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Regulatory & Safety: Top Headlines

Pre CPhI Special

Complex regs and unknown markets top API shippers' logistics headaches

Shipping regs a top concern at CPhI WW?

07-Oct-2014 - The world is getting larger, at least it is in terms of the pharmaceutical industry, according to execs who cite security concerns when shipping to new markets as the top logistics worry.

Related news

News in brief

Impax settles lawsuit related to manufacturing issues for $8m

30-Sep-2014 - Hampered by manufacturing issues, Impax Laboratories has decided to settle a lawsuit over allegations related to the issues in order “to eliminate the uncertainty, distraction, burden and expense of further litigation,” the company said in a SEC filing .

FDA says no to anti-addiction rule on Ritalin, painkillers

29-Sep-2014 - The US Food and Drug Administration has rejected a petition to force drugmakers to reformulate CNS-acting drugs like Adderall, Ritalin, and painkillers to prevent illegal use, but experts say the rule is only a matter of time.

India accuses American Enterprise Institute researchers of "smear campaign"

29-Sep-2014 - The Indian Government has accused the authors of a paper analysing the quality of drugs sold in Africa of leading an attack on the Indian drug industry, but researcher Roger Bate says they are “shooting the messenger.”

People on the Move

GSK appoints RBS chairman, AstraZeneca knight joins R&D charity

29-Sep-2014 - Plus the former Merck & Co VP joining a biopharma, and more in this week's column.

'Worst addiction epidemic in US history' sparks call for Hamburg's resignation

25-Sep-2014 - An anti-addiction group has called for a change in leadership at the US FDA following the approval of Zohydro and other high-dose opioid analgesics.

WHO welcomes industry response to Ebola crisis but calls for new drugs

24-Sep-2014 - The Pharma industry has responded to the Ebola crisis in West Africa with developmental vaccines and aid donations, but drugmakers still need to be incentivised to develop new therapies according to the WHO.

GS1 offers guide for adhering to new US supply chain security law

24-Sep-2014 - As the US Drug Supply Chain Security Act (DSCSA) traceability requirements become mandatory in 2015, standards group GS1 is offering a 137-page guideline to help manufacturers follow the new requirements.

Spotlight

Galen plans to sell “green whistle” pain drug in UK and Ireland

Galen plans to sell “green whistle” inhalable pain drug in UK and Ireland

Almac’s subsidiary Galen has licensed UK sales and marketing rights to an emergency pain drug nicknamed the...

Trial transparency: NICE stands firm on data

Trial transparency: NICE stands firm on data

The UK’s NICE says it will go over drug companies’ heads and get clinical trial data from...

Mannkind looks to Sanofi for secondary supply of inhalable insulin API

Mannkind looks to Sanofi for secondary supply of inhalable insulin API

Mannkind says Sanofi could become a second API supplier for its recently approved inhalable insulin drug Afrezza...

Drug prices will continue to vary accross Africa says analyst

Drug prices will continue to vary accross Africa says analyst

High importation costs and country-to-country differences in national healthcare systems mean drugmakers will continue to vary the...

Hyperion ends drug candidate truials after discovering fake data

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

Hyperion says it is “shocked and disheartened” after discovering Phase III trial data for a type 1...

ISPE offers preview to drug shortages prevention plan

ISPE offers preview to drug shortages prevention plan

The International Society for Pharmaceutical Engineering (ISPE) last week offered up a preview to its plan to...

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