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Breaking News on Global Pharmaceutical Technology & Manufacturing

Miracle cures and ‘hot motorbikes’ or black market meds and empty shelves: Pharma in North Korea

07-Jul-2015 - Even if claims about Kumdang-2 are real, access to the drug and other pharmaceuticals in North Korea is limited to those who can pay black market prices according to a UK-based defector.

Israel, Brazil added to list of countries with API GMP standards equivalent to EU

07-Jul-2015 - The European Commission last week officially added Israel and Brazil to a list of countries outside the EU that have standards of manufacture and supervision of APIs equivalent to those of the EU. 

European analytical lab network to speed nanomedicines to market

07-Jul-2015 - The EU has launched a €5m ($5.5m) programme across six facilities for characterising European nanomedicines.

UPDATE

Duplicated ECGs and data issues land Indian CRO Quest with WHO warning

06-Jul-2015 - Indian CRO Quest Life Sciences has been hit with a Notice of Concern (NOC) after the WHO questioned the data integrity of its clinical records.

PEOPLE ON THE MOVE

Pharma appointments: who's going places in July

06-Jul-2015 -

Canadian manufacturer hit with warning letter over cross-contamination issues

06-Jul-2015 - Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.

News in brief

Suspect Viagra pills seized in EU-wide swoop on organised crime gang

02-Jul-2015 - More evidence linking fake pharmaceuticals and organised crime emerged today with Dutch police seizing suspicious Viagra pills along with cocaine, MDMA and burglary tools.

UK will label drugs with their cost to the state

02-Jul-2015 - The UK health minister has announced plans to label all British prescription medicines with their cost to the taxpayer.

Staff cuts and accelerated access: MHRA’s plan for 2016

02-Jul-2015 - MHRA, the UK pharma regulator, says its staff cuts over the next three years will not impact its work with pharma.

New logo will help patients tell legit EU web pharmacies from illegal sites says EC

01-Jul-2015 - Europeans who want to fund organised crime can now do so more easily by buying medicines from web pharmacies that lack a new logo launched by the EC to stop the sale of fakes online.

US FDA extends track-and-trace deadline for pharmacies

01-Jul-2015 - The US FDA says has granted a four month amnesty to pharmacies which do not comply with new track-and-trace regulations that come into force today.

Sequenom case leaves pharma confused over patent law

30-Jun-2015 - US intellectual property (IP) rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer. 

ICH clarifies Q7 guidance on API GMP manufacturing

30-Jun-2015 - In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer  (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices) at all stages of the API supply chain.

Trial data: charity hits back at CRO’s anti-transparency bid

25-Jun-2015 - Charity Sense About Science is attempting to intervene in a UK CRO’s legal action against trial transparency.

‘Record-breaking’ 2015 will see surge in pharma acquisitions

25-Jun-2015 - Demand for CNS assets will help break records for pharma M&As in 2015, Neel Patel, VP of inVentiv Health consultancy Campbell Alliance, tells in-Pharmatechnologist.com. 

US FDA publishes API-salt naming policy

24-Jun-2015 - Naming drugs using active pharmaceutical ingredients (API) rather than their salts will cut down on medication and dosing errors according to the US Food and Drug Administration (FDA).

US FDA & INTERPOL seize fake meds from 1,000 websites

24-Jun-2015 - The US FDA has seized illegal medicines and medical devices sold by more than 1,050 websites.

BIO 2015

TTIP trade talks will 'force' FDA-EMA to sync regs, says biopharma

23-Jun-2015 - Eli Lilly’s President of Biomedicines says the transatlantic trade agreement TTIP will “force” the FDA and EMA to standardise regulations on manufacturing and trials.

US FDA: Generic pills must look similar to reference drugs to minimize patient safety risk

23-Jun-2015 - Generic pills are a safety risk if they are too different from their reference drug according to the US FDA, which wants developers to consider physical characteristics when making copycat meds.

BIO 2015

Does second prequalified vaccine mark China as ‘true global player’?

23-Jun-2015 - China is set to become a major vaccines manufacturer for emerging markets once it untangles some regulatory quirks, says a panel at BIO 2015. 

EU pharma industry a step closer to fake fighting drug repository

23-Jun-2015 - Industry efforts set up a drug database to help Europeans identify fake pharmaceuticals progressed this week after thee software firms signed development deals with project leader, EMVO.

News in brief

Dutch pharma policy NGO Health Action International opens Brussels office

23-Jun-2015 - Health Action International (HAI) has set up an office in Brussels, Belgium in a bid to further influence European pharmaceutical policy and improve access to medicines and public health.

South Korea mulls combining HIV drugs with antivirals to combat MERS

22-Jun-2015 - As the death toll from MERS in South Korea edged to two dozen scientists there say the outbreak is different from in Saudi Arabia and also from its the related virus SARS. 

|Dispatches from ACHEMA

Regulators play catch up with ever more complex manufacturing processes

18-Jun-2015 - EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.

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