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Industry groups take issue with FDA draft guidance on outsourcing facilities

Industry groups take issue with guidance on outsourcing facilities

Industry groups BIO (Biotechnology Industry Association) and GPhA (Generic Pharmaceutical Association) are calling for outsourcing facilities to be held to the same standards as other, larger manufacturers.

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News in brief

Drugmakers sponsoring trials in India will need to weigh the potential risks and benefits for the people who take part under new guidelines issued by the CDSCO.

Relypsa has entered into a multi-year commercial manufacturing and supply agreement with CMO Patheon for the finished product manufacture of patiromer, Relypsa's potential treatment of hyperkalemia.  

Recognizing the critical role of emerging biopharma companies and their recent influx of cash , Quintiles has launched a new ‘emerging biopharma solution’ that aims to capitalize on the unique development needs of the companies.  

Marken expects the first batch of trial supplies to reach its new depot in Sao Paulo, Brazil later this month.

Global Industry News

Purple not yet the new orange: US FDA biopharmaceuticals list lacks dates from

A new list of biopharmaceuticals published by the US FDA provides limited information with only the entries for Neupogen, Perjecta and Granix including expiry dates.

infographic feature

Better together? biosimilars sector says aye from

Partnerships are a mixed bag.For every oppressed group yearning to throw off the yoke of their imperialist overlords, there is an Art Garfunkel or Daryl Hall solo album to illustrate the positive impact collaboration can have.

Advanced Cell Technology wins US patent for dendritic cell manufacturing process from

Regenerative medicine company Advanced Cell Technology (ACT) has been issued a US patent from the US Patent and Trademark Office covering methods of manufacturing dendritic cells using a scalable process involving a renewable stem cell source as the starting materials. 

Protalix shares soar… then dive after Ebola drug comments from

Protalix shares rocketed 18% then reversed in one weekend after the Israeli protein manufacturer clarified it is not in talks to produce Ebola drug ZMapp.

Seaweed: the secret ingredient to HIV drug delivery? from

Food scientists may have hit on a novel delivery method for HIV antiretrovirals: a vaginal suppository made with seaweed.

ProBioGen adds bioreactors and hunts for staff in €20m investment from

CDMO ProBioGen has invested €20m ($26m) in its manufacturing plant in Germany and says it will install two 1,000L single-use bioreactors and employ roughly 75 new staff.

$20m Andromeda strains Hyperion as fake data ends diabetes drug development from

Hyperion says it is “shocked and disheartened” after discovering Phase III trial data for a type 1 diabetes candidate was manipulated by employees of recently acquired Andromeda Biotech.

Analyst: CMOs to prosper as biopharma reduces capacity sharing from

Biopharma firms are no longer offering spare capacity to rivals, according to an analyst, who says the trend is benefiting large CMOs.


Evotec confirms orphan drug development status with Shire contract

Evotec teams with Shire on Fabry's disease as pharma interest in orphans grows

Evotec has partnered with Shire to develop inhibitors against Fabry’s disease and says such collaborations will grow...

CRL nears 85% capacity use, but says sector pricing won't improve yet

CRL nears 85% capacity use, but says sector pricing won't improve yet

Charles River Laboratories is approaching its optimal capacity utilisation but says pricing will not improve until the...

CMO issues persist as Cubist announces third recall for antibiotic

CMO issues persist as Cubist announces third recall for potential glass in antibiotic

For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection...

AMRI: Big Pharma still reliant on CMOs for sterile injectables

Injectables outsourcing growing despite pharma M&A, says AMRI

Big Pharma is still reliant on CMOs despite talk of returning in-house, says AMRI, which has launched...

Quintiles sees strong demand from large pharma

Quintiles sees strong demand from large pharma

Quintiles CEO Tom Pike told investors last week that the company is seeing “very strong demand from...

Almac announces Government backed recruitment drive

Almac announces Government backed recruitment drive

Northern Ireland-based contractor Almac will create 348 jobs over the next five years in its pharma and...

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