Manufacturing News and Research

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

FDA grants Soligenix Orphan Drug Designation to RiVax for prevention of ricin intoxication

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax™ for the prevention of ricin intoxication. RiVax™ is a proprietary vaccine that contains a recombinant subunit of the A chain of ricin toxin which induces ricin neutralizing antibodies in humans and animals.

20 Jan 2011

Meridian Bioscience first quarter net sales decrease 12% to $37.3 million

Net sales for the first quarter of fiscal 2011 were $37,263,000 as compared to $42,457,000 for the same period of the prior fiscal year, a decrease of 12%. Net earnings for the first quarter of fiscal 2011 were $6,025,000, or $0.15 per diluted share, both decreases of 32% from the first quarter of fiscal 2010. Diluted common shares outstanding for the first quarter of fiscal 2011 and 2010 were 41,294,000 and 41,185,000, respectively.

20 Jan 2011

FDA approves Spectranetics PMA for manufacturing site change for CVX-300 laser system

Spectranetics Corporation today announced that the Food and Drug Administration (FDA) has approved the Company's premarket approval application (PMA) supplement requesting a manufacturing site change for the CVX-300® laser system.

20 Jan 2011

American Lung Association releases 2010 State of Tobacco Control Report

The American Lung Association released its State of Tobacco Control 2010 report today, which tracks progress on key tobacco control policies at the federal and state level, assigning grades based on whether laws are adequately protecting citizens from the enormous burden caused by tobacco use.

20 Jan 2011

Waters signs land-purchase agreement with Royal Bank of Scotland for new MS Headquarters in UK

Waters Corporation today announced it signed a land-purchase agreement with The Royal Bank of Scotland for a new Mass Spectrometry Headquarters in Wilmslow, Cheshire, near Manchester, U.K.

20 Jan 2011

U.S. Physical Therapy launches Fit2WRK to provide solutions for prevention of injuries in workplace

U.S. Physical Therapy, a national operator of outpatient physical therapy clinics, announced that it has successfully launched a workers compensation and disability initiative called Fit2WRK. Fit2WRK provides an integrated solution for the management and prevention of injuries in the workplace.

20 Jan 2011

Bluechiip, STMicroelectronics enter partnership to manufacture unique MEMS-based tracking tags

STMicroelectronics, the leading supplier of MEMS devices for consumer and portable applications, and Bluechiip Limited, an innovative early-stage company that has developed a groundbreaking tracking solution, today announced that the two companies are to cooperate in the manufacturing of unique MEMS-based tracking tags, aimed at a range of different markets, but initially in healthcare, such as biobanks.

20 Jan 2011

DARPA grants $5.6 million to Dana-Farber to develop viable countermeasures against unknown pathogen

Researchers at Dana-Farber Cancer Institute have received a $5.6 million grant from the Defense Advanced Research Projects Agency and the Army Research Office to develop transient immunity against known, unknown, naturally occurring, or engineered disease-causing pathogens.

20 Jan 2011

Africa's economic expansion not strong enough to reach poverty MDG, U.N. report says

"Africa's economy expanded by 4.7 percent in 2010 and is expected to maintain similar growth over the next two years," according to the U.N.'s World Economic Situation and Prospects 2011 report, which was released Tuesday in the Ethiopian capital Addis Ababa, Deutsche Presse-Agentur/M&C reports.

20 Jan 2011

Biomarin commences BMN 701 Phase 1/2 trial for treatment of Pompe disease

BioMarin Pharmaceutical Inc. announced today that it has initiated a Phase 1/2 trial for BMN 701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase in development for the treatment of Pompe disease.

20 Jan 2011

New project on developing countermeasures for natural and intentional exposure to disease pathogens

Researchers at Dana-Farber Cancer Institute have received a $5.6 million grant from the Defense Advanced Research Projects Agency (DARPA) and the Army Research Office (ARO) to develop transient immunity against known, unknown, naturally occurring, or engineered disease-causing pathogens. The ultimate goal is to develop a viable countermeasure to an unknown pathogen within seven days of receiving it in a laboratory.

19 Jan 2011

Cancer cells brought back under normal control

Scientists at The University of Nottingham have brought cancer cells back under normal control — by reactivating their cancer suppressor genes. The discovery could form a powerful new technology platform for the treatment of cancer of the breast and other cancers.

19 Jan 2011

FDA announces consent decree of permanent injunction against Deltex

The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan.

19 Jan 2011

Boehringer Ingelheim to acquire Amgen's Fremont California development and manufacturing facility

Amgen Inc. and Boehringer Ingelheim today announced they have signed an agreement under which Boehringer Ingelheim will acquire Amgen's rights in and substantially all assets at Amgen's Fremont California development and manufacturing facility.

19 Jan 2011

iBio grants commercial, royalty-bearing license to Fiocruz/Bio-Manguinhos for new yellow fever vaccine

iBio, Inc. today announced the grant of a commercial, royalty-bearing license to Fiocruz/Bio-Manguinhos of Brazil to develop, manufacture and sell certain vaccines based upon iBio's proprietary technology. Fiocruz/Bio-Manguinhos will invest more than $6 million to bring the first product - a new yellow fever vaccine - through Phase I clinical trials.

18 Jan 2011

DKMA issues GMP certificate to Cambrex Zenara Indian manufacturing facility

Cambrex Corporation announced today that the Danish Medicines Agency (DKMA) has issued a Certificate of Good Manufacturing Practice (GMP) compliance for its manufacturing site in Hyderabad, India, following an audit conducted in October 2010. The DKMA Certificate is accepted by all EU Health Authorities and by authorities of several other countries that recognize EU Certification.

18 Jan 2011

Aegis releases Discoverant 4.0 manufacturing intelligence software

Aegis Analytical Corp., the leading provider of Enterprise Manufacturing and Process Intelligence software, announced today the availability of Aegis Discoverant® 4.0, the latest version of its global software platform.

18 Jan 2011

PositiveID and RFID Solutions complete development of temperature-sensing microchip

PositiveID Corporation announced today that it has completed the development of its temperature-sensing microchip in conjunction with development partner RFID Solutions of Malaga, Spain. The microchip, which uses radio frequency identification (RFID) technology, is able to measure internal temperature within the body and communicate that temperature wirelessly to an external reader.

18 Jan 2011

Wisepower acquires Unidym

Arrowhead Research Corporation today announced that its Unidym, Inc. subsidiary has been acquired by Wisepower Co., Ltd., a publicly-traded, Seoul, Korea-based electronics company. Upfront consideration to Unidym shareholders consists of Wisepower stock and convertible bonds valued at US $5,000,000 with certain restrictions as to timing of stock sales.

18 Jan 2011

Alexza completes FDA review for AZ-004 NDA

Alexza Pharmaceuticals, Inc. announced today that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA or Agency) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting. In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010.

18 Jan 2011

Manufacturing News and Research

Further Reading

FDA grants Soligenix Orphan Drug Designation to RiVax for prevention of ricin intoxication

Meridian Bioscience first quarter net sales decrease 12% to $37.3 million

FDA approves Spectranetics PMA for manufacturing site change for CVX-300 laser system

American Lung Association releases 2010 State of Tobacco Control Report

Waters signs land-purchase agreement with Royal Bank of Scotland for new MS Headquarters in UK

U.S. Physical Therapy launches Fit2WRK to provide solutions for prevention of injuries in workplace

Bluechiip, STMicroelectronics enter partnership to manufacture unique MEMS-based tracking tags

DARPA grants $5.6 million to Dana-Farber to develop viable countermeasures against unknown pathogen

Africa's economic expansion not strong enough to reach poverty MDG, U.N. report says

Biomarin commences BMN 701 Phase 1/2 trial for treatment of Pompe disease

New project on developing countermeasures for natural and intentional exposure to disease pathogens

Cancer cells brought back under normal control

FDA announces consent decree of permanent injunction against Deltex

Boehringer Ingelheim to acquire Amgen's Fremont California development and manufacturing facility

iBio grants commercial, royalty-bearing license to Fiocruz/Bio-Manguinhos for new yellow fever vaccine

DKMA issues GMP certificate to Cambrex Zenara Indian manufacturing facility

Aegis releases Discoverant 4.0 manufacturing intelligence software

PositiveID and RFID Solutions complete development of temperature-sensing microchip

Wisepower acquires Unidym

Alexza completes FDA review for AZ-004 NDA

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