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News in brief

Finesse upgrades bioprocess software

23-Mar-2011 - Finesse Solutions has added off-line data processing modules to its bioprocess parameter control software, TruBio DV.

Melbourn Scientific extends testing capabilities; buys eight Copley Scientific dissolution testers

22-Mar-2011 - Copley Scientific, the Nottingham, UK-based lab equipment manufacturer, has confirmed delivery of eight tablet dissolution testers to contract research organisation (CRO), Melbourn Scientific.

News in brief

Genzyme manufacturing issue causes Thyrogen shortage

21-Mar-2011 - Genzyme will be unable to meet demand for Thyrogen until July 2011 because of a manufacturing issue.

Johnson & Johnson finalises terms of FDA consent decree

16-Mar-2011 - Johnson & Johnson, the multinational healthcare giant, has announced it has finalised the terms of a consent decree with the FDA over its stricken McNeil PPC manufacturing plants.

Biopharma key to Pall’s Q2 gains

16-Mar-2011 - Life sciences drove Pall’s growth in the second quarter of fiscal 2011, with sales to the biopharmaceuticals sector making the biggest gains.

News in brief

GEA gets FDA OK for H202 steralisation tech for freeze dryers

15-Mar-2011 - GEA Lyophil has won US FDA approval for a new gas-based steralistion technology for pharmaceutical freeze drying.

Fette sets up Goa tablet testing unit

15-Mar-2011 - German machine tool maker Fette Compacting has set up a tablet compression and flowability testing centre in Goa, India.

Carbon dioxide may be drug processing 'shortcut,' study

10-Mar-2011 - A new study suggests pressurised carbon dioxide can accelerate crystalisation during drug production, and potentially save manufacturers time and money.

New J&J recall insulin pump cartridges

09-Mar-2011 - US healthcare giant Johnson & Johnson (J&J) has recalled 384,000 of its insulin cartridges on concerns the products could cause serious health problems for diabetics.

GEA strikes Scandinavian representation deal with Christian Berner

08-Mar-2011 - GEA Pharma Systems, the German drug processing equipment manufacturer, has signed a representation agreement with Swedish hi-tech firm Christian Berner Tech Trade.

WHO approval of SFDA to boost global vaccine supplies

03-Mar-2011 - The WHO expects global vaccine supplies will benefit significantly after it approved the Chinese SFDA regulatory system.

News in brief

Foreign inspection worries keep FDA on GAO risk list

03-Mar-2011 - The GAO has again included the FDA in its high-risk series because of shortcomings in the oversight of overseas manufacturing facilities.

Agilent buys Biocius Life Sciences for undisclosed amount

03-Mar-2011 - Agilent Technolgies, the Santa Clara, US-based scientific instrument manufacturer, has acquired instrument manufacturer and contract research organisation (CRO), Biocius Life Sciences, for an undisclosed amount.

News in brief

FDA visiting Perrigo for post-warning letter reinspection

02-Mar-2011 - US FDA inspectors have arrived at Perrigo’s Allegan, Michigan, US facility to re-inspect it as part of its follow-up to a warning letter last year.

EU revises law on computerised systems in manufacturing

28-Feb-2011 - The EU has revised legislation on use of computerised systems in pharma manufacturing to bring it up-to-date.

German Sanofi plant receives FDA cGMP warning letter

24-Feb-2011 - Sanofi-aventis has received an FDA warning letter after the agency identified violations of cGMP at its Frankfurt am Main, Germany plant.

News in brief

US House aims to ID individuals behind heparin contamination

24-Feb-2011 - A formal investigation to identify individuals responsible for the 2008 heparin-contamination has been launched by a US House panel.

updated

CEO: Sanofi may provide Genzyme with fill/finish long term

17-Feb-2011 - Sanofi Aventis’ CEO, Chris Veibacher, said the French drugmaker may look at providing some fill/finish capacity for Genzyme in the long term.

Capsugel buys FlexTab to expand into high value markets

17-Feb-2011 - Pfizer’s Capsugel unit has bought an injection molding technology that, it believes, will expand its capsule filling business into new “high value segments.”

European Parliament votes yes on falsified medicines directive

17-Feb-2011 - The European Parliament has approved the falsified medicines directive and described it as a “huge step” in efforts to protect patients.

News in brief

Valutek launches “breathable” cleanroom glove

15-Feb-2011 - Valutek hopes new reusable cleanroom glove will help pharma researchers wave goodbye to laboratory discomfort.

Batch variation has implications for developing world

14-Feb-2011 - Variation between drug batches in developing countries poses “serious clinical implications” and should be tackled by regulators.

Novasep and instrAction team on taxane process development

09-Feb-2011 - Novasep and instrAction have partnered to develop improved methods for the production of taxane-based active pharmaceutical ingredients (API) citing growing demand for cancer treatments as key driver.

USP launches drug quality programme in sub-Saharan Africa

09-Feb-2011 - The United States Pharmacopeoia (USP) will help regulators in sub-Saharan Africa ensure drug quality in a new scheme designed to boost testing and analysis capacity.

News in brief

EMA opens EudraGMP inspection database to public

08-Feb-2011 - The EMA has revised its EudraGMP database to give the public more information on GMP inspections.

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