The US FDA has issued a product safety alert and recommended a compounding pharmacy cease manufacturing operations after observing unsanitary conditions at a Californian facility.
Evotec has been hired to manage candidate drug compounds by the US National Cancer Institute (NCI) under an agreement the CRO hopes will help it win further contracts.
Sterigenics will triple gamma sterilisation capacity at a site in Arkansas on the back of strong demand from pharmaceutical and medical device customers.
Medical affairs and post-market research are fast growing opportunities for CROs according to observers who say drug companies are starting to outsource more late-phase and post approval work.
The US FDA has revoked approval for Sun Pharmaceutical Industries’ extended-release epilepsy drug Elepsia XR over concerns the firm's manufacturing plant in Halol, India does not meet quality standards.
Drugmakers need more certainty and reliabilty around their supply chain in light of increased regulatory vigilance says Mylan, itself carrying out remediation across several Indian facilities.
Sandoz has reiterated its call for US FDA guidance on biosimilar interchangeability arguing that the lack of clarity makes it hard to gauge what impact switching rules will have on pricing.
A Massachusetts-based police department has published contact and salary details of Big Pharma CEOs in an effort to force industry to help manage opiate addiction.
Aid agencies providing relief to refugees across Europe say drug firms should give financial support or make products more affordable rather than donate pharmaceuticals.
More evidence of sponsor demand for direct-to-patient (DTP) services with Marken announcing an expansion of its deal with GlobalCare Clinical Trials just a week after rival Almac launched its to-the-door study drug delivery offering in Europe.
A Japanese company has filed the first US FDA application for a drug with an embedded sensor which can tell doctors if patients have taken their pills.
Illegal internet pharmacies and a desire for cheaper meds mean fake drugs are a problem even in smaller pharmaceutical markets say Estonian regulators.
A favourable regulatory environment encouraged by the 21st Century Cures Act will help drive CRO demand for Medidata’s cloud-based technologies, according to a Citi analyst.
A Florida company is recalling 26 sexual enhancement and diet pills after the US FDA discovered some contain undeclared active pharmaceutical ingredients (APIs).
IBM Watson Health has struck deals with pharma company Teva and contract research organisation Icon to use its big data cloud tech to improve clinical trials and drug development.
Sandoz has joined biosimilar developers calling on the US FDA to provide clear guidance on interchangability just a day after launching Zarxio, its Neupogen (filgrastim) copycat.
An Indian TB drugmaker has been hit with a WHO Notice of Concern but an independent audit carried out by its customer Svizera Europe disputes the GMP violations raised.
Update - Wholesale cost of Zarxio will be 15% less than Amgen's Neupogen
Pfizer failed to report hundreds of serious adverse drug reactions (ADRs) in the required timeframes according to Japan’s Ministry of Health, Labor and Welfare (MHLW) which has issued the US firm with a business improvement order.
Amgen has retracted a study showing how grizzly bears could hold the key to understanding diabetes after one of the authors was found to have manipulated data.
Clinical trial operators are slowly converting to electronic Trial Master Files (eTMFs) but almost a third still rely on paper to manage data, according to cloud-based software provider Veeva.
New US drug shortages this year are running roughly at the same levels as the last two years, and far below the record highs seen earlier this decade, the US FDA told in-Pharmatechnologist.
The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.
A drugmaker trialling an autoimmune disease treatment in the UK has been cleared to use electronic informed consent by the National Health Service (NHS).
The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.
