Blog
RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 17 Jul 2020
FDA grants fast track designation for DB102 in patients with newly diagnosed glioblastoma
17 July 2020 - Denovo Biopharma today announced that the U.S. FDA has granted fast track designation for DB102 (enzastaurin) being ...
Posted by Michael Wonder on 16 Jul 2020
Farxiga granted fast track designation in the US for heart failure following acute myocardial infarction leveraging an innovative registry-based trial design
16 July 2020 - Phase III DAPA-MI trial will evaluate Farxiga as a treatment to reduce mortality and the risk of ...
Posted by Michael Wonder on 16 Jul 2020
Hanmi’s fatty liver drug won FDA’s fast track designation
16 July 2020 - Hanmi Pharmaceutical said Thursday that the U.S. FDA has granted fast-track designation to its LAPSTriple Agonist ...
Posted by Michael Wonder on 16 Jul 2020
Deep dive into big pharma AI productivity: one study shaking the pharmaceutical industry
15 July 2020 - The pharmaceutical business is perhaps the only industry on the planet, where to get the product from ...
Posted by Michael Wonder on 16 Jul 2020
FDA grants priority review to Merck’s new drug application for vericiguat
16 July 2020 - Application based on first contemporary outcomes study focused exclusively on chronic heart failure patient population following a ...
Posted by Michael Wonder on 16 Jul 2020
Knopp Biosciences receives rare paediatric disease designation for Kv7 activator KB-3061 for treatment of KCNQ2 epileptic encephalopathy
15 July 2020 - Knopp Biosciences announced today that it has received rare paediatric disease designation from the U.S. FDA ...
Posted by Michael Wonder on 15 Jul 2020
Improving clinical trial enrollment — In the COVID-19 era and beyond
15 July 2020 - More than 3 million people in the United States are known to have been infected with SARS-CoV-2. ...