Biotherapeutics News and Research

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FDA requests additional data on CMC section of NDA for taliglucerase alfa from Protalix BioTherapeutics

Protalix BioTherapeutics, Inc. announced today that, in connection with the New Drug Application (NDA) filed by the Company in December 2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug Administration (FDA) has requested additional data regarding the Chemistry, Manufacturing and Controls (CMC) section of the NDA.

2 Feb 2010

Mentor Capital's Cancer Immunotherapy Index: First funding tranche to extend investment closes

Mentor Capital, Inc.'s first funding tranche to extend its investment in its proprietary Cancer Immunotherapy Index closes today. Cash investment from 1,400 existing shareholders projects to be approximately 20% oversubscribed from target. Company management reservation to fund will be correspondingly reduced to remain within the $1.2 Million seed funding limit. Already authorized follow-on public funding tranches total an additional $125 Million that will also be targeted for investment into the best of the Cancer Immunotherapy Index companies.

2 Feb 2010

Pfizer's new pipeline shows growth and diversity in research and development

Pfizer Inc. today provided an update to its pipeline for the first time since the close of the acquisition of Wyeth in October, 2009. The new development pipeline, composed of assets from both legacy companies, includes 133 programs from phase 1 through registration, and shows growth and increased diversity in each of the areas where the company invests in research and development.

28 Jan 2010

Juvaris BioTherapeutics completes second close on its Series B equity financing

Juvaris BioTherapeutics, Inc., a biotechnology company developing adjuvanted vaccines for infectious diseases, announced that it has completed a second close on its Series B equity financing of up to $25 million. The additional equity investment came from an undisclosed strategic corporate investor who joins SV Life Sciences and Kleiner Perkins Caufield & Byers in the round.

27 Jan 2010

LFB completes conversion of all acquired preferred stock

GTC Biotherapeutics, Inc. announced that LFB Biotechnologies, a wholly owned subsidiary of LFB S.A. (Laboratoire Français du Fractionnement et des Biotechnologies S.A., Les Ulis, France) and a strategic shareholder in GTC, has converted the convertible preferred stock it previously purchased in November 2009 under the terms described in the financing agreements approved by GTC shareholders in July 2009 into a total of 5.3 million shares of common stock.

9 Jan 2010

Oxygen Biotherapeutics' common stock approved for listing on NASDAQ Capital Market

Oxygen Biotherapeutics, Inc. announced today that its common stock has been approved for listing on the NASDAQ Capital Market.

9 Jan 2010

New stem cell therapies to feature at 5th Annual Stem Cell Summit in NYC

Six new stem cell therapies, all forecast to reach physicians in 2010, will be featured at the 5th Annual Stem Cell Summit on February 16 in New York City. These new therapies include allograft products, innovative forms of autologous stem cell technologies, and at least one FDA-approved stem cell drug. New studies showing rehydration of the disc nucleus, regeneration of new heart muscle and others are also on the agenda.

9 Jan 2010

Seven new biopharmaceutical companies join PhRMA, Forbes reports

Forbes recently reported that seven new biopharmaceutical companies have now joined the Pharmaceutical Research and Manufacturers of America (PhRMA).

From CSL Ltd 9 Jan 2010

Danaher offers GBP 50 million pounds for Genetix Group acquisition

Danaher Corporation announced today its intention to make a recommended cash takeover offer, through an indirect wholly owned subsidiary, to acquire all of the issued and to be issued shares of Genetix Group plc for 85 pence per share implying an aggregate price of approximately GBP 50 million pounds (USD $82 million) net of cash acquired.

From Danaher 18 Dec 2009

Research uncovers structural basis for multifunctionality of aminoacyl tRNA synthetases

Research published in the December 13, 2009 edition of Nature Structural Biology uncovers the structural basis for the multifunctionality of aminoacyl tRNA synthetases. Aminoacyl tRNA synthetases are universal and essential enzymes of protein synthesis machinery found in all organisms.

14 Dec 2009

Protalix Biotherapeutics completes NDA submission for taliglucerase alfa

Protalix Biotherapeutics, Inc. today announced the completion of its New Drug Application (NDA) submission with the U.S. Food and Drug Administration (FDA) for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for the potential treatment of Gaucher’s disease.

9 Dec 2009

RCT licensee Dyax receives approval from the FDA for KALBITOR

RCT licensee Dyax Corp. has received approval from the U.S. Food and Drug Administration for KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

7 Dec 2009

Oxygen Biotherapeutics commences enrollment in clinical trial of Oxycyte emulsion for TBI

Oxygen Biotherapeutics, Inc. today announced that the first patient has been enrolled in the company's Phase II-b, dose escalation, clinical trial in Switzerland for use of Oxycyte(TM) emulsion in traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.

5 Dec 2009

DCVax therapeutic cancer vaccine manufacturing process receives patent approval

Northwest Biotherapeutics, Inc. ("NWBT" or the "Company") announced today that the US Patent and Trademark Office has allowed its patent application on a system for automation of the initial stages of the manufacture of the Company's DCVax® therapeutic cancer vaccines.

4 Dec 2009

FDA approves additional intended use of Roche's cobas TaqScreen MPX Test

Roche announced today that the United States Food & Drug Administration (FDA) approved an additional intended use for its licensed nucleic acid test, to screen source plasma in pools comprised of up to 96 individual donations. The test, called the cobas® TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative, in-vitro test for the simultaneous, direct detection of the human immunodeficiency virus (HIV-1 Group M RNA, HIV-1 Group O RNA , HIV-2 RNA), hepatitis C virus RNA and hepatitis B virus DNA in human plasma.

From Roche Sequencing and Life Science 2 Dec 2009

PX’Therapeutics sets up additional biomanufacturing unit

PX’Therapeutics SA (formerly known as Protein’eXpert) announces the set up of an additional biomanufacturing unit dedicated to the production of therapeutic proteins and monoclonal antibodies in mammalian cells.

24 Nov 2009

Lee's Pharmaceutical granted exclusive license to Jennerex' lead product for HCC

Jennerex, Inc., a clinical-stage biotherapeutics company developing a proprietary breakthrough class of targeted oncolytic virus therapeutics, today announced in conjunction with Lee's Pharmaceutical Holdings, the execution of a collaboration and license agreement for Jennerex's lead product candidate, JX-594, in certain Asian territories.

18 Nov 2009

Scarab Genomics reduces the E. coli K-12 genome, optimizing it for recombinant DNA and protein production

Scarab Genomics has made a series of planned, precise deletions to the E. coli K-12 genome, reducing the genome by more than 15%. The multiple-deletion series (MDS™) strains eliminate non-essential genes, cryptic virulence genes, and sequences of recombinogenic and mobile insertion sequence (IS) DNA, while preserving robust growth in rich and minimal media.

10 Nov 2009

GTC Biotherapeutics announces financial results for third quarter 2009

GTC Biotherapeutics, Inc.’s total net loss for the third quarter ended September 27, 2009 was $5.1 million, or $0.48 per share, compared with $6.1 million, or $0.59 per share, in the third quarter of 2008. The total net loss for the first nine months of 2009 was $26.2 million, or $2.51 per share, compared to $16.5 million, or $1.71 per share, for the first nine months of 2008.

6 Nov 2009

LFB Biotechnologies exercises its option to purchase $12.8 million of stocks in GTC Biotherapeutics

GTC Biotherapeutics, Inc. announced that LFB Biotechnologies, a wholly owned subsidiary of LFB S.A. (Laboratoire français du Fractionnement et des Biotechnologies S.A., Les Ulis, France) and a strategic shareholder in GTC, has exercised its option to purchase $12.8 million of additional convertible preferred stock under the terms described in the financing agreements approved by GTC shareholders in July 2009. This transaction provides $6.4 million of new cash proceeds to GTC.

2 Nov 2009

Biotherapeutics News and Research

FDA requests additional data on CMC section of NDA for taliglucerase alfa from Protalix BioTherapeutics

Mentor Capital's Cancer Immunotherapy Index: First funding tranche to extend investment closes

Pfizer's new pipeline shows growth and diversity in research and development

Juvaris BioTherapeutics completes second close on its Series B equity financing

LFB completes conversion of all acquired preferred stock

Oxygen Biotherapeutics' common stock approved for listing on NASDAQ Capital Market

New stem cell therapies to feature at 5th Annual Stem Cell Summit in NYC

Seven new biopharmaceutical companies join PhRMA, Forbes reports

Danaher offers GBP 50 million pounds for Genetix Group acquisition

Research uncovers structural basis for multifunctionality of aminoacyl tRNA synthetases

Protalix Biotherapeutics completes NDA submission for taliglucerase alfa

RCT licensee Dyax receives approval from the FDA for KALBITOR

Oxygen Biotherapeutics commences enrollment in clinical trial of Oxycyte emulsion for TBI

DCVax therapeutic cancer vaccine manufacturing process receives patent approval

FDA approves additional intended use of Roche's cobas TaqScreen MPX Test

PX’Therapeutics sets up additional biomanufacturing unit

Lee's Pharmaceutical granted exclusive license to Jennerex' lead product for HCC

Scarab Genomics reduces the E. coli K-12 genome, optimizing it for recombinant DNA and protein production

GTC Biotherapeutics announces financial results for third quarter 2009

LFB Biotechnologies exercises its option to purchase $12.8 million of stocks in GTC Biotherapeutics

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