Manufacturing News and Research

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

CytRx announces its plans to advance multiple oncology development programs in 2010

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced its plans for 2010 aimed at advancing the clinical development of its high-value drug development pipeline and enhancing shareholder value.

22 Jan 2010

CMO to manufacture Gaia BioPharma's GAI-122 Mitochondria-targeted neuroprotective agent

AlphaRx Inc. announced today that its licensee, Gaia BioPharma Limited, has signed an agreement with a contract manufacturing organization (CMO), to manufacture GAI-122 for use in the planned Phase I and II clinical trials of that product candidate. GAI-122 is being developed as I.V. administered formulation of an intracellular neuroprotectant that employs AlphaRx's proprietary nano-emulsion formulation technology.

22 Jan 2010

New sensor could help diagnose and treat a variety of diseases

A tiny new sensor could provide fresh, inexpensive diagnosis and treatment methods for people suffering from a variety of diseases.

22 Jan 2010

FDA accepts ACT Biotech's ACTB1003 IND

ACT Biotech Inc., a privately held biotechnology company developing a portfolio of oral kinase inhibitors as anti-cancer drugs, today announced the acceptance of the Investigational New Drug (IND) application for ACTB1003 by the US Food and Drug Administration (FDA). The company has now assembled a complete preclinical package, including manufacturing and toxicology studies, allowing ACTB1003 to enter a clinical trial.

22 Jan 2010

Genzyme receives PDUFA date from FDA for its Biologics License Application for Lumizyme

Genzyme Corporation announced today that it has received a June 17, 2010 PDUFA date from the FDA for its Biologics License Application for Lumizyme™ (alglucosidase alfa) seeking approval for the therapy produced at the 4000 L scale.

21 Jan 2010

Pharmasset commences PSI-7977 Phase 2a trial for HCV

Pharmasset, Inc. today announces the initiation of a 28-day Phase 2a study with PSI-7977, a chirally pure isomer form of PSI-7851, a nucleotide analog polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV). The trial will evaluate various doses of PSI-7977 in combination with Pegasys (peginterferon alfa 2a) and Copegus (ribavirin) in patients with HCV genotype 1 who have not been treated previously.

21 Jan 2010

Abaxis' new CRP assay receives FDA marketing clearance

Abaxis, Inc., a medical products company manufacturing point-of-care blood analysis systems, today announced that the U.S. Food and Drug Administration (FDA) has granted 510K marketing clearance of the new C-Reactive Protein (CRP) assay when used by healthcare professionals in conjunction with the Piccolo Xpress™ point-of-care analyzer.

21 Jan 2010

BioLife Solutions announces biologic packaging products pre-filled with GMP biopreservation media

BioLife Solutions, Inc., a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, and OriGen Biomedical, a leading provider of biologic packaging products for research and clinical blood and cell-based therapies, today announced that the companies will introduce sterile standard and custom biologic packaging products pre-filled with BioLife's serum-free, protein-free HypoThermosol® cell and tissue storage/transport media and CryoStor™ cryopreservation media.

21 Jan 2010

TriLink BioTechnologies and Nacalai USA enter into distribution agreement

TriLink BioTechnologies (TriLink), has entered into an agreement with Nacalai USA, Inc., a San Diego based manufacturing and marketing company, for the distribution of TriLink's modified nucleic acid products in Japan, Singapore, South Korea and Taiwan.

21 Jan 2010

Sinovac Biotech announces financial update, new joint ventures and developments

Sinovac Biotech Ltd. (SVA) ("Sinovac" or the "Company"), a leading China-based vaccine manufacturer, today announced the following recent developments.

21 Jan 2010

Discovery of new class of compounds may help fight hepatitis C

Stanford University School of Medicine scientists have discovered a novel class of compounds that, in experiments in vitro, inhibit replication of the virus responsible for hepatitis C. If these compounds prove effective in infected humans as well, they may dramatically accelerate efforts to confront this virus’s propensity to rapidly acquire drug resistance, while possibly skirting some of the troubling side effects common among therapies in current use and in late-stage development.

21 Jan 2010

FDA approves Thoratec's HeartMate II LVAS for DT

Thoratec Corporation, a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has received FDA approval of its PMA (Pre-Market Approval) supplement, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) for Destination Therapy (DT).

21 Jan 2010

Healthcare industry in Asia Pacific to grow up to US$349 billion by 2012

Frost & Sullivan believes that the healthcare industry is undergoing a paradigm shift from "sickness care" to "wellness". Focused on the 5 Ps – Preventive, Pre-emptive, Personalized, Predictive and Personal Responsibility – the healthcare industry in Asia Pacific is expected to grow to US$349 billion by 2012.

21 Jan 2010

New white paper examines how PCR mycoplasma tests and analysis save time and money

Contamination by mycoplasmal organisms is an ever-present concern in biopharmaceutical manufacturing. Their properties make them ready sources of contamination, while rendering them difficult and time-consuming to detect. A new free white paper, examines how PCR mycoplasma tests and analysis, deployed by a cutting-edge laboratory, minimizes testing delays and enable safe, high-volume biopharmaceutical production.

20 Jan 2010

AMRI’s Rensselaer labs and manufacturing facilities receive SafeBridge Potent Compound Safety Certification

SAFEBRIDGE® CONSULTANTS, INC., headquartered in Mountain View, California, has announced that AMRI’s high potency research laboratories and GMP-manufacturing facilities in Rensselaer, New York have met the criteria established under the SafeBridge program for “Potent Compound Safety Certification” and have been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients (“APIs”).

20 Jan 2010

Zecotek Photonics' Real-Time 3D2D Display System exhibited in Zurich

Zecotek Photonics Inc., a developer of leading-edge photonics technologies for medical, industrial and scientific markets, today announced that its Real-Time 3D2D Display System is exhibited in Zurich, Switzerland to a select number of European display manufacturers.

20 Jan 2010

ConvaTec offers medical supplies for Haiti's relief efforts

ConvaTec, a world-leading provider of medical technologies for community and hospital care, today announced that it has made an initial donation of more than $400,000 in medical supplies to rescue and relief efforts in Haiti, following the devastating earthquake that hit that nation last week.

20 Jan 2010

Ericson Manufacturing supports breast cancer research and community outreach projects

In 2010 Ericson Manufacturing Company will make significant strides in the support of national breast cancer awareness through a new partnership with Susan G. Komen for the Cure®, the world’s largest breast cancer advocacy organization.

20 Jan 2010

Fraunhofer USA CMB receives $60,000 gift from ProTecs to complete vaccine manufacturing plant

The Fraunhofer USA Center for Molecular Biotechnology, a not-for-profit, 501 (c3) research organization, announced today that it has received a $60,000 gift from ProTecs, Inc., to complete its new, state of-the-art vaccine manufacturing plant in Newark, Delaware.

20 Jan 2010

Novartis obtains exclusive worldwide rights to develop and commercialize Chiasma's TPE technology

Chiasma, Inc., a privately held biopharma company, announced today that it has granted Novartis an option to obtain exclusive worldwide rights to develop and commercialize the Company's Transient Permeability Enhancer (TPE) technology for use with certain related small molecule products either in development or currently marketed by Novartis.

19 Jan 2010

Manufacturing News and Research

Further Reading

CytRx announces its plans to advance multiple oncology development programs in 2010

CMO to manufacture Gaia BioPharma's GAI-122 Mitochondria-targeted neuroprotective agent

New sensor could help diagnose and treat a variety of diseases

FDA accepts ACT Biotech's ACTB1003 IND

Genzyme receives PDUFA date from FDA for its Biologics License Application for Lumizyme

Pharmasset commences PSI-7977 Phase 2a trial for HCV

Abaxis' new CRP assay receives FDA marketing clearance

BioLife Solutions announces biologic packaging products pre-filled with GMP biopreservation media

TriLink BioTechnologies and Nacalai USA enter into distribution agreement

Sinovac Biotech announces financial update, new joint ventures and developments

Discovery of new class of compounds may help fight hepatitis C

FDA approves Thoratec's HeartMate II LVAS for DT

Healthcare industry in Asia Pacific to grow up to US$349 billion by 2012

New white paper examines how PCR mycoplasma tests and analysis save time and money

AMRI’s Rensselaer labs and manufacturing facilities receive SafeBridge Potent Compound Safety Certification

Zecotek Photonics' Real-Time 3D2D Display System exhibited in Zurich

ConvaTec offers medical supplies for Haiti's relief efforts

Ericson Manufacturing supports breast cancer research and community outreach projects

Fraunhofer USA CMB receives $60,000 gift from ProTecs to complete vaccine manufacturing plant

Novartis obtains exclusive worldwide rights to develop and commercialize Chiasma's TPE technology

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