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Headlines > December 2015

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Rx, drugs and rock & roll: when pharma and music share the same stage

23-Dec-2015 - If ‘Love is the drug’ should Roxy Music be subject to regulatory scrutiny? Can The Verve say ‘The drugs don’t Work’ without conducting a clinical trial? We explore the harmonious...

GSK to supply US with Ventolin from French plant after production halt at Zebulon

22-Dec-2015 - GSK has temporarily halted production of Ventolin HFA inhalers at its plant in Zebulon, North Carolina while it investigates customer complaints.

US FDA carries on criticizing wayward Sun plant in Halol

22-Dec-2015 - The US FDA has warned Sun Pharmaceutical Industries about its facility in Halol, India just months after it withdrew approval for an epilepsy drug made at the site.

Labelling survey reveals deep inefficiencies

21-Dec-2015 - Almost half of all manufacturers have reported production downtime resulting from barcode labelling problems, according to a new survey.

Martin Shkreli charged with securities fraud

18-Dec-2015 - ‘Twas the week before Christmas, and what do you know?

Capsugel double acquisition bolsters dosage forms business

17-Dec-2015 - The addition of Xcelience and Powdersize will strengthen Capsugel's position in the dosage forms solutions market, according to the company.

New bill provides $2.7bn to FDA, $32bn to NIH

17-Dec-2015 - Under new legislation, the FDA and NIH will receive discretionary funding to combat antibiotic resistant bacteria and advance prevision medicine initiatives.

IPO ready BeiGene adopts GE tech for China cancer biologics plant

16-Dec-2015 - Nasdaq-bound Chinese biopharma BeiGene has chosen GE Healthcare’s Flexfactory platform for the monoclonal antibody (mAb) plant it is building in Suzhou.

More systems training needed to help inspectors spot data falsification say PIC/S experts

16-Dec-2015 - Data falsification at API facilities is getting harder to spot say regulators who have called for more systems training and international collaboration.

FDA updates definitions: what constitutes a manufacturing site change?

16-Dec-2015 - The FDA is seeking comment on a draft guidance which outlines the administration’s thoughts on what constitutes a manufacturing site change.

AstraZeneca commits £75m to replace warehouse and packaging unit at UK plant

15-Dec-2015 - AstraZeneca has invested £75m ($114m) to build packaging and warehouse facilities at its manufacturing site in Macclesfield, UK.

Sun selling Ohio plant in post-Ranbaxy network restructure

15-Dec-2015 - Sun Pharma has announced it will divest a plant in Ohio to further consolidate manufacturing operations following its $4bn acquisition of Ranbaxy.

Protea and Agilent collaboration looks to address drug discovery and QA/QC

15-Dec-2015 - Protea Biosciences has teamed up with Agilent Technologies to offer drugmakers mass spectrometry alternatives to UV detection in QA/QC of recombinant proteins.


Pot, Kettle: Industry criticism of parasite drug price hiker Shkreli doesn't ring true

14-Dec-2015 - If even the apparently non-joke, potential US presidential candidate Donald Trump criticizes your behaviour, you must know what you are doing is unpopular. 

Exec tasked with helping Lonza address "Visp challenge" to step down

14-Dec-2015 - Beat In-Albon, the man tasked with improving profitability at Lonza’s manufacturing site in Visp, Switzerland, will step down at the end of the year.

Legislation strengthens trade laws, IP enforcement

14-Dec-2015 - Trade agreement strengthens enforcement and is important to pharmaceutical industry, says expert.

US FDA warns compounders of contaminated baclofen API from China

14-Dec-2015 - The US FDA has alerted compounders of potential particulate matter in an API sourced from Chinese drugmaker Taizhou Xinyou Pharmaceutical & Chemical.

Dengvaxia approval vindicates €350m 'industrial risk' says Sanofi Pasteur

11-Dec-2015 - Sanofi Pasteur says Mexican approval for Dengvaxia vindicates the ‘industrial risk’ it took when it invested €350m in a dengue fever vaccine plant in 2009.

DuPont and Dow to merge

11-Dec-2015 - DuPont and The Dow Chemical Company have ended speculation by announcing they are to merge and the combined company will be called DowDuPont.

Making waves: scientists use seaweed to grow stem cells

11-Dec-2015 - Scientists have identified seaweed as a source of nutrients for the expansion of pluripotent stem cells needed for future drug testing.

Ingredient importers: Get ACE in place by February, says US FDA

10-Dec-2015 - A new system will simplify and speed-up US imports of pharma ingredients the FDA says, but industry needs to be on board by the end of February.

Pfizer wins US approval for first chewable, extended-release ADHD pill

10-Dec-2015 - The US FDA has approved a chewable, long-acting ADHD drug that was developed for Pfizer by formulation specialist Tris Pharma.

FDA ‘best practices’ guide seeks to speed drug development

09-Dec-2015 - Early and efficient communication is the key to cutting approval times says the US FDA, which published a draft best practices guide for drug firms this week.

Severe shortage? 1,500 inspectors too few for India's 10,000 plants says ASSOCHAM

09-Dec-2015 - New Delhi industry group ASSOCHAM says international criticism of Indian drug and API plants is due to a ‘severe shortage’ of regulatory inspectors.

Facing an anti-venom shortage, WHO tries to mobilise new suppliers

09-Dec-2015 - Sanofi's recent decision to stop making anti-venom could lead to shortages from next year and place the lives of thousands of people in jeopardy, says the World Health Organisation (WHO).

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