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