Manufacturing News and Research

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

OraSure commences enrollment in final study for FDA approval of OraQuick Rapid HIV-1/2 OTC test

OraSure Technologies, Inc., the market leader in oral fluid diagnostics, announced today that it has enrolled the first subject in its final phase of clinical studies for United States Food and Drug Administration ("FDA") approval of the Company's OraQuick® Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter ("OTC") market.

13 Dec 2010

HeartWare prices public offering of convertible senior notes due 2017

HeartWare International, Inc. announced today the pricing of a public offering of $125 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") yesterday.

10 Dec 2010

Serodus licenses selective serotonin-4 antagonist for potential heart failure treatment from Roche

Serodus AS today announced that it has entered into a license agreement with Roche for a selective serotonin-4 (5-HT4) antagonist for the potential treatment of heart failure (RO1160367).

10 Dec 2010

Caliper to acquire CRi for $20.0 million

Caliper Life Sciences, Inc., a leading provider of products and services for drug discovery research, today announced that it has entered into a definitive agreement to acquire privately-held Cambridge Research & Instrumentation, Inc. (CRi) for approximately $20.0 million, including net debt. CRi's patented preclinical and tissue-based multiplexed analysis systems will expand Caliper's life sciences tools portfolio, particularly as it bridges into clinical research, pathology and clinical market applications.

10 Dec 2010

McNeil recalls ROLAIDS Ultra Strength SoftChews and SoftChews plus Gas Relief in Canada

McNeil Consumer Healthcare, Division of Johnson & Johnson Inc. is voluntarily recalling all lots of ROLAIDS® Ultra Strength SoftChews® and ROLAIDS® Ultra Strength SoftChews® plus Gas Relief distributed in Canada.

10 Dec 2010

PharmaDirections congratulates Orexigen on FDA Advisory approval for Contrave

PharmaDirections congratulates Orexigen Therapeutics on achieving FDA Advisory Board approval for their anti-obesity drug Contrave™. PharmaDirections is proud to have been Orexigen's pharmaceutical development partner and to have developed and produced the first Contrave™ product to undergo full clinical development.

10 Dec 2010

Oxygen Biotherapeutics reports net revenue of $27,126 for second quarter of fiscal 2011

Oxygen Biotherapeutics, Inc., a development stage biomedical company focused on developing oxygen-rich intravenous and topical products, today announced results for the fiscal year second quarter ended October 31, 2010.

10 Dec 2010

FDA grants approval to manufacture Collagenase SANTYL Ointment at DPT Laboratories' facility

Healthpoint today announced that the U.S. Food and Drug Administration has granted approval to manufacture commercial supplies of Collagenase SANTYL Ointment, a biologic enzymatic debriding agent, at DPT Laboratories' Center of Excellence for Sterile & Specialty Products facility in Lakewood, New Jersey.

10 Dec 2010

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

Manufacturing News and Research

Further Reading

OraSure commences enrollment in final study for FDA approval of OraQuick Rapid HIV-1/2 OTC test

HeartWare prices public offering of convertible senior notes due 2017

Serodus licenses selective serotonin-4 antagonist for potential heart failure treatment from Roche

Caliper to acquire CRi for $20.0 million

McNeil recalls ROLAIDS Ultra Strength SoftChews and SoftChews plus Gas Relief in Canada

PharmaDirections congratulates Orexigen on FDA Advisory approval for Contrave

Oxygen Biotherapeutics reports net revenue of $27,126 for second quarter of fiscal 2011

FDA grants approval to manufacture Collagenase SANTYL Ointment at DPT Laboratories' facility

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

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