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.
As a day of climate strikes unfolds across the world, we ask how far pharma is engaged on the issue, as well as noting recent innovations that suggest companies are looking at what can be done.
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.
Both the FDA and EMA announce NDMA contamination of ranitidine medicines and a lawsuit is immediately filed against manufacturers for ‘concealing’ the carcinogen.
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.
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.
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.
Daiichi Sankyo’s Turalio becomes the first FDA-approved TGCT treatment, after receiving breakthrough therapy, priority review and orphan drug designation.
The EMA demands drug developers to change the name of medicines containing liposomal, following reports of ‘serious medication errors’, some leading to death.
API recalls have sparked discussion on the development of impurities during manufacturing and the ways in which risks can be mitigated, according to an industry expert.
Aptar’s needle-free, emergency powder formulation treatment for patients with diabetes and severe hypoglycemia is the company’s first combination drug delivery device with active packaging.
Roche agrees for Sanofi to be responsible for the OTC marketing and distribution of Tamiflu in the US market, as it works on approval for its Xofluza competitor product.
July has seen a number of actions taken by regulators to manage the supply of medicine, including a crackdown on CBD manufacturers and repackers of opioid medication.
Merck to invest in its North Carolina facilities as it expands production capacity to meet demand for its HPV vaccine Gardasil, and grow its packaging operations
O2h Ventures and AI Fund invest in Small Pharma, as it works to complete studies for its lead program, a metabolite of ketamine as an oral anti-depressant.
