Manufacturing News and Research

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

CSL Biotherapies statement on FDA warning letter

Today the US Food and Drug Administration (FDA) published a Warning Letter issued by its Office of Compliance and Biologics Quality to CSL Biotherapies, a division of CSL Limited. The FDA regulates the manufacture, marketing and distribution of CSL Biotherapies’ influenza vaccine, Afluria®, in the US market.

21 Jun 2011

Indian biotechnology market to reach over $11 billion by 2017

The Indian biotechnology market is set to reach over $11 billion by 2017, according to a new report available on companiesandmarkets.com. The market will be driven by foreign investment, growing R&D and infrastructure investment, an emerging contract research market, drug discovery and growth in manufacturing outsourcing to India.

21 Jun 2011

BioLife becomes the leading supplier of pre-formulated cord blood stem cell freeze media products

BioLife Solutions, Inc., a leading developer and manufacturer of clinical grade biopreservation media products for cells and tissues, today announced that it has become the leading supplier of pre-formulated GMP cryopreservation media for umbilical cord blood stem cells, a key segment of the Company's strategic biobanking market.

21 Jun 2011

FDA to beef up monitoring of imports

As Food and Drug Administration (FDA) commissioner, Dr. Margaret A. Hamburg has been trying to correct inadequately controlled imported food and drugs overwhelming her organization’s ability to monitor them.

21 Jun 2011

Consumer focus on health and well-being drive demand for L-carnitine market

Consumer focus on health and well-being have driven demand for the L-carnitine market, an amino acid understood to provide distinct health benefits, according to a new report on companiesandmarkets.com. By 2017, it is expected that the L-carnitine market will achieve a value of $127.7 million.

21 Jun 2011

ZMDI and Power-One announce digital power management development and patent license agreement

ZMD AG (ZMDI), a global supplier of energy-efficient analog and mixed-signal solutions for automotive, industrial, and medical applications, and Power-One, a leading provider of renewable energy and energy-efficient power conversion and power management solutions, entered into a non-exclusive, worldwide, field of use agreement for Digital Power Technology (DPT) patents from Power-One.

20 Jun 2011

FDA's new strategy calls for coalitions of international regulators, increased data sharing

The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the "Pathway to Global Product Safety and Quality."

20 Jun 2011

NanoViricides plans to lease new cGMP manufacturing and lab space

NanoViricides, Inc. announced today that it will be leasing new space for cGMP production of its nanoviricides drug candidates against various viral diseases.

20 Jun 2011

Pulmatrix introduces novel iSPERSE inhaled dry powder drug delivery platform

Pulmatrix, a clinical stage biotechnology company discovering and developing a new class of therapies for the prevention, treatment and control of respiratory diseases, today announced the launch of iSPERSE, the company's novel inhaled dry powder drug delivery platform.

20 Jun 2011

Neovasc first quarter revenues increase 10% to $1,169,920

Neovasc Inc., today announced financial results for the three months ended March 31, 2011 and advances in its product development programs.

20 Jun 2011

Australian Government announces new tax credit system for R&D activities

Providing a valuable incentive for U.S. investment in Australia, the Australian Government announced an agreement under which the Parliament will enact a AU$1.8 billion R&D tax credit that will deliver funding to innovative firms in industries including advanced manufacturing, information and communications technologies, and biotechnology.

18 Jun 2011

RHEI receives Chinese SFDA acceptance letter for MuGard

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, diabetes, and RNAi, announced that its MuGard partner in China, RHEI Pharmaceuticals has received the acceptance letter from the State Food and Drug Administration (SFDA) of China acknowledging all necessary documentation for the MuGard has been submitted and accepted.

17 Jun 2011

Joint venture to manufacture and distribute tenofovir gel in Africa

CONRAD and the South African Government's Technology Innovation Agency (TIA) on Tuesday announced a license agreement that grants TIA the rights to manufacture and distribute tenofovir gel in Africa, according to a CONRAD statement.

17 Jun 2011

Enterologics to acquire BioBalance from NYHC

Enterologics, Inc. announced today that it is acquiring all the shares of The BioBalance Corporation and its subsidiary BioBalance LLC from New York Health Care, Inc.

17 Jun 2011

CEVEC and Catalent Pharma Solutions offer joint cell line development service

CEVEC Pharmaceuticals, the German developer of a novel, market leading human protein expression system derived from amniocytes, and Catalent Pharma Solutions, a leading global drug development and delivery solutions provider, announced today a joint commercial cell line development service for pharma and biotech customers worldwide. The offering combines the benefits of CEVEC’s human cell line, CAP-Technology, with Catalent’s unique GPEx® (Gene Product Expression) Technology to generate high expressing stable human cell lines in a much shorter timeframe than traditional methods.

16 Jun 2011

Adaptimmune melanoma trial opening

Adaptimmune announced today that it has opened a Phase I/II, two cohort, open label clinical trial in metastatic melanoma at Washington University, St. Louis, Missouri.

16 Jun 2011

InNexus files patent protection for new Age-related Macular Degeneration therapeutic

InNexus Biotechnology Inc., a biopharmaceutical company creating and developing innovative solutions for cancer, inflammation and other difficult-to-treat diseases, announced today that it has filed for patent protection covering a novel antibody product for Age-related Macular Degeneration (AMD) and other eye disorders.

16 Jun 2011

QIAGEN to acquire Ipsogen

QIAGEN N.V. has made an offer and entered into exclusive negotiations to purchase a 47% initial stake in Ipsogen S.A. and subsequently make a public offer to fully acquire a global leader in molecular profiling and personalized healthcare diagnostics for a broad range of hematological cancers.

From QIAGEN Manchester Limited 15 Jun 2011

APP announces $38 million expansion of New York manufacturing facility

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today a $38 million expansion of its Grand Island, New York manufacturing facility.

15 Jun 2011

TIA, CONRAD enter license agreement to manufacture and distribute Tenofovir1% gel in Africa

CONRAD and the South African Government's Technology Innovation Agency (TIA) today announced a license agreement that grants TIA the rights to manufacture and distribute Tenofovir1% gel in Africa.

15 Jun 2011

Manufacturing News and Research

Further Reading

CSL Biotherapies statement on FDA warning letter

Indian biotechnology market to reach over $11 billion by 2017

BioLife becomes the leading supplier of pre-formulated cord blood stem cell freeze media products

FDA to beef up monitoring of imports

Consumer focus on health and well-being drive demand for L-carnitine market

ZMDI and Power-One announce digital power management development and patent license agreement

FDA's new strategy calls for coalitions of international regulators, increased data sharing

NanoViricides plans to lease new cGMP manufacturing and lab space

Pulmatrix introduces novel iSPERSE inhaled dry powder drug delivery platform

Neovasc first quarter revenues increase 10% to $1,169,920

Australian Government announces new tax credit system for R&D activities

RHEI receives Chinese SFDA acceptance letter for MuGard

Joint venture to manufacture and distribute tenofovir gel in Africa

Enterologics to acquire BioBalance from NYHC

CEVEC and Catalent Pharma Solutions offer joint cell line development service

Adaptimmune melanoma trial opening

InNexus files patent protection for new Age-related Macular Degeneration therapeutic

QIAGEN to acquire Ipsogen

APP announces $38 million expansion of New York manufacturing facility

TIA, CONRAD enter license agreement to manufacture and distribute Tenofovir1% gel in Africa

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