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Breaking News on Global Pharmaceutical Technology & Manufacturing

Pre CPhI Special

Complex regs and unknown markets top API shippers' logistics headaches

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.

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 - The Chairman who steered the Royal Bank of Scotland Group (RBS) after its financial crisis losses will join GSK’s Board as a Non-Executive Director and...

'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 stipulations.

Production on hold at GSK vaccine plant after poliovirus enters water supply

23-Sep-2014 - GlaxoSmithKline will not restart production at a vaccine plant in Belgium until an independent investigation determines how liquid contaminated with polio virus was released into the local sewage system.

Pharmacies banned from compounding for docs without prescription

23-Sep-2014 - The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.

Say ‘cheese’: database collects pill photos

22-Sep-2014 - The US National Institutes of Health (NIH) is collecting photos of pills and tablet in a database for use in apps to improve public safety.

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.

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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