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RSS FeedPosted 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 ...
Posted by Michael Wonder on 12 Nov 2020
Cystic Fibrosis Canada says 'life-changing' drug coming to Canada, but approval months away
11 November 2020 - The drug's manufacturer says it's moving forward with its cystic fibrosis medicines in Canada. ...
Posted by Michael Wonder on 12 Nov 2020
The challenges ahead with monoclonal antibodies: from authorisation to access
11 November 2020 - When President Trump received an infusion of a monoclonal antibody cocktail (REGN-COV2, Regeneron) on October 2, ...
Posted by Michael Wonder on 11 Nov 2020
Angiocrine Bioscience announces FDA regenerative medicine advanced therapy designation granted to AB-205 (universal E-CEL cell therapy) to treat organ vascular niche injuries for the prevention of severe toxicities in lymphoma patients undergoing curative high-dose therapy with autologous stem cell transplantation
11 November 2020 - Angiocrine Bioscience today announced that the U.S. FDA granted the regenerative medicine advanced therapy designation for AB-205, ...