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RSS FeedPosted by Michael Wonder on 25 Jul 2021
COVID-19 demand leads to Australian shortages of rheumatoid arthritis drug
25 July 2021 - Australia is facing shortages of a rheumatoid arthritis drug that has been used to treat COVID-19 ...
Posted by Michael Wonder on 25 Jul 2021
Australia is racing to make mRNA COVID vaccines here — but can we do it without big pharma?
26 July 2021 - Australia is one of many nations seeking to make the type of COVID-19 vaccine pioneered by Pfizer ...
Posted by Michael Wonder on 25 Jul 2021
EMA CHMP adopts positive opinion recommending authorisation for the use of the Moderna COVID-19 Vaccine in adolescents (12-17 years of age) in the European Union
23 July 2021 - . 23, 2021-- Moderna today announced that the EMA's CHMP adopted a positive opinion recommending marketing authorisation ...
Posted by Michael Wonder on 25 Jul 2021
Patient advocacy organisations and FDA drug approval: lessons from Aduhelm
23 July 2021 - In the wake of last month’s controversial FDA approval of Biogen’s Aduhelm, Alzheimer’s Association CEO Harry ...
Posted by Michael Wonder on 25 Jul 2021
Highlights from the 19-22 July CHMP meeting
23 July 2021 - Two new medicines recommended for approval. ...
Posted by Michael Wonder on 24 Jul 2021
Kyowa Kirin provides update on application for marketing authorisation of istradefylline in Europe for the treatment of ‘OFF’ episodes in people living with Parkinson’s
23 July 2021 - Kyowa Kirin today announced that the EMA's CHMP issued a negative opinion for istradefylline as an add-on ...
Posted by Michael Wonder on 24 Jul 2021
Incyte provides regulatory update on retifanlimab for the treatment of certain patients with squamous cell carcinoma of the anal canal
23 July 2021 - Incyte today announced that the U.S. FDA has issued a complete response letter regarding its biologics license ...
Posted by Michael Wonder on 24 Jul 2021
COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU
23 July 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously COVID-19 Vaccine ...
Posted by Michael Wonder on 24 Jul 2021
Dalvance (dalbavancin) receives FDA approval to treat acute bacterial skin and skin structure infections in paediatric patients
23 July 2021 - Dalvance is the first and only single dose infusion to treat acute bacterial skin and skin structure ...
Posted by Michael Wonder on 23 Jul 2021
Most clinical trials failed to meet U.S. transparency requirements for recently approved drugs
22 July 2021 - In the latest look at clinical trial transparency, a new analysis found that only 26% of ...
Posted by Michael Wonder on 23 Jul 2021
‘When memory fades’: misinformation about Alzheimer’s disease and Aduhelm must be limited
21 July 2021 - Surgeon General Vivek Murthy issued a timely and thought-provoking advisory about the serious threat to public ...
Posted by Michael Wonder on 23 Jul 2021
TGA hopes to approve Moderna COVID-19 vaccine by early August
23 July 2021 - Therapeutic Goods Administration head John Skerritt said the Moderna vaccine looked promising, but he was still ...
Posted by Michael Wonder on 23 Jul 2021
TGA provisional approval of Pfizer-BioNTech COVID-19 vaccine to include 12-15 year age group
23 July 2021 - The TGA has provisionally approved the use of the Pfizer BNT162b2 COVID-19 vaccine (Comirnaty) in individuals 12 ...
Posted by Michael Wonder on 23 Jul 2021
GBT provides regulatory and pipeline updates in sickle cell disease
22 July 2021 - Submits supplemental new drug application to the U.S. FDA for Oxbryta (voxelotor) in children with SCD ages ...
Posted by Michael Wonder on 22 Jul 2021
Novartis aims to beat rivals to novel $10 billion cancer treatment market
22 July 2021 - Trial results for new targeted therapy ‘pretty remarkable’, says CEO. ...