Manufacturing News and Research

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

Columbia Laboratories third quarter total net revenues decrease to $4.9 million

Columbia Laboratories, Inc. today reported financial results for the three- and nine-month periods ended September 30, 2011.

3 Nov 2011

Clinical-grade viral vector can cure choroideremia

Researchers at Ohio State University Medical Center and Nationwide Children's Hospital have developed a viral vector designed to deliver a gene into the eyes of people born with an inherited, progressive form of blindness that affects mainly males.

3 Nov 2011

New laser technique could create tissue scaffolds, microneedles

In the emerging field of tissue engineering, scientists encourage cells to grow on carefully designed support scaffolds. The ultimate goal is to create living structures that might one day be used to replace lost or damaged tissue, but the manufacture of appropriately detailed scaffolds presents a significant challenge that has kept most tissue engineering applications confined to the research lab.

3 Nov 2011

Obama takes action to address drug shortages

President Barack Obama issued an executive order Monday directing the Food and Drug Administration to, among other steps, speed up reviews of manufacturers' applications to begin or alter production of a drug in potentially short supply.

2 Nov 2011

SurModics to sell Pharma assets to Evonik for $30 million

SurModics, Inc., a leading provider of surface modification technologies to the healthcare industry, announced today that it has entered into a definitive agreement to sell its SurModics Pharmaceuticals assets to Evonik Industries AG for $30 million in cash.

2 Nov 2011

GSK, Alnylam collaborate to apply VaxiRNA technology for influenza vaccine production

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it has formed a collaboration with GlaxoSmithKline (GSK) focused on Alnylam's VaxiRNATM technology for certain GSK vaccine products, including influenza. VaxiRNA is a new RNAi technology for the enhanced production of viruses used in the manufacture of vaccine products. GSK, a leading vaccine manufacturer, is the first company to form a collaboration accessing this new platform.

2 Nov 2011

NovaSterilis reports significant findings from sterilization of absorbable suture study

NovaSterilis Inc. a leader in the development and commercialization of supercritical carbon dioxide (SCCO2) technology in collaboration with CC Chu Ph.D (Cornell) reports successful findings from research funded by a National Institutes of Health (NIH) phase l grant. These results meet the study goal to sterilize absorbable sutures to a sterility assurance level 10-6 (SAL6) without chemical or mechanical degradation. NovaSterilis intends to apply for phase II funding to develop the process ready for commercial application.

1 Nov 2011

Pall, NIBRT co-host master class on single-use systems in manufacturing of biopharmaceuticals

Pall Life Sciences and the National Institute for Bioprocessing Research and Training (NIBRT) in Ireland recently co-hosted a master class on the use of single-use systems in the development and manufacturing of biopharmaceuticals.

From Pall Corporation 29 Oct 2011

Sorin Group third quarter revenues decrease 2.1% to €171.4 million

Sorin Group: Revenues of €171.4 million, a 2.1% decline (-4.9% as reported) over the same period last year.

29 Oct 2011

Standard Register reports revenue of $157.5 million for third quarter 2011

Standard Register today announced its financial results for the third quarter. The Company reported revenue of $157.5 million and a net profit of $8.4 million, or $0.29 per diluted share.

29 Oct 2011

Biogen Idec third quarter revenues increase 11% to $1.3 billion

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing and commercialization of innovative therapies, today announced its third quarter 2011 results.

28 Oct 2011

Researchers announce new method to build important heparin drug

Robert Linhardt is working to forever change the way some of the most widely used drugs in the world are manufactured. Today, in the journal Science, he and his partner in the research, Jian Liu, have announced an important step toward making this a reality. The discovery appears in the October 28, 2011 edition of the journal Science in a paper titled "chemoenzymatic synthesis of homogeneous ultra-low molecular weight heparins."

28 Oct 2011

Gilead submits Quad NDA to FDA for treatment of HIV-1 infection

Gilead Sciences, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the "Quad", a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults.

28 Oct 2011

Gilead, Bristol-Myers Squibb to develop and commercialize fixed-dose combination for HIV

Bristol-Myers Squibb Company and Gilead Sciences, Inc. today announced a licensing agreement for Bristol-Myers Squibb to develop and commercialize a fixed-dose combination containing Bristol-Myers Squibb's protease inhibitor REYATAZ (atazanavir sulfate) and Gilead's cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain HIV medicines to potentially allow for one pill once daily dosing.

27 Oct 2011

Elan's third quarter total revenue increases 17% to $328.5 million

Elan Corporation, plc today reported its third quarter and first nine months 2011 financial results.

27 Oct 2011

Premier awards Lantheus three-year supplier agreement for nuclear imaging products

Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, today announced it has been awarded a three-year supplier contract with Premier Purchasing Partners, L.P., the group purchasing unit of the Premier healthcare alliance, for its radiopharmaceutical imaging agents.

24 Oct 2011

SafeMinds praises UNEP's draft treaty ban on use of mercury in pharma products

SafeMinds applauds UNEP's draft treaty language which does not exempt the use of mercury in pharmaceutical products, including vaccines, from the global ban. Governmental regulators, public health officials and pharmaceutical companies have recognized that the toxicity of mercury in pharmaceutical and personal care products, to which people are directly exposed, justifies a preventive approach to minimize all exposures.

24 Oct 2011

Mesoblast cleared to begin first phase 2 clinical trial for wet AMD

Regenerative medicine company Mesoblast Limited (ASX: MSB) today announced that it has received regulatory clearance from the Singapore Health Sciences Authority (HSA) to commence the first Phase 2 trial of its proprietary allogeneic (off-the-shelf) adult stem cell therapy for patients with proliferation of leaky blood vessels in the eyes – neovascular (“wet”) Age-related Macular Degeneration (AMD).

24 Oct 2011

Mesoblast receives Singapore HSA regulatory clearance to begin wet AMD Phase 2 trial

Regenerative medicine company Mesoblast Limited today announced that it has received regulatory clearance from the Singapore Health Sciences Authority (HSA) to commence the first Phase 2 trial of its proprietary allogeneic (off-the-shelf) adult stem cell therapy for patients with proliferation of leaky blood vessels in the eyes – neovascular Age-related Macular Degeneration.

24 Oct 2011

Embryonic stem cell therapy patents knocked back in Europe

The European Union's highest court ruled Tuesday that scientists cannot patent stem cell techniques that use human embryos for research, a decision some scientists said could threaten major medical advances if it prevents biotech companies from turning a profit.

20 Oct 2011

Manufacturing News and Research

Further Reading

Columbia Laboratories third quarter total net revenues decrease to $4.9 million

Clinical-grade viral vector can cure choroideremia

New laser technique could create tissue scaffolds, microneedles

Obama takes action to address drug shortages

SurModics to sell Pharma assets to Evonik for $30 million

GSK, Alnylam collaborate to apply VaxiRNA technology for influenza vaccine production

NovaSterilis reports significant findings from sterilization of absorbable suture study

Pall, NIBRT co-host master class on single-use systems in manufacturing of biopharmaceuticals

Sorin Group third quarter revenues decrease 2.1% to €171.4 million

Standard Register reports revenue of $157.5 million for third quarter 2011

Biogen Idec third quarter revenues increase 11% to $1.3 billion

Researchers announce new method to build important heparin drug

Gilead submits Quad NDA to FDA for treatment of HIV-1 infection

Gilead, Bristol-Myers Squibb to develop and commercialize fixed-dose combination for HIV

Elan's third quarter total revenue increases 17% to $328.5 million

Premier awards Lantheus three-year supplier agreement for nuclear imaging products

SafeMinds praises UNEP's draft treaty ban on use of mercury in pharma products

Mesoblast cleared to begin first phase 2 clinical trial for wet AMD

Mesoblast receives Singapore HSA regulatory clearance to begin wet AMD Phase 2 trial

Embryonic stem cell therapy patents knocked back in Europe

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