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Rising demand drives SGS to up capacity of Chinese testing labs

Rising demand drives SGS to up capacity of Chinese testing labs

By Zachary Brennan

Contract analytical and bioanalytical service provider SGS Life Science Services has completed construction of its Shanghai, China, cGMP chemistry and biotechnology testing laboratories and will further increase space at its microbiology lab at the site. 

SCRS makes Covance its fifth CRO partner

SCRS makes Covance its fifth CRO partner

By Zachary Brennan

The Society for Clinical Research Sites (SCRS), a trade organization representing the interests of clinical research sites, has announced a two-year partnership with LabCorp’s Covance. 

CTTI offers range of QbD recommendations for clinical trials

CTTI offers range of QbD recommendations for clinical trials

By Zachary Brennan

The Clinical Trials Transformation Initiative, a public-private partnership between Duke University and the FDA, has created a list of four recommendations related to quality by design (QbD) for clinical trials.

Parexel to lay off 850 amid restructuring

Parexel to lay off 850 amid restructuring

By Zachary Brennan

Massachusetts-based CRO Parexel is eliminating 850 positions, which it expects will cost the company $30m to $40m in employee separation benefits.

Salt

US FDA publishes API-salt naming policy

By Gareth Macdonald

Naming drugs using active pharmaceutical ingredients (API) rather than their salts will cut down on medication and dosing errors according to the US Food and Drug Administration (FDA).

IDT Biologika acquires Aeras’ vaccine manufacturing facility

IDT Biologika acquires Aeras’ vaccine manufacturing facility

By Zachary Brennan

Vaccine developer Aeras and CMO (contract manufacturing organization) IDT Biologika have formed a strategic partnership that includes the acquisition of Aeras's Biopharmaceutical Development Center (BDC) manufacturing facility by IDT. 

An evolution: B-MS, Celgene offer early insights into RBM

Dispatches from DIA

An evolution: B-MS, Celgene offer early insights into RBM

By Zachary Brennan

Two early adopters of RBM (risk-based monitoring) – Bristol-Myers Squibb and Celgene – have provided details into the way they’re reducing clinical trial site visits to increase efficiencies around identifying risks earlier and more efficiently.

apceth expands gene, cell therapy manufacturing business

apceth expands gene, cell therapy manufacturing business

By Zachary Brennan

German-based contract manufacturer apceth has received regulatory approval to use two new GMP cleanrooms for aseptic processing, which will be used for the handling and genetic manipulation of various types of cell and gene therapies. 

Roundup of new CRO tech, research collaborations and more

Roundup of new CRO tech, research collaborations and more

By Zachary Brennan

The 51st annual DIA conference in Washington, DC has been abuzz all week with new offerings from the top CROs (contract research organizations), in addition to new collaborations between top sponsors and academic institutions. Here’s a rundown of the...

Novasep signs deals to build in Japanese market

Novasep signs deals to build in Japanese market

By Gareth Macdonald

Novasep has signed two partnership agreements for the Japanese markets.  The agreements were with Allied Laboratories, a life science and chemical consulting company, and with AR Brown, which will represent Novasep’s CMO services in the Japanese market. 

SynteractHCR driving growth via smaller clients, CEO says

Dispatches from DIA 2015

SynteractHCR driving growth via smaller clients, CEO says

By Zachary Brennan

With more than 90% of revenue coming from pharma and biotech companies outside the top 25, CRO SynteractHCR is seeing more growth stemming from an influx of funding to smaller biotech companies, CEO Wendel Barr told us on the third day of the 51st annual...

Hacking groups like Anonymous and LulzSec are a threat to industry, say experts

BIO 2015

Ex-Homeland Security cyber chief warns of threats to pharma

By Fiona BARRY

The pharma industry must fight “vendor indifference” so suppliers and services companies are not prey to cyber attacks that can lose drug companies hundreds of thousands of dollars in minutes, according to US Homeland Security’s former head of cybercrimes...

21st Century Cures: What it could mean for CROs

Dispatches from DIA 2015

21st Century Cures: What it could mean for CROs

By Zachary Brennan

Last month, a US House committee unanimously passed a bill that would set up a host of new provisions tied to clinical trials, many of which will have an impact on the way contract research organizations (CROs) operate.

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