Hikma Pharmaceuticals said that its wholly-owned US subsidiary, West-Ward Pharmaceuticals Corp. has launched Methylergonovine Maleate Tablets, USP, 0.2mg, the genericRead more
Hikma Pharmaceuticals’s US subsidiary West-Ward Pharmaceuticals has launched Methotrexate for Injection, USP in a 1g preservative-free presentation and Methotrexate Injection,Read more
Hikma Pharmaceuticals has launched Dexrazoxane for Injection, 250mg and 500mg vials, the generic equivalent to Zinecard, through its US wholly-owned subsidiaryRead more
West-Ward Pharmaceuticals, wholly-owned Hikma Pharmaceuticals’s US subsidiary has launched Ifosfamide Injection, 1g/20mL vials, the generic equivalent to Ifex.Read more
Hikma Pharmaceuticals will add Surendera Tyagi as Group Chief Scientific Officer and Global Head of Research and Development, who willRead more
Hikma Pharmaceuticals has reached a licensing agreement with South Korea-based Celltrion, Inc. and Celltrion Healthcare, Inc (Celltrion) for the firstRead more
Hikma Pharmaceuticals has acquired six products from Boehringer Ingelheim GmbH (Boehringer Ingelheim).Read more
Vectura Group confirmed on Thursday what its partner Hikma Pharmaceuticals said in its interim results statement about its abbreviated new drug application (ANDA) filing for a US generic version of Advair Diskus.Read more
During H1 2017, the Generics business launched 7 products, including all dosage forms and strengths, and received 14 product approvals.
We announced on 11 May 2017 that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) in relation to our abbreviated new drug application (ANDA) for our generic version of GlaxoSmithKline’s Advair Diskus® (fluticasone propionate and salmeterol inhalation powder). Since then we, supported by our partner Vectura, have had constructive discussions with the FDA and we have been able to clarify and resolve a number of the questions raised. The discussions with the FDA have confirmed our initial assessment that there are no material issues regarding the substitutability of the proposed device. We are in ongoing discussions with the FDA to address the remaining questions and will provide a more detailed update to the market as soon as we are able to do so.
We now expect Generics revenue to be around $620 million for the full year, reflecting the impact of increased competition on prices and volumes. Through our focus on portfolio optimisation and continued cost savings, we expect the Generics business to achieve core operating profit of around $30 million in 2017.Read more
Hikma Pharmaceuticals and Jazz Pharmaceuticals have found a mutual language regarding a Jazz’s Xyrem patent litigation.Read more