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Headlines > February 2014

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Europe slow to adopt anti-abuse formulations and tech, says expert

27-Feb-2014 - European regulators have been accused of making “no attempt” to counter misuse of prescription drugs in comparison with North American efforts to reformulate and restrict addictive drugs, according to a...

Novartis closing UK site, but will $1m per week R&D spend benefit CROs?

27-Feb-2014 - Novartis says it will continue to spend around $1m a week on clinical trials in the UK after its R&D site closes in June.

BASF hikes ethanolamine price due to continuous demand

27-Feb-2014 - BASF has hiked its prices for ethanolamines in Europe citing continuous demand increase.

Middle income countries face obstacles in access to drugs despite making them, study finds

27-Feb-2014 - National prioritization, investments in healthcare infrastructure and building better epidemiological and cost databases could bring more innovative medicines to middle-income countries, according to an independent study  conducted by Charles River Associates. ...

Capitol hearing puts pressure on India to ramp up quality controls

27-Feb-2014 - Doctors, lawyers, State Department and World Bank spokesmen met on Wednesday to discuss the state of the Indian pharmaceutical world.


Pharma head-hunter: critical we learn from finance, retail and Google

26-Feb-2014 - Fast-moving consumer goods industries and the financial world will be the next pools for sourcing pharmaceutical talent, says the CEO of pharmaceutical executive head-hunters RSA.

US FDA questions data integrity in warning for Indian drugmaker

26-Feb-2014 - Failing to ensure data integrity at a control laboratory in India has landed drugmaker USV with a US FDA warning letter.

Pfizer thyroid drug back in production after packaging prob caused a stink

26-Feb-2014 - Pfizer says its hypothyroid drug Levoxyl will be available within a week after a musty smell coming from the oxygen-absorbing canister stopped production last February.

New US House bill would require drug testing for pharma employees

26-Feb-2014 - Pharma industry employees and wholesalers with access to narcotic APIs would be subject to background checks and drug testing under new proposals being considered in the US.

FMC asks CBC to help it become bigger in Japan

25-Feb-2014 - FMC has hired Connell Brothers (CBC) to distribute its drug excipients in Japan, citing the move as a key step to building its business in the country.

US FDA’s Hamburg offers few details on trip to India

25-Feb-2014 - In a conference call Friday, FDA Commissioner Margaret Hamburg explained the importance of her recent trip to India, calling for more harmonization between the regulators.

FDA re-evaluates 5-year NCE exclusivity to incentivize development of fixed-combo products

25-Feb-2014 - The US FDA on Monday announced in a draft guidance that it’s revising its historical interpretation of the 5-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination...


Ranbaxy voluntarily halts production at its Indian API plants

25-Feb-2014 - Ranbaxy has temporarily halted all shipments from two API plants currently under a US FDA consent decree, although both the firm and an analyst say a shortage is unlikely.

Industry and politicians disagree on new drug safety fee plan

24-Feb-2014 - European politicians and industry have disagreed on new plans to ask pharmaceutical firms to pay fees for drug safety assessments.

US FDA's 'super-office' to focus on all things quality, home and away

24-Feb-2014 - Development of a new quality "super office" was motivated by a desire to simplify oversight and is not a response to the recent spate of problems at overseas suppliers, says...


Boehringer Ingelheim biopharma head joins Merck, plus EMA, Shire, EFPIA

24-Feb-2014 - Simon Sturge leaves Boehringer Ingelheim to head Merck's biosimilars unit, as well as the European Medicines Agency, Shire and EFPIA in this week's People on the Move column.

Great Excipact-ations: more excipient firms certified as predicted

20-Feb-2014 - Four more drug excipient suppliers have been certified under the newly independent Excipact quality scheme.

EMA and FDA to start monthly transatlantic drug safety teleconferences

20-Feb-2014 - The EMA has confirmed that new monthly drug safety discussions with US counterparts will focus on information exchange rather than policy development.

Fake US FDA inspector targeting Indian drugmakers in latest scam

20-Feb-2014 - Fraudsters who try to extort money by impersonating regulators are an ongoing problem, the US FDA says, after the Gujarat FDCA warns drugmakers about a new scam.

Delays in upgrading Pfizer injectable facility causes shortage

20-Feb-2014 - A longer than expected upgrade to one of its injectable plants has caused Pfizer to announce that there is a shortage of methylprednisolone sodium succinate injections.

Not transposing FMD could land Ireland, Italy, Poland and Slovenia in court says EC

19-Feb-2014 - The European Commission (EC) has increased the pressure on Ireland, Italy, Poland and Slovenia to fall into line with other EU member States and introduce anti-drug counterfeiting legislation.

US FDA recruiting more inspectors in India as Hamburg pushes need for quality

19-Feb-2014 - As Commisioner Margaret Hamburg flies back from an eight day tour of India, the US Food and Drug Administration (FDA) says it is recruiting seven new drug investigators in the...

US to expedite imports for some drugmakers under new supply chain plan

19-Feb-2014 - The US FDA announced on Monday that it would initiate a Secure Supply Chain Pilot Program to enhance the security of imported drugs.

Insulin pill tech can be used more widely says Oramed

18-Feb-2014 - Debate rages over the significance of safety data from a trial of Oramed’s oral insulin pill, but the firm is still confident in its delivery technology.

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