In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|April 16, 2020
Expert Working Group Finds Insufficient Evidence Linking Ibuprofen and COVID-19 Susceptibility
Author(s)BioPharm International Editors
The Commission of Human Medicines Expert Working Group has concluded that there is insufficient evidence to link ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), with susceptibility for contracting COVID-19 or worsening symptoms.
Advertisement
The Commission of Human Medicines (CHM) Expert Working Group has concluded that there is insufficient evidence to link ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), with susceptibility for contracting COVID-19 or worsening symptoms.
CHM’s Expert Working Group’s findings were published in an April 14, 2020 press release issued by CHM and the Medicines and Healthcare products Regulatory Agency of the United Kingdom. As a result of the findings, the advice is for patients to use paracetamol or ibuprofen when self-medicating symptoms of COVID-19 but that should further questions arise or if symptoms start to worsen they should follow the advice of the National Health Service.
The government response comes after there was some confusion over the potential link between NSAIDs and the potential of worsening COVID-19 symptoms, reports of which had been circulated widely on social media platforms. The European Medicines Agency issued advice about NSAIDs and COVID-19 in March and stated that the issue will be closely monitored.
Source:
Advertisement
Related to this article
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
Detalimogene voraplasmid produced a 56% complete response rate in BCG-unresponsive bladder cancer, with an estimated 43% of responses lasting a year.
FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Gene-corrected nula-cel freed all 3 RESTORE patients from transfusions, with sickle hemoglobin below 20% in the 2 followed for over 6 months.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
Matt Truppo, Richard Jaenisch, and Brian Drapeau examine AI's impact on drug success, human oversight, data governance, and biopharma's future.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
3
Blackstone to Provide Pfizer Up to $1.5 Billion for Monthly GLP-1 Berobenatide Development
4
Amgen’s Dazodalibep Reduces Systemic Disease Activity in Phase 3 Sjögren’s Trial
5