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Headlines > October 2014

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India cuts stability data reqs for API firms seeking docs to ship to EU

30-Oct-2014 - India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to ship to the EU.

Life on Mars? Ground control to remotely deliver drugs in space

30-Oct-2014 - Animal astronauts on the International Space Station will test an implant which allows doctors back on earth to deliver drugs by remote control.

Apps pathetic: Drug industry mobile techs underperforming

30-Oct-2014 - Hardly anybody downloads Big Pharma apps according to a new report that suggests drugmakers seeking greater mHealth engagement should ditch the product-focused model and seek expert help.

Novo Nordisk to hire 90 at newly acquired plant in New Hampshire

30-Oct-2014 - Novo Nordisk on Wednesday announced plans to hire up to 90 people at its newly-acquired manufacturing facility in West Lebanon, New Hampshire. 

Auf Wiedersehen PET? India to ban plastic bottles for liquid drugs

29-Oct-2014 - India will ban PET packaging for liquid drug formulations for children, the elderly and women of reproductive age in November according to a Government statement.

Sanofi's US-based CEO Viehbacher resigns after board votes to remove him

29-Oct-2014 - So it appears the future of Sanofi’s CEO Christopher Viehbacher was on the agenda after all.

Feature

Why there's no sign of Pfizer among top pharma employers

29-Oct-2014 - A head-hunter explains why Regeneron, Novo Nordisk and Genentech top a global survey of science employers, but Pfizer is nowhere to be seen in the top 20.

EDQM sets new policy for testing of bacterial endotoxins

29-Oct-2014 - The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set a new policy for the testing of bacterial endotoxins.

Pharma Action crude heparin plant due to open next week

28-Oct-2014 - A plant being set up by Pharma Action and meat supplier Toennies will produce 15 tonnes of 100% traceable crude heparin a year.

Neuro experts call for drug name shake-up; manufacturers more cautious

28-Oct-2014 - Psychiatric drugs should be renamed according to their chemical make-up, not the symptoms they treat, according to leading neuropsychopharmacologists.

Hikma confirms FDA sent Warning Letter for environmental issues

28-Oct-2014 - Jordanian drugmaker Hikma says it has received a US FDA (Food and Drug Administration) Warning Letter over environmental monitoring at its plant in Portugal.

People on the Move

People on the Move

27-Oct-2014 - Former employees of Procter & Gamble, Merck & Co. and Bristol Myers Squibb have all found new homes in the pharma industry in this week's People column.

Tower of Basel: Roche spends $3bn on giant R&D site

27-Oct-2014 - Roche has announced plans to invest 3bn Swiss Francs ($3.2bn) in a 433-ft R&D centre and extra offices for 3,600 employees.

Superbug-driven surge in polymyxin demand prompts EMA to reassess safety info

27-Oct-2014 - A superbug-fuelled resurgence of polymyxin antibiotics has prompted the European Medicines Agency (EMA) to re-examine safety warnings for the side effect heavy anti-infectives

breaking news

Novo Nordisk subpoenaed over Danish manufacturing site

27-Oct-2014 - Novo Nordisk has been served with a subpoena over alleged manufacturing issues at its site in Kalundborg, Denmark.

Lawyers question legality of US FDA final guidance on delaying, denying inspections

27-Oct-2014 - What may seem to be relatively minor changes between the FDA’s draft and final guidance on delaying, denying, limiting or refusing a facility inspection could actually be more major as...

Starting debate: EMA says rules on API materials need clarification

23-Oct-2014 - Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.

GSK £1bn savings plan to hit manufacture towards 2017, but UK likely immune

23-Oct-2014 - GlaxoSmithKline plans to cut manufacturing, sales and R&D as part of a three year plan to save £1bn ($1.6bn) annually. 

EMA launches rolling review process for Ebola vaccine makers

23-Oct-2014 - Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.    

Actavis takes axe to Forest again, with New York jobs to go

23-Oct-2014 - Almost 100 jobs at a commercial packaging facility in New York are set to go as part of Actavis’s continued integration of Forest Laboratories.

Oral influenza vaccine one step closer, says Vaxart

22-Oct-2014 - A seasonal flu vaccine taken in the form of an oral solid dose has been found comparable to currently available jabs, according to data presented by developer Vaxart.

EMA tells us it looks forward to continuing close relationship with DG SANCO

Juncked: Plan to move EMA from DG Health to DG Enterprise is abandoned

22-Oct-2014 - DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.

Global TB drug development efforts underfunded says WHO

22-Oct-2014 - Janssen-Cilag’s bedaquiline and Otsuka’s delamanid notwithstanding, the drug industry is not spending enough on the development of tuberculosis medicines according to the WHO.

NIH: without budget cuts, we’d have Ebola vaccine

22-Oct-2014 - The head of the US National Institutes of Health has said the organisation would have developed a finished Ebola vaccine by now if its funding had not been slashed over...

NEWS FROM CPHI

The key to market exclusivity? Forget molecules, patent your tests

21-Oct-2014 - Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.

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