When national businesses become global operations… With the industry sourcing more raw materials and services from around the world and distributing its products in new markets, companies are adapting their business processes to suit a more complex global operating environment.
23-Jun-2015 - Eli Lilly’s President of Biomedicines says the transatlantic trade agreement TTIP will “force” the FDA and EMA to standardise regulations on manufacturing and trials.
10-Jun-2015 - Site audits by Brazilian pharma regulator ANVISA are “exactly the opposite” to the US FDA’s, says CMO Kemwell as it prepares to export to Brazil for Johnson & Johnson.
10-Jun-2015 - Drug companies will continue to supply Greece for the time being, but mounting debts make it hard to predict what will happen in the longer term according to industry group...
03-Jun-2015 - Multinational excipient-makers will drive US interest in EXCiPACT, the industry-led certification scheme says as a UK Colorcon plant becomes the eighteenth site to receive accreditation.
07-May-2015 - Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application...
28-Apr-2015 - Mylan has rejected an unsolicited bid by Teva and upped its offer for Perrigo, as the ongoing saga in the generics space continues.
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...
23-Apr-2015 - Technology transfer is the first step to bringing pharma investments to Africa, says the African Regulatory Network (ARN).
21-Apr-2015 - Almost 600 staff at Allergan’s headquarters in Irvine, California, will be laid off in the Botox maker’s latest round of job cuts.
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...
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.
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 - 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...
01-Apr-2015 - Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.
30-Mar-2015 - Sun Pharmaceutical Industries has completed its $4bn (€3.7bn) acquisition of Ranbaxy after receiving the thumbs up from the US Federal Trade Commission (FTC).
27-Mar-2015 - Aarti Drugs says the US FDA has not provided details of observations that earned its E-22 facility in Tarapur, India an import ban.
17-Mar-2015 - The European pharma market isn’t likely to deliver much growth over the next five years as generic markets commoditize, IMS Health VP Graham Lewis warned participants at the DCAT (Drug,...
23-Feb-2015 - The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.
19-Feb-2015 - The Indian Government wants to build API production capacity and revive state run manufacturer Hindustan Antibiotics to cut reliance on Chinese imports.
16-Feb-2015 - Warburg Pincus-backed HIV drug ingredient firm Laurus Labs has set up a US presence and development facility in a bid to win more North American customers.
09-Feb-2015 - Pfizer visited three troubled facilities in Hospira’s manufacturing network before entering a $17bn definitive merger agreement, the company says.
29-Jan-2015 - Novartis has divested, restructured, or mothballed 24 manufacturing plants since 2010 but says its new NBS cost-saving business will not focus on streamlining and consolidating sites.
27-Jan-2015 - A coating and packaging expansion at a facility in Germany will feed the demand for end-to-end softgel services, Catalent Pharma Solutions says.
15-Jan-2015 - AstraZeneca and Baxter are opting to transport pharmaceuticals by ocean and land routes as costs and cold chain security drive a drop in air freight.