Manufacturing News and Research

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Manufacturing is the production of products across all industries, on a large-scale, using machinery.

TxCell reviews its manufacturing strategy to focus on R&D and strategic partnerships - its core, high added value businesses

TxCell SA, a biotechnology company developing innovative, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that it is operating a strategic review that should result in the outsourcing of all existing and future clinical and commercial manufacturing operations to contract manufacturing organizations (CMOs).

15 Oct 2015

ADMT announces filing of FDA 510(k) application for Angiodroid The CO2 Injector for Angiography

ADM Tronics Unlimited, Inc. has announced that a Premarket Notification 510(k) application has been filed with the US Food and Drug Administration for Angiodroid The CO2 Injector for Angiography (the "Angiodroid Injector") by Angiodroid America, Inc., a subsidiary of Angiodroid, Srl, in affiliation with Triotech Ventures and ADMT, as previously announced.

15 Oct 2015

XTL signs agreement with Yeda to amend development milestones for lupus treatment

XTL Biopharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of unmet clinical needs with a focus on treatments for autoimmune diseases, today announced that it has reached agreement with Yeda Research and Development Company Ltd. to amend the development milestones in the License Agreement signed between the parties in January 2014 for the development of hCDR1 for the treatment of systemic lupus erythematosus (SLE).

13 Oct 2015

Study: RNA editing technique shows promise in treating rare, severe form of muscular dystrophy

An RNA editing technique called "exon skipping" has shown preliminary success in treating a rare and severe form of muscular dystrophy that currently has no treatment, based on a new study from Northwestern Medicine and the University of Chicago. Children with the disease lose significant muscle strength early in life.

13 Oct 2015

Federal judge grants permanent injunction against South Dakota medical laser manufacturer

A federal judge in the U.S. District Court for the District of South Dakota yesterday granted the U.S. Food and Drug Administration a permanent injunction against 2035 Inc. and Robert "Larry" Lytle, doing business as QLasers PMA and 2035 PMA.

12 Oct 2015

FDA takes major step to put greater emphasis on the prevention of foodborne illness

The U.S. Food and Drug Administration today took one of the most significant steps in decades to prevent foodborne illness by finalizing the first two of seven major rules under the bipartisan FDA Food Safety Modernization Act (FSMA).

9 Oct 2015

Hi-Tech Pharmaceuticals signs definitive agreement to acquire iForce

Hi-Tech Pharmaceuticals, a leading global provider of Sports Nutrition products, Contract Manufacturing, and iForce Nutrition ("iForce"), one of the fastest-growing Sports Nutrition companies in the United States, today announced that they have entered into a definitive agreement in which Hi-Tech has agreed to acquire iForce.

9 Oct 2015

Primasil innovation helps improve Paxman™ cooling cap

Collaboration between Primasil Silicones and its academic partner University of Huddersfield has enabled Paxman™ to bring relief to cancer patients undergoing chemotherapy by further reducing the risk of hair-loss during treatment.

From Paxman 7 Oct 2015

Cell Therapy Catapult launches Cell History File

The Cell Therapy Catapult, the organisation dedicated to the growth of the UK cell and gene therapy industry by bridging the gap between scientific research and commercialisation, today announces the availability of the Cell History File (CHF) template document. The Cell History File template has been developed in conjunction with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the Human Tissue Authority (HTA) and other cell therapy developers and manufacturers from academia and industry.

7 Oct 2015

VWR announces acquisition of Purification Technologies

VWR, a leading, global, independent provider of laboratory products, services and solutions, announced today that it has acquired Purification Technologies Inc., a specialty solvent company that performs high volume purification of selected high purity solvents. This acquisition will enhance VWR's growing laboratory and production chemical manufacturing portfolio to better support its laboratory and biopharmaceutical manufacturing customers.

7 Oct 2015

Lonza, Benitec partner to develop scalable manufacturing process for AAV-based viral gene therapies

Lonza Houston, Inc., a global leader in biological, cell and viral gene therapy manufacturing, and Benitec Biopharma, a clinical stage biotechnology company commercializing a patented gene-silencing technology, DNA-directed RNA interference (ddRNAi), today announced that they have entered into a Manufacturing Services Agreement to develop a scalable manufacturing process for Benitec's ddRNAi-based, Adeno-Associated Virus (AAV)-delivered products intended for therapeutic use in humans.

7 Oct 2015

Solix Algredients introduces Solasta Astaxanthin to B2B marketplace

Solix Algredients, Inc. has introduced Solasta Astaxanthin to the B2B ingredients marketplace. Solasta is a natural astaxanthin extract produced from the microalga Haematococcus pluvialis, the richest natural source of the antioxidant. Research has shown that algal astaxanthin has superior antioxidant activity compared to other well-known antioxidants.

7 Oct 2015

Provepep synthesizes bioactive homodimer form of IL-10 using SEA peptide ligation technology

Provepep, the peptide business unit of Provence Technologies Group, a specialist fine chemistry research group, today announces that it has successfully synthesized tens of mg of bioactive homodimer form of IL-10.

7 Oct 2015

Michigan researchers use Raman spectroscopy to study various childhood diseases

Renishaw, a world leader in metrology and spectroscopy, reports on the use of its inVia confocal Raman microscope in the study of various diseases–with a major focus on childhood diseases–at the Children's Hospital of Michigan and Wayne State University.

6 Oct 2015

Vertera Spine receives FDA 510(k) clearance for COHERE Cervical Interbody Fusion Device

Vertera Spine, a developer of medical devices with advanced functional surface technologies for spine applications, today announced it has received U.S. Food and Drug Administration 510(k) clearance for its COHERE Cervical Interbody Fusion Device.

6 Oct 2015

Envisia's ENV515 (travoprost XR) meets primary efficacy endpoint in phase 2a glaucoma trial

Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today reported results from its first clinical trial of the Company's lead product candidate, ENV515 (travoprost XR).

6 Oct 2015

Beddit releases first Apple Watch app that integrates with Beddit Smart to improve sleep quality

Today, Beddit released its first Apple Watch app that integrates with its sensor device, Beddit Smart™, to provide around-the-clock sleep tracking, personalized coaching and convenient glances with information on sleep quality.

6 Oct 2015

NIH-funded researchers test new gene therapy to improve visual function in mice

Researchers funded by the National Institutes of Health have developed a novel mouse model for the vision disorder Leber hereditary optic neuropathy (LHON), and found that they can use gene therapy to improve visual function in the mice. LHON is one of many diseases tied to gene mutations that damage the tiny energy factories that power our cells, called mitochondria.

6 Oct 2015

FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Enbrel (etanercept) - a tumor necrosis factor alpha (TNF-α) inhibitor

5 Oct 2015

FIGO takes stand on human exposure to toxic chemicals

Dramatic increases in exposure to toxic chemicals in the last four decades are threatening human reproduction and health, according to the International Federation of Gynecology and Obstetrics (FIGO), the first global reproductive health organization to take a stand on human exposure to toxic chemicals.

1 Oct 2015

Manufacturing News and Research

Further Reading

TxCell reviews its manufacturing strategy to focus on R&D and strategic partnerships - its core, high added value businesses

ADMT announces filing of FDA 510(k) application for Angiodroid The CO2 Injector for Angiography

XTL signs agreement with Yeda to amend development milestones for lupus treatment

Study: RNA editing technique shows promise in treating rare, severe form of muscular dystrophy

Federal judge grants permanent injunction against South Dakota medical laser manufacturer

FDA takes major step to put greater emphasis on the prevention of foodborne illness

Hi-Tech Pharmaceuticals signs definitive agreement to acquire iForce

Primasil innovation helps improve Paxman™ cooling cap

Cell Therapy Catapult launches Cell History File

VWR announces acquisition of Purification Technologies

Lonza, Benitec partner to develop scalable manufacturing process for AAV-based viral gene therapies

Solix Algredients introduces Solasta Astaxanthin to B2B marketplace

Provepep synthesizes bioactive homodimer form of IL-10 using SEA peptide ligation technology

Michigan researchers use Raman spectroscopy to study various childhood diseases

Vertera Spine receives FDA 510(k) clearance for COHERE Cervical Interbody Fusion Device

Envisia's ENV515 (travoprost XR) meets primary efficacy endpoint in phase 2a glaucoma trial

Beddit releases first Apple Watch app that integrates with Beddit Smart to improve sleep quality

NIH-funded researchers test new gene therapy to improve visual function in mice

FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

FIGO takes stand on human exposure to toxic chemicals

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