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USP joins campaign against illegal online pharmacies

USP joins campaign against illegal online pharmacies

Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.

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News in brief

A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has resulted in a Form 483 with three observations.

EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.

Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.

EFPIA (European Federation of Pharmaceutical Industries and Associations) and EGA (European Generics Association) have released comments suggesting specific changes to the EMA’s draft guidance on stability data for manufacturing changes.

Global Industry News

ICH plans new guidance on multi-regional clinical trials from Outsourcing-Pharma.com

As the US FDA, EMA and Japan’s PMDA have released guidelines and related position papers on multi-regional clinical trials, the ICH is now proposing to do the same but with a more multi-national approach.

Planning essential to ensure temperature control, say logistic firms from Outsourcing-Pharma.com

Temperature fluctuations during shipping have led to costly clinical data delays and product recalls, but such problems can be avoided through supply chain pre-planning say distribution firms.

Catalent contract secure as Roche buys InterMune for $8.3bn from Outsourcing-Pharma.com

Roche has bought InterMune for $8.3bn (€6.3bn) and says it will continue contracts with Catalent and two API suppliers for the manufacture of its lead product Esbriet (pirfenidone).

PSC to enter US injectables space with new CMO at former PurTox site from Outsourcing-Pharma.com

PSC Biotech plans to enter the US sterile injectables contracting space after buying a plant originally set up by J&J unit Mentor Biologics to make a Botox rival.

People on the Move

Big changes for philanthropic orgs, CROs and services companies from Outsourcing-Pharma.com

How to speed up development: share work with rivals, say scientists from Outsourcing-Pharma.com

Drug developers should add their early-stage discoveries to an open-source database or pay a fine to cut wasted time duplicating results, say researchers.

Spotlight

Hikma buys Boehringer Ingeleheim CMO Ben Venue Labs

Ben Venue assets will bolster sterile injectables network, says Hikma

Hikma has bought defunct manufacturer Ben Venue and says it could reactivate the site in the long-term,...

Is your drug name ok? Run a role-play, says FDA

Is your drug name ok? Run a role-play, says FDA

Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug...

Generics: change in pill shape makes patients 66% more likely to quit

Generics: change in pill shape makes patients 66% more likely to quit

Switching patients to generic pills of a different shape and colour increases the chances they will end...

Eli Lilly swaps dry powder for insulin in Indianapolis restructure

Lilly swaps dry powders for insulin at Indiana site in post-patent shake-up

Patent expiration and a large molecule pipeline has prompted Eli Lilly to repurpose a solid oral dose...

Sterile injectables M&A could indicate return to in-house, says F&S
UPDATE

Sterile injectables M&A could indicate return to in-house production

Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says...

Glenmark to build first US manufacturing plant

Glenmark to build first US manufacturing plant

India-based Glenmark Pharmaceuticals has announced plans to set up a new oral solid dosage manufacturing facility in...

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