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May 30, 2014
11:10 EDTGSK, GNMSFGenmab says Glaxo to start additional pivotal studies with ofatumumab
Genmab A/S (GNMSF) announced its collaboration partner GlaxoSmithKline (GSK) has taken the decision to start additional pivotal studies with the subcutaneous formulation of ofatumumab. Phase III studies of subcutaneous ofatumumab in RRMS are expected to begin in 2015, following encouraging data from a Phase II study reported in October 2013.In addition, GSK plans to file an IND for a potential pivotal study of subcutaneous ofatumumab in NMO, a rare autoimmune disorder which affects the optic nerve and spinal cord, in 2014. Further details about the RRMS and NMO programs will be available in due course. A Phase III study of subcutaneous ofatumumab in pemphigus vulgaris, a rare autoimmune disorder of the skin, was announced in 2013.
News For GSK;GNMSF From The Last 14 Days
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October 8, 2015
07:08 EDTGSKCodexis earns $6.5M milestone payment from GlaxoSmithKline
Codexis (CDXS) announced that it successfully completed Wave 2 of the transfer of its proprietary CodeEvolver protein engineering platform technology to GlaxoSmithKline (GSK) in Q3 of 2015. Codexis expects to receive a $6.5M payment from GSK for completion of this milestone in Q4. Codexis has received a $6M upfront payment and a $5M Wave 1 technology transfer milestone payment from GSK since announcing the technology collaboration and license agreement with GSK in July 2014. The agreement grants GSK a license to use Codexis' CodeEvolver platform technology to develop novel enzymes for use in the manufacture of GSK's pharmaceutical and health care products. The CodeEvolver platform technology has been installed and is operational at a GSK facility in Pennsylvania. Codexis is eligible to receive an additional $7.5M payment from GSK subject to the satisfactory completion of the final CodeEvolver technology transfer milestone. Codexis also has the potential to receive numerous additional contingent milestone payments under the agreement with GSK that range from $5.75M-$38.5M per project based on GSK's successful application of the licensed technology. In addition, Codexis will be eligible to receive royalties based on net sales, if any, of a limited set of products developed by GSK using Codexis' CodeEvolver protein engineering platform technology.
October 6, 2015
13:32 EDTGSKBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space 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).
October 1, 2015
08:04 EDTGSKPfizer completes acquisition of Nimerix, Mencevax from GSK
Pfizer (PFE) announced that it has completed the acquisition of GlaxoSmithKline's (GSK) quadrivalent meningococcal ACWY vaccines Nimenrix and Mencevax.
September 30, 2015
12:41 EDTGSKGlaxoSmithKline exercises option for Liquidia Technologies' inhaled therapeutics
Liquidia Technologies announced that GlaxoSmithKline has exercised its option under a Collaboration and Option Agreement signed in 2012 to exclusively license the right to research, develop, and commercialize inhaled therapeutics derived from the company's proprietary PRINT technology. Through this collaboration, Liquidia and GSK will continue to work together with the goal of advancing inhaled therapeutics into clinical studies. According to the agreement signed in June 2012, Liquidia was granted an upfront payment comprised of cash and equity, R&D funding, and potential development milestones and royalties. As a result of the GSK decision to exercise the option, Liquidia will receive an option fee, continued R&D funding, and potential product-based development and regulatory milestone payments. Liquidia has also retained the ability to independently develop an inhaled treatment for a particular disease field.
September 28, 2015
07:52 EDTGSKIIR Holdings to hold a conference
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September 27, 2015
16:58 EDTGSKGlaxoSmithKline, Theravance report Phase 3 data on Anoro Ellipta for COPD
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September 25, 2015
05:23 EDTGNMSFGenmab's Daratumumab granted MAA by CHMP
Genmab (GNMSF) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted accelerated assessment to the Marketing Authorization Application for daratumumab. The MAA is for daratumumab as a treatment for patients with relapsed and refractory multiple myeloma. The MAA was submitted to the EMA on September 9, 2015 by Janssen-Cilag International NV. In August 2012, Genmab granted Janssen Biotech (JNJ) an exclusive worldwide license to develop, manufacture and commercialize daratumumab. The MAA submission includes data from the Phase II study of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a PI and an IMiD. Safety and efficacy data from the Phase I/II study and safety data from three other studies have also been included in the submission. A regulatory application for daratumumab has also been submitted to the U.S. Food and Drug Administration and has been granted Priority Review with a PDUFA date of March 9, 2016.

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