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RSS FeedPosted by Michael Wonder on 15 Nov 2020
Vaccines including for COVID-19 will be made in new Australian plant
15 November 2020 - A state-of-the-art facility focusing on producing vaccines for things like COVID-19 and snake bites will be built ...
Posted by Michael Wonder on 14 Nov 2020
FDA issues complete response letter for sutimlimab, an investigational treatment for haemolysis in adults with cold agglutinin disease
14 November 2020 - Complete response letter refers to deficiencies from a pre-license inspection of a third-party manufacturing facility. ...
Posted by Michael Wonder on 13 Nov 2020
Heron Therapeutics resubmits new drug application to FDA for HTX-011 for the treatment of post-operative pain
13 November 2020 - Heron Therapeutics today announced that the new drug application was resubmitted to the U.S. FDA for HTX-011, ...
Posted by Michael Wonder on 13 Nov 2020
Highlights from 9-12 November CHMP meeting
13 November 2020 - The EMA’s CHMP recommended five medicines for approval at its November 2020 meeting. ...
Posted by Michael Wonder on 13 Nov 2020
EU secures 300 million doses of BioNTech, Pfizer’s COVID-19 vaccine
13 November 2020 - The European Commission has secured a supply deal with BioNTech and Pfizer for 300 million doses ...
Posted by Michael Wonder on 13 Nov 2020
FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer
13 November 2020 - Today, the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) in combination with chemotherapy for the ...
Posted by Michael Wonder on 13 Nov 2020
Health Canada extends approval of Imvamune to immunisation against monkeypox and orthopox viruses
12 November 2020 - Bavarian Nordic announced today that Health Canada has expanded the approval of the Company’s non-replicating smallpox ...
Posted by Michael Wonder on 13 Nov 2020
Coronavirus: the vaccine is coming, so who should get it first?
13 November 2020 - A specific class of “superspreaders” should be top of the queue for any COVID-19 vaccine once ...
Posted by Michael Wonder on 13 Nov 2020
Angelini Pharma and Sunovion Pharmaceutical Europe receive EMA approval for Latuda, first atypical antipsychotic for the treatment of adolescent schizophrenia in patients starting from 13 years of age
12 November 2020 - Angelini Pharma and Sunovion Pharmaceutical Europe announced today the EMA approval for Latuda (lurasidone), with the indication ...
Posted by Michael Wonder on 12 Nov 2020
FDA grants a breakthrough device designation for Spiderwort spinal cord technology
12 November 2020 - Spiderwort is pleased to announce that the U.S. FDA has designated CelluBridge, Spiderwort’s spinal cord scaffold implant, ...
Posted by Michael Wonder on 12 Nov 2020
Janssen submits applications in U.S. and EU seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Darzalex (daratumumab) subcutaneous formulation in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma
12 November 2020 - Applications supported by positive results from the Phase 3 APOLLO trial, which demonstrated longer progression-free survival in ...
Posted by Michael Wonder on 12 Nov 2020
Promising new therapy for COVID-19 cleared by U.S., still under review by Health Canada
12 November 2020 - Antibody treatment co-developed by Canadian scientists has been approved by US FDA. ...
Posted by Michael Wonder on 12 Nov 2020
EMA publishes agenda for 9-12 November CHMP meeting
12 November 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 12 Nov 2020
BioXcel Therapeutics announces completion of pre-NDA meeting with FDA for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders
11 November 2020 - Initiated rolling submission of new drug application with U.S. FDA. ...
Posted by Michael Wonder on 12 Nov 2020
Coronavirus: vaccine rollout for five million Aussies tipped for March
11 November 2020 - The regulator of medicines in Australia has confirmed it expects to be able to approve the ...