Tuesday, 18 February 2020

Biologics News

  • India announces new biosimilar regulatory guidelines

    Biologics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 19 Jun, 2012

    Boston: India has announced the much-awaited new and simple regulatory guidelines for similar biologics which have been approved and marketed in USA or Europe for more than four years. Th...Read more

  • Aussie's CardioCel gets US approval

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 11 Feb, 2014

    Singapore: Australia based Admedus has received FDA clearance to market CardioCel in the US. CardioCel is the group's lead regenerative tissue product to repair and treat a range of cardio...Read more

  • Asia biologics manufacturers face the 'quality challenge'

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 07 Mar, 2012

    Biologics manufacturers in Asia have to be more vigilant and give higher priority to product safety and product efficacy. Even though countries like India and China can lower manufacturing ...Read more

  • Boehringer develops disposable manufacturing technology

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 11 Sep, 2012

    Singapore: Boehringer Ingelheim has developed and implemented a flexible set-up and operational approach for disposable technologies within its global biopharmaceutical development and manu...Read more

  • California closer to get biosimilars bill

    Biologics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 06 Sep, 2013

    Singapore: The US State of California's biosimilar Senate Bill 598, which is a pharmacy substitution law to allow greater patient access to more affordable FDA-approved biologic medicines,...Read more

  • Can Asian biologics manufacturers live up to global regulatory standards?

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 07 Mar, 2012

    When it comes to contract biologics manufacturing, despite the increasing opportunities, there is a concern regarding the Asian countries' ability to abide by the regulatory system that com...Read more

  • Sigma-Aldrich to launch Austrianova's encapsulation technology

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 03 Jun, 2014

    Singapore: Sigma-Aldrich, bioscience and technology company, is set to commercialize a kit for hand-driven, self-encapsulation of cells, designed by the Singapore based biotech company Aust...Read more

  • Old drug gives hope for new treatment in autism

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 15 Mar, 2013

    Singapore: Autism results from abnormal cell communication. Testing a new theory, researchers at the University of California, San Diego School of Medicine, have used a newly discovered fun...Read more

  • Immune cells essential to establish pregnancy: Study

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 11 Jul, 2013

    Singapore: Research from University of Adelaide have shown that immune cells known as macrophages are critical to fertility by creating a healthy hormone environment in the uterus.Laborator...Read more

  • GE Healthcare, Osaka University join hands

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 20 Aug, 2013

    Singapore: GE Healthcare Life Sciences has tied up with Osaka University to allow students to have access to GE Healthcare's expertise in training and technologies for biopharmaceutical res...Read more

  • Luye Pharma invests in NuSep's PrIME technology

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 20 Aug, 2012

    Singapore: SGX-listed Luye Pharma Group is investing S$6 million (A$4.6 million) in NuSep's Singapore subsidiary Prime Biologics in exchange for a 10 percent interest in the company. Under...Read more

  • Merck launches Mobius FlexReady chromatography solution

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 07 Aug, 2012

    Singapore: Merck Millipore, the life science division of Merck, launched Mobius FlexReady Solution with Smart Flexware Assemblies for chromatography. As the newest addition to the company's...Read more

  • AB Sciex launches technology to predict drug efficacy

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 04 Mar, 2014

    Singapore: AB Sciex, a global leader in analytical technologies, has launched a breakthrough technology solution called CESI-MS, to help biopharmaceutical scientists to accurately predict e...Read more

  • Life Technologies DNA Kit gets US DNA Index System approval

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 24 Apr, 2014

    Singapore: GlobalFiler Express Kit by Life Technologies has been approved by the United States Federal Bureau of Investigation for use by laboratories generating DNA profiles for inclusion ...Read more

  • CSL files biologics license plea with FDA

    Biologics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 30 May, 2012

    Singapore: The US Food and Drug Administration (FDA) has accepted Australia-based CSL Behring's biologics license application for standard review. The application is for a human 4-factor pr...Read more

  • MNCs boost Asia biologics industry

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 07 Mar, 2012

    Entry of multinational companies has been a big boost to Asia's position in biologics manufacturing, especially with cGMP compliance. Singapore has been way ahead than others in attracting ...Read more

  • WuXi inks cancer biomarker service deal with US firm

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 26 May, 2014

    Singapore: US based Targos, clinical biomarker service provider has signed a collaboration deal with China's WuXi PharmaTech to support its bioanalytical work for pharmaceutical customers. ...Read more

  • Boehringer shuts generic injectables arm, axes 1,100 staff

    Biologics |  News | By BioSpectrum Bureau  | 0 Comment | 07 Oct, 2013

    Singapore: Boehringer Ingelheim is closing down its generic sterile injectables manufacturing arm, Ben Venue Laboratories, by the end of 2013, giving away pink slips to over 1,100 employees...Read more