06-Mar-2014 - The Alliance for a Stronger FDA has expressed disappointment that President Obama’s FY 15 budget request for FDA falls short of what the agency needs to fulfill its responsibilities.
05-Mar-2014 - Fresenius Kabi has announced plans for a new $47m (€34m) infusion products manufacturing and cancer drug compounding facility in Australia.
04-Mar-2014 - The New Zealand Medicines and Medical Services Safety Authority is looking to update its abbreviated evaluation process, which is intended to be a simpler and quicker process than the standard evaluation process.
04-Mar-2014 - The US FDA outlined in draft guidance the ways in which sponsors must submit data for their HIV vaccines and other treatments.
03-Mar-2014 - Plans to give customs officers the power to seize and destroy suspected fake medicines as they move through the EU have been welcomed by industry group EFPIA.
03-Mar-2014 - UCB has more than drugs in its 2015 pipeline, while BUPA and biotechs hire new recruits.
27-Feb-2014 - Doctors, lawyers, State Department and World Bank spokesmen met on Wednesday to discuss the state of the Indian pharmaceutical world.
26-Feb-2014 - Fast-moving consumer goods industries and the financial world will be the next pools for sourcing pharmaceutical talent, says the CEO of pharmaceutical executive head-hunters RSA.
26-Feb-2014 - Failing to ensure data integrity at a control laboratory in India has landed drugmaker USV with a US FDA warning letter.
25-Feb-2014 - In a conference call Friday, FDA Commissioner Margaret Hamburg explained the importance of her recent trip to India, calling for more harmonization between the regulators.
24-Feb-2014 - European politicians and industry have disagreed on new plans to ask pharmaceutical firms to pay fees for drug safety assessments.
20-Feb-2014 - The EMA has confirmed that new monthly drug safety discussions with US counterparts will focus on information exchange rather than policy development.
20-Feb-2014 - Fraudsters who try to extort money by impersonating regulators are an ongoing problem, the US FDA says, after the Gujarat FDCA warns drugmakers about a new scam.
19-Feb-2014 - The European Commission (EC) has increased the pressure on Ireland, Italy, Poland and Slovenia to fall into line with other EU member States and introduce anti-drug counterfeiting legislation.
19-Feb-2014 - As Commisioner Margaret Hamburg flies back from an eight day tour of India, the US Food and Drug Administration (FDA) says it is recruiting seven new drug investigators in the country.
19-Feb-2014 - The US FDA announced on Monday that it would initiate a Secure Supply Chain Pilot Program to enhance the security of imported drugs.
18-Feb-2014 - Despite splintering into rival companies a century ago, Merck & Co. and Merck KGaA have once again been subject to mistaken identity, after protestors accidentally picketed the latter’s London offices.
17-Feb-2014 - All change at biopharmas this week, as we reveal the industry movers at four biologics firms. Plus, which company is making board hires after a $52m private placement?
13-Feb-2014 - A Hong Kong API distributor has received a Warning Letter from the US FDA after failing to have a Quality Unit and incorrectly labelling products.
12-Feb-2014 - It is too early to predict what impact proposed changes to US rules on chemical plant security and anti-terrorism measures would have on the drug industry according to PhRMA.
12-Feb-2014 - The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.
11-Feb-2014 - The National Institutes of Health and 10 pharmaceutical companies have launched a partnership to transform the current model for identifying and validating promising biological targets for Type 2 diabetes, Alzheimer’s disease, lupus and rheumatoid arthritis.
11-Feb-2014 - NSF International has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC) as part of a way to ensure a more streamlined supplier qualification process.
11-Feb-2014 - European drug manufacturers will have to control the critical aspects of their operations through qualification and validation over the lifecycle of the product and process, according to a new draft GMP guideline from the European Commission.
A longer than expected upgrade to one of its injectable plants has caused Pfizer to announce that...
Despite splintering into rival companies a century ago, Merck & Co. and Merck KGaA have once again...
Sinopharm expects customer drug launches and its recent investment in cancer injectables to drive revenue gains and...
The US FDA has upgraded Hospira’s troubled Rocky Mount, North Carolina plant to VAI (voluntary action indicated)...
It is too early to predict what impact proposed changes to US rules on chemical plant security...
Pfizer says its ‘off the shelf’ aseptic processing capacity is shifting the paradigm of pharma manufacturing, with...