05-Dec-2013 - Drugmakers seeking ANDAs for certain solid dose, extended-release drugs will need to test what impact alcohol has on their products under new draft guidance on bioequivalence issued by the US FDA.
03-Dec-2013 - The Head of GSK's vaccine unit is off to Takeda, and Amgen has a new Board member - Welcome to in-Pharmatechnologist.com's People on the Move.
03-Dec-2013 - Asking qualified persons (QP) to certify that drug batches comply with manufacturing quality rules in destination EEA markets is unrealistic say groups commenting on proposed revisions to Annex 16 of the EU GMP guidelines.
02-Dec-2013 - A drug industry supply chain group has welcomed the introduction of new US laws designed to make it easier to track pharmaceuticals through the supply chain.
28-Nov-2013 - The US FDA has started work on a national track and trace system for pharmaceuticals after President Barack Obama signed the Drug Quality and Safety Act into law last night.
27-Nov-2013 - The US Food and Drug Administration (FDA) has hit Wockhardt with a second import alert this year, this time at its Chikalthana, India facility.
25-Nov-2013 - New appointments at AstraZeneca offshoot MedImmune, Pfizer and Immunocore in this week's in-Pharmatechnologist's People on the Move.
25-Nov-2013 - Merck Serono has announced plans to build an $80m plant for the production of diabetes and cardiovascular drugs in China.
21-Nov-2013 - The high cost of energy in the UK is having a negative impact on drug and chemical firms' ability to compete according to manufacturers quizzed by the Chemical Industries Association (CIA).
19-Nov-2013 - US authorities will soon have a new system capable of tracking drugs from the factory floor to the pharmacy shelf after the Senate passed the “Drug Quality and Security Bill” last night.
19-Nov-2013 - An industry group has called for greater regulatory harmonization in South America, arguing that both the drug industry and patients would benefit.
18-Nov-2013 - US Senators will debate pharmaceutical track and trace legislation later today in a session that could have a dramatic impact on how drug supply chains in the country are monitored.
11-Nov-2013 - [View the story "AAPS at the Alamo" on Storify]
11-Nov-2013 - France-based biotech firms Genticel, TxCell and Neovacs all have new senior appointments in this week's People on the Move Gallery, perhaps more fittingly titled Les gens qui bougent...
07-Nov-2013 - Roche could restart its antibiotic development activities if a superbug busting drug candidate being developed by new partner Polyphor fulfils its early clinical promise.
07-Nov-2013 - Remediation at troubled Rocky Mount facility will continue into 2014 Hopira says as it awaits an inspection by the US Food and Drug Administration (FDA).
06-Nov-2013 - The US FDA told us that China has “taken longer than FDA had hoped” in approving the visas of new FDA inspectors that would more than double the agency's presence in China.
05-Nov-2013 - In one of the largest healthcare fraud settlements in US history, Johnson & Johnson has pleaded guilty to introducing a misbranded drug and must pay approximately $2.2bn (€1.6bn) to resolve criminal and civil liability.
05-Nov-2013 - Payers should keep pharmaceutical firms’ quality records in mind when making purchasing decisions to help prevent drug shortages and stimulate manufacturing innovation according to the US FDA.
04-Nov-2013 - Teva has named an interim CEO days after previous chief Jeremy Levin stepped down amid rumours of boardroom disagreements, plus news from AstraZeneca, Shire and the CDER.
29-Oct-2013 - Novo Nordisk has recalled 30 batches of a prefilled insulin product following a dosage error at a manufacturing facility in China.
29-Oct-2013 - Welcome to in-Pharmatechnologist's People (not!) on the Move, with Teva's CEO denying he is contemplating resigning following reports he had fallen out with the Board over recent job cuts.
28-Oct-2013 - Drug giant GlaxoSmithKline says operations have restarted at an OTC plant forced to close last week following a methane leak.
21-Oct-2013 - News from Mylan in Europe and Johnson & Johnson tops this week's in-Pharmatechnologist.com's People on the Move.
21-Oct-2013 - In calling an unregistered product ‘fake,’ the Ghanaian FDA has sparked a media war with industry, but are critics using this as an excuse to knock the regulators whilst importers gain undeserved sympathy? in-Pharmatechnologist’s Dan Stanton believes so.
Dispatches from AAPS
The US FDA is working with GEA to validate continuous manufacturing as the pharma industry enters “the start...
The US FDA and European Medicines Agency (EMA) is now offering additional joint guidance on the concept...
Novartis has confirmed it is closing a UK facility as part of a global R&D review but...
In one of the largest healthcare fraud settlements in US history, Johnson & Johnson has pleaded guilty to...
The acquisition of Bend Research by Capsugel may be “a marriage made in heaven” for customers, the...