Manufacturing News and Research

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

No doughnut hole in global mail-order pharmacy

Thanks to the Patient Protection and Affordable Care Act signed into law by President Obama on March 23, 2010, Medicare enrollees who enter the dreaded "doughnut hole" -- the Medicare Part D coverage gap that has made seniors responsible for all their drug costs between $2,830 and $6,440 -- will save $250 in 2010. But Betterthanmedicare.com is already saving seniors thousands of dollars, because the global mail-order pharmacy has no doughnut hole.

2 Apr 2010

Interactive workshop focuses on standardization to improve value and practicality of imaging biomarkers

The U.S. Food and Drug Administration, SNM and the Radiological Society of North America (RSNA) are hosting a joint two-topic workshop, April 13-14, 2010 at the Natcher Conference Center of the National Institutes of Health, Bethesda, Md. The first day of the workshop will focus on general issues of standardization to control variability and inconsistency in methods of acquisition, interpretation and analysis of images in clinical trials.

2 Apr 2010

NewLink Genetics occupies new administrative and manufacturing facility

NewLink Genetics Corporation announced that it has taken occupancy of its new administrative and manufacturing facility. The building includes both a cGMP manufacturing suite as well as administrative and executive offices. It is located on the campus of the Iowa State University Research Park in Ames, Iowa.

2 Apr 2010

Medtronic to appeal U.S. jury verdict in CoreValve system patent infringement case

Medtronic, Inc., announced today that it will appeal the $73.5 million jury verdict returned in the U.S. District Court in Delaware deciding that the CoreValve® transcatheter aortic valve system infringes a valid U.S. Andersen patent owned by Edwards Lifesciences.

2 Apr 2010

Biotech reports record financial results for 2010 first quarter

Biotech racked up impressive gains for both the month of March and the first quarter of 2010. The Burrill Biotech Select Index posted a 3.7 percent jump in value in March and an 8 percent overall gain for Q1 '10.

2 Apr 2010

ImmunoCellular Therapeutics files Annual Report with Securities and Exchange Commission for 2009

ImmunoCellular Therapeutics announced today that it has filed its Annual Report with the Securities and Exchange Commission for the period ended December 31, 2009 on Form 10-K.

1 Apr 2010

Radiology benefit management programs can protect patients from radiation exposure

Making sure patients receive the right diagnostic imaging tests at the right times in high-quality facilities significantly reduces unnecessary radiation exposure, HealthHelp chief medical officer Mark Hiatt, M.D., testified at a public meeting held by the U.S. Food and Drug Administration.

1 Apr 2010

PolyMedix secures $14M credit facility with Hercules Technology II

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has secured a $14 million credit facility with Hercules Technology II, L.P., an affiliate of Hercules Technology Growth Capital, Inc.

1 Apr 2010

Biostar Pharmaceuticals fiscal 2009 revenues up 57.2%

Biostar Pharmaceuticals, Inc., the Xianyang-based manufacturer of a leading over-the-counter Hepatitis B medicine, Xin Aoxing Oleanolic Acid Capsule, and other pharmaceutical products, today announced its 2009 year-end financial results.

1 Apr 2010

Soligenix's revenues for 2009 increase by 22%

Soligenix, Inc., a late-stage biopharmaceutical company, today announced its financial results for 2009.

1 Apr 2010

Tanda Professional Restore light therapy now made available for at-home use

During a press conference yesterday, doctors and experts unveiled a groundbreaking medical device using the healing properties of light therapy for pain management and improving mobility. For the first time ever, a licensed medical device that delivers clinical levels of light therapy only previously available in a doctor's office, has now been made available for at-home use.

1 Apr 2010

Cord Blood America signs License and Cooperation Agreement with AXM Pharma in China

Cord Blood America, Inc., the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells, a biological insurance policy, to families nationwide and internationally, announced today that it has signed a License and Cooperation Agreement for the processing and storage of umbilical cord blood in China with AXM Pharma, Inc.

1 Apr 2010

IVAX Diagnostics reports net revenue of $4.5M for quarter ended December 31, 2009

IVAX Diagnostics, Inc., a fully integrated in vitro diagnostics company, reports its financial results for the fourth quarter and full year ended December 31, 2009.

31 Mar 2010

2010 BIO International Convention to discuss issues that impact drug discovery and development

The 2010 BIO International Convention will feature a robust health and medical program highlighting the latest scientific breakthroughs and policy and business development issues that impact drug discovery and development. Hosted by the Biotechnology Industry Organization, the Convention will be held May 3-6, 2010 in Chicago, Ill. at McCormick Place.

31 Mar 2010

Tongjitang Chinese Medicines' net revenue rises 31.5% in fourth quarter 2009

Tongjitang Chinese Medicines Company, a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced its financial results for the fourth quarter of 2009 and for the full year ended December 31, 2009.

31 Mar 2010

Sanofi Pasteur accelerates deployment of Intercim's Pertinence Suite MOM software solution

Intercim, announces that Sanofi Pasteur, the vaccines division of the Sanofi-aventis Group, is accelerating the use of Pertinence Suite, Manufacturing Operations Management (MOM) software solution, within the European and North American sites of the worldwide leader of vaccines.

31 Mar 2010

AgaMatrix, sanofi-aventis announce long-term partnership for BGM solutions

AgaMatrix, Inc. and sanofi-aventis today announced that they have signed a long-term agreement for the development, supply and commercialization of blood glucose monitoring (BGM) solutions. Under the terms of the agreement, AgaMatrix and sanofi-aventis will co-develop innovative solutions in diabetes management that incorporate AgaMatrix's WaveSense™ technology. Sanofi-aventis will commercialize through its Global Diabetes Division such integrated solutions for patients with diabetes, along with current sanofi-aventis insulins and delivery devices.

31 Mar 2010

Ikaria Holdings acquires NDA and IND application for LUCASSIN drug

Ikaria Holdings, Inc. announced today that it has acquired the New Drug Application (NDA) and the Investigational New Drug (IND) application to LUCASSIN® (terlipressin for injection) from Orphan Therapeutics, assuming all future development and ownership of the drug in North America and Australia.

31 Mar 2010

Hospira acquires Orchid's injectables formulations business

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced it has completed the acquisition of the generic injectable pharmaceuticals business of Orchid Chemicals & Pharmaceuticals Ltd., a leading Indian pharmaceuticals company, for approximately $400 million.

31 Mar 2010

Savient Pharmaceuticals' resubmission of BLA for KRYSTEXXA accepted for FDA review

Savient Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has acknowledged receipt of and accepted for review the March 15, 2010 resubmission of the Biologics License Application for KRYSTEXXA™ (pegloticase), a treatment for chronic gout in patients refractory to conventional therapy.

30 Mar 2010

Manufacturing News and Research

Further Reading

No doughnut hole in global mail-order pharmacy

Interactive workshop focuses on standardization to improve value and practicality of imaging biomarkers

NewLink Genetics occupies new administrative and manufacturing facility

Medtronic to appeal U.S. jury verdict in CoreValve system patent infringement case

Biotech reports record financial results for 2010 first quarter

ImmunoCellular Therapeutics files Annual Report with Securities and Exchange Commission for 2009

Radiology benefit management programs can protect patients from radiation exposure

PolyMedix secures $14M credit facility with Hercules Technology II

Biostar Pharmaceuticals fiscal 2009 revenues up 57.2%

Soligenix's revenues for 2009 increase by 22%

Tanda Professional Restore light therapy now made available for at-home use

Cord Blood America signs License and Cooperation Agreement with AXM Pharma in China

IVAX Diagnostics reports net revenue of $4.5M for quarter ended December 31, 2009

2010 BIO International Convention to discuss issues that impact drug discovery and development

Tongjitang Chinese Medicines' net revenue rises 31.5% in fourth quarter 2009

Sanofi Pasteur accelerates deployment of Intercim's Pertinence Suite MOM software solution

AgaMatrix, sanofi-aventis announce long-term partnership for BGM solutions

Ikaria Holdings acquires NDA and IND application for LUCASSIN drug

Hospira acquires Orchid's injectables formulations business

Savient Pharmaceuticals' resubmission of BLA for KRYSTEXXA accepted for FDA review

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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