Nicox responds to the CRL from USFDA for latanoprostene bunod

Paris-listed international ophthalmic company Nicox, on Friday said that its exclusive licensee has said it has submitted a response to the Complete Response Letter (CRL) received from the U.S. Food and Drug Administration (FDA) on August 7, 2017 concerning the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024% for the reduction of intraocular pressure in patients with glaucoma or ocular hypertension. 

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Hikma reduces net debt for $64M in 1H, revenue 1% up

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.

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RedHill gets rights to promote capsules to gastroenterologists in certain U.S. territories

Israel-based RedHill Biopharma, a biopharmaceutical company focused on drugs for gastrointestinal and inflammatory diseases and cancer, has made a deal with ParaPRO, an Indiana-based pharmaceutical company, granting RedHill the exclusive rights to promote Esomeprazole Strontium Delayed-Release Capsules to gastroenterologists in certain U.S. territories.

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