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Headlines > June 2014

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India delays bar codes for primary packaging indefinitely

30-Jun-2014 - With almost a week before Indian exporters would be required to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) in India has pushed back...

People on the Move

Who's going places?

30-Jun-2014 - Big changes in biologics in this week's column, as we round up the pharma industry's new scientific hires.

China demands ‘famous brand’ suppliers and added value, says Romaco

30-Jun-2014 - Chinese pharma is looking for added value and “famous brands” from its processing providers, the tableting and packaging supplier Romaco has said. 

Economists brand Lilly drug R&D cost quiz "misinformation"

26-Jun-2014 - An online quiz about drug R&D has been criticised by economists who say its developer - Eli Lilly - is misinforming the public about the cost and time it takes...

IMCD expands IPO citing demand and desire for deals

26-Jun-2014 - Dutch API and excipients distributor IMCD has increased the number of shares it will make available in its initial public offering (IPO), citing demand.

Oasmia's vitamin A excipient tech attract global pharma collaborator

26-Jun-2014 - Oasmia Pharmaceutical AB has teamed up with a “global pharmaceutical company” interested in its vitamin A-based nanoparticle formulation tech in a move that expands its business model to drug development...

Exporters rush to meet Chinese FDA serialisation requirements

26-Jun-2014 - Pharmaceutical companies are rushing to respond to shortened deadlines from China’s Food and Drug Administration (CFDA) for serialising drug packaging.

US FDA guidance widens ‘nanotechnology’ definition

25-Jun-2014 - The United States Food and Drug Administration (FDA) has announced it will consider products outside the nanoscale, up to 1,000 nanometres (nm), to involve nanotechnology and so be potentially liable...

GSK confident despite ongoing endotoxin problems at Canadian flu vaccine plant

25-Jun-2014 - GSK is confident it can meet Flulaval production targets ahead of this winter’s flu season despite ongoing endotoxin contamination problems at a Canadian plant hit with US FDA warning letter. ...

update

Ethanol diluent in injectables an intoxication risk says US FDA

24-Jun-2014 - The use of ethanol as a diluent in injectables is under the spotlight following a new US FDA warning that its presence in the cancer medicine docetaxel poses an intoxication...

SAFC to make virus-resistant cell lines

24-Jun-2014 - BioReliance and its parent company SAFC say they are working on viral-resistant cell lines that will prevent contamination in bioreactors.

Copley develops new testing techs for generic respiratory drugs

24-Jun-2014 - Copley Scientific has launched new technologies to help developers of generic inhalable drugs stick to specific testing guidelines issued by the US FDA and USP. 

Big Pharma Insourcing replacing Asian suppliers as competition for western CMOs

23-Jun-2014 - Hidden costs and quality issues have encouraged pharma to abandon China and India, but Western CMOs are now under threat from a return to in-house manufacture, says a procurement consultant

NIH 3D printer project to allow public to create drug models

23-Jun-2014 - The US National Institutes of Health (NIH) has launched a 3D Print Exchange which will turn data submitted by the public into files for printing 3D models.

Hospira recalls Marcaine anaesthetic after vial contamination

23-Jun-2014 - Hospira has recalled a batch of its anaesthetic Marcaine due to visible fragments in the vials.

Marketing agency targets poor interns for GSK paid trials

19-Jun-2014 - Representatives for GSK have targeted struggling graduates and unpaid interns as volunteers for clinical trials, saying the payments – up to £8,000 ($13,600) per year – “could be your solution” to money problems.

WHO and USP programme to help manufacturers of key drugs

19-Jun-2014 - The WHO, the United States Pharmacopeial Convention (USP) and the US Agency for International Development (USAID) will work with regulators to help countries manufacture a key tuberculosis drug.

Dispatches from DIA

TransCelerate stops short of offering membership to CROs

19-Jun-2014 - Big pharma industry group TransCelerate discussed but ultimately decided against allowing CROs to join the collaborative, though research contractors will be engaged routinely, members of the group said.

Character building: US FDA sets strict guidance on pharma tweets

18-Jun-2014 - Drug firms that tweet to promote pharmaceuticals will also need to detail their most serious risks under newly issued USFDA draft guidance. 

Roche: ‘If suppliers don’t open up their books, then we are done’

18-Jun-2014 - Drug raw materials suppliers have not recognised their potential value to biopharmaceutical customers according to Roche which has called for a transformation in the vendor relationship.

Arecor and CPI team on biologics stability research project

17-Jun-2014 - Formulations that stop biopharmaceuticals being degraded by vials and syringes could help biopharmas avoid recalls and improve product shelf life says the UK team behind an industry focused research collaboration.

Fette launches new press for commercial-scale production

17-Jun-2014 - Fette Compacting America claims its new tablet press technology can accelerate the production of large drug batches.

Novartis calls in third-party trial reviewer after Japan SAE scandal

17-Jun-2014 - Novartis has called in a third party organization to review how it conducts clinical trials in light of the adverse event reporting scandal that broke in Japan last week.

SOCMA highlights contribution to facility security report

16-Jun-2014 - A US presidential report on plans to improve chemical facility safety and security has incorporated a number of recommendations from the Society of Chemical Manufacturers and Affiliates (SOCMA).

Mannkind preps Afrezza plant ahead of anticipated approval

16-Jun-2014 - Two billion cartridges of inhaled insulin drug Afrezza will be manufactured annually by Mannkind, the firm says as it awaits final approval next month.

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