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.
Hospira has invested 15m AUD ($14m) in a Victoria injectables plant it says will continue to make drugs for export despite the economic downturn and strong Australian dollar.
As contract manufacturers continue to consolidate, some in the industry are questioning whether the resulting companies have the ability to offer the same services as the former individual companies.
Gilead has granted seven Indian drugmakers licenses to produce generic versions of its $1,000 a pill drug Sovaldi to increase access to hepatitis C medicines in 91 developing countries.
In a venture with plasma products manufacturer Octapharma, DHL has opened a €3.4m ($4.4m) cold-chain logistics centre in Germany for the pharma and life sciences industries.
The high cost and complexity of producing biopharmaceuticals for clinical trials limits supplies and makes effective logistics even more important than for small molecule studies says Almac.
Indian drugmaker Amanta has received a warning letter after the US FDA found evidence of data falsification and unsanitary conditions – including dead and decaying frogs next to a product exit dock – during an inspection last year.
German jobs are safe despite a programme that will cut the cost of operations by 15%, Boehringer Ingelheim says as it reacts to international price reductions.
Amgen is slashing 15% of its workforce and closing two US manufacturing facilities as part of a restructure the firm says will save $700m (€520m) a year.
Increased emphasis on global clinical trials is promoting consolidation of contract research organisations (CROs), according to an industry report by M&A services firm 11T Partners.
Robust quality systems differentiate Biocon from other Indian manufacturers, the firm says, despite political turmoil in the Middle East and North Africa impacting first quarter 2015 sales.
AmerisourceBergen has reported “outstanding operational and financial performance” for the third quarter 2014, and is set to pass the $100bn revenue mark for the fiscal year.
Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.
Germany-based full-service CRO (contract research organization) Accovion has expanded European presence with new offices in Italy, France and Eastern Europe.
