26-Nov-2014 - Bipartisan bills introduced in the US House of Representatives and the Senate would give manufacturers of Ebola therapies vouchers to speed up review of a drug of their choice.
25-Nov-2014 - The lack of women on pharma boards is well-known, so why are companies still slow to balance the genders? A recruiter tells us the problem is “demand, not supply” and why quotas aren't a simple fix.
25-Nov-2014 - The two guidelines offer help to manufacturers looking to use potentially hazardous phthalates as excipients in drugs, as well as those that have shared facilities where multiple drugs are produced.
25-Nov-2014 - Two pharma giants are today looking for new employees after pushing out the CEO of Lundbeck and a Novartis researcher for rule-breaking.
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.
24-Nov-2014 - The US Food and Drug Administration (FDA) is encouraging hospitals to purchase their compounded drugs from organisations registered as outsourcing facilities, and has issued guidance on accreditation.
24-Nov-2014 - Plus the latest drug industry hirings, firings and awards in this week's column.
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.
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.
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 .
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.
19-Nov-2014 - The Association of the British Pharmaceutical and novel drugmakers feature in this week's People on the Move column.
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.
18-Nov-2014 - 2014 has seen record pharma M&A activity but top management of some of the key dealmakers – including Novartis, AstraZeneca and Shire – say size doesn’t always matter.
18-Nov-2014 - Drug shortages could be an issue in the near future as some wholesale distributors and drug suppliers may not be able to meet a key Jan. 1 deadline from the Drug Supply Chain and Security Act (DSCSA), an expert says.
18-Nov-2014 - US FDA commissioner Margaret Hamburg is traveling to China this week and at least part of her trip will be devoted to securing visas for new drug manufacturing site inspectors.
17-Nov-2014 - Ongoing concerns about marketing practices have taken the shine of a report suggesting Big Pharma efforts have improved parients' access to drugs in developing countries over the past two years.
13-Nov-2014 - The EMA said Wednesday it will formally respond to a letter sent by EU ombudsman Emily O'Reilly to the agency in which she took particular issue with some redacted information from AbbVie’s CSRs (clinical study reports).
10-Nov-2014 - The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies.
06-Nov-2014 - BARDA, the US government’s Biomedical Advanced Research and Development Authority, has revealed it sees Ebola “as a bioterrorism threat.”
05-Nov-2014 - A Pfizer Director has called for clearer manufacturing commitments in NDA and post-approval applications and the US FDA says, following its restructure, this will come.
04-Nov-2014 - IN PICTURES: Plus who's on the move at biotechs and the UK's National Health Service.
03-Nov-2014 - In the future pharma will be reliant on technology, says physician-scientist Daniel Kraft, who warns that companies which fail to innovate risk being left behind.
03-Nov-2014 - [View the story "Cali-pharm-ia: Live from AAPS 2014" on Storify]
03-Nov-2014 - Two major influenza vaccine producers have run into manufacturing issues that have delayed and reduced the number of doses that will be provided for the US.
Dispatches from AAPS
Inhaled delivery of the labour inducing peptide oxytocin could help prevent millions of deaths in the lesser-developed...
dispatches from AAPS
In the future pharma will be reliant on technology, says physician-scientist Daniel Kraft, who warns that companies...
India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to...
Animal astronauts on the International Space Station will test an implant which allows doctors back on earth...
A head-hunter explains why Regeneron, Novo Nordisk and Genentech top a global survey of science employers, but...
The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set...