Archive for January, 2012

VRTX FDA Approval. NPSP NDA accepted. BDSI VTUS shelf filings. MNKD offering

Jan 31, 2012 No Comments by

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the FDA approved KALYDECO, the first medicine to treat the underlying cause of cystic fibrosis (CF). The approval decision was made in advance of its mid-April PDUFA date under priority review. BioDelivery Sciences International, Inc. (Nasdaq: BDSI) filed a shelf allowing it to issue $40 million of shares, debt […]

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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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AMLN ALKS FDA Approval. INFI Phase 2 fail. BNVI to delist + RPRX RPTP TLON IMGN news

Jan 27, 2012 No Comments by

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced the FDA  approved BYDUREON, the first once-weekly treatment for type 2 diabetes. BYDUREON will be available in pharmacies nationwide in February. Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it is halting development of saridegib (IPI-926) in combination with gemcitabine for pancreatic cancer. Interim data […]

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MITI acquired by AMGN. TSRX and CVM raise cash. CHTP shelf filing

Jan 26, 2012 No Comments

Amgen (NASDAQ:AMGN) and Micromet, Inc. (NASDAQ:MITI) today announced that the companies have entered into a definitive merger agreement under which Amgen will acquire Micromet for$11 per share in cash or approximately $1.16 billion. The acquisition includes blinatumomab, a Bispecific T cell Engager (BiTE) antibody in Phase 2 clinical development for acute lymphoblastic leukemia (ALL). Blinatumomab is also in clinical development for the treatment of […]

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ALXA PDUFA date extended. ENMD ONCY raise cash + AEZS NBY news

Jan 24, 2012 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced on Monday that its PDUFA date for ADASUVE, originally set for February 4, 2012, has been delayed until May 4, 2012. The extension was due to a modified Risk Evaluation and Mitigation Strategy (REMS) program, which the FDA deemed was a major amendment and exercised its right to extend the PDUFA date by […]

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ALTH receive negative CHMP opinion. INSM hold lifted + NVS CAPS GALE ZIOP SQNM news

Jan 20, 2012 No Comments

Allos Therapeutics, Inc. (NASDAQ: ALTH) today received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation for the medicinal product Folotyn, intended for the treatment of peripheral T-cell lymphoma. The Company plans to submit a request for re-examination of the CHMP opinion within two weeks. CHMP made the following comments as to […]

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CTIC EMA decision delay. ZIOP and SQNM offerings. NBIX prices offering

Jan 19, 2012 No Comments

Cell Therapeutics, Inc. (NASDAQ: CTIC) announced that it now expects the Committee for Medicinal Products for Human Use (“CHMP”) to issue an opinion on its Marketing Authorization Application (“MAA”) for Pixuvri in mid-February. It had originally guided of a decision at the end of this week.  The next meeting is scheduled for February 13-16, 2012. It […]

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NBIX offering. ANTH files shelf.

Jan 18, 2012 No Comments

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it is offering to sell shares of its common stock in an underwritten public offering. Anthera Pharmaceuticals, Inc (Nasdaq: ANTH) filed a shelf today allowing it to sell from time to time a combination of stock and warrants up to $100m. This replaces its $75m shelf filed in […]

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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 13 2012

Jan 14, 2012 No Comments

See individual posts made in the last week for more detail. PDUFA/NDA FILINGS/ADVISORY COMMITTEE NEWS Delcath Systems, Inc. (Nasdaq: DCTH) intends to refile its NDA during 2Q 2012 for the treatment of patients with metastatic melanoma in the liver. Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) – PDUFA date of June 27 set for lorcaserin in patients with obesity. AVEO Pharmaceuticals, Inc. (NASDAQ: […]

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BMY wasn’t alone in bidding for INHX

Jan 14, 2012 No Comments

As many of you may be aware BMY offered INHX $26 per share for its acquisition last week.  I posted on twitter a link detailing a SEC filing noting that it had offered $20/share just the previous week only to be informed that it needed to increase its bid as another company was offering more. I have pasted […]

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