Janssen treatment for UK adults with schizophrenia “major step forward”
A new treatment for adults with schizophrenia that is administered twice a year has been approved for use in the UK.
Developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, Byannli (paliperidone palmitate) is the first long-acting injectable schizophrenia treatment to be given marketing authorization in the UK, representing the longest available dosing interval for an anti-psychotic medication in the country.
Approval from the Medicines and Healthcare products Regulatory Agency (MHRA) was based on data from a randomized, double-blind clinical trial that found the treatment is as effective as shorter-acting formulations of paliperidone palmitate at preventing relapse after 12 months.
Commenting on the approval, Professor David Taylor, Director of Pharmacy and Pathology at the Maudsley Hospital in London has called it a “major step forward.” He added: “Long-acting injectable treatments can offer better protection against relapse and greater patient convenience compared with oral medication.
"This authorization is a major step forward for people living with schizophrenia, providing them with the option of a treatment that needs to be administered only twice a year.”
Venus Remedies joins Antimicrobial Industry Alliance
Venus Remedies is the latest pharma organization to join the Antimicrobial Industry Alliance, a global sector coalition that was formed in 2017 following the United Nations’ call for action from governments and industries to address the rise of anti-microbial resistance (AMR).
The coalition has approximately 100 members, most of which are life sciences companies and trade associations.
Venus Remedies, a pharmaceutical organization headquartered in India, has been committed to tackling AMR for more than 10 years. In January 2022 new research showed that AMR is now a leading cause of mortality worldwide, responsible for the deaths of at least 1.2 million people in 2019.
FDA resumes inspections as omicron variant wanes
The US Food and Drug Administration (FDA) is resuming domestic inspections of medical devices as Covid-19 infection rates decline across the country.
The agency had announced in December 2021 that it was pausing inspections to ensure the safety of its employees and those of the firms it regulates.
“In addition to the resumption of planning and conducting domestic surveillance inspections on February 7, the FDA continues to conduct both foreign and domestic mission-critical inspections, as well as provide effective oversight of foods, drugs, medical products and tobacco leveraging a variety of tools, including remote assessments,” the agency said in a statement.
Also in the news
- Johnson & Johnson is facing a push from shareholders to ban global sales of talc baby powder, due to alleged links to cancer.
- Pharmaceutical organizations are increasingly moving their operations to the cloud. Mentions of cloud computing in the filings of pharma companies rose 50 per cent between the second and third quarters of 2021.
- Four companies have been issued with fines of more than £35 million by the UK's competition watchdog for entering into illegal arrangements that led to a 700 per cent increase to the NHS price of prochlorperazine, an anti-sickness medication.
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