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Breaking News on Global Pharmaceutical Technology & Manufacturing

Diluent mix-up not vaccine most probable cause of Syrian deaths says WHO

18-Sep-2014 - 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.

Dispatches from ChemOutsourcing

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

18-Sep-2014 - 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.

US FDA warns patients off all products from Texas compounding pharmacy

17-Sep-2014 - The US FDA has warned the public not to use any sterile medicines made by Downing-owned NuVision Pharmacy, Texas, which failed to comply with a recall order.

update

Moving EMA to DG Enterprise will increase risk of adverse events says NGO

17-Sep-2014 - 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 planned European Commission reshuffle.

Trial transparency: NICE stands firm on data

16-Sep-2014 - The UK’s NICE says it will go over drug companies’ heads and get clinical trial data from regulators if sponsors fail to supply their results.

EMA guideline on pharmacovigilance inspections comes into effect

16-Sep-2014 - As the EMA has announced that the main objectives of its pharmacovigilance legislation are largely being achieved , the agency is still implementing a number of the individual modules that make up the over-arching law.

EC rejig will see DG Enterprise and Industry take responsibility for EMA

15-Sep-2014 - The EU commission plans to strip DG Sanco of responsibility for the running the European Medicines Agency (EMA) and hand it to the directorate in charge of enterprise and industry.

News in brief

Human hair in heparin vial prompts Hospira recall

15-Sep-2014 - Hospira has pulled a lot of heparin sodium after human hair discovered in vial.

People on the Move

Sanofi, Amgen, FDA: All change

15-Sep-2014 - Who's in, who's out: all the latest changes in senior pharmaceutical appointments.

Drug prices will continue to vary accross Africa says analyst

11-Sep-2014 - High importation costs and country-to-country differences in national healthcare systems mean drugmakers will continue to vary the cost of products in Africa according to an industry analyst.

@MHRA: regulators could track #drug reactions via Twitter

11-Sep-2014 - The UK Medicines and Healthcare products Regulatory Agency (MHRA) says Twitter, Facebook and smartphone apps could soon be used to gather adverse drug reactions (ADRs).

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

10-Sep-2014 - 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.

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

09-Sep-2014 - 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.

Arrested: compounding pharmacist linked to 2012 meningitis deaths

09-Sep-2014 - US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012.

People on the Move

Roche director resigns to avoid conflict of interest with Google's Calico

08-Sep-2014 - Plus senior hires at Merck Serono, Astellas, the European Medicines Agency, and more.

MHRA and Novartis lead consortium to develop adverse drug reaction app

08-Sep-2014 - The drug industry and regulators have teamed up to develop a smartphone app to make the gathering and reporting of adverse drug reactions easier.

ISPE offers preview to drug shortages prevention plan

08-Sep-2014 - The International Society for Pharmaceutical Engineering (ISPE) last week offered up a preview to its plan to help manufacturers avoid or mitigate drug shortages due to manufacturing or quality issues.

Ben venue fallout continues to cause headache for Boehringer Ingelheim

04-Sep-2014 - Divested sterile manufacturer Ben Venue has continued to cause trouble for Boehringer Ingelheim with a second recall this year of an injectable drug made at the now defunct site.

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

03-Sep-2014 - Canadian drugmaker Intellipharmaceutics has developed a kill-switch formulation it says will prevent drug misuse and accidental overdoses.

TransCelerate recommends what to protect in trial transparency efforts

03-Sep-2014 - Industry group TransCelerate Biopharma has developed a new recommended approach for protecting patients’ personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others as part of plans to release more data under consideration in the EU and US.

Gangsters imported fake drugs from Asia says Europol

02-Sep-2014 - Millions of fake pharmaceuticals seized earlier today were imported from Asia by an organised crime group that planned to sell them online say European law enforcement agencies that co-ordinated the swoop. 

Compounding the problem: US warns two more pharmacies

01-Sep-2014 - The US FDA has criticised the Compounding Shop and Zion Rx Formulations Services for making unapproved and contaminated drugs.

People on the Move

People: The ice bucket challenge, ex-Novartis exec moves to Biogen

01-Sep-2014 - Our People on the Move column tracks pharma's movers and shakers.

US FDA 2009 import ban legal NAFTA panel tells Apotex

01-Sep-2014 - The US FDA import ban imposed on Apotex in 2009 was legal and the firm was not treated more harshly than generics rival Teva according to a State Department arbitration panel.

Baxter donates IVs to aid groups fighting Ebola in Africa

29-Aug-2014 - Baxter International has donated intravenous fluids to aid organisations treating Ebola infected patients in Liberia and Sierra Leone.

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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