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Plant-produced monoclonal antibody enters Phase I

20-Jul-2011 - Clinical trials of a monoclonal antibody produced in transgenic tobacco plants, a potentially low-cost, scalable system, have begun in Europe.

Granules and Ajinomoto OmniChem to open Indian API facility

19-Jul-2011 - Granules and Ajinomoto OmniChem have teamed up to produce high value APIs and intermediates at a new Indian plant.

EC drafts GDP guidance to tackle supply chain threats

18-Jul-2011 - Europe has proposed draft distribution guidance in response to globalisation and threats to the pharmaceutical supply chain.

Tamper evident devices must be traceable & unique; Rx-360

18-Jul-2011 - Physical endurance, traceability and uniqueness are key characteristics for tamper evident devices used in raw material supply, according to Rx-360.

FDA offers grant to improve biopharm production steps

13-Jul-2011 - The FDA is offering a grant to research projects that improve the reliability, speed and quality of biopharm production processes.

FDA must be empowered to oversee supply chain; report

13-Jul-2011 - Congress must grant the FDA additional powers to bring oversight of manufacturing inline with shifts in production practices, according to a report.

EU should revoke licenses if emission caps exceeded; report

11-Jul-2011 - Production plants exceeding emission levels could have manufacturing authorisations revoked under EU GMP proposals made by Sweden.

Law enforcement must take apart fake drug networks; Lilly

11-Jul-2011 - Eli Lilly has called for law enforcement to find and dismantle the supply sources and distribution networks underpinning fake online pharmacies.

WTO rules against China in raw material export quota case

06-Jul-2011 - A WTO panel has ruled China’s export limits on raw materials, including some with pharma uses, are unfair after claims they drive up prices.

News in brief

Strides receives OK from EMA

05-Jul-2011 - Onco Therapies Limited (OTL), a division of Aglia, a wholly owned subsidiary of Strides Arcolab Limited, has been given the go ahead from Europe for its Oral Dosage Oncology facility.

USP publishes free drug quality standards collection online

04-Jul-2011 - The USP has published a free, online collection of standards to support drug quality, particularly where regulatory resources are limited.

Developments in the pharma manufacturing space

30-Jun-2011 - in-Pharmatechnologist.com presents a round up of developments in the pharmaceutical manufacturing space with news from Dendreon, Amcor and Cody Labs.

News in brief

New CEPs for DSM and Aanjaneya Lifecare

28-Jun-2011 - The European Directorate for the Quality of Medicines and Healthcare (EDQM) issued a new batch of CEP for drug products.

NeoStem’s China antibiotics unit gets expanded SFDA approval

14-Jun-2011 - US stem-cell therapy firm NeoStem predicts that output of its China-based generic antibiotics subsidiary Suzhou Erye Pharmaceutical will increase after further manufacturing approval from the SFDA.

Baxter ordered to pay compensation in heparin case

13-Jun-2011 - US drugmaker Baxter International has been ordered to pay compensation of $625,000 to the estate of man who received a dose of heparin that was contaminated with over-sulfated chondroitin sulphate (OSCS).

Hovione and PSI team on poorly soluble APIs

09-Jun-2011 - Portugal-headquartered API manufacturer Hovione has teamed up with Particle Sciences (PSI) to tackle the issue of poor drug solubility.

News in brief

Aurobindo Pharma gets US FDA OK for alprazolam extended-release

09-Jun-2011 - Drug maker Aurobindo Pharma has been cleared to make a generic equivalent of Pfizer’s CNS drug Xanax XR by the US FDA.

update

Lonza announces CHF10m Singapore biomanufacturing expansion

08-Jun-2011 - Switzerland-based life sciences supplier Lonza says it will invest CHF10m (€8m) to expand a Singapore plant that is part of its custom biomanufacturing business.

SAFC and Pfenex partner on protein production

08-Jun-2011 - US supplier SAFC has teamed up with Pfenex in a partnership focused on the production of therapeutic proteins and vaccine components.

Excipact auditing certification scheme explained

08-Jun-2011 - April saw the publication of the second draft of Excipact, a set of certification standards for third-party auditors of excipient manufacturers.

Functional excipients to drive US market to $2bn by 2015, study

08-Jun-2011 - Demand for functional excipients will drive growth of the US market over the next few years according to new analysis.

Cangene wins $61m extension to BARDA supply deal

08-Jun-2011 - BARDA is extending its botulism antitoxin supply contract with Cangene, adding $61m (€42m) to the value of the deal over the next three to four years.

Bilfinger Berger wins €30m deal for work on Genzyme plant

01-Jun-2011 - Bilfinger Berger has won a €30m ($43m) contract to help Genzyme add 8,000L of production capacity at its site in Geel, Belgium.

Ashland to pay $3.2bn for ISP

01-Jun-2011 - Ashland will buy International Specialty Products (ISP) in a deal designed to expand it's business in less cyclical, high-growth markets such as pharmaceuticals and personal care.

EC adopts OIB categories for gelatin source BSE risk assessment

30-May-2011 - From July the EC will require that gelatin used in parenteral drugs is sourced from countries in World Organisation for Animal Health's (OIE) lowest risk categories for bovine spongiform encephalopathy (BSE).

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