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

HeartWare announces $100 million convertible senior notes offering

HeartWare International, Inc. announced today its intention to offer, subject to market and other conditions, $100 million principal amount of convertible senior notes due 2017 (the "notes") pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission ("SEC") today. HeartWare also intends to grant the underwriters an option to purchase up to an additional $15 million principal amount of notes to cover over-allotments, if any.

9 Dec 2010

Zealand receives EUR 500,000 milestone payment from Helsinn Healthcare for ZP1846 development program

Zealand Pharma, a biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs that recently listed on NASDAQ OMX, today announces the receipt of a EUR 500,000 (DKK 3.73 million) milestone payment as part of its license agreement with Helsinn Healthcare for the development of ZP1846 for the treatment of chemotherapy-induced diarrhoea. This milestone payment has no impact on the Company's outlook for 2010.

9 Dec 2010

DENTSPLY, DIO enter strategic partnership for dental implant production

DENTSPLY International Inc. announced that it has entered into a strategic partnership with DIO Corporation, based in Busan, South Korea. DIO operations include a state-of-the art manufacturing facility in Busan, producing dental implant devices and associated accessories, which are marketed in numerous countries including many emerging markets.

9 Dec 2010

Nottingham researchers develop new 'score' to detect heart disease in younger people

Experts at The University of Nottingham have developed a new 'score' to help GPs detect heart disease in younger people - before it damages their health.

9 Dec 2010

DPT granted FDA approval to manufacture Collagenase SANTYL Ointment for wound care

DPT Laboratories, Ltd., a pharmaceutical contract development and manufacturing organization, announced today that it received FDA approval to manufacture commercial supplies of a leading sterile ointment for wound care at its Center of Excellence for Sterile & Specialty Products in Lakewood, N.J. Beginning this month, Healthpoint will ship commercial lots of Collagenase SANTYL® Ointment produced at DPT's Lakewood facility to its North American customers.

9 Dec 2010

India, EU trade agreement will not restrict ability for India's pharmaceutical firms to export generic drugs, official says

"India and the European Union (EU) have agreed that the comprehensive bilateral trade agreement being negotiated by the two will not result in an intellectual property regime that restricts the ability of Indian pharmaceutical firms to export generic or off-patent drugs by being far more stringent than the TRIPS [Trade-Related Aspects of International Property Rights] regime of the World Trade Organization," LiveMint.com reports in an article that describes recent debates over the agreement.

9 Dec 2010

e-cigarettes spark debate in U.S.

Electronic cigarettes have been seen as a tobacco product but not as drugs. The US Food and Drug Administration had appealed to the court to treat these cigarettes as drugs but the court says this is an oversight. The FDA cited five e-cigarette distributors for poor manufacturing practices and falsely claiming that the products help people stop smoking.

8 Dec 2010

Vaccine World Summit to be held in New Delhi 1-3 March, 2011

From the 1st to the 3rd of March 2011, vaccine leaders from developing and developed world will meet at Vaccine World Summit in New Delhi. The event will be hosted by IMAPAC, in partnership with DCVMN (Developing Countries Vaccine Manufacturers Network).

8 Dec 2010

Financial Times contrasts 'bottom up' and 'top down' approaches to developing country drugs

The Financial Times contrasts the model of drug development for developing countries being used by non-profit groups like the Meningitis Vaccine Project (MVP), which recently rolled out the MenAfriVac, to that of some pharmaceutical companies.

8 Dec 2010

Shrink, EV Group enter development agreement for StemDisc stem cell and cell culturing platform

Shrink Nanotechnologies, Inc., an innovative nanotechnology company developing products and licensing opportunities in the solar energy industry, medical diagnostics and sensors and biotechnology research and development tools businesses, announced today that it has entered into a multi-year development and manufacturing agreement with EV Group, a 30 year old Austria-based leader in the nano-imprint lithography process designing and equipment manufacturing.

8 Dec 2010

Objet, Clearstep enter collaboration for digital orthodontic solutions

Objet Geometries Ltd., the innovation leader in 3D printing for rapid prototyping and additive manufacturing, today announced collaboration with Clearstep Laboratories, a leading provider of digital orthodontic solutions. Objet's high resolution, 3D printing systems will facilitate Clearstep™ to become more efficient in manufacturing custom-made orthodontic clear aligners on a mass scale. Working together, Clearstep and Objet will bring the advantages of digital printing technology to orthodontics.

8 Dec 2010

Beike exits stem cell joint venture with SiriCell

Shenzhen Beike Biotechnology Co. Ltd. ("Beike") and SiriCell Technologies, Inc. announced that they are ending their partnership in "Beike Holdings Limited", a joint venture formed by the two companies in 2008. Going forward, Beike will exit the joint venture, and all current and future Beike Holdings-initiated business activities will operate exclusively under the SiriCell brand. Beike Holdings was established to expand the availability of Beike's stem cell products outside of China through collaborative hospital partnerships and new international subsidiaries.

8 Dec 2010

Cephalon, Mesoblast to develop, commercialize novel adult MPC therapeutics

Cephalon, Inc. and Mesoblast Limited, today announced they have entered into a strategic alliance to develop and commercialize novel adult Mesenchymal Precursor Stem Cell therapeutics for degenerative conditions of the cardiovascular and central nervous systems.

8 Dec 2010

Cytomedix receives ISO 13485 and Canadian Medical Device Certification for Gaithersburg facility

Cytomedix, Inc. today announced that it has received certification for the ISO 13485 Quality Management Standard for Medical Devices as well as Canadian Medical Device Certification for its Gaithersburg facility. The announcement certifies Cytomedix as a provider of high-quality devices for the medical industry and allows the Company to operate commercially in Europe and in Canada.

7 Dec 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg. The NDA is based on the reference listed drug Ziagen® by ViiV Healthcare.

7 Dec 2010

Selcia's radiochemistry facility granted GMP certificate

Selcia Limited, a leading independent provider of Carbon-14 (C-14) radiolabelling services, is pleased to announce that its radiochemistry facility has been granted a Good Manufacturing Practice (GMP) certificate for the preparationand C-14 labellingofActive Pharmaceutical Ingredients (APIs)for clinical trials following a successful inspection by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

7 Dec 2010

Virally structured nano-electrodes boost energy capacity ten-fold

Viruses have a bad rep—and rightly so. The ability of a virus to quickly and precisely replicate itself makes it a destructive scourge to animals and plants alike. Now an interdisciplinary team of researchers at the University of Maryland's A. James Clark School of Engineering and College of Agriculture and Natural Resources, brought together by Professor Reza Ghodssi, is turning the tables, harnessing and exploiting the "self-renewing" and "self-assembling" properties of viruses for a higher purpose: to build a new generation of small, powerful and highly efficient batteries and fuel cells.

7 Dec 2010

Positron achieves highest possible compliance notice from Nuclear Regulatory Commission

Positron Corporation, a leading molecular imaging company specializing in the field of nuclear cardiology, today announced it had achieved the highest mark of compliance in a recent inspection by the Nuclear Regulatory Commission (NRC).

7 Dec 2010

No evidence of toxicity in hemophilia B patients enrolled in gene therapy trial

Investigators report no evidence of toxicity in the four hemophilia B patients enrolled to date in a gene therapy trial using a vector under development at St. Jude Children's Research Hospital and UCL (University College London) to correct the inherited bleeding disorder.

7 Dec 2010

Fraunhofer USA CMB receives FDA approval to initiate Phase I clinical trial of H5N1 influenza vaccine

Fraunhofer USA Center for Molecular Biotechnology announced today it has received approval from the Food and Drug Administration to proceed with the first human clinical trial of plant-produced H5N1 influenza vaccine.

6 Dec 2010

Manufacturing News and Research

Further Reading

HeartWare announces $100 million convertible senior notes offering

Zealand receives EUR 500,000 milestone payment from Helsinn Healthcare for ZP1846 development program

DENTSPLY, DIO enter strategic partnership for dental implant production

Nottingham researchers develop new 'score' to detect heart disease in younger people

DPT granted FDA approval to manufacture Collagenase SANTYL Ointment for wound care

India, EU trade agreement will not restrict ability for India's pharmaceutical firms to export generic drugs, official says

e-cigarettes spark debate in U.S.

Vaccine World Summit to be held in New Delhi 1-3 March, 2011

Financial Times contrasts 'bottom up' and 'top down' approaches to developing country drugs

Shrink, EV Group enter development agreement for StemDisc stem cell and cell culturing platform

Objet, Clearstep enter collaboration for digital orthodontic solutions

Beike exits stem cell joint venture with SiriCell

Cephalon, Mesoblast to develop, commercialize novel adult MPC therapeutics

Cytomedix receives ISO 13485 and Canadian Medical Device Certification for Gaithersburg facility

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Selcia's radiochemistry facility granted GMP certificate

Virally structured nano-electrodes boost energy capacity ten-fold

Positron achieves highest possible compliance notice from Nuclear Regulatory Commission

No evidence of toxicity in hemophilia B patients enrolled in gene therapy trial

Fraunhofer USA CMB receives FDA approval to initiate Phase I clinical trial of H5N1 influenza vaccine

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