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19-Mar-2015 - The FDA has defended the speed at which it finalises draft guidance on drugs in response to criticism from Republican senators.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.
13-Mar-2015 - Despite slamming the US FDA for tentatively approving two Ranbaxy ANDAs (abbreviated new drug applications) for the first Nexium and Valcyte generics, US District Judge Beryl Howell said last week the agency can revoke the approvals because of manufacturing concerns.
13-Mar-2015 - More drugs for tropical diseases have been donated since the London declaration of 2012, but getting them to the remote communities is still a challenge according to a consortium led by the Liverpool School of Tropical Medicine (LSTM).
12-Mar-2015 - Speciality Compounding has been ordered to cease production by the US Courts after tests confirmed injectable drugs made at its facility in Texas were contaminated by bacteria.
11-Mar-2015 - For the second time this year, the FDA has issued a warning letter to API (active pharmaceutical ingredient) and intermediate manufacturer Novacyl and this time it’s for the company’s manufacturing site in Thailand.
11-Mar-2015 - Patients who mix Chantix with alcohol can become aggressive or suffer memory loss says the US FDA, which has ordered Pfizer to update the smoking cessation drug’s side-effects label.
10-Mar-2015 - J&J unit McNeil-PPC has admitted breaking US law by selling contaminated liquid medications, including Infants’ Tylenol and Children’s Motrin, deemed adulterated under the federal Food, Drug and Cosmetic Act (FDCA).
10-Mar-2015 - The Danish and Austrian authorities have warned against toxic food supplements ahead of an EU-wide safety logo set to crack down on illegal retailers posing as online pharmacies.
10-Mar-2015 - Biosimilars will mean more facility inspections and reviews according to the US FDA, which is confident its funding will be increased accordingly.
10-Mar-2015 - The US FDA has turned to smartphone technology to fight drug shortages with an app aimed at doctors, pharmacists and patients.
09-Mar-2015 - Quality troubles for Hospira continue as the company announced on Friday recalls of two injections, in addition to the recall of two infusion pumps, as well as a Form 483 for an Indian manufacturing site.
Dispatches from DCAT
The European pharma market isn’t likely to deliver much growth over the next five years as generic...
More drugs for tropical diseases have been donated since the London declaration of 2012, but getting them...
The FDA has tested hundreds of creatively named bogus supplements and found they contain hidden APIs. Take...