Manufacturing News and Research

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

NEOP receives stockholder approval to increase company shares to 205 milliion

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, announced at its 2010 Annual Meeting of Stockholders that it received the approval of its stockholders to increase the number of authorized shares of the Company from 155 million to 205 million. In addition, stockholders re-elected Neoprobe President and CEO David C. Bupp, and elected for the first time, Brendan A. Ford and Eric K. Rowinsky, M.D. as Directors of the Company for terms ending at the 2013 Annual Meeting. Stockholders also approved the appointment of BDO Seidman, LLP to act as the Company's independent registered public accounting firm for 2010.

17 Jul 2010

FDA can promote personalized medicine by identying gaps in laboratory operations: ACLA

The Food and Drug Administration can promote progress toward personalized medicine by approaching the oversight of laboratory developed tests (LDTs) in a focused, flexible, and balanced way according to the American Clinical Laboratory Association (ACLA). ACLA, which represents the nation's leading clinical laboratories, says that the factors supporting this approach include the growing role that such tests play in clinical decision making, especially in the area of new advanced diagnostics that derive from the mapping of the human genome and help fulfill the promise of personalized medicine.

17 Jul 2010

LLC to provide contract drug development services

LyoTechnica, LLC has announced that it has been established to provide contract drug development services for injectable pharmaceuticals. The company and its affiliates bring over 80 years of combined experience in lyophilization and liquid dosage form development as well as over 100 years experience in commercial scale manufacturing of parenteral drugs. The company offers analytical and formulation development, manufacturing of sterile stability batches and stability testing services.

16 Jul 2010

FDA confirms GRAS status for Ajinomoto's AjiGRAS-Leucine

Ajinomoto AminoScience LLC (AAS) today announced that it has confirmed GRAS (Generally Recognized As Safe) status of its AjiGRAS-Leucine, meeting the safety standards demanded by the US Food and Drug Administration (FDA). As the only formulation of Leucine currently with FDA acknowledged GRAS status, Ajinomoto's AjiGRAS-Leucine is the first amino acid to be allowed as an ingredient for use in conventional foods like non-milk and milk based meal replacements, sports and isotonic beverages, vitamin enhanced waters, and meal replacement bars, at levels of 0.5 to 3 grams per serving.

16 Jul 2010

Insulet gone live with Pilgrim's on-demand Corrective and Preventive Action management solution

Pilgrim Software, Inc., a world-leading provider of Enterprise Risk, Compliance and Quality Management (ERCQM) software solutions, today announced that Insulet Corporation, a Massachusetts-based medical device company, has gone live with Pilgrim's On-Demand "SaaS" delivery of its automated management solution for Corrective and Preventive Action (CAPA) management.

16 Jul 2010

Elusys, Lonza partner for commercial production of Anthim antibody for inhaled anthrax treatment

Elusys Therapeutics and Lonza today announced an agreement for the scale-up and commercial production of Anthim, a therapeutic monoclonal antibody in late-stage development for the treatment of inhaled anthrax. Under the new contract, Lonza will provide process scale-up, technology transfer, validation, and commercial manufacturing at one of its facilities in the USA. The manufacturing process for Anthim was optimized for full scale production by Lonza under a separate agreement announced in 2009.

16 Jul 2010

Glaxo announces a $2.3 billion in legal liability charges

British pharmaceutical giant GlaxoSmithKline, announced this Thursday that its second-quarter charges related to legal cases involving the two drugs Avandia (diabetes drug) and Paxil (drug for anxiety and depression) would run up to $2.36 billion. Avandia’s use and its potential risk of causing heart problems were being debated this week by an advisory panel to the US Food & Drugs Administration (FDA).

16 Jul 2010

PharmSource ranks Patheon as top global contract development and manufacturing organization

Patheon, a global provider of drug development and manufacturing services to the international pharmaceutical industry announced today that it has been ranked as a top global contract development and manufacturing organization. PharmSource(R), a respected independent pharmaceutical research organization, recently published a study looking at the number of FDA new drug approvals (NDAs and BLAs) which were outsourced by sponsor companies and subsequently launched.

15 Jul 2010

Watson Pharmaceuticals signs exclusive, worldwide licensing agreement with Itero Biopharmaceuticals

Watson Pharmaceuticals, Inc. today announced an exclusive, worldwide licensing agreement with Itero Biopharmaceuticals, Inc., a venture-backed specialty biopharmaceutical company, to develop and commercialize Itero's Recombinant Follicle Stimulating Hormone. The product is currently in preclinical development as a biosimilar molecule for the treatment of female infertility.

15 Jul 2010

Biomagnetics Diagnostics reports positive test results of unique PVA film formulation

Biomagnetics Diagnostics Corp., a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, and other innovative technologies, today announced the results of recent testing of the unique PVA film formulation produced by Lanzhou Sanhuan New Technology Development Ltd. of Ganzu, China. Earlier this week, Biomagnetics announced its intent to acquire Lanzhou as the first of several planned acquisitions to be done at a $1.00 share price valuation for Biomagnetics Diagnostics' common shares.

15 Jul 2010

First 1M doses of smallpox vaccine for immune-compromised populations delivered

Delivery to the Strategic National Stockpile of the first 1 million doses of the nation's first smallpox vaccine for certain immune-compromised populations is now complete, the result of a Project BioShield contract.

15 Jul 2010

Merck acquires Millipore for $7.0 billion

Merck KGaA, a global pharmaceutical and chemical company, today announced the successful completion of its acquisition of Millipore Corporation, a leading Life Science company based in Billerica, Massachusetts, USA, for an aggregate purchase price including debt and cash of approximately $7.0 billion. Merck agreed to acquire Millipore on February 28, 2010 for $107 in cash per share of Millipore common stock.

15 Jul 2010

Concert Medical releases 'Conductor' family of Interventional Coronary Guidewires in U.S.

Concert Medical, LLC today announced the launch of the "Conductor™" family of Interventional Coronary Guidewires to the U.S. market. These guidewires are designed to address an extensive range of coronary disease cases at a superior value. The FDA granted Concert Medical clearance for the use and sale in the U.S. of the Conductor product line in September 2009.

15 Jul 2010

CardioGenics Holdings' subsidiary signs second product agreement with Merck Chimie

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care Point-Of-Care analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced that the Company's subsidiary, CardioGenics Inc., has entered into an agreement with Merck Chimie S.A.S. to adopt its proprietary biological-linking technology to Merck-supplied magnetic beads designed to increase yields in antibody manufacturing.

15 Jul 2010

OSI Electronics receives $4 million order from innovative medical device manufacturer

OSI Systems, Inc., a vertically-integrated provider of specialized electronic products for critical applications in the Security and Healthcare industries, today announced that OSI Electronics, a business within its Optoelectronic and Manufacturing division, has received an order of approximately $4 million for electronic sub-assemblies from an innovative medical device manufacturer.

14 Jul 2010

BioInvent reports net revenues of SEK 63.1M for January - June 2010 period

BioInvent reached an important milestone when the results of a phase II trial of TB-402 following orthopaedic surgery, were reported in May. The data showed that TB-402 is statistically better at preventing thrombosis than enoxaparin, the current standard treatment. Supported by these good results, BioInvent and the company's partner, ThromboGenics, will now prioritise securing a development partner for the programme to ensure that the necessary resources is in place to take the product candidate to the market.

14 Jul 2010

WL Ross and Mac Crawford announce joint venture to co-invest in and restructure healthcare companies

Wilbur L. Ross, Jr., CEO of WL Ross & Co. LLC, and Edwin "Mac" Crawford announced today a joint venture, Crawford-Ross, to co-invest in and restructure healthcare companies. Mr. Ross said, "We are prepared to invest more than $1 billion to support Mac and his team as we jointly build a major position in healthcare."

14 Jul 2010

Microtest white paper guides medical device manufacturers in applying new FDA regulations to combination products

A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories (http://www.microtestlabs.com/combination-products-20/)

14 Jul 2010

Neptune first-quarter 2010 revenue up by 45% to $4,162,000

Neptune Technologies & Bioressources Inc. today reports its consolidated financial results for the three-month period ended May 31, 2010, appoints IR firm and updates on options and warrants.

14 Jul 2010

Invida Group, Amdipharm partner to promote proprietary products in key Asian markets

Invida Group Pte Ltd, the leading specialty biopharmaceutical company focused on the commercialization of healthcare products throughout Asia Pacific, today announced that it has entered into an agreement with Amdipharm for the licensing and commercialization of its proprietary products throughout Asia. Under this agreement, Invida will leverage its full suite of capabilities to bring Amdipharm's products to market, from regulatory approval and licensing, through packaging and supply chain optimization, to commercialization, sales, and marketing.

14 Jul 2010

Manufacturing News and Research

Further Reading

NEOP receives stockholder approval to increase company shares to 205 milliion

FDA can promote personalized medicine by identying gaps in laboratory operations: ACLA

LLC to provide contract drug development services

FDA confirms GRAS status for Ajinomoto's AjiGRAS-Leucine

Insulet gone live with Pilgrim's on-demand Corrective and Preventive Action management solution

Elusys, Lonza partner for commercial production of Anthim antibody for inhaled anthrax treatment

Glaxo announces a $2.3 billion in legal liability charges

PharmSource ranks Patheon as top global contract development and manufacturing organization

Watson Pharmaceuticals signs exclusive, worldwide licensing agreement with Itero Biopharmaceuticals

Biomagnetics Diagnostics reports positive test results of unique PVA film formulation

First 1M doses of smallpox vaccine for immune-compromised populations delivered

Merck acquires Millipore for $7.0 billion

Concert Medical releases 'Conductor' family of Interventional Coronary Guidewires in U.S.

CardioGenics Holdings' subsidiary signs second product agreement with Merck Chimie

OSI Electronics receives $4 million order from innovative medical device manufacturer

BioInvent reports net revenues of SEK 63.1M for January - June 2010 period

WL Ross and Mac Crawford announce joint venture to co-invest in and restructure healthcare companies

Microtest white paper guides medical device manufacturers in applying new FDA regulations to combination products

Neptune first-quarter 2010 revenue up by 45% to $4,162,000

Invida Group, Amdipharm partner to promote proprietary products in key Asian markets

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