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RSS FeedPosted by Michael Wonder on 28 Jul 2020
Janssen receives CHMP positive opinion for expanded use of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia
24 July 2020 - Positive opinion is supported by Phase 3 E1912 study evaluating ibrutinib-rituximab combination versus chemo-immunotherapy in first-line treatment ...
Posted by Michael Wonder on 28 Jul 2020
Momenta Pharmaceuticals announces FDA rare paediatric disease designation for nipocalimab in HDFN
28 July 2020 - Momenta Pharmaceuticals today announced that its novel drug candidate, nipocalimab, has received rare paediatric disease designation ...
Posted by Michael Wonder on 28 Jul 2020
Black Diamond Therapeutics granted fast track designation by the FDA for BDTX-189 for the treatment of adult patients with a solid tumour harbouring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion mutation
28 July 2020 - Black Diamond Therapeutics today announced that the U.S. FDA granted fast track designation to BDTX-189 for the ...
Posted by Michael Wonder on 28 Jul 2020
Foresee Pharmaceuticals announces submission of NDA for FDA approval of LMIS 50 mg
27 July 2020 - Foresee Pharmaceuticals announced today that it has submitted to the U.S. FDA a new drug application ...
Posted by Michael Wonder on 28 Jul 2020
Lumos Pharma announces sale of priority review voucher
27 July 2020 - ) -- Lumos Pharma today announced that it has entered into a definitive agreement to sell ...
Posted by Michael Wonder on 28 Jul 2020
European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis
27July 2020 - The EU marketing authorisation is based on pivotal data comparing the pharmacokinetics, efficacy and safety of the intravenous ...
Posted by Michael Wonder on 28 Jul 2020
Dr. Reddy's Laboratories received approval of Xeglyze (abametapir) 0.74% lotion in the U.S.
27 July 2020 - Dr. Reddy’s Laboratories today announced approval of Xeglyze (abametapir) 0.74% topical lotion, new drug application by the ...
Posted by Michael Wonder on 27 Jul 2020
TGA approves Zeposia for patients with multiple sclerosis
27 July 2020 - Zeposia has been approved under the Black Triangle Scheme. ...
Posted by Michael Wonder on 27 Jul 2020
EU talks with Pfizer, Sanofi, J&J on COVID vaccines hit snags
28 July 2020 - European efforts to secure potential COVID-19 vaccines from Pfizer, Sanofi and Johnson & Johnson are mired in ...
Posted by Michael Wonder on 27 Jul 2020
scPharmaceuticals announces FDA acceptance of Furoscix new drug application resubmission
27 July 2020 - FDA sets PDUFA date of 30 December 2020. ...
Posted by Michael Wonder on 27 Jul 2020
Insmed receives positive CHMP opinion for Arikayce liposomal 590 mg nebuliser dispersion for the treatment of NTM lung infections caused by MAC in non-CF patients with limited treatment options
24 July 2020 - If approved, Arikayce will be first and only therapy in the European Union for this difficult to ...
Posted by Michael Wonder on 27 Jul 2020
Eton Pharmaceuticals submits new drug application to the FDA for orphan drug dehydrated alcohol injection
27 July 2020 - Since the start of COVID-19, the FDA has recalled more than 75 contaminated hand sanitisers due to ...
Posted by Michael Wonder on 27 Jul 2020
Checkmate Pharmaceuticals granted FDA fast track designation for CMP-001 combined with PD-1 blockade in the treatment of certain types of metastatic or unresectable melanoma
27 July 2020 - Checkmate Pharmaceuticals today announced that the U.S. FDA granted fast track designation to its product candidate, ...
Posted by Michael Wonder on 27 Jul 2020
Gilead and Galapagos announce positive European CHMP opinion for Jyseleca (filgotinib) for the treatment of adults with moderate to severe rheumatoid arthritis
24 June 2020 - Clinical development program of filgotinib demonstrated durable efficacy balanced with a consistent safety profile in rheumatoid ...
Posted by Michael Wonder on 27 Jul 2020
Sobi will file for a re-examination of emapalumab in Europe following negative opinion by CHMP
24 July 2020 - Swedish Orphan Biovitrum today announced that the Committee for Medicinal Products for Human use (CHMP) has adopted ...