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RSS FeedPosted by Michael Wonder on 08 Sep 2020
Liminal BioSciences announces resubmission of biologics license application to U.S. FDA for Ryplazim (plasminogen)
8 September 2020 - Results from pivotal Phase 2/3 study met co-primary endpoints for improvement in trough plasminogen activity levels and ...
Posted by Michael Wonder on 08 Sep 2020
U.S. FDA approves Athena Bioscience's new drug application for Qdolo (tramadol hydrochloride) oral solution
8 September 2020 - FDA approved Qdolo (tramadol hydrochloride), an oral liquid, accommodates dosing flexibility, precise titration. ...
Posted by Michael Wonder on 08 Sep 2020
FDA approves first NGS-based companion diagnostic for RET fusion positive non-small cell lung cancer
8 September 2020 - CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for Gavreto. ...
Posted by Michael Wonder on 08 Sep 2020
FDA sets up vaccine safeguards to counter pressure from Trump
8 September 2020 - Guidelines for emergency approval designed to insulate reviewers from influence. ...
Posted by Michael Wonder on 08 Sep 2020
Biopharma leaders unite to stand with science
8 September 2020 - Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the ...
Posted by Michael Wonder on 08 Sep 2020
RadioMedix and Curium announce FDA approval of Detectnet (copper Cu 64 dotatate injection) in the U.S.
7 September 2020 - RadioMedix and its commercial partner Curium announced today that Detectnet (copper Cu 64 dotatate injection) was approved ...
Posted by Michael Wonder on 08 Sep 2020
Janssen announces European Commission decision for expanded use of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia
7 September 2020 - Patients who were new to chronic lymphocytic leukaemia treatment lived longer without disease progression with the Imbruvica ...
Posted by Michael Wonder on 07 Sep 2020
Vaccine experts 'surprised' over Government's 'optimistic' COVID-19 vaccine rollout timeline
7 September 2020 - Vaccine experts have cautioned against the Federal Government's plan to have a COVID-19 vaccine ready by January ...
Posted by Michael Wonder on 07 Sep 2020
Leader of U.S. vaccine push says he‘ll quit if politics trumps science
3 September 2020 - Moncef Slaoui, the scientific head of Operation Warp Speed, spent 29 years making vaccines at GlaxoSmithKline. ...
Posted by Michael Wonder on 07 Sep 2020
Australia secures onshore manufacturing agreements for two COVID-19 vaccines
7 September 2020 - A $1.7 billion agreement between the Australian Government and pharmaceutical companies means that a free COVID-19 vaccine ...
Posted by Michael Wonder on 07 Sep 2020
CSL in deal with commonwealth to produce Oxford University and University of Queensland COVID-19 vaccines
7 September 2020 - Australia’s biggest health company CSL will manufacture two separate COVID-19 vaccines - including the world’s leading ...
Posted by Michael Wonder on 06 Sep 2020
Here's how Trump could bigfoot the FDA and get a vaccine out ahead of the science
5 September 2020 - In 1905, the agency that would later become part of the US FDA approved its first ...
Posted by Michael Wonder on 05 Sep 2020
Biocon, Mylan launch Semglee and seek biosimilar, interchangeable status
31 August 2020 - For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to ...
Posted by Michael Wonder on 05 Sep 2020
Seniors suffer the most from antiquated FDA approval process
4 September 2020 - Americans have been heartbroken as report after report shines a light on the COVID-19 pandemic sweeping ...
Posted by Michael Wonder on 05 Sep 2020
Genentech announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion positive non-small cell lung cancer
4 September 2020 - Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers. ...