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RSS FeedPosted by Michael Wonder on 06 Aug 2021
Novavax and European Commission finalise advance purchase agreement for up to 200 million doses of COVID-19 vaccine
4 August 2021 - Agreement for 100 million doses with option for additional 100 million doses through 2023. ...
Posted by Michael Wonder on 06 Aug 2021
Spectrum Pharmaceuticals receives complete response letter from FDA for Rolontis (eflapegrastim)
6 August 2021 - Spectrum Pharmaceuticals today announced receipt of a complete response letter from the U.S. FDA regarding the company’s ...
Posted by Michael Wonder on 06 Aug 2021
Merck’s Keytruda (pembrolizumab) significantly prolonged recurrence-free survival compared to placebo as adjuvant therapy for patients with stage II resected high-risk melanoma in Phase 3 KEYNOTE-716 trial
5 August 2021 - US FDA grants priority review to Merck’s application for Keytruda based on these data. ...
Posted by Michael Wonder on 06 Aug 2021
Novavax delays Covid vaccine emergency authorisation submission to FDA until fourth quarter
5 August 2021 - The company says it is still on track to produce 100 million doses per month by the ...
Posted by Michael Wonder on 06 Aug 2021
Interoperability of track and trace systems: key to public health protection
6 August 2021 - EMA has endorsed recommendations developed by the International Coalition of Medicines Regulatory Authorities to facilitate the use ...
Posted by Michael Wonder on 06 Aug 2021
Formycon and Bioeq announce submission of the biologics license application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the U.S. FDA
5 August 2021 - Formycon and its license partner Bioeq announce that the biologics license application for FYB201, Formycon’s biosimilar ...
Posted by Michael Wonder on 06 Aug 2021
Altoida awarded FDA breakthrough designation for development of world’s first precision neurology device for prediction of Alzheimer's disease
5 August 2021 - Breakthrough designation will advance the development of industry’s first predictive diagnostic device for conversion to Alzheimer’s disease, ...
Posted by Michael Wonder on 05 Aug 2021
Exelixis announces U.S. FDA accepts for priority review the supplemental new drug application for Cabometyx (cabozantinib) for patients with previously treated radioactive iodine refractory differentiated thyroid cancer
5 August 2021 - U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act action date of 4 December ...
Posted by Michael Wonder on 05 Aug 2021
Pillar Biosciences receives premarket approval from FDA for its oncoReveal Dx lung and colon cancer assay
5 August 2021 - Pillar Biosciences today announced the U.S. FDA has given premarket approval to its oncoReveal Dx Lung ...
Posted by Michael Wonder on 05 Aug 2021
Eiger announces FDA breakthrough therapy designation for avexitide for treatment of congenital hyperinsulinism
5 August 2021 - All five orphan programs now have breakthrough therapy designation. ...
Posted by Michael Wonder on 05 Aug 2021
From Our Perspective: FDA approval demonstrates the role of real world evidence in regulatory decision-making on drug effectiveness
4 August 2021 - In this CDER From Our Perspective, experts discuss the recent FDA approval of Prograf (tacrolimus) in combination ...
Posted by Michael Wonder on 05 Aug 2021
MT-3921 granted FDA fast track designation for treatment of spinal cord injury
4 August 2021 - Mitsubishi Tanabe Pharma announced today that Mitsubishi Tanabe Pharma Development America has received fast track designation ...
Posted by Michael Wonder on 05 Aug 2021
COVID-19 vaccine weekly safety report (5 August 2021)
5 August 2021 - Three additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 05 Aug 2021
Lupus drug will be ‘game changer’
5 August 2021 - The first targeted treatment for the debilitating auto-immune condition lupus could soon be available in Australia after ...
Posted by Michael Wonder on 05 Aug 2021
Health Canada approves Arazlo lotion for acne vulgaris treatment
4 August 2021 - Bausch Health said that Health Canada has approved the Notice of Compliance for Arazlo ( tazarotene) ...