Biotech
Merck hopes to resubmit the NDA for Cladribine January 31 (NASDAQ:MKGAY)
Cladribine Tablets is a drug for young adults, especially females, who are suffering from multiple sclerosis (MS), which is a neurological disorder that affects the nerve cells in the spinal cord and the brain. The drug has been developed by Merck KGaA (NASDAQ:MKGAY.PK). Merck KGaA is a German-based pharmaceutical company.
Continue reading...FDA response for ACT anticipated on January 31 (NASDAQ:ACTC)
30 January 2010 – 2:51 pm PST
On November 19, 2009, Advanced Cell Technology, Inc. (NASDAQ: ACTC.OB), which is a biotechnology company that uses cloning techniques to develop a number of life-saving drugs, disclosed that the company has sent an Investigational New Drug (IND) Application to the Food and Drug Administration (FDA).
Continue reading...Acura (NASDAQ:ACUR) and King (NASDAQ:KG) expected to meet with FDA January 31
30 January 2010 – 10:55 am PST
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Acurox (containing a combination of oxycodone HCL ad niacin) is a drug that – through the use of Aversion Technology – aims to alleviate moderate and severe pain, and to prevent various misuse and abuse techniques (such as injection of tablets into the veins, taking crushed tablets through the nose, and consuming excess tablets through [...]
Continue reading...Phase 1 clinical trial results expected on January 31, 2010 (Nasdaq:ACHN)
30 January 2010 – 10:45 am PST
On December 15, 2009, Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) disclosed some crucial information from the initial results of the second stage of the Phase 1 trial.
Continue reading...Stedesa PDUFA date extended 3 months to April 30, 2010 (NASDAQ:SEPR), (TYO:4506)
30 January 2010 – 10:44 am PST
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Stedesa (eslicarbazepine acetate) is a drug for adults who are suffering from epilepsy, which is a chronic and common neurological disorder that causes frequent seizures. This drug has been developed by Sepracor Inc. (NASDAQ:SEPR).
Continue reading...Zactima’s FDA Application withdrawn (NASDAQ:AZN)
30 January 2010 – 10:42 am PST
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In June 2009, AstraZeneca (NASDAQ:AZN) submitted applications to both the United States of America’s regulator the Food & Drug Administration (FDA) and the European Medicines Agency (EMEA), which is the European equivalent of the FDA. The applications were submitted for the drug that the company has recently discovered and developed – called ZACTIMA (the proposed [...]
Continue reading...Results from Phase 2 trial of Sapacitabine expected on January 31 (Nasdaq:CYCC)
29 January 2010 – 7:22 pm PST
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Sapacitabine is a drug that is being developed by Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC or Nasdaq: CYCCP), a biopharmaceutical company that discovers, develops and then commercialized drugs for cancers and other life-threatening diseases.
Continue reading...AIMM Trial Expected to End on January 31 (NASDAQ:VICL)
29 January 2010 – 6:45 pm PST
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On December 28, 2009, Vical Incorporated (NASDAQ: VICL) disclosed that an independent organization – called the Safety Monitoring Board (SMB) – had been analyzing the safety issues of the company’s Phase 3 AIMM (Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma) trial.
Continue reading...Phase 2 trial of ADXS11 likely to begin on January 31 (OTC:ADXS)
29 January 2010 – 6:29 pm PST
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ADXS11-001 is a “live, attenuated Listeria monocytogenes (Lm)†vaccine that is being developed by Advaxis Inc, (OTC:ADXS). The company had recently completed the Phase 1 trial of the novel vaccine. On October 1, 2009, the company announced that the results received from the Phase 1 trial had been favorable. Now the company plans to begin the [...]
Continue reading...FDA decision on WC 3016 anticipated tomorrow (NASDAQ:WCRX)
25 January 2010 – 11:56 am PST
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WC 3016 is a type of oral contraceptive (of low dose) that is being developed by Warner Chilcott Ltd. (NASDAQ: WCRX). This drug is used by women for birth control. Since it is still in its development phase, it is not sold in the market yet.
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30 January 2010 – 2:53 pm PST
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