European authorities want to revise the guidelines covering first-in-human studies in light of the French trial in which one man died and others were hospitalised earlier this year.
Researchers suggest targeted nanosystem drug delivery could be the key to crossing gastrointestinal tract and blood-brain barriers – a prevailing issue with oral medications.
Private equity fund Apax Partners will take control of Spanish API manufacturer Inke when it completes the acquisition of Invent Farma later this year.
CrownBio’s new stable cell lines feature various immune checkpoints and receptors which are key targets and pathways for oncology drug discovery and development.
The pharma industry could learn valuable lessons from the aerospace and automotive industries when it comes to designing new products, according to Swiss researchers.
The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.
Researchers have developed a new magnetically controlled drug that can dissolve clots up to 4,000 times more efficiently than ordinary enzyme-based drugs.
Juniper Pharma Services has invested in a tablet press that can produce 42,000 pills an hour citing customers’ clinical trial supply needs as the driver.
As a dedicated Chemical Biology Consortium center, AMRI will provide a variety of drug discovery services to help advance early stage drug discovery projects.
The UK MHRA has identified GMP deficiencies at an Akums Drugs & Pharmaceuticals facility in India that was being lined up to make progesterone for Nordic Pharma.
A revised concept paper on first-in-human trials will be ready next month according to the EMA which is reviewing the French Phase I trial in which one volunteer died in January.
Partners Group, a private markets investment manager, has agreed to acquire global pharmaceutical services provider PCI Pharma Services citing “trends towards outsourcing.”
Rising drug prices and the subsequent increasing number of drugs ineligible for reimbursement will challenge drug developers to provide clinical superiority evidence.
Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.
Selcia has opened a production facility for 14C radiolabelled drug ingredients in the UK citing growing demand from CROs and sponsors running first-in-man studies.
Indian API maker JP Laboratories is unable to sustain GMP compliance at its facility in Daund, Maharashtra according to the Italian Medicines Agency (IMA).
Aesica Pharmaceuticals has adopted a flexible serialization system capable of helping customer meet track and trace requirements in China, Korea and other key markets.
As “one of the fastest growing areas in pharma,” the demand for finished dosage formulations is having an impact on several aspects of the CMO industries.
Suir Pharma is set to close or be sold with the loss of 130 jobs less than a year after it was acquired by Slovakian API manufacturer Saneca Pharmaceuticals.
More drug discovery work will be outsourced this year according to a report which suggests pharmaceutical industry desire to reduce the risk of failure and cut costs persists.
Juniper Pharma Services has upped mixing capacity at its facility in Nottingham, UK to give it the ability to support Phase III studies of topical and semi-solid products.
Envirotainer has opened a ‘service station’ in Delhi, India to help local API and generic drug manufacturers comply with international shipping regulations.
