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Competition is on the horizon for costly narcolepsy treatments

pharmaphorum

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

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Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod

pharmaphorum

The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims is the first to be fully interchangeable with the originator product. The post Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod appeared first on.

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Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

2007; 66(11-12): 963–8. 2007; 848(1): 79–87. 2007; 87(12): 2207–16. IPQ International Pharmaceutical Quality. Cited 2023Feb]. Available from: [link] Egelhofer V, Gobom J, Seitz H, et al. Evaluation of pi marker sources for CIEF characterization of a therapeutic antibody. Chromatographia. Flatman S, Alam I, Gerard J, Mussa N.

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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). 2007; 2(1):5-11. In August 2024, the European Commission approved EURneffy (adrenaline nasal spray) in the EU as the first needle-free emergency option to treat anaphylaxis. 2022 ; 17(11). Fitzcharles-Bowe C et al. Hand (N Y).

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Oncology biosimilar case studies: rituximab biosimilars

Pharmaceutical Technology

Rituxan received its first FDA approval in 1997 for the treatment of B-cell non-Hodgkin’s lymphoma (B-NHL) and reached peak global sales of $7.5bn in 2014. Globally, the first rituximab biosimilar, Dr Reddy’s Laboratories’ Reditux, was approved in India in 2007. Rituxan’s success made it a prime target for biosimilar developers.

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The evolution of AAVs in cell and gene therapy

European Pharmaceutical Review

More recently, the FDA granted approval of Roctavian in June 2023. Clinical Trials Information System mandatory in EU “[In] the European regulatory framework for advanced therapies, we are guided overall by REGULATION (EC) No 1394/2007,” Warner noted. Batty discussed some of the capabilities of haemophilia gene therapies in 2023.

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Company profile: NeoImmuneTech

pharmaphorum

With Orphan Drug Designations (ODD) having been granted already by the EMA and US FDA in idiopathic CD4 lymphopenia as well as in GBM and progressive multifocal leukoencephalopathy (in the US only), there is no doubt that NeoImmuneTech is in a good position to accelerate the development of its main asset. He received his Ph.D.

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