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  • Tetraphase’s IV Eravacycline Marketing Authorization Application submitted and validated in Europe

    Tetraphase Pharmaceuticals, a clinical-stage biopharmaceutical company said on Thursday that the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA).

  • Vectura, Hikma, FDA talk on generic version for GSK’s Advair Diskus

    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.

  • 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.

  • NiceLabel selected among 100 Great Supply Chain Partners

    NiceLabel has been chosen to the SupplyChainBrain’s annual list of the top 100 providers whose solutions have made significant impact on companies’ efficiency, customer service and overall supply chain performance.

  • 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.

  • BMS finds co-primary endpoint in CheckMate Opdivo-combination related study, misses statistical significance BMS

    Bristol-Myers Squibb announced results from the CheckMate -214 trial on Tuesday, investigating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) versus sunitinib in intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma.

  • AstraZeneca’s Science Committee Chairman retires

    AstraZeneca’s Bruce Burlington will retire at the end of August 2017 as a Non-Executive Director and as a member of the Audit Committee, the Nomination and Governance Committee, and from his role as Chairman of the Science Committee, after seven years’ stay with the company. 

  • Novo Nordisk trial shows superior glucose control and weight loss with semaglutide compared to dulaglutide NovoNordisk

    Novo Nordisk’s SUSTAIN 7 trial results, announced on Wednesday, showed that treating people with type 2 diabetes with once-weekly semaglutide reduced HbA1c and body weight compared to treatment with dulaglutide. The trial tested the 0.5 mg semaglutide compared with 0.75 dulaglutide, and 1.0 mg semaglutide compared with 1.5 mg dulaglutide, when added to metformin.

  • Opthalmic company Nicox cashes €26.25 million from 3.5M new ordinary shares

    Nicox S.A. the international ophthalmic company, today announced a reserved capital increase of its ordinary shares to a specific category of investors. The gross proceeds from the financing are €26.25 million, for a total of 3,500,000 new ordinary shares.

  • Akers Biosciences revenues, gross profit up 10%, overhead lowered 10% Akers Biosciences

    Akers Biosciences has announced the results for the first half 2017 in which it posted gross profit to be up 10% to $1,342,160, compared to the same period previous year, $1,217,634. As the total revenues moved up 10% for first 6 months of 2017 which were $1,865,112, compared to the 2016’s first half of $1,694,510, Akers Biosciences’s loss before income tax was reduced by 20% to $2,051,918, from first half in 2016, $2,517,861.