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Stallergenes Greer acquires Palforzia peanut allergy treatment business from Nestle

Written by | 9 Sep 2023

Nestlé announced that is has divested Palforzia, its peanut allergy treatment business, to Stallergenes Greer, a biopharmaceutical company which specializes in the diagnosis and treatment of allergies. The… read more.

New long-term Leqvio data from ORION-8 study, presented at ESC congress, demonstrates consistent efficacy and safety beyond six years – Novartis

Written by | 8 Sep 2023

Novartis announced new long-term data from ORION-8, a Phase III open-label extension of ORION-9, ORION-10, ORION-11 and ORION-3 trials. The data demonstrated that with twice-yearly dosing (after an… read more.

Tivdak improved overall survival in patients with recurrent or metastatic cervical cancer compared with chemotherapy alone – Seagen + Genmab

Written by | 7 Sep 2023

Seagen Inc. and Genmab A/S announced that the Phase III innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line… read more.

FDA approves Tyruko, first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis – Sandoz

Written by | 6 Sep 2023

Sandoz, a global leader in generic and biosimilar medicines, announced that the FDA has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. Tyruko is approved to treat… read more.

European Commission approves Evrysdi for babies under two months old with spinal muscular atrophy (SMA) – Roche

Written by | 5 Sep 2023

Roche announced that the European Commission has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorisation to include infants with a clinical diagnosis of SMA… read more.

FDA approves Veklury to treat COVID-19 in people with mild to severe hepatic impairment with no dose adjustment – Gilead Sciences

Written by | 4 Sep 2023

Gilead Sciences, Inc. announced that the FDA approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) with no dose adjustments to treat COVID-19 in… read more.

EU approves Abrysvo for respiratory syncytial virus – Pfizer

Written by | 3 Sep 2023

Pfizer announced that the European Commission (EC) has granted marketing authorization for Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both… read more.

BioMarin announces first person treated commercially with Roctavian for severe hemophilia A in Europe

Written by | 2 Sep 2023

BioMarin Pharmaceutical Inc. announced that an individual in Germany with severe hemophilia A was treated with Roctavian (valoctocogene roxaparvovec-rvox), marking the first time that the gene therapy has… read more.

FDA grants priority review for Xtandi in non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence – Astellas + Pfizer

Written by | 1 Sep 2023

Pfizer Inc. and Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the companies’ supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for… read more.

Results of phase IV trial (ZOSTER-076) of Shingrix shows efficacy and safety in Herpes Zoster – GSK

Written by | 31 Aug 2023

GSK announced positive results from the first-ever efficacy trial of Shingrix (Recombinant Zoster Vaccine or RZV) in China. These results come from the post-license phase IV trial (ZOSTER-076),… read more.

MHLW approval of Lumicef for palmoplantar pustulosis in Japan – Kyowa Kirin

Written by | 30 Aug 2023

Kyowa Kirin Co., Ltd. announces that the company has received approval from the Ministry of Health, Labour and Welfare (“MHLW”) for partial change of approved indication of Lumicef… read more.

Inceptiv spinal cord stimulator with closed-loop sensing to treat chronic pain receives CE Mark – Medtronic plc

Written by | 29 Aug 2023

Medtronic plc has received CE (Conformité Européenne) Mark approval for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). It is the first Medtronic SCS device to offer a… read more.

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