRX ZIOP ALTH VICL ARRY news

Jan 30, 2012 No Comments by

Roche Holding AG (ROG.VX, RHHBY) and Curis Inc. (CRIS)  - The FDA announced today that it approved vismodegib  for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. This […]

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ARQL Phase 2 meets endpoint. VRX lifts bid for ISTA + MDVN ARRY RNN news

Jan 17, 2012 No Comments

ArQule, Inc. (NASDAQ: ARQL) today announced that its Phase 2 trial of tivantinib in patients with hepatocellular carcinoma (HCC) produced statistically significant data in previously treated patients (hazard ratio = 0.64; p-value = 0.04). Complete data from this trial will be released at a peer-reviewed forum later this year. Adverse events were reported at similar rates in the […]

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Weekly Summary of key pharma events – week ended January 6 2012

Jan 07, 2012 No Comments

See individual posts made in the last week for more detail. PDUFA/NDA FILINGS/ADVISORY COMMITTEE NEWS AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) said that it intends to file its NDA for tivozanib during 2012 following full data release at ASCO this year. Cornerstone Therapeutics (NASDAQ: CRTX) – NDA for lixivaptan for the treatment of hyponatremia was filed on Dec. 29, […]

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ISTA and RIGL pipeline updates. CRTX NDA filing + NEOL GEVA NAVB news

Jan 05, 2012 No Comments

Cornerstone Therapeutics (NASDAQ: CRTX) yesterday announced that it had acquired Cardiokine Inc. Cardiokine filed a New Drug Application (NDA) for its lead compound, lixivaptan for treatment of hyponatremia on Dec. 29, 2011. INSYS Therapeutics (pinksheets:NEOL) today announced it had received FDA approval of its cancer pain medication, SUBSYS fentanyl sublingual spray. ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) gave a […]

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Weekly Summary of key pharma events – week ended 12/16/11

Dec 17, 2011 No Comments

See individual posts made in the last week for more detail. PDUFA/FDA RELATED EVENTS NeurogesX, Inc. (Nasdaq:NGSX) will meet with the FDA Anesthetic and Analgesic Drug Products Advisory Committee on February 9, 2012 to discuss the available efficacy and safety data for sNDA of QUTENZA for the management of neuropathic pain related to HIV-associated peripheral neuropathy. Isis Pharmaceuticals, […]

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ISTA rejects takeover offer. MELA and STEM price offerings.

Dec 16, 2011 No Comments

ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) informed investors today that its Board had unanimously rejected a takeover offer from Valeant Pharmaceuticals International, Inc. (NYSE: VRX) to acquire all shares for $6.50 per share. ISTA noted that the offer was grossly inadequate and significantly undervalues ISTA as it is poised for significant revenue growth next year. The company has […]

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SNTS NDA filing soon. ISTA due 1Q 2012 + DEPO CYTK VICL ALNY:

Nov 02, 2011 No Comments

Santarus, Inc. (NASDAQ:SNTS) said today that they are on track to file their NDA for UCERIS 9 mg by the end of 2011. Depomed, Inc. (Nasdaq:DEPO) today reported financial results for the third quarter ended September 30, 2011 and noted that they plan to meet with the FDA during 1Q 2012 to discuss their menopausal […]

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Data releases from DEPO ISTA POZN ANDS. Updates for MITI CYCC

Oct 13, 2011 No Comments

Depomed, Inc. (Nasdaq:DEPO) today announced top-line results from BREEZE 3, a Phase 3 trial evaluating the efficacy and safety of Serada (extended-release gabapentin tablets) for menopausal hot flashes. Efficacy data from the trial were positive and statistically significant for three of the four pre-specified primary endpoints of frequency and severity at four and 12 weeks. […]

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APPY reverse split + updates for ISTA CYTK ANTH

Jul 29, 2011 No Comments

AspenBio Pharma, Inc. (NASDAQ: APPY), effected today a one for five reverse split of its common shares to ensure continued compliance with NASDAQ minimum bid price rule listing requirements. However it only reduced the number of authorized common shares from 60 million to 30 million. ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) announced top-line results from the […]

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