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Headlines > July 2013

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Correction

EMD Millipore Passes Excipient Certification Scheme

31-Jul-2013 - EMD Millipore has become the first major drug excipient supplier to pass IPEC Federation’s Excipact certification scheme .

US FDA Amends Draft Guidance Documents List for 2013

31-Jul-2013 - The US FDA has amended the list of draft guidance documents it expects to release for the rest of the year with two new guidance topics, one deleted guidance and...

News in brief

Medicines and Vaccines Merge to Form Single NZ Body

31-Jul-2013 - Medicines New Zealand has merged with the Vaccines Industry Association of New Zealand (VIANZ) in order to share resources and provide a single point of contact for all stakeholders.

2,700 Jobs Could Go as Valeant Integrates B+L Acquisition

30-Jul-2013 - Valeant says it will slash its workforce by up to 15% and consolidate some of its non-US locations following the acquisition of Bausch & Lomb.

Codexis and Purolite Team on Immobilised Enzymes for Drugmakers

30-Jul-2013 - Codexis and Purolite have teamed up to create immobilized enzymes they say can speed up active pharmaceutical ingredient (API) development.

Fresenius Sacks Indian API Management Staff Over QC Data Cover-Up

30-Jul-2013 - Management and staff involved in manipulating quality data during an FDA inspection have been sacked by Fresenius Kabi as part of remediation actions at its Indian API facility.

News in brief

Catalent Completes Chinese Softgel Acquisition

30-Jul-2013 - Catalent has completed the purchase of a Chinese softgel firm following regulatory approval.

Pfizer Licenses Cell Line Tech from Lonza and BioWa

30-Jul-2013 - Newly rejigged Pfizer has licensed a cell line tech developed by Lonza and BioWa for use in its therapeutic antibody programme. 

PhRMA, GPhA Back Plan to Exempt Fees from Sequestration

29-Jul-2013 - Plans to make fees drugmakers pay the US FDA in future exempt from mandatory Government spending cuts have been welcomed by industry groups.

People: GSK's European Senior VP to Sort Out China Problems

29-Jul-2013 - Amidst accusations of widespread bribery and corruption in China, GlaxoSmithKline has appointed Herve Gisserot as its new head of business in the country.

$85m Plant Demonstrates Russia's Commitment to Pharma 2020, says NovaMedica

29-Jul-2013 - NovaMedica and the Russian Government are to build an $85m (€64m) facility as part of a joint venture encouraging local manufacturing, the company says.

Drug Pack Leak Test Firm Sepha Bought By Tasi

25-Jul-2013 - Tasi Group has acquired pharmaceutical leak testing firm Sepha and plans to seek more customers overseas.

News in brief

Mystery Pill Causes Prompt Paracetamol Recall in Australia

25-Jul-2013 - Australian firm Ascent Pharmaceuticals has issued a recall of one batch of paracetamol after concerns bottles may contain a foreign tablet.

Aesica Adds Stealthy Anti-Abuse Tech to Controlled Drug Offering

25-Jul-2013 - Aesica has licensed an anti-abuse technology from QRxPharma that it claims outperforms all other solutions currently on the market.

update

Lonza and Teva Abandon Biosimilars JV; Lonza Plans Site 'Consolidations'

25-Jul-2013 - Lonza says developing biosimilars with Teva would have been too costly and any biologics produced would have taken too long to bring to market.

To QbD or not to QbD? That is the Question...

24-Jul-2013 - Europe may soon approve the first biologic made according to quality by design (QbD) principles, but opinions are still split over whether the approach should even be applied to biopharmaceuticals.

Biopharma Companies Look to New Chromatography Columns

24-Jul-2013 - Biopharma firms, particularly those producing insulin and five of its analogues, have another option in the market of sub-2 micron solid-core chromatography columns with a recent offering from Waters.

Aussie Team Uses Hot Ethanol to Make Smaller API Particles

24-Jul-2013 - Appreciating warm alcohol, like being rubbish at cricket, is no longer a solely British preserve with researchers in Australia developing a hot ethanol-based manufacturing method that, they claim, produces smaller,...

EFPIA and PhRMA Endorse EU Regs on Clinical Trial Transparency

24-Jul-2013 - Industry bodies say they support the sharing of trial data following allegations yesterday they used patient groups to lobby new EU transparency regulations.

New Particle Tech May Let Formulators Cut Out Costly Lactose says Pulmatrix

24-Jul-2013 - Dry powder inhaler firms may soon be able to eliminate lactose from formulations if a new high dispersibility particle production platform is successful in trials.

EFPIA and PhRMA Accused of Mobilising Patients Against EU Trial Transparency Plans

23-Jul-2013 - The EFPIA and PhRMA are targeting an "army" of patient groups to lobby EU plans to publish clinical trial data, according to a leaked memo.

Tetracycline Shortage To Go On as US FDA Cannot Find New Source

23-Jul-2013 - The current US shortage of tetracycline is not likely to be resolved any time soon because of ongoing manufacturing and raw material supply issues according to the US FDA.

J&J's QA Initiative and Settlement Could See Troubled Plant Reopen

23-Jul-2013 - Johnson & Johnson’s troubled Fort Washington plant may reopen early next year, says the firm following a $23m lawsuit settlement.

Update

GSK Admits Some Senior Executives May Have Breached China Laws

23-Jul-2013 - GlaxoSmithKline (GSK) announced Monday a few of its senior executives may have breached China law as reports of a bribery scandal continue to surface. 

US Debates Dropping Duty for Drug Intermediates Imports

22-Jul-2013 - Import duties on some pharma intermediates could be suspended temporarily under legislation being debated in the US House of Representatives.

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