As African countries look to secure their supply chains, head of the WHO’s team on fighting falsified and substandard medicine speaks about how to ‘demand quality’.
Year-on-year, the number of trials for advanced therapeutics has doubled, meaning that the UK now represents 12% of all global clinical trials in the area.
A lease agreement has been signed for the EMA to move into tailor-made premises in Amsterdam, with staff set to begin working from the space in January.
Speaking at the FT Pharmaceutical & Biotechnology conference earlier this week, Ipsen’s CCO said that pharma manufacturers need to focus more on the ‘why’.
PPD puts the spotlight on special patient populations by supporting clinical trials with Asian participants, preparing developers to expand into the Asian market.
FDA’s Janet Woodcock testifies to Congress about the potential risks to US national security of the pharmaceutical industry’s reliance on Chinese imports.
The company’s Shanghai facility passes the European regulator’s inspection with no ‘critical’ or ‘major’ findings regarding the commercial products produced at the site.
Representatives from the EMA and China’s NMPA convene to share expertise on GMP for APIs, GCP standards, and on the environmental impact of manufacturing.
As part of an evaluation of its manufacturing network, the company concluded that the Ringaskiddy production building was no longer a competitive, long-term option.
Takeda has sold selected prescription and OTC products to Acino covering its Near East, Middle East and Africa portfolio, as it looks to trim down its portfolio following the acquisition of Shire.
Broad adoption of blockchain technology requires manufacturers to look at their investments in the supply chain, just as they look at R&D, AmerisourceBergen executive says.
With nitrosamines back in the headlines due to the recent discovery of contaminants in ranitidine, the EMA releases the five potential causes of the impurities plaguing the industry.
AstraZeneca enters a $270m deal with Cheplapharm to divest seven drugs, in order to reduce its portfolio of ‘mature’ medicines and reinvest in other therapeutic areas.
Almac joins a working group made up of clinical supply chain industry members, in order to contribute to the use case discussion about blockchain technology.
Torrent announces that it will recall batches of losartan tablets for the sixth time, after the detection of NMBA exceeding acceptable daily intake levels in latest recall.
As a day of climate strikes unfolds across the world, we ask how far pharma is engaged on the issue, as well as noting recent innovations that suggest companies are looking at what can be done.
South Korea looks to accelerate review timelines and study start-up with a new five-year plan that will benefit biotechs looking for locations outside the US to ‘ramp up’ clinical development programs, says CRO.
In response to the UK government’s publication of potential ramifications of a no-deal Brexit, the ABPI responded that the pharma industry needs more details on mitigation strategies.
The global CRO Cromsource has opened a new office in Research Triangle Park – home to many current and potential clients – after growing more than 150% over the two years, says COO.
Catalent to invest $9m in the building of an early-stage clinical supply facility in San Diego, due to open in the summer of 2020, to integrate its CDMO business.
The acquisition of Bioclinica’s clinical research site business extends PPD’s trial enrollment business to five continents, 20 countries, and more than 180 research sites.
Strides acquires the only FDA-approved integrated soft gel capsule manufacturing facility in the US, owned by Micelle, to support its operations in India.
The US FDA issues a Form 483 to Shilpa Medicare, after an investigation noted five observations that require action, including an unreliable power supply.
The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.
ARG opens new offices in Warsaw as well as Amsterdam, the new home of the European Medicines Agency, both ‘ideal’ locations among Brexit uncertainty, says CEO.
Bolstered by manufacturing advancements, the global revenues of the pharmaceutical excipients market are expected to grow at a CAGR of 5.8% in the coming years.
As part of its global network expansion strategy, PCI Pharma Services is investing in a new dedicated clinical facility near Dublin, Ireland, which will provide space for secondary packaging, storage, logistics, and distribution.
