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RSS FeedPosted by Michael Wonder on 20 Sep 2021
FDA approves first biosimilar to treat macular degeneration disease and other eye conditions
17 September 2021 - The U.S. FDA today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the ...
Posted by Michael Wonder on 20 Sep 2021
FDA clears first technology to distinguish between bacterial and viral infections using the body’s immune response – the MeMed BV test and MeMed key platform
20 September 2021 - MeMed BV is a first-of-its kind test that decodes the immune response to accurately distinguish between bacterial ...
Posted by Michael Wonder on 20 Sep 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for LAG-3-blocking antibody relatlimab and nivolumab fixed dose combination as treatment for patients with unresectable or metastatic melanoma
20 September 2021 - The application is based on Phase 2/3 RELATIVITY-047 trial, in which the relatlimab and nivolumab fixed-dose combination ...
Posted by Michael Wonder on 20 Sep 2021
AbbVie submits regulatory application to FDA for risankizumab-rzaa (Skyrizi) for the treatment of patients 16 years and older with moderate to severe Crohn's disease
20 September 2021 - In three pivotal Phase 3 trials, risankizumab-rzaa demonstrated significant improvements in clinical remission and endoscopic response as ...
Posted by Michael Wonder on 20 Sep 2021
EU panel rejects Pfizer’s tanezumab for osteoarthritis pain
19 September 2021 - Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor ...
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
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 ...