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Breaking News on Global Pharmaceutical Technology & Manufacturing

Drugs stolen while trucker changed his clothes recovered thanks to hidden GPS

30-Jul-2015 - A shipment of drugs stolen while a truck driver went home to change his clothes were recovered in half an hour thanks to a GPS tracking device embedded in the cargo.

European pharma: CEO talent is the new measure of company calibre

30-Jul-2015 - Industry headhunters have picked their top CEOs in European pharma, saying the most successful investors keep chief execs in place even through hard times.  

TRIAL TRANSPARENCY

CRO vs HRA trial transparency case ends in a win for industry

29-Jul-2015 - A five-month legal battle over the duties of trial sponsors to publish results has ended with a judge ruling the UK regulator acted unlawfully and sponsors will not be required to publicly register UK Phase I adult trials which began before September 2013.

FDA offers draft guidance on quality metrics used to assess drug manufacturing

29-Jul-2015 - New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.

Senate Committee OK’s extra $40m to FDA but refuses Obama’s $146m plan

28-Jul-2015 - The Senate Committee on Appropriations has approved $2.6bn in funding to the US FDA for FY2016.

EU and Swiss regulators strengthen ties with confidentiality agreement

27-Jul-2015 - A confidential information exchange agreement will strengthen the relationship between the EMA and Swiss regulators and could save on resources, the agencies say.

First part of European fake fighting database linked to securPharm

23-Jul-2015 - The first part of a Europe-wide database intended to help identify fake drugs is operational after being linked to Germany’s securPharm system.

Funds worth €3.5tr back Alltrials, but none promise to pull cash from drug firms that don't

23-Jul-2015 - Investor backing puts transparency on the pharma agenda says SenseAboutScience, even though none of the funds pledging support for Alltrials have committed to pull investment from drug firms that disagree.

Compound sentence? Two 'outsourcing facilities' hit with US FDA warning letters

22-Jul-2015 - Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.

Novartis defends Afinitor after thrashing from BMS and Exelixis trials

22-Jul-2015 - Novartis expects sales of Afinitor to slow after BMS and Exelixis announced this week their pipeline drugs beat it on renal cell carcinoma.

IPEC calls on FDA to establish new review process for novel excipients

22-Jul-2015 - As part of a push to bring more novel excipients to market, IPEC-Americas is calling on the FDA to create a new regulatory review process that could relieve some of the uncertainty around the use of new excipients.

Thermo Fisher partners with CDC to aid public health labs

21-Jul-2015 - Thermo Fisher Scientific has developed new software via a partnership with the Special Bacteriology Reference Laboratory at the CDC (Centers for Disease Control and Prevention) that helps public health labs to more quickly identify microbial pathogens potentially at the root of global outbreaks. 

Another injectables recall for Mylan

21-Jul-2015 - Mylan has recalled 14 lots of calcium chloride intravenous infusion after customers found the prefilled syringes were not compatible with needless adaptors.

PEOPLE ON THE MOVE

Sanofi announces global restructuring plan

20-Jul-2015 - And more people on the move this week in pharma.

Life ban for founder of fake US drug company with $12m in sales

15-Jul-2015 - The founder of a phony pharma company which made $12m importing fake chemo drugs to the US has been banned for life by the US FDA from working with any pharma businesses.

US FDA bans imports manufactured at Emcure’s Indian plant

14-Jul-2015 - India’s Emcure Pharmaceuticals has been banned from shipping any of the drugs manufactured at its Maharashtra-based facility to the US, according to an import alert from the US FDA.

PEOPLE ON THE MOVE

Pharma who's who

13-Jul-2015 -

Did you pay your GDUFA fees? 29 drugmakers didn't, says US FDA

13-Jul-2015 - Almost 20 API makers – mostly from India and China – have been cited by the US FDA for failing to pay their annual facility fees.

US House passes 21st Century Cures Act

10-Jul-2015 - With an overwhelming majority, the House on Friday morning passed a new bipartisan bill that would increase NIH funding by about $8.75bn and the FDA by $550m over the next five years.

White House questions key aspects of 21st Century Cures Act prior to House vote

10-Jul-2015 - With the bipartisan 21st Century Cures Act coming up for a vote Friday in the US House, the White House and others are raising a number of concerns over how the bill would be paid for and what it will actually do to speed new cures to market.

TTIP: MEPs back investor-friendly legal system proposal despite opposition

09-Jul-2015 - Proposed amendments to TTIP backed by MEPs will either encourage foreign investment or allow US drug firms to sue EU states whose laws restrict profits, depending who you ask.

Mylan recalls cancer and arthritis injectables

09-Jul-2015 - Mylan is expanding its recall of injectable Gemcitabine and Methotrexate batches after finding visible particulates.

FDA rule requires drugmakers to report manufacturing disruptions six months in advance

09-Jul-2015 - A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption causes a shortage.

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.

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