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The CHMP has recommended Ondibta, a biosimilar insulin glargine pre-filled pen for pts (age≥ 2), reference medicine Lantus SoloStar. The EC will now review the opinion, and approval is anticipated across the EU and EEA states
Insulin glargine is a long-acting, once-daily basal insulin analog that provides up to 24 hours of steady, peakless glucose-lowering activity
Ondibta completed head-to-head P-III trials in both the EU and the US against Lantus, with studies in…
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The CHMP has recommended Waskyra, an ex vivo gene therapy for Wiskott-Aldrich Syndrome (WAS)
Waskyra is a single-administration therapy that uses a patient’s CD34+ hematopoietic stem and progenitor cells, modified with a lentiviral vector carrying the WAS gene
The therapy will be available to pts at IRCCS Ospedale San Raffaele, where the clinical trial was conducted. The BLA for WAS…
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The UK’s MHRA has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, axial spondylarthritis & ulcerative colitis in adult pts & juvenile idiopathic arthritis, following CHMP’s positive opinion
Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while…
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The CHMP has recommended Shingrix in a PFS (Recombinant Zoster Vaccine or RZV), simplifying administration by eliminating vial reconstitution for the prevention of shingles (herpes zoster). EU marketing authorization is expected in December 2025
The opinion was based on data showing that the PFS matches the existing vaccine
Shingrix combines glycoprotein E antigen with…
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The CHMP has recommended Wayrilz (rilzabrutinib) for adults with ITP unresponsive to other treatments, with a final decision expected soon; under regulatory review for ITP in China
Opinion was based on the P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO during a 12–24-wk, followed by 28 wks, and then a four-week…
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The EMA’s CHMP has granted approvals to 5 Biologics and 5 new chemical entities in September 2025, leading to treatments for patients and advances in the healthcare industry
The major highlighted drug, Merck’s Enflonsia, has Adopted Positive Opinion for RSV Prevention in Infants
PharmaShots has compiled a list of 9 drugs that have been…
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The CHMP has recommended Brinsupri (Brensocatib) for treating NCFB pts (≥12yrs.) with two or more exacerbations in the prior 12 mos.
Opinion was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial (n=256) assessing Brinsupri (10 or 25mg, PO) vs PBO in NCFB pts for 52 & 24wks., respectively, with WILLOW enrolling pts who had…
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The CHMP has recommended Libtayo (cemiplimab) as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiation
Opinion was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.; n=209) vs PBO (n=206) to treat…
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The US FDA has approved Palsonify for 1L treatment of adults with acromegaly who are ineligible for or inadequately respond to surgery; commercially available in the US by Oct 2025 & MAA under EMA's review, with CHMP opinion expected in H1’26
Approval was based on 2 P-III (PATHFNDR-2 & PATHFNDR-1) trials assessing Palsonify vs PBO…
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The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis across 30 EEA states
In trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts…

