Blog
RSS FeedPosted by Michael Wonder on 18 Oct 2020
PBAC recommends Zeposia for patients with relapsing-remitting multiple sclerosis
16 October 2020 - Did Celgene really request its use for the treatment of non-premenopausal patients with hormone receptor positive, ...
Posted by Michael Wonder on 18 Oct 2020
Highlights from 12-15 October CHMP meeting
16 October 2020 - Ten new medicines recommended for approval. ...
Posted by Michael Wonder on 18 Oct 2020
Novartis receives positive CHMP opinion for Leqvio (inclisiran), a potential first-in-class siRNA for the treatment of high cholesterol
16 October 2020 - If approved, inclisiran will be the first and only small interfering RNA (siRNA) in Europe for patients ...
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 16 Oct 2020
Recommendations made by the PBAC - September 2020 intracycle meeting and out of session between July 2020 and September 2020 meetings
16 October 2020 - The recommendations from the September 2020 PBAC intracycle meeting are now available. ...
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
NICE draft guidance recommends siponimod for treating secondary progressive multiple sclerosis
15 October 2020 - NICE has today issued draft guidance which now recommends siponimod (Mayzent; Novartis) for treating secondary progressive multiple ...
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
NICE recommends Novartis’ Mayzent on the heels of SMC approval
15 October 2020 - NICE has recommended Novartis’ Mayzent for use by NHS England, only a few days after the ...
Posted by Michael Wonder on 15 Oct 2020
Prime Minister committed to PHARMAC investigation, but Health Minister at odds
15 October 2020 - On 30 September Prime Minister Jacinda Ardern committed to having an investigation into PHARMAC’s decision-making processes, ...