Blog
RSS FeedPosted by Michael Wonder on 21 Sep 2021
Covid-19 delta outbreak: major PHARMAC review report delayed by lockdown
22 September 2021 - Act says it is "not good enough" an interim report for a much touted independent PHARMAC ...
Posted by Michael Wonder on 19 Sep 2021
Highlights from the CHMP 13-16 September 2021 meeting
17 September 2021 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2021 meeting. ...
Posted by Michael Wonder on 19 Sep 2021
Should regulatory authorities approve drugs based on surrogate outcomes?
16 September 2021 - The aducanumab controversy is the latest example of surrogate outcomes failing to predict clinically important outcomes. ...
Posted by Michael Wonder on 19 Sep 2021
GSK receives CHMP positive opinions recommending approval of Nucala (mepolizumab) in three additional eosinophil driven diseases
17 September 2021 - If approved in Europe, mepolizumab would be the only treatment indicated for use in four eosinophil-driven diseases. ...
Posted by Michael Wonder on 19 Sep 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)
17 September 2021 - Recommendation based on data from Phase 3 KEYNOTE-355 trial. ...
Posted by Michael Wonder on 19 Sep 2021
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with Waldenström’s macroglobulinaemia
17 September 2021 - The CHMP recommendation is based on results from the Phase 3 ASPEN trial, in which BRUKINSA ...
Posted by Michael Wonder on 18 Sep 2021
Roche receives positive CHMP opinion for Gavreto (pralsetinib) for the treatment of adults with RET fusion positive advanced non-small-cell lung cancer
17 September 2021 - If approved, Gavreto will be the first and only targeted treatment approved by the EMA that ...
Posted by Michael Wonder on 18 Sep 2021
Pharmacist substitution of PBS medicines without a prescription during shortages (Serious Scarcity Substitution Instrument)
18 September 2021 - Where a Serious Scarcity Substitution Instrument has been issued by the TGA, community pharmacists can substitute specific ...
Posted by Michael Wonder on 18 Sep 2021
Alvotech welcomes positive CHMP opinion for AVT02, a proposed biosimilar to Humira
17 September 2021 - Alvotech today welcomed the positive opinion of the EMA's CHMP recommending the approval of Alvotech‘s high-concentration AVT02 ...
Posted by Michael Wonder on 18 Sep 2021
Incyte announces Health Canada conditional approval of Pemazyre (pemigatinib) as first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma
17 September 2021 - Incyte today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre (pemigatinib), ...
Posted by Michael Wonder on 18 Sep 2021
FDA advisory committee votes unanimously in favour of Comirnaty booster for emergency use in people 65 and older and certain high risk population
17 September 2021 - Committee reviewed clinical data showing a booster dose of Comirnaty elicits high neutralisation titres against SARS-CoV-2 and ...
Posted by Michael Wonder on 18 Sep 2021
Exelixis announces U.S. FDA approval of Cabometyx (cabozantinib) for patients with previously treated radioactive iodine-refractory differentiated thyroid cancer
17 September 2021 - FDA approval based on Phase 3 COSMIC-311 pivotal trial, which demonstrated significant improvement in progression-free survival with ...
Posted by Michael Wonder on 17 Sep 2021
Keytruda made available on the NHS for certain oesophageal cancer patients
17 September 2021 - NICE has recommended MSD’s Keytruda (pembrolizumab) combined with chemotherapy for the first-line treatment of certain oesophageal ...
Posted by Michael Wonder on 17 Sep 2021
Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full Health Canada approval for individuals 12 years and older
16 September 2021 - Health Canada Notice of Compliance is based on a comprehensive submission package including six month efficacy ...
Posted by Michael Wonder on 17 Sep 2021
BridgeBio Pharma receives FDA fast track designation for investigational therapy for the treatment of limb-girdle muscular dystrophy type 2i (LGMD2i)
15 September 2021 - If successful, BridgeBio's drug could be the first approved therapy for patients with LGMD2i. ...
Posted by Michael Wonder on 17 Sep 2021
ICER releases draft evidence report on therapies for severe asthma
16 September 2021 - Public comment period now open until 14 October 2021; requests to make oral comment during public ...