Manufacturing News and Research

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

Plant-based vaccine factory to produce vaccines and therapeutics within weeks of outbreaks

The Fraunhofer Center for Molecular Biotechnology in Newark, Delaware, the Fraunhofer Center for Manufacturing Innovation in Boston, Massachusetts, the Boston University College of Engineering, and the biopharmaceutical company iBio, Inc. in Newark, Delaware, announced today that they have developed a fully automated, scalable "factory" that uses natural (non-genetically-modified) green plants to efficiently produce large quantities of vaccines and therapeutics within weeks.

23 Apr 2010

pHase Pharmaceuticals launches new drug development company

pHase Pharmaceuticals, LLC announces the launch of its new drug development company. pHase Pharmaceuticals is led by a cohesive team of drug development experts who have extensive experience bringing new drugs to market and garnering FDA approval.

23 Apr 2010

FDA grants tentative approval for Sagent Pharmaceuticals' adenosine injection

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration had granted tentative approval of adenosine injection, USP, the generic equivalent of Astellas Pharmaceuticals' Adenoscan®, in 60 mg per 20 mL and 90 mg per 30 mL vials. IMS data indicate that the 2009 U.S. innovator market for these adenosine presentations approximated $124 million. The Company plans to launch the product upon expiry of applicable innovator patents.

23 Apr 2010

Colorcon acquires NP Pharm

Colorcon, Inc. today announced the acquisition of the full-service pharmaceutical excipient company, NP Pharm, a Division of Ethypharm. This acquisition expands Colorcon's global excipient product offerings in the pharmaceutical and nutritional markets.

23 Apr 2010

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension).

23 Apr 2010

Align Technology reports 28.5% increase year-over-year in first-quarter revenues

Align Technology, Inc. today reported financial results for the first quarter of fiscal 2010, ended March 31, 2010.

22 Apr 2010

Columbia Laboratories' net revenues from US progesterone sales for first-quarter up 36%

Columbia Laboratories, Inc. today announced preliminary results for the quarter ended March 31, 2010.

22 Apr 2010

Life sciences companies shifting away from traditional document management systems to emerging ECC solutions

Virtify, Inc., today announced the availability of a new IDC Health Insights study titled "Managing Paper at Its Roots: Extending Beyond Document Management to Enterprise Content Compliance." The new IDC Health Insights study, which was commissioned by Virtify, shows a growing trend in the life sciences industry away from traditional document management systems to emerging Enterprise Content Compliance (ECC) solutions.

22 Apr 2010

Syntagon contract research organisation announces strategic pricing initiative

Leading contract research organisation, Syntagon, has unveiled a strategic pricing initiative that will see substantial cost savings for biotechnology and pharmaceutical customers taking compounds into phase I and phase II clinical trials.

22 Apr 2010

Cybex International defends intellectual property rights related to patented Plate Loaded Leg Press

Cybex International, Inc., a leading manufacturer of premium exercise equipment, announced today that it has decisively responded to infringements of its intellectual property rights related to its patented Plate Loaded Leg Press and the company's pending patent applications for the Bravo Functional Trainer.

22 Apr 2010

ImmunoCellular Therapeutics, UPENN sign research agreement

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is developing immune based therapies for the treatment of various forms of cancer, announced today that the Company has entered into a sponsored research agreement and an option agreement with The University of Pennsylvania to support process development and manufacturing in a planned Phase II clinical trial of ICT-107, the Company's dendritic-cell based cancer vaccine product candidate for the treatment of glioblastoma multiforme.

22 Apr 2010

Genmab introduces new pre-clinical antibody program and novel bispecific antibody technology

Genmab A/S will announce today at its Annual General Meeting a new pre-clinical antibody program, HuMax-cMet,as well as a novel next generation bispecific antibody technology.

22 Apr 2010

Affymetrix reports first-quarter total revenue of $80.2M

Affymetrix, Inc., today reported its operating results for the first quarter of 2010. Total revenue for the quarter was $80.2 million, as compared to total revenue of $78.6 million in the first quarter of 2009.

22 Apr 2010

Access Pharmaceuticals to present MuGard clinical data at 2010 MASCC conference

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company specializing in products for cancer and supportive care, announced today that it will present data from the ongoing work involving its lead product, MuGard, and host an oral mucositis symposium at the MASCC conference being held in Vancouver, B.C. on June 24-26, 2010. MuGard is Access Pharma's FDA-approved product for the management of oral mucositis, a debilitating side effect of many anticancer treatments.

22 Apr 2010

Simcere's diosmectite API in generic drug Biqi passes EU-GMP inspection

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that its diosmectite, the Active Pharmaceutical Ingredient (API) in Simcere's branded generic drug Biqi, has passed EU-GMP inspection. This enables Simcere to market diosmectite in the European Union countries.

22 Apr 2010

MicroStockProfit.com: CUR reports net loss of $5,096,983 for third-quarter of 2009

MicroStockProfit.com announces an investment report featuring Neuralstem Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

21 Apr 2010

New sensor wristband monitors various body functions

A small blood lab that fits into the pocket of a jacket can quickly analyze the risk of blood clots in legs prior to a long distance flight; a sensor wristband for measuring electric smog can warn pacemaker patients of life-threatening exposure: "Smart plastics" can turn such tools into reality.

21 Apr 2010

Elan's first-quarter total revenue up by 27% to $310.5M

Elan Corporation, plc, today reported its first quarter 2010 financial results.

21 Apr 2010

Stemedica receives FDA IND approval for ischemic stroke clinical trial using allogeneic stem cells

Stemedica Cell Technologies, Inc., a world leader in stem cell research and manufacturing, announced that the U.S. Food and Drug Administration (FDA) approved an Investigational New Drug (IND) for a clinical trial for ischemic stroke using Stemedica's high potency proprietary allogeneic stem cells (adult human).

21 Apr 2010

Air Methods delivers first medically equipped Bell 429 helicopter to Mercy One

Air Methods Corporation, the largest air medical transportation company in the world, recently delivered the first medically equipped Bell 429 helicopter to Mercy One, its hospital-based services customer in Des Moines, Iowa. Air Methods' Products Division is the first in the world to design, engineer, manufacture, and certify a medical interior for the Bell 429 helicopter.

20 Apr 2010

Manufacturing News and Research

Further Reading

Plant-based vaccine factory to produce vaccines and therapeutics within weeks of outbreaks

pHase Pharmaceuticals launches new drug development company

FDA grants tentative approval for Sagent Pharmaceuticals' adenosine injection

Colorcon acquires NP Pharm

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Align Technology reports 28.5% increase year-over-year in first-quarter revenues

Columbia Laboratories' net revenues from US progesterone sales for first-quarter up 36%

Life sciences companies shifting away from traditional document management systems to emerging ECC solutions

Syntagon contract research organisation announces strategic pricing initiative

Cybex International defends intellectual property rights related to patented Plate Loaded Leg Press

ImmunoCellular Therapeutics, UPENN sign research agreement

Genmab introduces new pre-clinical antibody program and novel bispecific antibody technology

Affymetrix reports first-quarter total revenue of $80.2M

Access Pharmaceuticals to present MuGard clinical data at 2010 MASCC conference

Simcere's diosmectite API in generic drug Biqi passes EU-GMP inspection

MicroStockProfit.com: CUR reports net loss of $5,096,983 for third-quarter of 2009

New sensor wristband monitors various body functions

Elan's first-quarter total revenue up by 27% to $310.5M

Stemedica receives FDA IND approval for ischemic stroke clinical trial using allogeneic stem cells

Air Methods delivers first medically equipped Bell 429 helicopter to Mercy One

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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