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RSS FeedPosted by Michael Wonder on 11 May 2022
Amicus Therapeutics receives notification of PDUFA date extensions for AT-GAA
10 May 2022 - Amicus Therapeutics today announced that the U.S. FDA has extended the review period by 90 days ...
Posted by Michael Wonder on 20 Apr 2022
Making #MedicinesMatter for all Australians
21 April 2022 - Medicines Australia has launched a social media campaign to highlight key policy issues for the election ...
Posted by Michael Wonder on 14 Apr 2022
U.S. FDA extends review of biologics license application for Regen-Cov (casivirimab and imdemivab) for treatment and prophylaxis of COVID-19
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...
Posted by Michael Wonder on 13 Apr 2022
Irish cancer patients wait four months longer for access to new drugs than rest of Europe
11 April 2022 - Cancer patients in Ireland are waiting on average four months longer than people with the disease ...
Posted by Michael Wonder on 11 Apr 2022
Drug makers pledge speedier European market launches to avert stricter regulation
11 April 2022 - Drug makers on Monday pledged to speed up the market launch of new drugs in underserved ...
Posted by Michael Wonder on 10 Apr 2022
Faster patient access to new medicines must be a priority for next Government
10 April 2022 - With the Federal Election campaign now formally underway, Medicines Australia is reminding the major parties of ...
Posted by Michael Wonder on 06 Apr 2022
U.S. FDA aims to decide on strain selection for COVID boosters by June
6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...
Posted by Michael Wonder on 05 Apr 2022
Rights watchdog urges quick reimbursement of expensive new drugs
5 April 2022 - The National Human Rights Commission of Korea welcomed the recent reimbursement of CAR-T cell therapy Kymriah ...
Posted by Michael Wonder on 04 Apr 2022
Alnylam announces three month extension of review period for new drug application for vutrisiran
4 April 2022 - New PDUFA goal date scheduled for 14 July 2022. ...
Posted by Michael Wonder on 01 Apr 2022
Merck provides update on FDA review of supplemental biologics license application for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 April 2022 - - Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug ...
Posted by Michael Wonder on 25 Mar 2022
Bristol Myers Squibb announces new Prescription Drug User Fee Act goal date for Reblozyl (luspatercept-aamt) supplemental biologics license application
25 March 2022 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the supplemental ...
Posted by Michael Wonder on 21 Mar 2022
Provention Bio announces FDA acceptance of the biologics license application resubmission for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals
21 March 2022 - FDA Sets Goal Date of August 17, 2022. ...
Posted by Michael Wonder on 18 Mar 2022
Advocates say PHARMAC too slow on drugs to help treat COVID-19
19 March 2022 - Kiwis have been left waiting for a new antiviral drug to treat COVID-19 because PHARMAC was too ...
Posted by Michael Wonder on 15 Mar 2022
New access tool launched as part of SMC’s joint work on streamlining patient access to innovative medicines
8 March 2022 - A new UK wide health technology assessment access forum has been developed by partners including the ...
Posted by Michael Wonder on 15 Mar 2022
Prolonged price negotiation for Kymriah devastates leukaemia patients
15 March 2022 - Drained by dragging price negotiations between Novartis and the Government for breakthrough cancer treatment Kymriah (tisagenlecleucel), ...