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$FDA accepts TxCell’s IND application for Ovasave for treatment of refractory Crohn’s disease$

FDA accepts TxCell’s IND application for Ovasave for treatment of refractory Crohn’s disease

TxCell SA, a biotechnology company developing innovative, personalized T cell immunotherapies using antigen specific regulatory T-cells for severe chronic inflammatory and autoimmune diseases, announces today that the United States Food and Drug Administration has accepted TxCell’s Investigational New Drug application for the company’s lead product, Ovasave(R), currently in a phase 2b clinical trial for the treatment of patients with refractory Crohn’s disease.

30 Jun 2015

SeraCare Life Sciences inks CRADA with NCI to create positive controls for cancer assays

SeraCare Life Sciences, a leading partner to global in vitro diagnostics manufacturers, today announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute, part of the National Institutes of Health, to create reference materials and positive controls for cancer assays.

26 Jun 2015

Biontech, Siemens enter into strategic collaboration on manufacture of personalized cancer vaccines

Siemens and BioNTech AG, a fully integrated biotechnology company developing truly personalized cancer immunotherapies, have entered into a strategic collaboration.

25 Jun 2015

IDT’s fully licensed MGB Eclipse qPCR probes available for online ordering

Integrated DNA Technologies (IDT), has become the only company to add fully licensed Minor Groove Binder (MGB) Eclipse GMP probes to its online service, enabling quick and efficient ordering.

From Integrated DNA Technologies 25 Jun 2015

TxCell’s pilot manufacturing facility activities put on temporary partial hold

TxCell SA, a biotechnology company developing innovative, personalized T cell immunotherapies using antigen specific regulatory T-cells for severe chronic inflammatory and autoimmune diseases, announces today that it has temporarily put its pilot manufacturing facility activities at Besançon, France on partial hold.

24 Jun 2015

Planning for first clinical trial of MERS-CoV vaccine candidate now underway

Researchers from Ludwig-Maximilians-Universitaet in Munich have demonstrated, in a preclinical setting, the protective effect of a candidate vaccine directed against the coronavirus that causes Middle East Respiratory Syndrome. Planning for the first clinical trial is now underway.

22 Jun 2015

ScinoPharm Taiwan, Raffles PharmaTech collaborate to manufacture Celecoxib

ScinoPharm Taiwan, Ltd. and Raffles PharmaTech announced today the collaboration to manufacture "Celecoxib," a non-steroidal and anti-inflammatory analgesic active pharmaceutical ingredient (API).

22 Jun 2015

Omeros signs exclusive license agreement with Fagron affiliates for commercialization of OMS103

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for both large-market as well as orphan indications, today announced that it has entered into an exclusive license agreement with affiliates of Fagron NV for the commercialization of OMS103, Omeros' product for arthroscopic surgery.

16 Jun 2015

Althea obtains European GMP certificate from HPRA for commercial aseptic filling and testing

Ajinomoto Althea, Inc., a leading provider of biopharmaceutical contract development and manufacturing services announced today that it has officially received its European GMP certificate from the Health Products Regulatory Authority for commercial aseptic filling and testing.

16 Jun 2015

Time for a switch for patients with rheumatoid arthritis and ankylosing spondylitis

The comparable safety and efficacy of switching patients to a biosimilar anti-TNF-α monoclonal antibody from the reference medicinal product (RMP) has been further established in data presented at EULAR 2015, the annual meeting of the European League Against Rheumatism.

10 Jun 2015

Takara Bio Europe launches Cellartis DEF-CS Xeno-Free Culture Medium for iPS cell culture

Takara Bio Europe AB, formerly Cellartis AB, a wholly-owned subsidiary of Takara Bio Inc., announced today that it is launching an advanced cell culture medium for iPS cell culture. This chemically-defined culture medium is pre-clinical grade, free from human- and animal-derived components, and designed for efficient expansion of undifferentiated human iPS cells.

3 Jun 2015

New finding may lead to development of immunity-based therapies for tuberculosis

A study by researchers at UT Southwestern Medical Center has identified how an enzyme involved in protecting the body from pathogens senses Mycobacterium tuberculosis (TB), a bacterial pathogen that infects millions of people worldwide and causes about 1.5 million deaths annually.

2 Jun 2015

Genticel announces positive results of new multivalent HPV therapeutic vaccine based on Vaxiclase platform

Genticel, a French biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus (HPV), announces today positive preclinical in vivo proof of concept results of GTL002, its multivalent HPV therapeutic vaccine candidate based on the Company’s versatile Vaxiclase platform.

2 Jun 2015

Scientists study active substance against dreaded hospital pathogen Staphylococcus aureus

In the German Center for Infection Research (DZIF), scientists from the universities of Tübingen, Münster and Munich join forces and prepare together with the company Hyglos clinical studies on an active substance against the dreaded hospital pathogen Staphylococcus aureus: A highly effective protein from bacteria-specific viruses, so-called bacteriophages, shall rapidly kill the bacteria, which frequently occur in the nose.

30 May 2015

SCI Logistics announces official opening of new healthcare-dedicated facility in Canada

SCI Logistics today announced the official opening of a new facility dedicated to fulfilling highly specialized requirements to the health care industry.

12 May 2015

China Pharma revenue decreases 20% to $5.7 million in Q1 2015

China Pharma Holdings, Inc., an NYSE MKT listed corporation with its fully-integrated specialty pharmaceuticals subsidiary based in China, today announced financial results for the quarter ended March 31, 2015.

12 May 2015

JHL Biotech closes $45.6 million Series C round of financing

JHL Biotech, Inc., an emerging biopharmaceutical company, today announced that it has closed a Series C fundraising of $45.6 million, led by funds managed by a global renowned crossover fund with over US$1.6 trillion in AUM, with participation from existing investor Milestone Capital and new investors Sungent BioVenture and Liwick Investment Management.

12 May 2015

Panacea Pharmaceuticals selects Goodwin to complete novel vaccine Fill / Finish project

Goodwin Biotechnology, Inc., a biological Contract Development and Manufacturing Organization that specializes in bioprocess development and GMP manufacturing of biopharmaceuticals utilizing Mammalian Cell Culture expression systems and Bioconjugation technologies, was selected by Panacea Pharmaceuticals, Inc. to complete a novel Fill / Finish project, as well as Quality Control release and stability testing for a therapeutic, nanoparticle cancer vaccine based on the Human Aspartyl (Asparaginyl) β-Hydroxylase (HAAH) tumor-specific protein to support Phase I clinical trials in patients with various solid tumor cancers.

11 May 2015

Full range of Lab M media for detection and isolation of Listeria shown together for the first time

The document, ‘Listeria solutions… whatever your method’, clearly shows that whichever testing method users subscribe to, whatever the lab size, and whether they prefer dehydrated culture media...

8 May 2015

T cell expansion technology: an interview with Alexander Malykhin, CVPF, University of Pennsylvania

T cells are taken from the patient’s blood and then modified using lentivirus, adenovirus or RNA electroporation.

From Beckman Coulter Life Sciences - Flow Cytometry 5 May 2015

GMP News and Research

FDA accepts TxCell’s IND application for Ovasave for treatment of refractory Crohn’s disease

SeraCare Life Sciences inks CRADA with NCI to create positive controls for cancer assays

Biontech, Siemens enter into strategic collaboration on manufacture of personalized cancer vaccines

IDT’s fully licensed MGB Eclipse qPCR probes available for online ordering

TxCell’s pilot manufacturing facility activities put on temporary partial hold

Planning for first clinical trial of MERS-CoV vaccine candidate now underway

ScinoPharm Taiwan, Raffles PharmaTech collaborate to manufacture Celecoxib

Omeros signs exclusive license agreement with Fagron affiliates for commercialization of OMS103

Althea obtains European GMP certificate from HPRA for commercial aseptic filling and testing

Time for a switch for patients with rheumatoid arthritis and ankylosing spondylitis

Takara Bio Europe launches Cellartis DEF-CS Xeno-Free Culture Medium for iPS cell culture

New finding may lead to development of immunity-based therapies for tuberculosis

Genticel announces positive results of new multivalent HPV therapeutic vaccine based on Vaxiclase platform

Scientists study active substance against dreaded hospital pathogen Staphylococcus aureus

SCI Logistics announces official opening of new healthcare-dedicated facility in Canada

China Pharma revenue decreases 20% to $5.7 million in Q1 2015

JHL Biotech closes $45.6 million Series C round of financing

Panacea Pharmaceuticals selects Goodwin to complete novel vaccine Fill / Finish project

Full range of Lab M media for detection and isolation of Listeria shown together for the first time

T cell expansion technology: an interview with Alexander Malykhin, CVPF, University of Pennsylvania

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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