Chesapeake IRB has announced back-to-back acquisitions of two independent institutional review boards (IRBs) as the company aims to expand its services.
Following its proposed LabAnswer acquisition, Accenture will form a scientific informatics service division, which it said will enable new patient treatments with “new insights into human biology.”
Marken has launched a new hybrid logistics service that leverages UPS’ existing global transportation network – including airports, pilots, and aircraft.
Patient-operated mobile technology will be demanded on all clinical trials, says mProve, as the industry undergoes an evolution and embraces digital health solutions.
Non-profit organisations have challenged the proposed addition of long-acting insulin analogues to the World Health Organisation’s Model List of Essential Medicines, citing price as a key factor.
Enhanced clinical trial design legislation proposes an alternative to the Right to Try Act – both of which address the FDA's current compassionate use program.
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.”
The US FDA has refused to reapprove Sun Pharma Advanced Research LTD’s epilepsy drug Elepsia XR (levetiracetam) citing problems at its plant in Halol, India.
Proposed amendments to the European Medicines Agency’s (EMA) access to documents policy have been criticised by medicines watchdogs, including not-for-profit Health Action International and Prescrire.
Burkholderia cepacia contamination is a risk for drug makers according to the US FDA, which says only rigorous testing can ensure the safety of non-sterile, water-based products.
Contract research organizations (CROs) continue to see high instances of turnover, which can lead to delayed timelines and sponsor scrutiny, according to a recent survey.
AB Science’s candidate cancer drug Masitinib (masitinib) should not be approved according to an EMA committee, which cited concerns about data and failings identified in a 2015 trial.
Nova DFL’s dental adrenaline product has been denied marketing authorisation after French regulators raised seven critical deficiencies at its facility in Brazil.
AB Science SA has halted French trials of its Ph III drug candidate masitinib after regulators uncovered good clinical practice (GCP) and pharmacovigilance deviations in an earlier study.
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.
The EMA has not experienced any concerns with the safety of the 28 biosimilar products it has recommended, according to an information guide published for healthcare professionals.
Issues in the quality testing of drug substance and product were among eight observations cited in a Form 483 following an inspection at Biocon’s site last month.
The WHO has announced plans to extend its prequalification scheme to include cancer biosimilars and says it will pressure industry for fairer prices for all biologics.
endpoint has combined features of its IRT platform with its global inventory management tool, DRIVE, to extend IRT accessibility across the clinical development portfolio.
The European Commission has urged UK Pharma firms to check how Brexit will impact their drugs, pointing out that EU law requires that authorisation holders have a base in a member state or EEA country.
The US FDA has identified problems at Dr Reddy’s generic drug manufacturing site in Bachupally, India according to a filing on the Bombay Stock Exchange (BSE).
Industry group the ABPI has called on the next UK Government to support local drug production, increase National Health Service (NHS) funding and put life sciences at the heart of its post-Brexit plan.
The UK MHRA saw an increase in sterility issues at drug plants in 2016 although quality system problems remained the most common deficiency seen during inspections.
The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.
Drug track and trace rules introduced in Saudi Arabia prompted a €300,000 ($326,078) investment in processing technology and software according to Sweden-based contractor Recipharm.
The US FDA has handed Sun Pharmaceutical Industries Ltd a Form 483 detailing critical observations made during an inspection of its Dadra, India facility.
Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.
Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the MHRA limit communication to essential information.
TransCelerate has chosen the Veeva Vault SiteExchange to simplify investigative site collaboration as part of its Shared Investigator Platform Initiative.
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.
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.
Deutsche Post DHL Group’s contract logistics business, DHL Supply Chain, has announced its intention to acquire Brazilian transport service provider Polar Transportes.
