The Friends of Cancer Research, in collaboration with Iqvia and other health care research organizations, are working to determine where and when real-world data can be trusted.
US FDA follows up the first generic approval of naloxone nasal spray by encouraging companies to apply with generic applications amid the North American opioid crisis.
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.
Darmerica recalls two lots of product labeled as quinacrine, a compound used as a sclerosing agent, which were instead found to contain a treatment for malaria.
There has been a lot of discussion surrounding the use of artificial intelligence in drug development – with several deals, alliances, and partnerships made so far this year. Here, Outsourcing-Pharma takes a look back at some of these announcements, as...
Aetion today announced that former FDA Commissioner Scott Gottlieb has joined its board of directors to help to advance the use of RWE in drug development and commercialization.
Both the FDA and EMA announce NDMA contamination of ranitidine medicines and a lawsuit is immediately filed against manufacturers for ‘concealing’ the carcinogen.
Purdue reaches agreement to settle opioid litigation it is facing in the US by pursuing bankruptcy and providing a suggested $10bn towards the opioid crisis.
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 FDA has extended its agreement with CluePoints to augment the agency’s oversight of clinical trials using data-driven approaches, with additional testing ideas focusing on moderators of treatment effect and real-world evidence, says CCO.
Fewer investigators cite patient recruitment as a top challenge in a recent report which finds investigators also more willing to participate in future clinical trials if working with a preferred central lab.
Mallinckrodt announces a settlement agreement on a lawsuit included in the first federal trial over the opioid crisis, shortly after reaching a deal on a previous investigation.
Mundipharma signs agreement to progress an antifungal candidate through to commercialization, with the potential for it to become the first approved treatment in 13 years.
Increasingly complex clinical trials are putting pressure on CROs to expand their service offerings in what has been a historically monolithic space – with diagnostics also continuing to play a more important role in the market, says industry expert.
Organizations or individuals desiring change is often the reason for retirements, but the timing is often crucial and so it proved for two major institutions in the UK.
The last month of summer saw several hires, including a lead for Worldwide Clinical Trials’ Japan operations, CEO appointments at CordenPharma and LabConnect, and Altasciences’ new CSO, who joins the company from Syneos.
US FDA updates Mylan’s ANDA to commercialize a generic of Lilly’s Alimta with a tentative approval, putting the company on course to enter the market in 2022.
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.
The FDA this week released a new draft guidance encouraging the inclusion of male patients in breast cancer clinical trials, the incidence of which has increased approximately 26% over the last 25 years.
J&J is ordered to pay $572m to the state of Oklahoma, after a court judgement found against the pharmaceutical company for its role in the opioid crisis.
A joint study conducted by the EMA and FDA showed that marketing approval decisions were 90% shared for new medicines, as the agencies push for a closer working relationship.
The FDA posted a public missive alongside a warning letter to a Chinese OTC drug manufacturer, highlighting the efforts it had been making to address data integrity issues.
Rinvoq from AbbVie to be available in the US in late August 2019, after receiving FDA approval for the treatment of adults with active rheumatoid arthritis.
Celgene’s Inrebic becomes the first treatment for myelofibrosis to be approved by the US FDA since 2011 after having received a priority review and orphan drug designation.
Intraprise Health creates the BluePrint Protect platform designed to solve cybersecurity challenges across the pharmaceutical supply chain as third-party data sharing accelerates.
FDA approves the third anti-TB drug in more than 40 years after the compound showed significantly higher success rates in patients with multi drug-resistant and extensively drug-resistant TB.
After 2018 saw numerous sartan drugs recalled for possible carcinogenic impurities, in 2019, the industry kept an eye on the regulatory issues that followed and the breakthroughs that have mitigated some of the risks.
Seres Therapeutics draws distinction between its quality practices and those of the fecal microbiota for transplantation (FMT) operations that triggered FDA alert.
Courts continue to rule in favor of Lilly’s lung cancer treatment patent, as the District Court for Appeals concludes generic producers like Dr Reddy’s to be potentially infringing.
