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Stock Market & Financial Investment News

News Breaks
April 3, 2012
08:40 EDTMAPP, RHHBY, THLD, EXEL, TSPT, RIGLLazard Capital to host a bus tour
Biotech Bus Tour travels throughout San Francisco to visit with various companies on April 2-4.
News For TSPT;THLD;RIGL;EXEL;MAPP;RHHBY From The Last 14 Days
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November 20, 2014
07:38 EDTEXELThe Federal Energy Regulatory Commission (FERC) to hold a meeting
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November 19, 2014
08:03 EDTRHHBYPTC to receive $10M milestone payment from Roche as SMA program advances
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07:52 EDTRHHBYInforma Business Information to hold a conference
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November 18, 2014
14:59 EDTRHHBYRanbaxy sues FDA for rescinding approval of Nexium, Valcyte copies, Reuters says
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11:22 EDTRHHBYTeva patent victory over Warner Chilcott, Roche affirmed
The U.S. Court of Appeals for the Federal Circuit ruled that a district court was correct to grant summary judgment to Teva (TEVA) in a patent dispute with Warner Chilcott and Roche (RHHBY) over patents related to osteoporosis drug risedronate.
November 17, 2014
07:05 EDTTHLDThreshold Pharmaceuticals announces TH-302, bevacizumab Phase 1/2 interim data
Threshold Pharmaceuticals announced interim data from a U.S. investigator-sponsored Phase 1/2 clinical trial of the investigational anticancer drug TH-302 in combination with bevacizumab for the treatment of glioblastoma, or GBM, the most lethal form of brain cancer. All patients in the study had previously progressed on single-agent bevacizumab, the only FDA-approved therapy for GBM patients with progressive disease following prior therapy. As reported by the investigator, in a total of 22 evaluable patients, best responses included one complete response and three partial responses for a response rate of 18%, and ten stable disease assessments for a clinical benefit rate of 64%; eight patients had progressive disease. Median progression-free survival was 2.8 months, and median overall survival was 4.6 months. In addition, the FDA, through its Office of Orphan Product Development, recently awarded Dr. Brenner a grant for a Phase 2 clinical trial of TH-302 for the treatment of GBM. His is one of 15 grants the FDA awarded in 2014 in order to boost the development of medical device, drug, and biological products for patients with rare diseases. According to the FDA, the grants are for clinical studies on safety and/or effectiveness of products that could either result in, or substantially contribute to, approval of the products.
05:30 EDTRHHBYInovio, Roche terminate collaboration for INO-5150
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November 16, 2014
13:12 EDTEXELExelixis announces data from trial of XL888 and vemurafenib
Exelixis announced preliminary results from a phase 1 investigator-sponsored trial, IST, evaluating the safety and activity of XL888, an Exelixis-discovered small molecule oral inhibitor of Heat Shock Protein 90, HSP90, in combination with vemurafenib in patients with unresectable stage III/IV BRAF V600 mutation-positive melanoma. Safety and efficacy results support the further investigation of 90 mg of XL888 twice weekly, BIW and vemurafenib 960 mg twice daily,BID, in additional studies that would include a third agent. The trial results were presented today by Keiran Smalley, Ph.D., an investigator on the trial and an associate professor at H. Lee Moffitt Cancer Center, Tampa, Florida, in a late-breaking oral presentation session at the Society for Melanoma Research 2014 International Congress, which is taking place November 13-16, in Zurich, Switzerland. Based on these results, as well as findings from coBRIM, the phase 3 pivotal trial of cobimetinib, an Exelixis-discovered MEK inhibitor, and vemurafenib in previously untreated metastatic melanoma patients with a BRAF V600 mutation, the Moffitt Center plans to initiate a phase 1b IST of the triple combination of vemurafenib, cobimetinib, and XL888 in a similar patient population. “The BRAF inhibitor vemurafenib is active in BRAF-mutated malignant melanoma, but development of resistance is common. Preclinical studies led by Keiran Smalley, Ph.D. suggested that most BRAF inhibitor resistance mechanisms involve proteins that are clients of HSP90, and the preclinical evaluation of XL888 showed that it is highly active in vemurafenib-resistant melanoma models,” said Jeffrey Weber, MD, Ph.D., director of the Donald A. Adam Comprehensive Melanoma Research Center at the Moffitt Cancer Center and Research Institute in Tampa, FL. “The current phase 1 data show that both drugs can be given together, and compelling initial response results suggest potential cooperative activity.” “About half of metastatic melanoma patients whose tumors harbor a BRAF V600 mutation respond to vemurafenib, but most of them develop resistance and their tumors begin to regrow,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “Multiple mechanisms drive this resistance, and the team at Moffitt found that many of them involve upregulation of HSP90 client proteins that are sensitive to XL888. We look forward to supporting the Moffitt team as they continue to evaluate XL888 as part of our IST program.”
November 14, 2014
14:53 EDTRHHBYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
13:27 EDTRHHBYRoche reports FDA nod for Avastin in platinum-resistant recurrent ovarian cancer
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November 13, 2014
07:10 EDTTHLDSociety for NeuroOncology to hold a meeting
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November 12, 2014
11:17 EDTRHHBYLeerink major pharma & biotech analysts hold analyst/industry conference call
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07:22 EDTRHHBYAssociation of Molecular Pathology is holding annual meeting
2014 Annual Meeting of AMP is being held in National Harbor, Maryland on November 12-15.
November 11, 2014
15:43 EDTRHHBYLeerink major pharma & biotech analysts hold analyst/industry conference call
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07:07 EDTTHLDThreshold Pharmaceuticals receives FDA fast track designation for TH-302
Threshold Pharmaceuticals announced that the FDA granted Fast Track designation for TH-302, an investigational anticancer drug, for the treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma, or STS. The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. An important feature of Fast Track is that the FDA may consider a "rolling review" of completed sections of the New Drug Application before the complete application is submitted.
November 10, 2014
16:07 EDTRHHBYUBS to hold a conference
UBS European Conference is being held in London, England on November 11-12.

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