Manufacturing News and Research

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

First Edition: April 5, 2013

Today's headlines include reports about how President Barack Obama's budget proposal -- to be released next week -- will handle Medicare and Medicaid.

5 Apr 2013

FDA approves CryoLife's next generation HeRO device

CryoLife, Inc., a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced today that it has received U.S. Food and Drug Administration 510(k) clearance for a next generation HeRO (Hemodialysis Reliable Outflow) device.

5 Apr 2013

FDA clears ERYTECH Pharma' IND to start Phase I clinical trial of ERYASP in patients with ALL

ERYTECH Pharma SA announced today that it has received clearance of its Investigational New Drug Application from the United States Food and Drug Administration to initiate a Phase I clinical trial of its product ERYASP, L-asparaginase loaded erythrocytes, in patients 40 years or older with newly diagnosed Acute Lymphoblastic Leukemia.

4 Apr 2013

New medical device detects biothreat agents

Researchers at Sandia National Laboratories are developing a medical instrument that will be able to quickly detect a suite of biothreat agents, including anthrax, ricin, botulinum, shiga and SEB toxin.

3 Apr 2013

Handheld ultrasound devices: an interview with Warren Ortmann, Signostics

Ultrasound devices use sound waves to image the organs of the body safely, without the use of radiation. The sound waves are produced by applying a current to a piezoelectric crystal housed in a transducer. The crystal alters shape and creates a sound wave.

3 Apr 2013

New device to improve patients' hearing

Around 17 million people in Germany suffer from impaired hearing. For many of them, their hearing is so damaged that a standard hearing aid is no longer enough.

3 Apr 2013

Inovio Pharmaceuticals reports release of phase II clinical trial results of ChronVac-C

Inovio Pharmaceuticals, Inc. today announced the release of preliminary clinical trial results by its collaborator ChronTech AS of their open label phase II clinical study of ChronVac-C, ChronTech's vaccine to treat hepatitis C virus infection.

2 Apr 2013

GE Healthcare seeks approval to supply Optison to EU market from Oslo manufacturing facility

GE Healthcare today announced that it has submitted an application to amend its European Marketing Authorisation that will allow the company to manufacture Optison 0.19 mg/ml dispersion for injection within its own facility.

30 Mar 2013

Chromatrap chromatin immunoprecipitation (ChIP) assay range added to Porvair Sciences’ portfolio of products for epigenetics

Porvair Sciences has announced the addition of the novel Chromatrap chromatin immunoprecipitation (ChIP) assay range to its portfolio of products for epigenetics.

From Chromatrap® - Porvair Sciences Ltd 28 Mar 2013

Clinigen announces acquisition of Cardioxane from Novartis

Clinigen Group plc today announced the acquisition of Cardioxane (dexrazoxane) from Novartis for US$33 million in cash, payable in two tranches.

From Clinigen Group 26 Mar 2013

Harvard scientists to further advance blood-cleansing technology for treating sepsis

The Wyss Institute for Biologically Inspired Engineering at Harvard University announced today that it was awarded a $9.25 million contract from the Defense Advanced Research Projects Agency to further advance a blood-cleansing technology developed at the Institute with prior DARPA support, and help accelerate its translation to humans as a new type of sepsis therapy.

26 Mar 2013

FDA proposes tighter regulations to improve AEDs

The U.S. Food and Drug Administration today issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators.

25 Mar 2013

New study reveals management practices improve health care outcomes in hospitals

Researchers have long surmised that management techniques successful in manufacturing and technology sectors may improve health care quality. However, there has been very little evidence about how these practices are disseminated in hospitals and whether they are associated with better performance.

20 Mar 2013

Specialized medical materials testing solutions to be showcased by Zwick at the BIOMEDevice Conference and Exposition

Zwick USA, the subsidiary of global materials and component testing equipment leader Zwick/Roell AG, will be demonstrating its zwicki-Line system at the BIOMEDevice Conference and Exposition to be held here April 10 and 11.

18 Mar 2013

Harvard’s Wyss Institute to harness Sony DADC's expertise to advance Organs-on-Chips technologies

Today the Wyss Institute for Biologically Inspired Engineering at Harvard University and Sony DADC announced a collaboration that will harness Sony DADC's global manufacturing expertise to further advance the Institute's Organs-on-Chips technologies.

18 Mar 2013

Synthesis & Solid State Pharmaceutical Centre: an interview with Dr Mary Shire, University of Limerick

This is a new research centre led by the University of Limerick that supports the pharmaceutical sector in Ireland. The centre will carry out research on the key aspects of what it takes to synthesise the pharmaceutically active molecule to isolate a pure material and to formulate this into a medicine.

14 Mar 2013

Natural Dental Implants’ REPLICATE System now available in Germany and Switzerland

Berlin-based Natural Dental Implants AG, the developer of the REPLICATE Non-Surgical Tooth Replacement System, today announced the availability of the system to customers in Germany and Switzerland.

12 Mar 2013

Influenza drug: an interview with Dr Jenny McKimm-Breschkin, CSIRO

Influenza or flu for short is caused by a family of viruses, which can be called influenza A or influenza B. Influenza A viruses are found in humans, animals – like swine and horses- and mostly aquatic birds. Influenza B is only found in humans.

11 Mar 2013

New technology can turn off genes more precisely, say UCSF researchers

Scientists at UC San Francisco have found a more precise way to turn off genes, a finding that will speed research discoveries and biotech advances and may eventually prove useful in reprogramming cells to regenerate organs and tissues.

8 Mar 2013

Laboratorios Grifols, Cadence announce new supply agreement for OFIRMEV

Cadence Pharmaceuticals, Inc., a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, today announced a new supply agreement with Laboratorios Grifols, S.A. for the development, manufacture and supply of commercial quantities of OFIRMEV (acetaminophen) injection in flexible plastic bags.

6 Mar 2013

Manufacturing News and Research

Further Reading

First Edition: April 5, 2013

FDA approves CryoLife's next generation HeRO device

FDA clears ERYTECH Pharma' IND to start Phase I clinical trial of ERYASP in patients with ALL

New medical device detects biothreat agents

Handheld ultrasound devices: an interview with Warren Ortmann, Signostics

New device to improve patients' hearing

Inovio Pharmaceuticals reports release of phase II clinical trial results of ChronVac-C

GE Healthcare seeks approval to supply Optison to EU market from Oslo manufacturing facility

Chromatrap chromatin immunoprecipitation (ChIP) assay range added to Porvair Sciences’ portfolio of products for epigenetics

Clinigen announces acquisition of Cardioxane from Novartis

Harvard scientists to further advance blood-cleansing technology for treating sepsis

FDA proposes tighter regulations to improve AEDs

New study reveals management practices improve health care outcomes in hospitals

Specialized medical materials testing solutions to be showcased by Zwick at the BIOMEDevice Conference and Exposition

Harvard’s Wyss Institute to harness Sony DADC's expertise to advance Organs-on-Chips technologies

Synthesis & Solid State Pharmaceutical Centre: an interview with Dr Mary Shire, University of Limerick

Natural Dental Implants’ REPLICATE System now available in Germany and Switzerland

Influenza drug: an interview with Dr Jenny McKimm-Breschkin, CSIRO

New technology can turn off genes more precisely, say UCSF researchers

Laboratorios Grifols, Cadence announce new supply agreement for OFIRMEV

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