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Dispatches from ChemOutsourcing

ICH elemental impurities guideline expected to be finalized at end of September

24 elements will need to be evaluated by manufacturers of finished products

After much discussion and some confusion , the ICH’s (International Conference on Harmonization) Q3D guideline , which will govern elemental impurities in final drug products, is expected to be finalized at the end of this month.

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News in brief

Use of the muscle relaxant atracuriam to resuspend freeze-dried measles vaccines instead of the proper diluent almost certainly caused the death of more than a dozen Syrian infants according to the WHO.

Scientists looking to solve the looming threat of antimicrobial resistance have discovered an antibiotic in the vagina.

Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in European Commission reshuffle plan.

Hospira has invested 15m AUD ($14m) in a Victoria injectables plant it says will continue to make drugs for export despite the economic downturn and strong Australian dollar.

Global Industry News

Opinion

Public or private: Where Catalent goes, will other CMOs follow? from Outsourcing-Pharma.com

Following the recent IPO from Catalent, has private equity called time on the CDMO industry? Outsourcing-pharma’s Dan Stanton thinks it has for now.

Evotec looks to recover payments from Andromeda over faked Phase III data from Outsourcing-Pharma.com

Evotec has taken legal action to recover €3.4m ($4.4m) in milestone payments from Andromeda Biotech which was found to have faked data in a Phase III trial.

'Fastest way to biosimilar approval? As the CRO flies,' says industry group from BioPharma-Reporter.com

Almost all of the biosimilars currently approved have been developed using a third-party research organisation according to a survey from the Association of Clinical Research Organizations (ACRO).

Merck KGaA is latest bi-curious antibody developer in ADC deal with Sutro from BioPharma-Reporter.com

Merck KGaA has partnered with bispecific antibody firm Sutro Biopharma to develop and produce antibody drug conjugates (ADCs).

Dispatches from ChemOutsourcing

CMO consolidation: Do biopharma partners see any benefits? from Outsourcing-Pharma.com

As contract manufacturers continue to consolidate , some in the industry are questioning whether the resulting companies have the ability to offer the same services as the former individual companies. 

People on the Move

Who's the next big thing in outsourcing? from Outsourcing-Pharma.com

Results from the 50 Most Influential People in Vaccines, Aligent changes CEOs, and more...

US gov rallies industry to join mission to Indonesia and the Phillipines from Outsourcing-Pharma.com

Pharma service companies looking to access the growing Philippine and Indonesian markets have been invited to join a Public-Private trade mission by the US Department of Commerce.

Spotlight

Ben venue fallout continues to cause headache for Boehringer Ingelheim

Ben venue fallout continues to cause headache for Boehringer Ingelheim

Divested sterile manufacturer Ben Venue has continued to cause trouble for Boehringer Ingelheim with a second recall...

‘James bond’-like tech is the end to overdoses, says formulation firm

‘James bond’-like tech is the end to overdoses, says formulation firm

Canadian drugmaker Intellipharmaceutics has developed a kill-switch formulation it says will prevent drug misuse and accidental overdoses.

Find other oral forms for tablet-hating patients, drugmakers told

Find other oral forms for tablet-hating patients, drugmakers told

Pharma firms must provide imaginative solid dosage alternatives to tablets and capsules, says research claiming more than...

Gangsters imported fake drugs from Asia says Europol

Gangsters imported fake drugs from Asia says Europol

Millions of fake pharmaceuticals seized earlier today were imported from Asia by an organised crime group that...

Compounding the problem: US warns two more pharmacies

Compounding the problem: US warns two more pharmacies

The US FDA has criticised the Compounding Shop and Zion Rx Formulations Services for making unapproved and...

Is Pfizer now eyeing up Actavis three months after failed AZ bid?
INFOGRAPHIC

Is Pfizer now eyeing up Actavis three months after failed AZ bid?

Pfizer is rumoured to be eyeing up Actavis three months after failing to woo AstraZeneca in a...

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