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Breaking News on Global Pharmaceutical Technology & Manufacturing

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.

Dealing with activist shareholders: Allergan CEO shares advice at BIO

18-Jun-2015 - Ex-Allergan CEO David Pyott has spoken of his “total war” battling Valeant’s failed hostile takeover, and given advice to other pharmaceutical companies on how to deal with activist shareholders.

GSK backs US cell genetics institute; more takeover rumours

17-Jun-2015 - Rumoured Big Pharma takeover target GSK has invested $95m to set up an cell genetics research institute to help developers better identify drug candidates.

BIO 2015

Ex-Homeland Security cyber chief warns of threats to pharma

17-Jun-2015 - The pharma industry must fight “vendor indifference” so suppliers and services companies are not prey to cyber attacks that can lose drug companies hundreds of thousands of dollars in minutes, according to US Homeland Security’s former head of cybercrimes Mark Weatherford.

update

EU trade secret proposals could help pharma avoid publishing trial results says NGO

16-Jun-2015 - Trade secrets proposals supported by the European Parliament’s legal affairs committee could allow drugmakers to withhold trial results and drug safety data says Health Action International.

ESC: Simpler trials would encourage cardiovascular disease drug developers

16-Jun-2015 - A new trial model is needed to encourage cardiovascular disease drug development say researchers who claim the large, lengthly studies used to prove safety and efficacy of such drugs are a disincentive.

Hospira hit with Canada import ban over data integrity concerns

16-Jun-2015 - Health Canada has issued Hospira with an import ban over concerns about a testing lab at its manufacturing facility in Liscate, Italy.

News in brief

EMA PSUR database fit for purpose

15-Jun-2015 - Drugmakers will be able to upload drug safety data to a single website from next year after a database developed by the EMA has been deemed fit for purpose by independent auditors.

US FDA teams with PatientsLikeMe to access post-market patient data

15-Jun-2015 - PatientsLikeMe says a deal allowing the US FDA to use its patient-generated data is an “unprecedented step toward enhancing post-market surveillance.”

US FDA upgrades Jubilant's troubled Washington plant to VAI

12-Jun-2015 - A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.

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