23-Oct-2014 - Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.
23-Oct-2014 - Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.
22-Oct-2014 - DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.
22-Oct-2014 - Janssen-Cilag’s bedaquiline and Otsuka’s delamanid notwithstanding, the drug industry is not spending enough on the development of tuberculosis medicines according to the WHO.
21-Oct-2014 - Generic drugmakers want biotherapeutic products to have general recommendations in the European Pharmacopoeia rather than individual monographs.
21-Oct-2014 - Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.
21-Oct-2014 - By early next year the US FDA is set to launch a new “super” office known as OPQ (Office of Pharmaceutical Quality), which will better align the review, inspection, and research of drugs.
20-Oct-2014 - Analysts predicting a second wave of global API hubs say it will be hard for manufacturers in Latin America, Ukraine and Taiwan to avoid the pitfalls that stymied former high growth sectors in Asia.
20-Oct-2014 - Over forty “necessary products” made at Apotex and IPCA facilities hit with an import alert can be sold in Canada after regulators took steps to prevent shortages.
16-Oct-2014 - Government contracts guaranteeing market share in Brazil are starting to attract innovators like Roche, Novartis and Sanofi and may see API suppliers get long-term work according to a spokesman for Sao Bernardo do Campo-based drugmaker, EMS.
15-Oct-2014 - Drug active ingredients in food supplements are Europe’s real falsified medicines problem according to the head of AIFA’s counterfeit prevention team.
15-Oct-2014 - Overzealous and unnecessary quality demands by some regulatory agencies are driving up the cost of medicines, according to the Indian Government.
15-Oct-2014 - The lack of an Ebola vaccine decades after the virus was discovered is due in part to IP protections in trade deals like TTIP that discourage innovation according to NGO, Health Action International (HAI).
14-Oct-2014 - 'Excipient compound' monographs should be included in the European Pharmacopoeia according to IPEC, which argues they would help manufacturers and promote acceptance of the standards outside Europe.
14-Oct-2014 - Gilead says its hepatitis C combination drug Harvoni will deliver significant healthcare savings in the long-term despite its $1,150 (€885) a pill price tag.
13-Oct-2014 - Growing drug complexity will soon make the European pharmacopoeia’s general chapters more valuable to innovative drugmakers than individual monographs according to Pfizer quality and compendial affairs expert, Graham Cook.
13-Oct-2014 - The pharmaceutical industry must change its ingredients and manufacturing methods to cash in on the enormous purchasing power of European Muslims, says an expert.
13-Oct-2014 - The auditing company, SGS, recently certified that Capsugel’s manufacturing sites in Colmar, France and Bornem, Belgium meet Good Manufacturing Practice (GMP) standards set by EXCiPACT for pharmaceutical excipients manufacturing.
08-Oct-2014 - Consolidation in the pharma industry is driving the second-hand processing equipment market but despite attempts to regulate the industry, a glut of online vendors means illegal drugmakers can buy such systems.
07-Oct-2014 - Counterfeit drugs and collaboration will be key topics for the EDQM say delegates at the organisation's 50th anniversary conference on Monday.