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EU Risks Drug Shortages If API Import Regs Not Waived for US Says SOCMA

Gareth.MACDONALD@wrbm.com (Gareth MACDONALD) — Wed, 19 Jun 2013 12:27:45 +0200

Europe could face drug shortages if the US is not granted exemption from new API import requirements, according to a US chemical industry trade association.

It Had To Be Yew? Not So Says Phyton With New Docetaxel CEP

Gareth.MACDONALD@wrbm.com (Gareth MACDONALD) — Wed, 19 Jun 2013 13:40:22 +0200

Phyton Biotech has received European approval for a version the cancer drug API docetaxel whose production does not rely on the scarce yew tree extract used in traditional manufacturing methods.

Sanofi Proposes London Site as Science-Park as Manufacturing Ends

Dan.Stanton@wrbm.com (Dan Stanton) — Wed, 19 Jun 2013 13:10:15 +0200

Sanofi has ended production at a historic London facility and says it plans to turn the site into a dedicated science park.

Eisai to Expand it's EMEA Packaging Capacity with New UK Plant

Dan.Stanton@wrbm.com (Dan Stanton) — Wed, 19 Jun 2013 13:21:20 +0200

Eisai has announced plans to expand its global packaging capabilities with a £8m ($12.5m) facility in the UK.

Industrial Action Halts Operations at Indian CMO Shasun Facility

Dan.Stanton@wrbm.com (Dan Stanton) — Tue, 18 Jun 2013 12:27:27 +0200

Shasun Pharmaceuticals’ says it is trying to restart operations at the earliest opportunity after workers went on strike at its API and formulation facility in India last Sunday.

Issues with GSK's Bottle Manufacturer Leads to MHRA Ventolin Alert

Dan.Stanton@wrbm.com (Dan Stanton) — Tue, 18 Jun 2013 13:21:44 +0200

A GlaxoSmithKline subsidiary has issued a recall of two batches of Ventolin syrup in the UK after glass fragments were found in some bottles.

UK Moves to Prevent API Shortages Ahead of New EU Import Laws

Gareth.MACDONALD@wrbm.com (Gareth MACDONALD) — Tue, 18 Jun 2013 12:04:47 +0200

The UK MHRA plans to let drugmakers import APIs that lack ‘written confirmation’ of quality if there is an overriding need to ensure continued supply.

MicroDose of Fresh Air for Teva with Respiratory Acquisition

Dan.Stanton@wrbm.com (Dan Stanton) — Tue, 18 Jun 2013 10:56:24 +0200

Teva has affirmed its respiratory drug delivery strategy with the purchase of MicroDose Therapeutx for a potential $165m (€123m).

ATMI Opens US Bio Development and Testing Lab

Gareth.MACDONALD@wrbm.com (Gareth MACDONALD) — Mon, 17 Jun 2013 13:52:20 +0200

ATMI has opened a development and testing lab in the US to let customers test its single-use production and technologies.

Capsugel Launches Lipidex Encapsulating Platform from New Dosage Form Unit

Dan.Stanton@wrbm.com (Dan Stanton) — Mon, 17 Jun 2013 11:42:06 +0200

The latest technology platform from Capsugel's four-month old DFS Unit offers greater bioavailabilty and stability in oral dose formulation, says the company.

Pharma Jobs: Sales Shake Up at IHolland & New CFO at Sinovac

Dan.Stanton@wrbm.com (Dan Stanton) — Mon, 17 Jun 2013 10:22:54 +0200

A new sales and marketing manager at tableting tech firm IHolland, and new CFO at Sinovac - that's right, it's In-Pharmatechnologist.com round-up of ladder-climbers in the world of pharmaceuticals.

Quality System Issues Most Frequent Cause of Drug Shortages, Survey Finds

Zachary.Brennan@wrbm.com (Zachary Brennan) — Mon, 17 Jun 2013 23:45:52 +0200

Manufacturers’ quality issues were among the most prevalent reasons for drug shortages, according to a survey conducted by the ISPE (International Society for Pharmaceutical Engineering).

US Supreme Court Rules Against Patentability of Naturally Occurring Genes

Zachary.Brennan@wrbm.com (Zachary Brennan) — Thu, 13 Jun 2013 17:27:48 +0200

The US Supreme Court has ruled unanimously that naturally occurring DNA is not patentable “merely because it has been isolated,” but synthetic DNA can be patented.

EC welcomes list of Indian API suppliers with ‘written confirmation’

Gareth.MACDONALD@wrbm.com (Gareth MACDONALD) — Thu, 13 Jun 2013 13:14:12 +0200

The European Commission has welcomed the publication of the list of Indian API makers issued with “written confirmations” of quality by the CDSCO.

Lonza Launches Combined Safety and Manufacturability Service for Biologics

Gareth.MACDONALD@wrbm.com (Gareth MACDONALD) — Thu, 13 Jun 2013 14:08:19 +0200

Lonza has launched a service to help biopharmas decide if promising protein drug candidates are worth developing, from an immunogenicity and manufacturing standpoint.

Biosimilar Developers Seek Clarity on US FDA Draft Guidance

Zachary.Brennan@wrbm.com (Zachary Brennan) — Thu, 13 Jun 2013 00:58:25 +0200

Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.

Is Pharma Excommunication Discouraging Potential Whistleblowers?

Dan.Stanton@wrbm.com (Dan Stanton) — Thu, 13 Jun 2013 11:29:18 +0200

Pharma employees who report manufacturing misconduct to stop adulterated drugs getting to market put their careers at risk and face being blackballed by industry says an American advocacy group.

GSK Pauses Ph I MS Trial and Sacks China R&D Chief

Gareth.MACDONALD@wrbm.com (Gareth MACDONALD) — Wed, 12 Jun 2013 11:37:22 +0200

GSK has ‘paused’ a Phase I trial of an MS drug and fired its China R&D chief, Jingwu Zhang, after finding 'manipulated' data in a paper published in Nature Medicine in 2010 .

Some China API Firms Wont Have 'Written Confirmations' by July says blue inspection body

Gareth.MACDONALD@wrbm.com (Gareth MACDONALD) — Wed, 12 Jun 2013 13:30:45 +0200

Some Chinese firms wont have the 'written confirmations' required to ship APIs to the EU from July according to the German audit firm tasked with helping manufacturers prepare by Beijing industry group, CCCMHPIE.

Teva's Packaging Switch Maybe Caused By Human Interference

Dan.Stanton@wrbm.com (Dan Stanton) — Wed, 12 Jun 2013 13:29:05 +0200

Malicious tampering could be behind the Furosemide packaging mix-up that may have led to several deaths in France, according to Teva.