Experts are calling for an increased focus on human cellular model development after animal tests failed to detect the toxicity of an experimental drug before the first-in-human clinical trial that left one dead.
Cure Pharmaceutical has entered into a strategic collaboration to test and develop potential cancer therapeutics utilising a blend of the cannabis plant-derived terpenes.
Bristol Myers Squibb (B-MS) has recalled one lot of the oral anti-clotting drug Eliquis in the US after a customer found 2.5mg strength tablets in a bottle labelled as containing 5mg tablets.
Pop Test Abuse Deterrent Technologies has received a patent for an opioid drug delivery and abuse deterrent ‘smart pill’ it says can prevent death, theft, diversion and counterfeiting.
Rich Pharmaceuticals has selected a clinical trial site in Thailand at which it will conduct a Phase I/II trial in collaboration with the contract research organization (CRO) CMIC ASIA-PACIFIC, PTE. LTD. (CMIC).
Cure Pharmaceutical has submitted a patent application for an oral film delivery technology it says can combine several active pharmaceutical ingredients without negative interaction.
Hovione has launched its first clinical trial and has already set sights on a second as the CDMO hopes to establish licensing partnership with pharma, says VP.
The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”
Pharma and CMOs must start addressing their serialization needs ahead of 2019’s EU Falsified Medicines Directive, says Tracelink which is bringing its supply chain event NEXUS to Barcelona next month.
The US Food and Drug Administration (FDA) has given the go ahead to Frontida BioPharm’s Pennsylvania, US-based site, eight months after distributing a Warning Letter for the facility.
Aptar Pharma has acquired 20% of the US-based company, Kali Care, less than two months after inaugurating its first facility outside of France as it aims to expand globally.
President Donald Trump should foster biotech investment if he wants more US-made pharmaceuticals say experts who argue that cutting regulations to attract small molecule drug manufacturers will only have a limited effect.
Ibuprofen patch developer Medherant Ltd. has hired France-based contractor Laboratoires Plasto Santé (LPS) to make the product for clinical trials due to start this year.
endpoint has combined features of its IRT platform with its global inventory management tool, DRIVE, to extend IRT accessibility across the clinical development portfolio.
Spaulding Clinical Research will conduct Evoke Pharma’s planned comparative exposure pharmacokinetic (PK) trial for its lead product candidate, Gimoti.
The US FDA has handed Sun Pharmaceutical Industries Ltd a Form 483 detailing critical observations made during an inspection of its Dadra, India facility.
Certara has launched a new solution for preparing, analyzing, and submitting pharmacokinetic (PK) data in Clinical Data Interchange Standards Consortium (CDISC) format.
The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.
Partnering and collaborating to advance drug delivery innovation is essential, now more than ever, say industry experts from Boehringer-Ingelheim and Merck.
The US FDA completed an inspection of Aurobindo Pharma Limited’s manufacturing plant in Bachupally, Hyderabad yesterday, issuing the Indian drug firm with a Form 483 detailing six observations.
LiveLeaf, Inc. has announced a collaboration with the contract research organization (CRO), Emery Pharma, to advance its development of novel prodrugs for FDA approval.
Arecor has entered a £45m ($56m) agreement to develop once daily injection of Cadila Pharmaceuticals’ basal insulin product using its reformulation technology.
Smithfield Foods Inc. has tasked a new bioscience unit with turning byproducts from its pork business into supplies for regenerative meds and drug firms.
Ohr Pharmaceutical has raised enough money to complete a Phase III trial of its AMD drug - Squalamine – just days after NASDAQ officials gave it 180 days to regain the exchange’s minimum listing price.
India has told state regulators to inspect API sites making oxytocin in an effort to prevent the hormone being used to speed up childbirth without medical justification.
A Combino Pharm dosage form plant in Malta has passed a US FDA inspection according to parent Medichem, which says it is now poised to expand its US business.
The inability to identify the best clinical trial sites is a big problem – and one of the major challenges negatively affecting drug pricing and sponsors, says CEO.
Pfizer CentreOne has recently expanded its fill-finish and highly potent solid oral dose service offerings at two of its contract manufacturing facilities as it aims to fulfill a promise to grow its capabilities.
As many as 400 contract manufacturing organisations (CMOs) will not be ready for upcoming US and EU track-and-trace regulations, says supply chain services firm TraceLink.
