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Regulatory & Safety: Top Headlines

US, Chinese regulators forge closer ties as FDA looks to triple staff

Hamburg getting cozy with a Chinese official

24-Nov-2014 - As FDA commissioner Margaret Hamburg wraps up her trip in China it looks like the FDA is creating a stronger bond with its Chinese counterparts as the FDA looks to triple its staff there.

Related news

News in brief

People on the Move

Does Sanofi have a replacement CEO in its sights?

24-Nov-2014 - Plus the latest drug industry hirings, firings and awards in this week's column.

Dispatches from the FT Global Healthcare and Biotech Conference

EMA: New pathways and Ebola vaccines can help expedite approvals

20-Nov-2014 - The EMA is “caught between a rock and a hard place” in expediting drug development, but an agency Executive says change can come through its new adaptive licensing pathway.

UK Hospitals to play part in Gov efforts to speed clinical trial process

20-Nov-2014 - UK life sciences minister George Freeman wants hospitals to play more of a role in clinical trials and says accelerating the drug development process in the post block-buster era is key for Big Pharma and patients.

MHRA says quality system deficiencies are most common issue from inspections

20-Nov-2014 - Deficiencies related to manufacturers’ quality systems are by far the most prevalent issue cited from inspections by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), the agency said in a report on 2013 inspections .

US FDA calls out two companies over fake Ebola treatments

20-Nov-2014 - The US FDA and the Federal Trade Commission have sent warning letters to two companies claiming to have drugs that treat Ebola though no such product has been approved by the agency.

People on the Move

Going places: pharma's movers and shakers

19-Nov-2014 - The Association of the British Pharmaceutical and novel drugmakers feature in this week's People on the Move column.

Questions raised over new $2.6bn price tag to bring a new drug to market

19-Nov-2014 - The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn, though some are saying that number seems inflated.

Regulatory & Safety: Featured news

Spotlight

DPI delivered peptide could prevent deaths during childbirth, says GSK
Dispatches from AAPS

Inhaler delivered peptide could prevent LDC deaths during childbirth, says GSK

Inhaled delivery of the labour inducing peptide oxytocin could help prevent millions of deaths in the lesser-developed...

Why Apple and Google hold the key to avoiding Pharmageddon
dispatches from AAPS

Why Apple and Google hold the key to avoiding Pharmageddon

In the future pharma will be reliant on technology, says physician-scientist Daniel Kraft, who warns that companies...

India cuts stability data reqs for API firms seeking docs to ship to EU

India cuts stability data reqs for API firms seeking docs to ship to EU

India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to...

Life on Mars? Ground control to remotely deliver drugs in space

Life on Mars? Ground control to remotely deliver drugs in space

Animal astronauts on the International Space Station will test an implant which allows doctors back on earth...

Why there's no sign of Pfizer among top pharma employers
Feature

Why there's no sign of Pfizer among top pharma employers

A head-hunter explains why Regeneron, Novo Nordisk and Genentech top a global survey of science employers, but...

EDQM sets new policy for testing of bacterial endotoxins

EDQM sets new policy for testing of bacterial endotoxins

The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set...

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