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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.

Tech transfer will drive pharma investment in Africa, says industry group

23-Apr-2015 - Technology transfer is the first step to bringing pharma investments to Africa, says the African Regulatory Network (ARN).

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.

US-Cuban embargo nears end as Pfizer and Regeneron make trade trip

21-Apr-2015 - Pfizer and Regeneron are in Cuba this week, scouting the country for business opportunities.

Dispatches from BPI 2015

Breakthrough barriers: Seeking fast track review means betting on data says Roche

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.

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.

API quality concerns prompt fines and drug recall orders in Taiwan

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.

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.

IPEC calls for excipient GMP standard implementation plans to be in place by Q4

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.

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.

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