Manufacturing News and Research

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

Biogen Idec second-quarter revenues increase 11% to $1.2 billion

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its second quarter 2010 results.

20 Jul 2010

Meridian Bioscience completes acquisition of Bioline group of companies

Meridian Bioscience, Inc., Cincinnati, Ohio announces that effective today it will have completed the purchase of all the outstanding capital stock of the Bioline group of companies consisting of Bioline Ltd (UK), Bioline GmbH (Germany), Bioline (Aust) Pty Ltd (Australia), Bioline Reagents Ltd, and Bioline USA, Inc for $23.3 million in cash on hand.

20 Jul 2010

Argos' Arcelis immunotherapy reduces viral load in interim analysis of Phase 2 HIV trial

Argos Therapeutics today announced that, in an interim analysis of a Phase 2 trial, its Arcelis immunotherapy targeted at HIV, AGS-004, demonstrated a significant reduction in viral load and a delay in viral rebound kinetics during a 12-week antiretroviral treatment interruption (ARTI) when compared to pre-ART viral loads.

20 Jul 2010

'Sloppy' practices at brain imaging center could have far-reaching repercussions for brain research

The Los Angeles Times: "The suspension of some research at a prominent Columbia University brain-imaging lab because of sloppy practices could have repercussions beyond that laboratory, potentially affecting brain-imaging studies nationwide and raising questions about the safety of participants, research experts said Saturday.

20 Jul 2010

Competitive Technologies anticipates $1M revenue from sales of Calmare Pain Therapy Treatment

Competitive Technologies, Inc. today announced it expects revenue from sales of its Calmare® Pain Therapy Treatment for the fourth quarter of fiscal 2010 to be about $1 million, nearly double that of the prior quarter. The Company expects significant additional growth in Calmare medical device sales in upcoming quarters resulting from the growing U.S. sales force of over 35 sales representatives.

19 Jul 2010

Pharma industry leaders reduce R&D time, costs with aspenONE Process Development software

Aspen Technology, Inc., a leading provider of software and services to the process industries, today announced that GlaxoSmithKline, AstraZeneca and other pharmaceutical industry leaders are reducing their research and development time and costs using newly patented technology that is part of AspenTech's aspenONE Process Development for Pharmaceuticals software.

19 Jul 2010

ThermoGenesis anticipates $7.3 million revenue for fourth-quarter 2010

ThermoGenesis Corp., a leading supplier of innovative products and services that process and store adult stem cells, said today it expects revenues for the quarter ended June 30, 2010, to be approximately $7.3 million and to report a small net loss for the quarter, in the range of $150,000 to $450,000, subject to final audit adjustments. The Company plans to report complete final results for the fourth quarter and all of fiscal 2010 and provide its outlook for fiscal 2011 in mid-September.

19 Jul 2010

On Assignment acquires Sharpstream

On Assignment, Inc. announced today the acquisition of Sharpstream, a privately owned provider of search services for executive to middle managers in the life sciences sector globally.

19 Jul 2010

Phase II data on Genetic Immunity's DermaVir vaccine to be presented at XVIII International AIDS Conference

Genetic Immunity, a US/Hungarian biopharmaceutical company developing nanomedicine-based immunotherapies for HIV/AIDS and other chronic diseases, is releasing Phase II data on the Company's novel DermaVir therapeutic vaccine for HIV/AIDS during the XVIII International AIDS Conference this week in Vienna, Austria. DermaVir, the first dendritic cell-targeting topical HIV vaccine candidate, employs nanotechnology to induce multi-faceted and long-lived immune responses capable of eliminating HIV infected cells.

19 Jul 2010

Artificial colours in food linked to cancer and behavioral disorders in children: Study

Artificial colours in foods, scientists have found may increase the risk of getting cancer, allergies and may trigger hyperactivity in susceptible children. This new report entitled, “Food Dyes: A Rainbow of Risks”, has come from the research conducted by the Centre for Science in the Public Interest (CSPI).

18 Jul 2010

BioRadar develops TransFMDV for Foot and Mouth Disease

BioRadar UK Ltd. predicted one year ago the current severe Foot and Mouth Disease (FMD) outbreaks after recording an increase of the Replikin Count (ref. 1) of the FMD Virus (FMDV) to its highest level in 52 years. Based on these findings, a new synthetic Replikins Trans-Strain FMD Vaccine, called TransFMDV(TM), has been developed and is now available. The announcement was made at the recent Biorbis Conference on Vaccine Production and Manufacturing in Amsterdam, the Netherlands. The conference was attended by major pharmaceutical company executives to examine how vaccine production could be accelerated in view of the problem last year of responding "too little, too late" to the H1N1 influenza pandemic.

17 Jul 2010

Ingen files patent to produce new drug insulin thermos product

Ingen Technologies, Inc. (Pink Sheets:IGNT), an emerging medical device manufacturer developing innovative solutions for the respiratory market, with a new patented and proprietary medical product line targeting the $8B respiratory market, announced today that the company has also filed a U.S patent and will begin the required manufacturing processes to produce the new drug insulin thermos product.

17 Jul 2010

Apicore announces successful conclusion of Somerset API manufacturing plant's FDA inspection

Apicore LLC announced today that the U.S. Food and Drug Administration (FDA) completed an inspection of its API manufacturing plant in Somerset, New Jersey on July 13, 2010.

17 Jul 2010

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

Manufacturing News and Research

Further Reading

Biogen Idec second-quarter revenues increase 11% to $1.2 billion

Meridian Bioscience completes acquisition of Bioline group of companies

Argos' Arcelis immunotherapy reduces viral load in interim analysis of Phase 2 HIV trial

'Sloppy' practices at brain imaging center could have far-reaching repercussions for brain research

Competitive Technologies anticipates $1M revenue from sales of Calmare Pain Therapy Treatment

Pharma industry leaders reduce R&D time, costs with aspenONE Process Development software

ThermoGenesis anticipates $7.3 million revenue for fourth-quarter 2010

On Assignment acquires Sharpstream

Phase II data on Genetic Immunity's DermaVir vaccine to be presented at XVIII International AIDS Conference

Artificial colours in food linked to cancer and behavioral disorders in children: Study

BioRadar develops TransFMDV for Foot and Mouth Disease

Ingen files patent to produce new drug insulin thermos product

Apicore announces successful conclusion of Somerset API manufacturing plant's FDA inspection

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

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