Blog
RSS FeedPosted by Michael Wonder on 18 Oct 2020
First CAR-T cell medicine for mantle cell lymphoma
16 October 2020 - EMA has recommended granting a conditional marketing authorisation in the European Union for Tecartus (autologous anti-CD19 ...
Posted by Michael Wonder on 18 Oct 2020
First treatment for rare condition primary hyperoxaluria type 1
16 October 2020 - EMA has recommended granting a marketing authorisation in the European Union for Oxlumo (lumasiran) for the ...
Posted by Michael Wonder on 18 Oct 2020
First long-acting injectable antiretroviral therapy for HIV recommended for approval
16 October 2020 - EMA has recommended the granting of marketing authorisations for two new antiretroviral medicines, Rekambys (rilpivirine) and Vocabria ...
Posted by Michael Wonder on 18 Oct 2020
CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis
16 October 2020 - Data further reinforce the well-established safety profile of Dupixent in adult and adolescent atopic dermatitis patients. ...
Posted by Michael Wonder on 17 Oct 2020
Health Canada approves Keytruda (pembrolizumab) as first-line treatment for patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma
15 October 2020 - Approval Based on Significant Overall Survival Findings from Phase 3 KEYNOTE-048 Trial. ...
Posted by Michael Wonder on 17 Oct 2020
Venclexta (venetoclax) receives FDA full approval for acute myeloid leukaemia
16 October 2020 - The FDA approval of Venclexta for newly diagnosed AML patients who are ineligible for intensive chemotherapy is ...
Posted by Michael Wonder on 15 Oct 2020
Health Canada approves first-ever gene replacement therapy, Luxturna
15 October 2020 - Luxturna (voretigene neparvovec), is the first approved therapy for previously untreatable inherited retinal disease. ...
Posted by Michael Wonder on 15 Oct 2020
Testing requirements are likely slowing biosimilar entries in the US
14 October 2020 - Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation ...
Posted by Michael Wonder on 15 Oct 2020
Scynexis announces submission of new drug application to the U.S. FDA for oral ibrexafungerp for the treatment of vaginal yeast infection
15 October 2020 - NDA submission is supported by positive data from two Phase 3 studies (VANISH Program) in women with ...
Posted by Michael Wonder on 15 Oct 2020
EMA cancer symposium: new approaches in patient-focused cancer medicine development
15 October 2020 - On Thursday, 29 October, EMA is hosting a symposium to discuss new approaches to facilitating and ...
Posted by Michael Wonder on 15 Oct 2020
FDA approves expanded indication for Merck’s Keytruda (pembrolizumab) in adult patients with relapsed or refractory classical Hodgkin lymphoma
15 October 2020 - Keytruda is the first anti-PD-1 therapy approved for adult patients with relapsed or refractory classic Hodgkin lymphoma ...
Posted by Michael Wonder on 15 Oct 2020
EMA confirms eligibility for submission of Moderna’s COVID-19 vaccine
15 October 2020 - The EMA has confirmed that Moderna’s COVID-19 vaccine candidate mRNA-1273 is eligible for submission under the ...
Posted by Michael Wonder on 15 Oct 2020
Taysha Gene Therapies receives rare paediatric disease designation and orphan drug designation for TSHA-102 as a treatment for Rett syndrome
14 October 2020 - Program leverages novel miRARE platform technology used to control transgene expression on a cellular basis. ...
Posted by Michael Wonder on 14 Oct 2020
TGA grants second provisional determination for a COVID-19 vaccine
14 October 2020 - The Therapeutic Goods Administration has granted a provisional determination to Pfizer Australia in relation to its ...
Posted by Michael Wonder on 14 Oct 2020
FDA approves first treatment for Ebola virus
14 October 2020 - Today, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three ...