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Flutiform safety results a 'significant milestone'

05-Nov-2007 - UK-based SkyePharma has been given a boost in regards to its asthma treatment following the release of positive Phase III results.

Pharmaceutical manufacturing: news in brief

02-Nov-2007 - In-PharmaTechnologist.com brings you a selection of other headlines from the pharmaceutical manufacturing industry.

Another safety scare for Roche

30-Oct-2007 - In another safety concern over a long-approved drug, Roche has been forced to add new warnings to its anti-transplant rejection drug CellCept (mycophenolate mofetil (MMF)) amid the news that it is associated with increased risk of miscarriage and congenital birth defects.

Explosions at two pharma plants

30-Oct-2007 - Two pharmaceutical companies have faced explosions at their plants in the last week, local media reported.

Survey asks: what to do about counterfeit drugs?

30-Oct-2007 - Action should be taken to curb the counterfeit drug trade, but not via legal intervention, the results of a European survey say.

Global pact to fight fakes

24-Oct-2007 - A major new trade agreement aiming to combat counterfeiting has been proposed by representatives of a number of key markets, including the US, EU and several other countries worldwide.

EU drug regulations not good enough, says report

22-Oct-2007 - The European Medicines Agency is prejudiced in favour of big pharma and EU drug regulations need an overhaul, a new report says.

Pharmaceutical manufacturing: news in brief

19-Oct-2007 - In-PharmaTechnologist.com brings you a selection of other headlines from the pharmaceutical manufacturing industry.

Viracept back on the market in selected countries

19-Oct-2007 - Roche heard early this morning that the European Commission (EC) has decided to reinstate the marketing authorisation for the company's HIV drug, Viracept (nelfinavir), but countries outside the EU have yet to make a final decision.

US dragging its heels on biosimilars, says report

16-Oct-2007 - The US is woefully lagging behind the EU when it comes to approving biosimilars, a new report says.

Pharmaceutical manufacturing: news in brief

12-Oct-2007 - In-PharmaTechnologist.com brings you a selection of other headlines from the pharmaceutical manufacturing industry.

Weekly Comment

'We are not anti-Asia' says EU chemicals body

09-Oct-2007 - There have been more calls this month to tighten regulations on pharmaceutical ingredient suppliers in the wake of the recent safety concerns emanating from low-cost regions such as China and India. However, despite having recently established a dedicated 'China Taskforce', a major EU chemicals consortium insists that it has nothing against the region or its manufacturers.

FDA generics initiative waste of money?

08-Oct-2007 - The Generic Pharmaceutical Association has questioned a new US Food and Drug Administration (FDA) initiative as possibly "throwing money down the drain".

Three more nailed in fake drugs scandal

08-Oct-2007 - Three more individuals have been sentenced following last month's exposure of the largest counterfeit drugs conspiracy ever to be encountered in the UK.

Genzyme gets slapped on the wrist by FDA

04-Oct-2007 - The US Food and Drug Administration (FDA) has sent a letter to Genzyme to warn it about manufacturing issues at its biomanufacturing facility in Lyon, France.

Weekly Comment

FDA told its safety monitoring of clinical trials not good enough

02-Oct-2007 - The US Food and Drug Administration (FDA) has been called into question again after the release of a damning report, this time suggesting the agency is inadequate in its safety monitoring of clinical trials.

Drug theft costs industry up to $1bn a year

02-Oct-2007 - Pharmaceutical companies not only have to face the consequences of a burgeoning counterfeit drug black market but have to contend with the theft of their own manufactured drugs for illicit uses, according to a US consumer advocacy group.

Discovery Labs finally sorts out manufacturing issues

02-Oct-2007 - Discovery Laboratories could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market as it has finally resolved the manufacturing issues that have plagued the product for months.

Inside India: special series

India should focus on quality not quantity

26-Sep-2007 - India's contract manufacturing industry is facing a situation of overcapacity, presenting a help but also a hindrance that needs to be addressed.

Weekly Comment

Viracept contaminant could be widespread, FDA says

25-Sep-2007 - Following the recent news that pharma heavyweight Pfizer has also been struck by contamination of its HIV drug Viracept (nelfinavir), in-PharmaTechnologist.com spoke to the US Food and Drug Administration (FDA) to find out how far reaching the consequences of this latest contamination case could be.

Tougher food import laws proposed

25-Sep-2007 - A bill proposing stricter import regulations has been presented to Congress, as fears over imported food products show no sign of diminishing.

Epinephrine CFC inhalers on the way out

25-Sep-2007 - The US Food and Drug Administration (FDA) has proposed plans to phase out chlorofluorocarbons (CFCs) in metered dose inhalers that contain epinephrine, but the decision could spell the end for some asthma treatments.

Wyatt lights up protein aggregation

25-Sep-2007 - Wyatt Technologies has launched a new instrument that automates protein aggregation measurement for use in all areas of the pharmaceutical industry from drug development to quality control (QC).

Up to 25,000 patients affected by Viracept contaminant, reapproval on the cards

25-Sep-2007 - European regulators have recommended that Roche's marketing authorisation for HIV drug Viracept (nelfinavir) be reinstated, following serious good manufacturing practice (GMP) deviations that caused toxic contamination of drug batches distributed to up to 25,000 patients.

FDA gives guidance on biologics-producing spore-forming microbes

18-Sep-2007 - The US Food and Drug Administration (FDA) has released new recommendations for manufacturers of biologics using spore-forming microorganisms.

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