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Breaking News on Global Pharmaceutical Technology & Manufacturing

PEOPLE ON THE MOVE

Favourite for Novo Nordisk CEO suddenly quits

30-Apr-2015 -

FDA’s Woodcock calls to cut clinical costs via new efficiencies

30-Apr-2015 - As the cost of clinical trials continues to grow, Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA told Senators earlier this week that there are “ways to greatly improve clinical trial efficiency,” and cut costs through the use of master protocols and real-world data.

EBG BIOSIMILARS 2015

Regulators: skip clinical data and extrapolate biosimilar indications

29-Apr-2015 - Sponsors can license biosimilars for multiple indications without performing clinical studies for each area, the EMA and FDA agree.

MHLW says PIC/S membership means high quality drugs will get to patients faster

29-Apr-2015 - Japan’s membership of the PIC/S international inspection and manufacturing scheme bodes well for patients in Japan and elsewhere according to the Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency (MHLW)

WHO: Pharmas should give cash not drugs to aid Nepal earthquake relief efforts

28-Apr-2015 - Drug companies that want to support aid efforts in Nepal should donate cash rather than medicines according to the World Health Organisation (WHO).

Allergan and Hospira recalls

28-Apr-2015 - Hospira has recalled one lot of the anaesthetic Bupivacaine after a customer discovered orange and black particles floating and embedded in a glass vial.

News from CPhI Japan

Sakigake: New Japanese drug laws will foster global innovation says MHLW

28-Apr-2015 - ‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.

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.

People on the Move

UN appoints new Ebola head

27-Apr-2015 - And microbiology awards to research scientists and Médecins Sans Frontières.

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 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.

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