27-Apr-2015 - Generic drug use in Japan has started to increase but 'brand loyalty' is still a considerable challenge according to industry experts.
23-Apr-2015 - Technology transfer is the first step to bringing pharma investments to Africa, says the African Regulatory Network (ARN).
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.
21-Apr-2015 - Pfizer and Regeneron are in Cuba this week, scouting the country for business opportunities.
16-Apr-2015 - To benefit from breakthrough therapy designation (BTD) pharma companies must be willing “bet on the right data” according to Roche, which says this could be a challenge for smaller firms.
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.
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.
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.
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.
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.
13-Apr-2015 - Thirteen Taiwanese drugmakers have been fined and ordered to recall products by regulators concerned the APIs they contain are food rather than pharma grade.
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.
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.
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.
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.
07-Apr-2015 - IPEC-Americas (International Pharmaceutical Excipient Council) stopped short of recommending a specific date for implementation of a new GMP standard for excipient manufacturers, but the group is calling on manufacturers to have an implementation plan in place by the end of Q3 of this year.
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.
02-Apr-2015 - Pfizer says it will stop selling vaccines in China after the country denied an import licence for anti-pneumonia conjugate Prevenar.
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.
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.
On December 19, 2014, the Guideline "ICH Q3D - Elemental Impurities" was issued by the ICH, providing a global policy for l...
Drug counterfeiting: a pharmaceutical industry problemCounterfeiters rely on two things: poorly secured pharmaceutical supply c...