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RSS FeedPosted by Michael Wonder on 11 Sep 2020
Medexus reports Health Canada approval of Gleolan for use in guided surgical resection of high grade gliomas
10 September 2020 - Medexus Pharmaceuticals today announces that on 9 September 2020, it received a Notice of Compliance from ...
Posted by Michael Wonder on 11 Sep 2020
Junshi Biosciences receives FDA breakthrough therapy designation for toripalimab for the treatment of nasopharyngeal carcinoma
10 September 2020 - Junshi Biosciences announced today that the US FDA has recently granted breakthrough therapy designation to toripalimab for ...
Posted by Michael Wonder on 10 Sep 2020
Terns Pharmaceuticals receives fast track designation for TERN-201 as a treatment for NASH
10 September 2020 - Clinical trial of semicarbazide-sensitive amine oxidase inhibitor TERN-201 in NASH patients planned for early 2021. ...
Posted by Michael Wonder on 10 Sep 2020
China debates cutting US access to drugs as hostilities spike
10 September 2020 - Some government advisers say China should cut drug exports to the US if Washington increases sanctions. ...
Posted by Michael Wonder on 10 Sep 2020
COVID-19 drug rationed in the US is plentiful in developing countries
9 September 2020 - During the coronavirus surge in Texas this summer, Dr. Thomas Patterson said he only had enough ...
Posted by Michael Wonder on 10 Sep 2020
Pfizer may win the COVID vaccine race. But distributing it could be another matter.
10 September 2020 - Needing deep-freeze storage could complicate a massive rollout. ...
Posted by Michael Wonder on 10 Sep 2020
FDA chief says he has ‘no intention’ of overruling career staff on coronavirus vaccine decision
10 September 2020 - The head of the FDA said he has “no intention” of overruling career scientists at the agency ...
Posted by Michael Wonder on 10 Sep 2020
Majority of Americans believe political pressure will cause FDA to rush a coronavirus vaccine, new poll finds
10 September 2020 - A majority of Americans, 62%, believe political pressure from the Trump administration will cause the US ...
Posted by Michael Wonder on 10 Sep 2020
‘Hell has frozen over’: The pharmaceutical industry stands in for a politically impaired FDA
10 September 2020 - How can Americans tell when the FDA has become so politically impaired that it cannot serve ...
Posted by Michael Wonder on 10 Sep 2020
Halozyme announces Janssen submission for FDA approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the treatment of patients with light chain amyloidosis
10 September 2020 - Follows FDA approval of Darzalex Faspro utilising Enhanze technology in May 2020 for the treatment of patients ...
Posted by Michael Wonder on 10 Sep 2020
Vaccine developers hustle to meet FDA data requirements to submit for approval
10 September 2020 - There are many questions regarding the approval of a potential COVID-19 vaccine. ...
Posted by Michael Wonder on 10 Sep 2020
EU review extended for BioMarin's gene therapy Valrox
10 September 2020 - European regulators have requested more data to review the marketing application for BioMarin's haemophilia A gene ...
Posted by Michael Wonder on 10 Sep 2020
FDA approves Trelegy Ellipta as the first once daily single inhaler triple therapy for the treatment of both asthma and COPD in the US
9 September 2020 - New asthma indication for Trelegy Ellipta introduces an important option for patients to the current treatment ...
Posted by Michael Wonder on 10 Sep 2020
Some good news on COVID-19
9 September 2020 - The virus seems to generate a robust and fairly long-lasting immune response. ...
Posted by Michael Wonder on 10 Sep 2020
BeiGene announces acceptance and priority review by Health Canada of new drug submission for Brukinsa (zanubrutinib) in Waldenström’s macroglobulinaemia
9 September 2020 - BeiGene today announced that its new drug submission for Brukinsa (zanubrutinib) for the treatment of patients with ...