This week in drug discovery (26 Feb – 1 March) 

News round-up for 26 Feb – 1 March by DDW Digital Content Editor Diana Spencer.

The news highlights this week all focus on regulatory decisions, both positive and negative. The first therapy was approved for allergic reactions to food, a drug for scleroderma secured Fast Track Designation, and the CHMP recommended an extension to the use of Carvykti in melanoma, but there was also bad news for Minerva Biosciences and Oncopeptides.

The top stories:

FDA approves first medication to reduce allergic reactions

The US Food and Drug Administration (FDA) has approved monoclonal antibody Xolair (omalizumab) for immunoglobulin E-mediated food allergy in some adults and children one year or older for the reduction of allergic reactions (Type I).

Scleroderma drug gets fast-tracked in the US

The US Food and Drug Administration (FDA) has granted Fast Track Designation for Certa Therapeutics’ investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma).

CAR-T therapy recommended for melanoma after first relapse

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a Type II variation for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma (RRMM).

Minerva value plummets following FDA rejection of roluperidone

The stock market value of Minerva Biosciences has dropped nearly 60%, following the US Food and Drug administration (FDA) decision not to approve roluperidone for symptoms of schizophrenia.

FDA withdraws approval of Oncopeptides’ Pepaxto

The US Food and Drug Administration (FDA) has announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), despite an appeal by manufacturer Oncopeptides.

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