Breaking News on Pharmaceutical Technology

Product news > QA/QC & validation

Latest news headlines

Products

Suppliers

Massive counterfeit drug ring cracked

18-Sep-2007 - The biggest counterfeit drugs conspiracy ever to be encountered in the UK was crushed this week, as gang members were found guilty of conspiracy by a UK court following a lengthy investigation by the authorities.

Pharma manufacturing products: news in brief

13-Sep-2007 - JDSU, Applied Biosystems, Hitachi High Technologies America, Infor and Brenton Engineering have all recently launched products used in the pharmaceutical manufacturing industry.

bioMerieux buys standards innovator BTF

13-Sep-2007 - Industrial microbiology expert bioMerieux has acquired Australian firm BTF, strengthening its quality control (QC) and manufacturing quality assurance (QA) offerings to the pharmaceutical industry.

Serious adverse drug events on the increase

11-Sep-2007 - The safety of America's drugs are being called into question following a damning report that claims serious adverse drug events have more than doubled in an eight year period.

FluMist finally on track

10-Sep-2007 - Manufacturing problems hindering production of MedImmune's intranasal flu vaccine FluMist have finally been resolved at the company's Liverpool, UK facility, with doses on track to be available for this year's flu season.

Labelling link-up for pharma manufacturers

16-Aug-2007 - A leading software provider to the life science industry has formed an alliance with a specialist supplier of radio frequency identification (RFID) printing and bar code labelling hardware to offer dedicated solutions to pharma, biotech and medical device manufacturers.

Pharma tops most IP-intensive list

14-Aug-2007 - The pharmaceutical industry has come up top in the most Intellectual Property (IP)-intensive industry in the US, according to a report released this week.

GSK disppointment at FDA Advair decision

09-Aug-2007 - GlaxoSmithKline (GSK) has suffered a blow in the advance of its top selling pharma drug Advair after US regulators issued a not approvable letter for an increased strength in the treatment of chronic obstructive pulmonary disease.

PerkinElmer expands LC/MS validation service

09-Aug-2007 - PerkinElmer has expanded its multi-vendor service offering to help firms reduce the cost of regulatory compliance in pharmaceutical drug development and manufacturing quality control laboratories.

Baxter recalls more infusion pumps

08-Aug-2007 - Baxter Healthcare remains in murky waters in regard to its infusion pumps after announcing yesterday it would be recalling an additional 986 of its Colleague brand pumps.

Celsis tech gets pharma recognition

07-Aug-2007 - Celsis' Rapid Microbiological Method (RMM) has been included in GlaxoSmithKline's (GSK) successful Veramyst New Drug Application (NDA), paving the way for broader acceptance of the time saving technique.

Skyepharma forced to delay NDA in US

06-Aug-2007 - SkyePharma will be delaying its New Drug Application (NDA) in the US for its asthma treatment Flutiform following an "unexpected" setback in the submission process.

Viagra, Cialis imitations seized in London raid

06-Aug-2007 - In the latest episode of illegal drug trading, a hoard of unlicensed medicines was seized by the UK Medicines and Healthcare products Regulatory Agency (MHRA) last week, taken from a London lock-up containing a stash of various male impotence drugs.

First ever non-contact process protects film-coated tabs

02-Aug-2007 - Solid-dose specialist Colorcon has hooked up with materials science firm DataLase to develop a new no-touch on-tablet marking technique specifically for film-coated tablets, helping to defend branded tabs from counterfeiting attempts and protect patient safety.

RFID set for explosive growth

26-Jul-2007 - The use of radio frequency identification (RFID) technologies in the healthcare industry is set for explosive growth over the coming years as teething problems from its formative years are overcome.

Cash injection for Dengue fever vaccine

24-Jul-2007 - US biotech firm VaxInnate has been awarded a lump sum from the National Institutes of Health (NIH) to support the development of the company's tetravalent Dengue fever vaccine.

MHRA stalls cannabis-based MS drug

23-Jul-2007 - A UK firm developing cannabis-derived multiple sclerosis (MS) treatments has decided to pull an EU application for its lead candidate Sativex, following demands by UK regulators for additional data in support of the treatment.

FDA draft guideline on ICH Q10

19-Jul-2007 - The US Food and Drug Administration (FDA) has released a draft guideline document outlining a model for implementing the International Conference on Harmonization's (ICH) Q10.

China gets tough on manufacturers

09-Jul-2007 - China is cracking down on its pharmaceutical manufacturers with the State Food and Drug Administration (SFDA) revoking the production licenses of five drug makers since July, according to reports in the local media.

Gel cap strength put to the test

05-Jul-2007 - A UK firm has introduced a new piece of kit for pharma firms to test how the contents of their hard gel capsules can affect the strength and stability of the outer shell.

Initiative launched to tackle ICH

04-Jul-2007 - The International Society for Pharmaceutical Engineering (ISPE) has launched a new initiative to help implement the International Conference on Harmonization (ICH) guidelines.

Anti-obesity drug slim on safety aspects

02-Jul-2007 - Sanofi-Aventis' hotly touted anti-obesity blockbuster drug has become weighted down in safety concerns as the French company withdraws its New Drug Application (NDA) in the US and awaits a safety review in the EU.

Plant-based insulin to jump to Phase II next year

27-Jun-2007 - Canadian biotech firm SemBioSys Genetics has presented an update on its project to promote plant-derived recombinant human insulin on a commercial scale, expecting to hop directly to Phase II trials early next year.

Viracept saga continues

25-Jun-2007 - In the latest episode of the Viracept contamination case, the drug is now at risk of losing its marketing authorisation across Europe while the dangers posed by the chemical contaminant are established and manufacturer Roche rectifies its manufacturing mistakes.

To test or not to test? The glycerin debate

14-Jun-2007 - Following last year's contaminated glycerin poisonings in Panama and last month's FDA guidance, US-PharmaTechnologist.com takes a look at the implications of testing for the excipient glycerin in the pharmaceutical supply chain.

Sign up for your free newsletter