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RSS FeedPosted by Michael Wonder on 25 May 2024
Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe
23 May 2024 - The European Commission decision is based on clinical evidence, including results from a Phase 3 clinical trial ...
Posted by Michael Wonder on 24 May 2024
Camurus receives EMA acceptance of MAA filing for octreotide SC depot (CAM2029) for the treatment of acromegaly
23 May 2024 - Camurus today announced that the EMA has accepted for review the company’s marketing authorisation application for octreotide ...
Posted by Michael Wonder on 22 May 2024
Sandoz receives European Commission approval for Wyost and Jubbonti, the first and only biosimilars of denosumab in Europe
22 May 2024 - EC approval based on robust development program confirming that biosimilar matches reference medicine in terms of ...
Posted by Michael Wonder on 21 May 2024
Wugen announces RMAT and PRIME designations for WU-CART-007 to accelerate regulatory reviews
20 May 2024 - Researchers to present new Phase 2 data showing safety and anti-leukaemic activity with WU-CART-007 and additional new ...
Posted by Michael Wonder on 09 May 2024
Aspaveli (pegcetacoplan) approved in Europe for use among treatment naïve adult patients with PNH
8 May 2024 - Sobi today announced that the European Commission has approved an indication extension for Aspaveli (pegcetacoplan) for ...
Posted by Michael Wonder on 06 May 2024
EMA validates Bristol Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer
6 May 2024 - Application based on results from the CheckMate-8HW study, in which Opdivo plus Yervoy demonstrated statistically significant ...
Posted by Michael Wonder on 02 May 2024
Johnson & Johnson submits regulatory applications to EMA for Tremfya (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease
1 May 2024 - Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI ...
Posted by Michael Wonder on 30 Apr 2024
Johnson & Johnson receives positive CHMP opinion recommending full approval for Sirturo (bedaquiline) for treatment of multidrug-resistant tuberculosis
29 April 2024 - Recommendation supported by results from the Phase 3 STREAM Stage 2 study, which show bedaquiline-containing regimens offer ...
Posted by Michael Wonder on 29 Apr 2024
Truqap plus Faslodex recommended for approval in the EU by CHMP for patients with advanced ER positive breast cancer
29 April 2024 - Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression ...
Posted by Michael Wonder on 27 Apr 2024
Highlights from the 22-25 April 2024 CHMP meeting
26 April 2024 - The EMA’s CHMP recommended eight medicines for approval at its April 2024 meeting. ...
Posted by Michael Wonder on 27 Apr 2024
Biogen receives positive CHMP opinion for Tofidence (tocilizumab), a biosimilar referencing RoActemra
25 April 2024 - CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing Tofidence ...
Posted by Michael Wonder on 27 Apr 2024
Pierre Fabre Laboratories receive positive CHMP opinion for Obgemsa (vibegron) in overactive bladder syndrome
26 April 2024 - Pierre Fabre Laboratories announced that the CHMP of the EMA has adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 27 Apr 2024
Takeda receives positive CHMP opinion for fruquintinib in previously treated metastatic colorectal cancer
26 April 2024 - If approved in the European Union, fruquintinib will be the first novel targeted therapy for metastatic colorectal ...
Posted by Michael Wonder on 27 Apr 2024
Johnson & Johnson receives positive CHMP opinion for Rybrevant (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
26 April 2024 - The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy ...
Posted by Michael Wonder on 27 Apr 2024
CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
26 April 2024 - Recommendation based on results from CheckMate-901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate ...