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.
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...
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.
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.
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.
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.
Sun Pharmaceutical Industries has completed its $4bn (€3.7bn) acquisition of Ranbaxy after receiving the thumbs up from the US Federal Trade Commission (FTC).
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, Chemical and Associated Technologies) conference on Monday.
Following its three acquisitions over the last year, AMRI is now looking to extend its footprint into India further with the acquisition of a FDA-approved API site, William Marth, president and CEO of AMRI, told attendees at the Barclays Global Healthcare...
Higher capacity utilization is improving prices across the non-clinical research sector according to Huntingdon Life Sciences CEO Brian Cass, who told Outsourcing-pharma.com the preclinical CRO may add scale to US operations.
Irix Pharmaceuticals will cater for North American customers’ desire for local supply according to Patheon, which says it plans to retain the API firm’s 180 staff.
The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.
The Indian Government wants to build API production capacity and revive state run manufacturer Hindustan Antibiotics to cut reliance on Chinese imports.
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.
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.
Novacyl Wuxi Pharmaceutical has received a US FDA warning letter for failing to investigate the origin of metal particles found in drugs made at its paracetamol plant in China.
Sweden’s pharmaceutical regulator is pushing hard to make water pollution regulations a binding part of GMP, and says “embarrassed” European agencies are dragging their feet more than big pharma.
Cromos Pharma has launched a free or reduced cost trial model to help small and mid-sized drugmakers overcome the funding Catch-22 that can derail development efforts.
GVK Biosciences has called marketing authorisation withdrawals by various European regulators “disproportionate,” arguing that ECG results at centre of data manipulation investigation have no bearing on safety.
Pharma companies have called on the Swedish government to prevent manufacturing going the way of R&D and leaving the country, after AstraZeneca closed its research in Lund in 2012.
Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.
CRO industry group ACRO has welcomed a US NIH draft policy promoting use of a single IRB for site reviews per institute-backed multi-centre study, arguing that the approach would accelerate trials without compromising safety.
The pace of recruitment is the biggest challenge in carrying out trials in Eastern Europe, says Mabion which has extended an agreement with local CRO Altiora for its biosimilar study.
Just in time for the holidays, GSK can ‘give thanks’ to the US Federal Trade Commission (FTC) which has approved the $7bn acquisition of Novartis’ vaccine business.
Rottendorf is looking to break from being “the best kept secret in the CMO world” by targeting the thousands of virtual and SME pharma firms in the US, according to its CEO.
How can a pharma company invest in continuous manufacturing without bleeding money when it retreats from a local market? Pfizer’s answer is production pods it can roll out anywhere in the world via helicopter… and pack away again if a market turns.
The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies.
The IPO boom for CROs is kicking off with INC Research’s stock offering, which as of Friday afternoon saw a nearly 10% rise, meaning the company raised more than $150m.
India will ban PET packaging for liquid drug formulations for children, the elderly and women of reproductive age in November according to a Government statement.
Strategic relationships with contract manufacturers are becoming the standard, but big and small pharma demands differ considerably according to the two largest CDMOs, DPx and Catalent.
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.
The Indian Government has accused the authors of a paper analysing the quality of drugs sold in Africa of leading an attack on the Indian drug industry, but researcher Roger Bate says they are “shooting the messenger.”
The market opportunity for each Indian drugmakers granted a license to manufacture Gilead’s hepatitis C drug Sovaldi could be worth over $600m, an analyst has calculated.
Pharma service companies looking to access the growing Philippine and Indonesian markets have been invited to join a Public-Private trade mission by the US Department of Commerce.
