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Is your drug name ok? Run a role-play, says FDA

Acting up: the FDA recommends doctors role-play to see if drug names are confusing. (Picture credit: ABC Media)

Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug names, saying simulation studies involving doctors, nurses and pharmacists are time-consuming and unhelpful.

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News in brief

The UK Government should seek licenses to use off-patent drugs in new indications according to MPs who say there is no incentive for pharma firms to apply for such approvals after a product goes generic.

Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.

GlaxoSmithKline has issued upbeat guidance despite a 12% fall in sales of its blockbuster asthma and COPD drug Advair, as new products enter the respiratory drug market.

Italian health Minister Beatrice Lorenzin will focus on making drug National price regulations and decisions more trasnparent during the country's presidency of the EU.

Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.

Global Industry News

Strategic partnerships driving consolidation of CDMO industry, says report from Outsourcing-Pharma.com

Growth of Pharma strategic partnerships with contract development and manufacturing organisations (CDMOs) is driving consolidation, according to an industry report.

Profits and capacity utilisation up at Lonza in H1 thanks to pharma from Outsourcing-Pharma.com

Lonza saw profits and capacity utilisation improve in the first half of 2014 with new pharma and biopharma supply contracts and ongoing restructuring being the key drivers.

WIRB-Copernicus Group acquires biosafety consulting firm Alliance Biosciences from Outsourcing-Pharma.com

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, has acquired biosafety consultancy Alliance Biosciences. Financial terms of the deal were not disclosed.

Philanthropist gives $650m to Broad Institute for psychiatric research from Outsourcing-Pharma.com

Philanthropist Ted Stanley has gifted $650m to the Broad Institute as part of a wider attempt to galvanize research on psychiatric disorders and bring new treatments to market. 

Single-use and M&As drive double-digit growth for Sartorius from BioPharma-Reporter.com

Sartorius Stedim Biotech has attributed strong sales and order growth in the second quarter 2014 to recent acquisitions and demand for single-use products.

Spotlight

G-CON: Pfizer investment an endorsement of 'podular' manufacturing

Pfizer investment an endorsement of 'podular' manufacturing, says G-CON

G-CON says a multi-million dollar investment by Pfizer could hasten the “paradigm shift” in pharma manufacturing towards...

US FDA enforcement evolving in India will drive compliance costs

Indian firms must invest in compliance as USFDA ups enforcement, says S&P

Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and...

Ease regulations to cure drug industry antibiotic resistance, says RPS

Ease regulations to cure drug industry antibiotic resistance, says RPS

The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College,...

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix has modified its much-debated painkiller Zohydro with abuse-deterrent formulations.

Afrezza approval: Validation for Mannkind's drug and delivery tech

Afrezza approval: US FDA validation for Mannkind's drug and delivery tech

The US FDA approved Afrezza last weekend after deeming that the inhaled insulin drug and the dry...

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