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RSS FeedPosted by Michael Wonder on 24 Jan 2022
Patients to receive new cancer drugs faster under Brexit rules shake-up
23 January 2022 - Seven medicines already approved as changes cut as much as a month off approval times. ...
Posted by Michael Wonder on 19 Jan 2022
Lieutenant General John Frewen says he expects TGA approval of Novavax vaccine is 'imminent'
19 January 2022 - The head of Australia's vaccine rollout expects one to two per cent of Australians who remain unvaccinated ...
Posted by Michael Wonder on 19 Jan 2022
UK’s NICE to launch sweeping changes to drug assessments to be faster, more agile
19 January 2022 - The health technology assessment body has been under pressure from drugmakers and patient groups for years to ...
Posted by Michael Wonder on 14 Dec 2021
PHARMAC still stalled on lung cancer drug
14 December 2021 - Lung cancer sufferers are still waiting on PHARMAC to reverse a decision made more than a ...
Posted by Michael Wonder on 08 Dec 2021
Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says
8 December 2021 - Pfizer CEO Albert Bourla said he’s confident the full results from the clinical trials will show that ...
Posted by Michael Wonder on 08 Dec 2021
Novavax COVID-19 vaccine could be approved very soon, says EMA chief
8 December 2021 - The head of the EMA on Tuesday said that it could soon approve the COVID-19 vaccine ...
Posted by Michael Wonder on 07 Dec 2021
U.S. plans to fast track revamped COVID-19 vaccines
5 December 2021 - Study from South Africa suggests the fast-spreading Omicron variant might cause less severe illness than its predecessors. ...
Posted by Michael Wonder on 07 Dec 2021
Critics blame diabetes deaths on PHARMAC taking years to fund new drug
6 December 2021 - Diabetes Foundation Aotearoa says PHARMAC's delay funding new diabetes drugs has led to many deaths in Māori ...
Posted by Michael Wonder on 01 Dec 2021
BioXcel Therapeutics announces extension of FDA review period of its NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders
1 December 2021 - PDUFA date extended by three months to 5 April 2022. ...
Posted by Michael Wonder on 01 Dec 2021
CTI BioPharma announces extension of FDA review period for pacritinib in myelofibrosis with severe thrombocytopenia
30 November 2021 - CTI BioPharma today announced the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 23 Nov 2021
Amryt provides update on regulatory review process for Oleogel-S10
23 November 2021 - FDA PDUFA goal date extended by three months to 28 February 2022. ...
Posted by Michael Wonder on 22 Nov 2021
Bristol Myers Squibb announces new PDUFA date for mavacamten
19 November 2021 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the new ...
Posted by Michael Wonder on 11 Nov 2021
Moderna booster progress ‘well advanced’ as regulator considers child vaccines
11 November 2021 - Moderna’s coronavirus vaccine could be approved for use as a booster within weeks and the medical ...
Posted by Michael Wonder on 09 Nov 2021
FDA’s Woodcock says agency has resumed normal review pace for biosimilars, generics
9 November 2021 - Janet Woodcock, MD, acting commissioner of the FDA, delivered an upbeat report on biosimilars and generics progress ...
Posted by Michael Wonder on 06 Nov 2021
Pharmaceutical Benefits Scheme continued dispensing arrangements
5 November 2021 - The Australian Government has extended the Continued Dispensing emergency arrangements until 30 June 2022, when they ...