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News from CPhI Japan

Generic firms still face brand loyalty challenge in Japan say experts

27-Apr-2015 - Generic drug use in Japan has started to increase but 'brand loyalty' is still a considerable challenge according to industry experts.

Special from BPI Europe 2015

Eliminating fear culture can save operational costs and jobs, says Pfizer

23-Apr-2015 - Pfizer reduced costs 40% without cutting jobs at a facility in Sweden using an alternative management approach to organisational and cultural behaviour, and hopes to do the same at its newly acquired Austrian plant.

Concerns over data manipulation lands Chinese API maker with US FDA Warning

22-Apr-2015 - The US FDA has hit cancer-drug API maker Yunnan Hande Bio-Tech with a warning letter citing concerns over potential manipulation of quality test data at a plant in China.

EDQM seeks industry input on water for injection monograph revision

20-Apr-2015 - The EDQM is revising its water for injection (WFI) monograph to accomodate cheaper and greener alternatives to distillation and has called on injectable drugmakers to contribute.

Concerns climate change will see tick-borne diseases spread to the UK are legitimate, says PHE

15-Apr-2015 - Concerns climate change will see malaria, West Nile virus and chikungunya spread to the UK are legitimate according to Public Health England, even though no insects carrying such diseases have been detected to date.

WHO: incentives and enforcement needed to improve trial data transparency

15-Apr-2015 - Publishing summary clinical trial results poses no threat to patient privacy according to the WHO, which says enforcing transparency laws and incentivising sponsors is key to making sure data from all trials is reported.

WHO says anything short of full trial disclosure skews public spending

14-Apr-2015 - Drug, vaccine and medical device developers should publish all trial results according to the WHO, which says anything less skews R&D priorities and public healthcare investment.

International convergence: Australia’s TGA proposes to adopt 10 EMA guidelines

13-Apr-2015 - In a sign that pharmaceutical regulators are merging their regulations further, Australia’s TGA (Therapeutic Goods Administration) is seeking to adopt 10 EMA (European Medicines Agency) guidelines on quality, biologics, clinical efficacy, safety, and more.

Eisai inks R&D Genomics data deal; cuts 25% US jobs

13-Apr-2015 - Eisai has inked a deal with a genome analytics firm to aid drug discovery days after announcing it would be cutting 25% of its in-house US workforce.

Collaboration is key to combatting counterfeiting

Fighting fake drugs about patient safety not competitive advantage says Rx-360

09-Apr-2015 - Fighting drug fakers relies on collaboration according to supply chain security group RX-360, which says drugmakers put rivalries on hold in the war against counterfeiters.

Update

Pfizer, Amgen’s Form 483s listed among more than 100 issued by US FDA already in 2015

08-Apr-2015 - Three Amgen manufacturing sites, along with Pfizer’s Perth, Australia site are part of a list of more than 100 US FDA Form 483s issued so far in 2015, according to a list obtained by In-Pharmatechnologist.com thanks to the FOIA (Freedom of Information Act) via the FDA.

'Unjustified' ban of GVK-tested drugs has damaged India, says Pharmexcil

08-Apr-2015 - The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.

Hospira cited for sterility issues in warning letter for Italian plant

08-Apr-2015 - Following a May 2014 inspection, US FDA officials have issued a warning letter with multiple cGMP (current good manufacturing practice) deficiencies for Hospira’s manufacturing facility in Liscate, Italy.

people on the move

Leadership changes in vaccines and oncology

07-Apr-2015 -

Calling all QA/QC whizzes: US FDA 'super' office hunts quality leader

07-Apr-2015 - The Director of the new 'super' Office of Pharmaceutical Quality must address issues surrounding increasing globalisation and manufacturing complexity, the FDA says as it begins the recruitment process.

Pfizer pulls vaccine sales out of China after Prevenar import ban

02-Apr-2015 - Pfizer says it will stop selling vaccines in China after the country denied an import licence for anti-pneumonia conjugate Prevenar.

Sanofi: 80% of population ignored as pharma targets lower-risk specialty R&D

02-Apr-2015 - Pharma has focused investment in lower risk specialty and orphan diseases to the detriment of 80% of the population, according to Sanofi’s head of R&D who calls for regulatory convergence to help reverse the trend.

FDA looks to incentivize abuse-deterrent opioid development with final guidance

02-Apr-2015 - Although the abuse-deterrent technology is still relatively new, the FDA has released final guidance explaining to manufacturers how to conduct studies to demonstrate that an opioid formulation has abuse-deterrent properties.

Hamburg exits US FDA calling on increased international co-operation

01-Apr-2015 - Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.

Peer-review cheating ring discredits another 43 papers

01-Apr-2015 - Publisher BioMed Central has withdrawn 43 papers from its scientific journals after discovering a conspiracy to rig peer review runs deeper than previously thought. 

UK politician pledge would ban 89% of animal research, say scientists

31-Mar-2015 - British MPs have signed an anti-animal cruelty pledge which scientists warn would “cripple” disease research and outlaw 89% of preclinical animal research.

EMA: TTIP and inspection databases a way of improving global manufacturing standards

31-Mar-2015 - Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.

Lilly says Indy Religious Freedom law is discriminatory and may hamper cancer and AD drug development

30-Mar-2015 - Indiana’s new “religious freedom” law is discriminatory and will make it harder to attract the staff needed to develop drugs for cancer and Alzheimer's disease according to Eli Lilly.

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