02-Apr-2015 - Although the abuse-deterrent technology is still relatively new, the FDA has released final guidance explaining to manufacturers how to conduct studies to demonstrate that an opioid formulation has abuse-deterrent properties.
01-Apr-2015 - Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.
01-Apr-2015 - Publisher BioMed Central has withdrawn 43 papers from its scientific journals after discovering a conspiracy to rig peer review runs deeper than previously thought.
31-Mar-2015 - British MPs have signed an anti-animal cruelty pledge which scientists warn would “cripple” disease research and outlaw 89% of preclinical animal research.
31-Mar-2015 - Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.
30-Mar-2015 - Indiana’s new “religious freedom” law is discriminatory and will make it harder to attract the staff needed to develop drugs for cancer and Alzheimer's disease according to Eli Lilly.
27-Mar-2015 - Testing the toxicity of drug candidates in animals is archaic and unreliable according to PETA, which joined preclinical CROs at SOT to put forward alternatives.
27-Mar-2015 - Aarti Drugs says the US FDA has not provided details of observations that earned its E-22 facility in Tarapur, India an import ban.
27-Mar-2015 - Biosimilar firms seeking US approval will not have to commit to share manufacturing data with reference drug firms before reviews, after the FDA rejected Amgen’s request for such a rule.
26-Mar-2015 - Makers and distributors of APIs (active pharmaceutical ingredients) will have to track their products throughout the supply chain and meet rules on cold chain transport and outsourcing under revised guidance from the European Commission.
24-Mar-2015 - Several FDA officials are currently visiting India and meeting with manufacturer CEOs and government officials to discuss the way the agency’s inspections are expected to change over time.
24-Mar-2015 - Utah will allow execution by firing squad as European pharmaceutical companies refuse to provide drugs for lethal injection.
24-Mar-2015 - Gene-editing technology CRISPR-Cas9 must not be used to alter human DNA until the risks have been researched and the ethical issues considered, say scientists.
24-Mar-2015 - Speculation GSK's meningitis B vaccine Bexsero will soon be available on the UK National Health Serivice will be welcomed by campaigners, protein supplier Sandoz and its parent company, Novartis.
23-Mar-2015 - Further evidence US diabetics pay more for drugs than sufferers in comparable countries has emerged this month in a study assessing the diseases’ economic impact.
23-Mar-2015 - The WHO’s latest report on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products has the organization divvying up certain responsibilities for controlling the fraudulent products between countries.
20-Mar-2015 - A district court judge from California has denied an injunction by Amgen meant to stop the launch of the first biosimilar approved by the US FDA – Sandoz’s Zarxio (filgrastim-sndz).
19-Mar-2015 - The pharma industry reached a high water mark in 2014 with a record number of new molecular entities approved by the US Food and Drug Administration, especially orphan drugs.
19-Mar-2015 - The FDA has defended the speed at which it finalises draft guidance on drugs in response to criticism from Republican senators.
18-Mar-2015 - Computer scientists have found a way to “translate” social media comments about drugs into adverse drug reaction (ADR) reports.
16-Mar-2015 - The DEA's mismanagement of the controlled substance API quota system and its poor relationship with the FDA have exacerbated drug shortages according to the US GAO.
16-Mar-2015 - Bacterial testing is moving from the lab to the manufacturing floor, says an expert at CRO Charles River.
More drugs for tropical diseases have been donated since the London declaration of 2012, but getting them...
Novasep and Lonza will both make the API for Celladon's heart attack therapy, Mydicar.
Utah will allow execution by firing squad as European pharmaceutical companies refuse to provide drugs for lethal...
Demand for pensioner friendly pills will be an important growth driver for the drug excipients sector according...
The WHO’s latest report on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products has the organization divvying up certain responsibilities for...
Further evidence US diabetics pay more for drugs than sufferers in comparable countries has emerged this month...