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RSS FeedPosted 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
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
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
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 16 Sep 2021
Moderna announces Health Canada approves its COVID-19 vaccine
16 September 2021 - Moderna today announced Health Canada has approved the new drug submission for Spikevax (elasomeran mRNA vaccine), which ...
Posted by Michael Wonder on 16 Sep 2021
Emergency use authorisation for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19
16 September 2021 - Expanded emergency use authorisation includes certain people who have been exposed to someone infected with SARS-CoV-2 ...
Posted by Michael Wonder on 16 Sep 2021
With remdesivir, the Federal Joint Committee assesses the additional benefit of an anti-viral COVID-19 drug for the first time
16 September 2021 - Do patients with COVID-19 have a better chance of surviving and recovering faster if they are treated ...
Posted by Michael Wonder on 16 Sep 2021
Nivolumab in skin cancer: additional benefit upgraded on the basis of an indirect comparison
16 September 2021 - For nivolumab (Opdivo), the pharmaceutical company was able to achieve a significantly better result in a second ...
Posted by Michael Wonder on 16 Sep 2021
BioCryst’s HAE med Orladeyo wins NICE nod
16 September 2021 - BioCryst’s Orladeyo (berotralstat) has received a positive recommendation from NICE for preventing recurrent attacks of hereditary ...
Posted by Michael Wonder on 16 Sep 2021
Takeda’s Exkivity (mobocertinib) approved by U.S. FDA as the first oral therapy specifically designed for patients with EGFR exon 20 insertion positive NSCLC
15 September 2021 - Next generation sequencing companion diagnostic test approved simultaneously to support identification of patients with EGFR exon 20 ...
Posted by Michael Wonder on 15 Sep 2021
Venetoclax in acute myeloid leukaemia: indication of a considerable added benefit
15 September 2021 - Third new area of application/those affected still live a good year on average - and thus ...
Posted by Michael Wonder on 15 Sep 2021
U.S. FDA grants Brukinsa (zanubrutinib) accelerated approval in relapsed or refractory marginal zone lymphoma
15 September 2021 - This marks the third FDA approval for Brukinsa and first approval in marginal zone lymphoma. ...