Blog
RSS FeedPosted by Michael Wonder on 15 Mar 2022
Drug industry says EMA’s PRIME scheme useful but could be improved
14 March 2022 - Eligibility criteria for admission to the EMA's priority medicines (PRIME) scheme are too strict to facilitate ...
Posted by Michael Wonder on 07 Mar 2022
Horizon Therapeutics announces FDA has granted priority review of the supplemental biologics license application for the concomitant use of Krystexxa (pegloticase injection) plus methotrexate for people living with uncontrolled gout
7 March 2022 - Application based on recent MIRROR randomised controlled trial results, which showed 71% of patients randomised to ...
Posted by Michael Wonder on 07 Mar 2022
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib tablets) in combination with azacitidine for patients with previously untreated IDH1 mutated acute myeloid leukaemia
7 March 2022 - sNDA based on data from the global, Phase 3, AGILE trial evaluating Tibsovo in combination with ...
Posted by Michael Wonder on 03 Mar 2022
PRIME enables earlier availability of life-changing medicines
3 March 2022 - EMA’s PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines that ...
Posted by Michael Wonder on 02 Mar 2022
Advanced Innovative Partners announces designation for rare paediatric disease drug
1 March 2022 - AIP is pleased to announce that the U.S Food and Drug Administration (FDA) has granted Orphan Drug ...
Posted by Michael Wonder on 01 Mar 2022
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) plus chemotherapy as neo-adjuvant treatment for resectable non-small cell lung cancer
28 February 2022 - Application based on CheckMate-816, the first Phase 3 trial with an immunotherapy-based combination to demonstrate improved event-free ...
Posted by Michael Wonder on 17 Feb 2022
U.S. FDA accepts for priority review Bristol Myers Squibb’s supplemental biologics license application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma
17 February 2022 - U.S. FDA has assigned a target action date of 24 June 2022. ...
Posted by Michael Wonder on 10 Feb 2022
FDA accepts Dupixent (dupilumab) for priority review in children aged 6 months to 5 years with moderate to severe atopic dermatitis
10 February 2022 - If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled ...
Posted by Michael Wonder on 10 Feb 2022
BioMarin sells priority review voucher for $110 million
9 February 2022 - BioMarin Pharmaceutical today announced that it has entered into a definitive agreement with an undisclosed purchaser to ...
Posted by Michael Wonder on 09 Feb 2022
FDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences
9 February 2022 - Adds five years of market exclusivity on approval. ...
Posted by Michael Wonder on 02 Feb 2022
QSAM Biosciences receives rare paediatric disease designation from FDA for CycloSam in the treatment of osteosarcoma
2 February 2022 - QSAM Biosciences today announces that the United States FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 27 Jan 2022
Lantern Pharma receives rare paediatric disease and orphan drug designations for LP-184 for the treatment of atypical teratoid rhabdoid tumour
24 January 2022 - Lantern Pharma today announced that the U.S. FDA has granted both rare paediatric disease designation and orphan ...
Posted by Michael Wonder on 26 Jan 2022
Catalyst Biosciences receives rare paediatric disease designation for CB 4332 for the treatment of CFI deficiency
25 January 2022 - Catalyst Biosciences today announced the U.S. FDA has granted rare paediatric disease designation for CB 4332 for ...
Posted by Michael Wonder on 24 Jan 2022
Codexis announces FDA orphan drug and rare paediatric disease designations for CDX-6512 for the treatment of homocystinuria
24 January 2022 - Codexis today announced that the U.S. FDA has granted the company orphan drug designation for CDX-6512 for ...
Posted by Michael Wonder on 17 Jan 2022
Enhertu granted priority review in the U.S. for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen
17 January 2022 - Application being evaluated under FDA Real-Time Oncology Review and Project Orbis ...