Apotex is getting reprimanded once again for its API facility in Bangalore, India, after the company failed to adequately respond to an FDA Form 483 over data integrity issues, according to an FDA warning letter dated June 16.
The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College, London, who told in-Pharmatechnologist.com the key to encouraging antibiotics manufacture is lightening companies’ regulatory burden.
An oral solid dose manufacturing plant in Bangalore, India operated by CMO Kemwell Biopharma has passed a customer-prompted audit by European regulators and had its cGMP status renewed for the next three years.
In a sweeping report on the industry as a whole, the European Commission says that with an annual output of €220bn, and nearly 800,000 employees, the pharma industry is vital for the EU economy, though more needs to be done to meet its full potential.
Elelyso has been certified as kosher by a US Jewish group, which says the process used to make the lysosomal storage disease drug means it conforms to religious dietary laws.
Bulk pharmaceutical ingredients increasingly used by compounding pharmacies have seen astronomical price hikes over the past two years and now payers are catching on to the trend and stepping in.
The US FDA has set emphasising the benefits of QbD, traceability and risk based manufacturing facility inspections as strategic priorities for the next four years in document published for consultation this week.
Biopharma firms continued to attract US venture capital investment in Q1 according to new analysis by PricewaterhouseCoopers (PwC), which says the number of firms that received backing is encouraging.
The European Medicines Agency’s Committee for Advanced Therapies (CAT) has revised a reflection paper on the classification of advanced-therapy medicinal products (ATMPs) to reflect cases in which medicines can be classified as ATMPs.
A regulatory expert has warned of the “unintended consequences” of that would require the US Food and Drug Administration (FDA) to begin reviewing drug candidates within 90 days of their approval in the EU.
US demand for biosimilars testing will grow substantially in the next few years according to BioOutsource, which expects to generate half of its revenue in the country by 2019.
With almost a week before Indian exporters would be required to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) in India has pushed back the deadline indefinitely.
Pharmaceutical companies are rushing to respond to shortened deadlines from China’s Food and Drug Administration (CFDA) for serialising drug packaging.
An online quiz about drug R&D has been criticised by economists who say its developer - Eli Lilly - is misinforming the public about the cost and time it takes to develop new medicines.
GSK is confident it can meet Flulaval production targets ahead of this winter’s flu season despite ongoing endotoxin contamination problems at a Canadian plant hit with US FDA warning letter.
Representatives for GSK have targeted struggling graduates and unpaid interns as volunteers for clinical trials, saying the payments – up to £8,000 ($13,600) per year – “could be your solution” to money problems.
Big pharma industry group TransCelerate discussed but ultimately decided against allowing CROs to join the collaborative, though research contractors will be engaged routinely, members of the group said.
Novartis has called in a third party organization to review how it conducts clinical trials in light of the adverse event reporting scandal that broke in Japan last week.
Formulations that stop biopharmaceuticals being degraded by vials and syringes could help biopharmas avoid recalls and improve product shelf life says the UK team behind an industry focused research collaboration.
The European Medicines Agency (EMA) has abandoned plans to stop researchers downloading clinical trial data but the European Ombudsman says she is unaware if other limits on transparency remain.
Local talent is not satisfying the “tremendous” demand for top-level pharma employees in Asia and recruiters are searching internationally for candidates, a pharmaceutical head-hunter has said.
As manufacturers will have to identify illegitimate product for trading partners and the US FDA beginning next year, the agency is now offering pragmatic advice in the form of draft guidance for drugmakers regarding situations where suspect product might...
The advocacy campaign to raise awareness about falsified and fake drugs has added 11 new partners to its cause, including US-based GPhA (Generic Pharmaceutical Association).
Supply chain security consortium Rx-360 has shifted its focus to China where it is forming a working group to further ensure compliance in a country that has had some difficulties with spurious drugs in the past.
Fans heading to the World Cup in Brazil should consider getting vaccinated against yellow fever according to Public Health England (PHC), which says manufacturing problems at Sanofi Pasteur MSD will not restrict access.
Aprecia Pharmaceuticals has selected inVentiv Health to sell and market its three-dimensional printing technology to create fast-melt pharmaceutical treatments.
The Form 483 from the US FDA cited Chicago-based Morton Grove Pharmaceuticals, which was acquired by Wockhardt in October 2007, for 12 different observations.
Alexion has recalled another nine lots of Soliris after finding "visible particles" in vials of the $600,000-a-year drug for the third time in 10 months.
European pharmaceutical manufacturing jobs are at risk according to a group representing generic firms which says price caps in EU member states are hurting drugmakers.
Veeva Systems says its new global alignment solution for pharmaceutical companies will bring together data interactions and content into its Commercial Cloud.
Clinverse, a company which automates the financial lifecycle of global clinical trial providers, and eClinical Insights, a provider of cloud-based clinical trials software, have formed a strategic partnership to offer an integrated tool for clients.
Clinical biomarker service company Targos is partnering with Wuxi PharmaTech to provide know-how, services, and quality standards to support Wuxi's bioanalytical work for biopharma customers.
For the seventh time since 2006, law enforcement, customs, and regulatory authorities from 111 countries collaborated to identify and root out Internet-based makers and distributors of illegal drug products and medical devices.
Amid ongoing efforts by the US FDA to crack down on foreign suppliers not meeting cGMP (current good manufacturing) requirements, India-based Sun Pharma is the latest company to be hit with a warning letter.
Outsourcing-Pharma.com reached out to contract testing supplier BioOutsource to see what its take is on biosimilars now that the FDA’s draft guidance on biosimilarity has been released. The following is a lightly edited interview with BioOutsource’s chief...
The US Food and Drug Administration (FDA) is founding a $3.3m (€2.4m) regulatory science centre jointly with the University of California San Francisco (UCSF) and Stanford University.
In a letter to the EMA (European Medicines Agency), the European Ombudsman Emily O'Reilly has expressed concern that a significant change of policy on trial data transparency could limit the amount of data that becomes available.
As the worldwide pharma supply chain gets even more complex, the US FDA is looking to leverage its existing relationship with its EMA (European Medicines Agency) counterparts to boost drug quality with a new initiative.
The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.
A Brazilian Court in Sao Paulo has ordered Eli Lilly pay about $450m for exposing former employees of its subsidiary to hazardous substances in a manufacturing facility operated between 1977 and 2003.
The counterfeiting of over-the-counter drugs is a growing problem according to an ex-criminal prosecutor, but the nature of such medicines means the problem often goes unreported.
