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RSS FeedPosted by Michael Wonder on 21 Jul 2020
EMA sets up infrastructure for real-world monitoring of COVID-19 treatments and vaccines
21 July 2020 - EMA has now set up an infrastructure to support the monitoring of the efficacy and safety ...
Posted by Michael Wonder on 21 Jul 2020
Molecular Partners provides regulatory update of European and Japanese filings of abicipar pegol
20 July 2020 - Molecular Partners today announced that Allergan, an AbbVie company, has informed Molecular Partners of their intent ...
Posted by Michael Wonder on 21 Jul 2020
TGA publishes AusPAR for Vemlidy
21 July 2020 - AusPAR published within days of its provisional registration; why do other take years? ...
Posted by Michael Wonder on 21 Jul 2020
PharmaMar has filed lurbinectedin for Temporary Marketing Authorisation with the Swiss Agency for Therapeutic Products
20 July 2020 - The filing is based on the Phase II multi-centre basket trial efficacy data. ...
Posted by Michael Wonder on 20 Jul 2020
Trials of a vaccine and new drug raise hope of beating COVID-19
20 July 2020 - The latest tests with Oxford University’s vaccine, and interferon beta, look promising. ...
Posted by Michael Wonder on 20 Jul 2020
Many drug companies working on COVID-19 vaccines and treatments are lobbying harder than usual
20 July 2020 - Pharmaceutical companies racing to develop coronavirus treatments and vaccines have upped their lobbying presence in the ...
Posted by Michael Wonder on 20 Jul 2020
Gene therapy shows promise for haemophilia, but could be most expensive U.S. drug ever
20 June 2020 - Jack Grehan, who was born with hemophilia, used to inject himself every couple of days with ...
Posted by Michael Wonder on 20 Jul 2020
Osmotica Pharmaceutical announces FDA user fee goal date of 29 December 2020 for arbaclofen extended release tablets
20 July 2020 - Osmotica Pharmaceuticals, through its subsidiary Osmotica Pharmaceutical US, announced today that the U.S. FDA considers the Company’s ...
Posted by Michael Wonder on 20 Jul 2020
Acadia Pharmaceuticals announces U.S. FDA accepted for filing the supplemental new drug application for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis
20 July 2020 - If approved, Nuplazid would be the first and only treatment indicated for dementia-related psychosis. ...
Posted by Michael Wonder on 20 Jul 2020
Rare disease drove two women on a mission to change FDA drug review process
19 July 2020 - Melissa Goetz and Lindsey Sutton are campaigning to improve the US drug review process for rare diseases. ...
Posted by Michael Wonder on 20 Jul 2020
Orphazyme completes rolling submission of new drug application to U.S. FDA for arimoclomol for Niemann-Pick disease type C
20 July 2020 - Company expects to submit marketing authorisation application for arimoclomol for Niemann-Pick disease type C to European Medicines Agency ...
Posted by Michael Wonder on 20 Jul 2020
Australian COVID researchers warn vaccines will have to be made overseas
20 July 2020 - Researchers at Monash University say if their COVID-19 vaccine is successful they will be forced to ...
Posted by Michael Wonder on 19 Jul 2020
Advanced therapy medicinal products regulations in the EU
16 July 2020 - This article explains some of the terminology relating to advanced therapy medicinal products, including gene and cell-based ...
Posted by Michael Wonder on 19 Jul 2020
Drug regulators remain united on COVID-19, says EU agency boss
18 July 2020 - The fight among governments to secure treatments has brought regulators closer together, says Guido Rasi. ...
Posted by Michael Wonder on 18 Jul 2020
Why biosimilar approval applications break down
17 July 2020 - Investigators found that process complexities have created numerous difficulties for biosimilar developers in regulatory filings, but ...