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RSS FeedPosted by Michael Wonder on 23 Jun 2022
Expediency versus efficacy: re-examining the FDA’s accelerated drug approval process
23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program ...
Posted by Michael Wonder on 23 Jun 2022
FDA explains when it will rescind breakthrough designations
23 June 2022 - The US FDA on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
23 June 2022 - EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
23 June 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use ...
Posted by Michael Wonder on 23 Jun 2022
COVID-19 vaccine weekly safety report (23 June 2022)
23 June 2022 - To 19 June 2022, the TGA has received 581 reports which have been assessed as likely to ...
Posted by Michael Wonder on 23 Jun 2022
Menarini Group and Radius Health submit new drug application to the U.S. FDA for elacestrant
22 June 2022 - Priority review requested; if accepted, anticipate an 8 month FDA review. ...
Posted by Michael Wonder on 23 Jun 2022
Novartis receives European Commission approval for Tabrecta for the treatment of METex14 skipping advanced non-small cell lung cancer
22 June 2022 - Approval based on the Phase II GEOMETRY mono-1 trial, which showed an overall response rate of 51.6% ...
Posted by Michael Wonder on 23 Jun 2022
Maviret (glecaprevir/pibrentasvir) approved by Health Canada for paediatric patients with chronic hepatitis C
22 June 2022 - This approval is supported by 98.4 per cent cure rate across this group of patients who ...
Posted by Michael Wonder on 23 Jun 2022
Novartis Tafinlar and Mekinist receives FDA approval for first tumour agnostic indication for BRAF V600E solid tumours
22 June 2022 - Approval supported by results from Phase II ROAR and NCI-MATCH studies demonstrating overall response rates up to ...
Posted by Michael Wonder on 22 Jun 2022
U.S. FDA approves Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in infants and children
22 June 2022 - Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four ...
Posted by Michael Wonder on 22 Jun 2022
Krystal Biotech submits biologics license application to U.S. FDA seeking approval of B-VEC for the treatment of patients with dystrophic epidermolysis bullosa
22 June 2022 - Krystal Biotech announced today the submission of a biologics license application to the U.S. FDA seeking ...
Posted by Michael Wonder on 22 Jun 2022
Ikena Oncology receives FDA fast track designation for novel TEAD inhibitor IK-930 to treat unresectable NF2 deficient mesothelioma
22 June 2022 - Ikena Oncology today announced that the U.S. FDA has granted fast track designation for IK-930, the Company’s ...
Posted by Michael Wonder on 22 Jun 2022
FDA grants breakthrough device designation to VR mental illness treatment
22 June 2022 - A British startup that uses virtual reality to help deliver cognitive behaviour therapy has been granted a ...
Posted by Michael Wonder on 22 Jun 2022
Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 low metastatic breast cancer with HR positive and HR negative disease
22 June 2022 - Application based on DESTINY-Breast04 results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan demonstrated superior progression-free and ...
Posted by Michael Wonder on 21 Jun 2022
Paratek Pharmaceuticals’ Nuzyra receives FDA fast track designation for the treatment of pulmonary non-tuberculous mycobacterial disease caused by mycobacterium avium complex and mycobacterium abscessus
21 June 2022 - Phase 2b study in MAB pulmonary infections on-going and enrolling as planned. ...