Blog Archives | Page 58 of 101

Recent BioBlast® Updates

Approval Alert: Astellas’ Vyloy™ (Zolbetuximab) Approved for Gastric Cancer in Europe and Korea

Sep 20, 2024

On 20 September 2024, Astellas Pharma announced that the European Commission has approved Vyloy™ (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable...

New Indication Alert: J&J’s Rybrevant® Combination US-Approved for NSCLC

Sep 19, 2024

On 19 September 2024, Johnson & Johnson (J&J) announced that it received FDA approval for Rybrevant® (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or...

CHMP Positive Opinions for 3 New Biologics and Extended Indications for 5 in EU

Sep 19, 2024

At its September 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biologics, each of which was designated as an orphan medicine during development, and recommended indication...

Sandoz & Samsung Bioepis/Biogen Aflibercept Biosimilars Recommended in Europe

Sep 19, 2024

At its September meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Sandoz’s and Samsung Bioepis/Biogen’s biosimilars to Regeneron’s Eylea® (aflibercept). Both Sandoz’s Afqlir™ and...

EMA’s CHMP Recommends Expanded Wegovy® Label for Obesity-Related HFpEF

Sep 19, 2024

On 19 September 2024, Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a label expansion for Novo Nordisk’s Wegovy® (semaglutide 2.4mg) to reflect reduced...

New Indication Alert: AstraZeneca’s Fasenra® FDA-Approved for EGPA

Sep 18, 2024

On 18 September 2024, AstraZeneca announced that its Fasenra® (benralizumab) has been approved by the FDA for eosinophilic granulomatosis with polyangiitis (EGPA). The approval was based on positive results from a Phase 3 trial (MANDARA) comparing the efficacy and...

New Indication Alert: MSD’s Keytruda® Plus Chemo FDA-Approved for MPM

Sep 18, 2024

On 18 September 2024, Merck (known as MSD outside the US and Canada) announced that Keytruda® (pembrolizumab) has been approved by the FDA, in combination with pemetrexed and platinum chemotherapy, for first-line treatment of adults with unresectable advanced or...

Accord BioPharma Receives FDA Approval for Second Strength of its Biosimilar Trastuzumab

Sep 18, 2024

On 18 September 2024, Accord BioPharma announced that the FDA has approved a 420mg strength of its Hercessi™ (trastuzumab-strf), biosimilar to Roche’s Herceptin®, for HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. Hercessi™ was...

GSK’s NDA for Blenrep® Combinations Accepted in Japan

Sep 17, 2024

On 17 September 2024, GlaxoSmithKline (GSK) announced that Japan’s Ministry of Health has accepted for review a new drug application for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) or PomDex (pomalidomide plus...

Daiichi/MSD Ph 3 Trial Shows Patritumab Deruxtecan Improves Progression-Free Survival in NSCLC

Sep 17, 2024

On 17 September 2024, Daiichi Sankyo and MSD announced positive results from a Phase 3 trial of their antibody drug conjugate, patritumab deruxtecan (HER3-DXd). In the trial (HERTENA-Lung02), patritumab deruxtecan showed statistically significant improvement in...

Formycon to Present Clinical Data on FYB202 (Ustekinumab) Later This Month

Sep 17, 2024

Formycon has announced that it will present study data for Fymskina (FYB202), biosimilar to Janssen’s Stelara® (ustekinumab), at the 2024 European Academy of Dermatology and Venerology Congress (25 to 28 September in Amsterdam) and the 2024 United European...

New Indication Alert: Dupixent® (Dupilumab) Receives First US Approval for Adolescents with CRSwNP

Sep 16, 2024

On 13 September 2024, Regeneron and Sanofi announced that their Dupixent® (dupilumab) has received FDA approval as an add-on maintenance treatment for patients aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This follows the...