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The FDA has designated another CareFusion recall as Class Ithe 11th time since the start of 2012 that the San Diegobased company has had a recall reach such a life-threatening level.This time, the recall involves ventilators, an all-too-common device when it comes to serious recalls. CareFusion recalled the EnVe and ReVel ventilators, made between May 2009 and August 2014, because of…
Isis Pharmaceuticals Reports Data From ISIS-SMN Rx Phase 2 Studies in Infants and Children With Spinal Muscular Atrophy* Phase 3 ENDEAR study in infants with SMA enrolling; on track to initiate Phase 3 study in children with SMA later this year*Isis to host a webcast at 11:30 a.m. EDT on Friday, October 10
Why is the medical device industry experiencing a slew of multibillion-dollar megamergers of late? Depending on whom you ask, it comes down to corporate greed, cost pressures under Obamacare, or regulatory hurdles.Those were the major themes emerging from dozens of Qmed/MPMN reader responses to an online survey asking why the huge mergers are taking place.Check out this word…
The Scripps Research Institute Scientists Create Mimic Of “Good” Cholesterol To Fight Heart Disease And Stroke
TSRI Scientists Create Mimic of Good Cholesterol to Fight Heart Disease and StrokeLA JOLLA, CA October 9, 2013 – Scientists at The Scripps Research Institute (TSRI) have created a synthetic molecule that mimics good cholesterol and have shown it can reduce plaque buildup in the arteries of animal models. The molecule, taken orally, improved cholesterol…
Just look into the light: not quite, but researchers at the UC Davis Center for Neuroscience and Department of Psychology have used light to erase specific memories in mice, and proved a basic theory of how different parts of the brain work together to retrieve episodic memories.Optogenetics, pioneered by Karl Diesseroth at Stanford University, is a new technique for manipulating and studying…
SAN DIEGO, Oct. 10, 2014 /PRNewswire/ –MabVax Therapeutics Holdings, Inc. (“MabVax”), a clinical stage oncology drug development company, announced today that FINRA has approved a change in the Company’s stock symbol. Effective today, the Company’s common shares will commence trading on the OTC Bulletin Board…
SAN DIEGO, Oct. 9, 2014 /PRNewswire/ –Pfenex Inc. (NYSE MKT: PFNX), a clinical-stage biotechnology company engaged in the development of high-value biosimilar therapeutics and difficult to manufacture proteins, today announced the initiation of a multi-product research program with PATH, a global health nonprofit…
SAN DIEGO, Oct. 10, 2014 /PRNewswire/ — MabVax Therapeutics Holdings, Inc. (“MabVax”), a clinical stage oncology drug development company, announced today that FINRA has approved a change in the Company’s stock symbol. Effective today, the Company’s common shares will commence trading on the OTC Bulletin Board under the trading symbol “MBVX” (OTCQB: MBVX.) The previous trading symbol was “TELK” (OTCQB: TELK).
J. David Hansen, President and CEO of the Company, said, “We are pleased to commence trading under the MBVX symbol. This marks one of the final steps associated with our recent merger. MabVax has made significant progress in the short period of time since the July merger. The Company has recently announced that targeting sequences from its fully-human antibody discovery program were partnered with Memorial Sloan-Kettering Cancer Center and Juno Therapeutics for the development of new CAR T-cell products for the treatment of certain solid tumors. The Company’s lead antibody program designated 5B1 will enter two Phase 1 trials by mid-year 2015. The first Phase 1 trial will test the 5B1 antibody coupled with a radiolabel as a PET imaging agent for the diagnosis of pancreatic cancer. That trial will will be followed closely by a second trial with the therapeutic version of the antibody that is intended to treat the same cancer.”
Mr. Hansen added; “MabVax recently received an Orphan Drug Designation for its neuroblastoma vaccine that will enter a Phase 2 clinical trial in 2015. The neuroblastoma vaccine will be the third therapeutic cancer vaccine that the Company will have in proof of concept Phase 2 clinical trials. Vaccines to treat sarcoma and ovarian cancer are expected to report out the key clinical trial endpoint of overall survival in the first half of 2016. It has been a remarkably productive quarter for the Company.”
MabVax Therapeutics Holdings, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody based therapies to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company’s proprietary vaccines. MabVax has the exclusive license to the therapeutic vaccines from Memorial Sloan Kettering Cancer Center. MabVax has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof of concept Phase II multi-center clinical trials, and a vaccine targeting neuroblastoma ready for Phase II clinical development. MabVax merged with Telik, Inc. on July 8, 2014. MabVax will continue developing the existing pipeline at MabVax, while evaluating development programs that were under way at Telik prior to the merger.
Additional information about the Company is available at www.mabvax.com.
Forward Looking Statements
This press release contains “forward-looking statements” regarding matters that are not historical facts, including statements relating to the Company’s development pipeline and stock symbol. We have no assurance that all of the product development pipeline will be fully developed by the Company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipates,” “plans,” “expects,” “intends,” “will,” “potential,” “hope” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its annual report on Form 10-K for the fiscal year ended December 31, 2013 and in the Proxy Statement dated July 25, 2014, as amended and supplemented from time to time and in our quarterly report on Form 10-Q for June 30, 2014. The parties do not undertake any obligation to update forward-looking statements contained in this press release.
SOURCE MabVax Therapeutics Holdings, Inc.
New partner to make Ebola drug for Mapp Biopharmaceutical, says CEO Kevin Whaley.
SAN DIEGO, Oct. 9, 2014 /PRNewswire/ — Pfenex Inc. (NYSE MKT: PFNX), a clinical-stage biotechnology company engaged in the development of high-value biosimilar therapeutics and difficult to manufacture proteins, today announced the initiation of a multi-product research program with PATH, a global health nonprofit organization, as part of an initiative to enhance production of vaccines.
“We are both pleased and honored to partner with a globally respected organization as PATH in their mission to develop and deliver health solutions for unmet medical needs,” stated Bertrand C. Liang, chief executive officer of Pfenex. “This project represents yet another example of how Pfenex’s experience in the area of complex protein development and manufacture can provide innovative solutions for global health, with a portfolio of antigens and adjuvants that have been difficult or impossible to express in other host systems or organisms facilitating vaccine development previously not possible.”
As part of a recent grant to PATH from the Bill & Melinda Gates Foundation to develop a model for enhancing the production of recombinant protein vaccines against two diseases that pose a high burden in low-resource countries, PATH is working with Pfenex on an initial pilot project for two important vaccine components. The first is a promising adjuvant, the double-mutant Escherichia coli heat-labile toxin (dmLT), used by PATH’s enteric vaccine initiative with several vaccine candidates under development. The second is a leading malaria transmission-blocking vaccine candidate, Pfs25, supported by PATH’s Malaria Vaccine Initiative. By partnering with Pfenex and using the high-expression system developed by Pfenex, PATH aims to accelerate the two vaccine programs in this pilot project.
A successful outcome could result in the advancement of the development of the dmLT and Pfs25, making them available in higher quantities and at lower costs. In addition, this project may lead to the creation of a platform to expedite the production of other recombinant protein vaccine antigens both for PATH and potentially other Bill & Melinda Gates Foundation-funded vaccine product development partnerships.
Pfenex has used, and intends to continue to use, its Investor Relations website (http://pfenex.investorroom.com), as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. For more information, visit (http://pfenex.investorroom.com).
About Pfenex Inc.
Pfenex Inc. is a clinical-stage biotechnology company engaged in the development of high-value and difficult to manufacture proteins including biosimilar therapeutics. The company’s lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab), for the potential treatment of patients with retinal diseases. Pfenex has leveraged its Pfēnex Expression Technology® platform to build a pipeline of product candidates and preclinical products under development including other biosimilars, as well as vaccines, generics and next generation biologics.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or Pfenex’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements in this press release include, but are not limited to, Pfenex’s expectations regarding the development and success of its vaccine antigens and the creation of a vaccine platform. Pfenex’s expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, challenges inherent in creating and developing vaccine antigens and a vaccine platform. Information on these and additional risks affecting Pfenex’s business and operating results are more fully discussed in the section entitled “Risk Factors” in its most recently filed Quarterly Report on Form 10-Q for the quarter ended June 30, 2014. The forward-looking statements in this press release are based on information available to Pfenex as of the date hereof, and Pfenex disclaims any obligation to update any forward-looking statements, except as required by law.
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SOURCE Pfenex Inc.