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January 24, 2014
11:35 EDTHALO, RHHBYHalozyme announces positive CHMP opinion on Roche's MabThera SC
Halozyme Therapeutics (HALO) announced that the EU Committee for Medicinal Products for Human Use, or CHMP, has recommended that the European Commission approve Roche's (RHHBY) subcutaneous formulation of MabThera using Halozyme's recombinant human hyaluronidase for the treatment of patients with common forms of non-Hodgkin lymphoma. The CHMP opinion is based primarily on data from Roche's Phase 3 SABRINA study. Roche expects a final decision from the European Commission in the coming months, Halozyme said. In 2006, Halozyme entered into an agreement with Roche and to date, Roche has elected to explore the use of rHuPH20 for up to a total of five exclusive targets, and Roche retains the option to apply rHuPH20 to three additional targets through the payment of annual license maintenance fees. Subject to the successful achievement of clinical, regulatory, and sales events, Roche will pay Halozyme additional milestones as well as royalties on product sales for Herceptin SC, MabThera SC and any other product candidates which would be successfully developed and commercialized under the agreement.
News For HALO;RHHBY From The Last 14 Days
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July 25, 2014
07:35 EDTRHHBYEMA recommends new indication for RoActemra in severe arthritis
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July 24, 2014
06:13 EDTRHHBYRoche reaffirms outlook for 2014
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06:12 EDTRHHBYRoche reports 1H core EPS CHF 7.57 vs. CHF 7.58 last year
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July 23, 2014
09:08 EDTRHHBYUltragenyx appoints Sunil Agarwal, M.D. as Chief Medical Officer
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July 22, 2014
09:04 EDTHALOHalozyme resumes enrollment and dosing of patients for PEGPH20 Phase 2 trial
Halozyme Therapeutics announced that it has resumed enrollment and dosing of patients in its ongoing Phase 2 trial evaluating PEGPH20 in patients with pancreatic cancer under the revised clinical protocol agreed to with the FDA in June. PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan.
05:21 EDTRHHBYRoche announces Genentech Avastin granted priority review by FDA
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July 21, 2014
07:11 EDTRHHBYInternational Society of DNA Vaccines to hold a conference
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06:43 EDTRHHBYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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July 20, 2014
15:42 EDTRHHBYRoche not looking for big acquisitions, Reuters says
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July 17, 2014
17:42 EDTRHHBYCepheid says Roche patent suit will not have material adverse impact on results
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July 16, 2014
11:23 EDTRHHBYRoche Alzheimer drug shows mixed results in trial, NYT says
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06:26 EDTRHHBYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
05:37 EDTRHHBYGenentech Avastin granted priority review by FDA
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July 14, 2014
11:20 EDTRHHBYExelixis seen as potential target for Roche, TheStreet says
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