Europe responding to gene therapy challenge, but picture remains fragmented

20 May 2019 - Germany, Italy and England using outcomes-based deals. ...

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UCB announces Nayzilam (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the US

19 May 2019 - Nayzilam allows for administration by a non-healthcare professional in patients actively seizing when and where a seizure ...

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U.S. FDA approves Gattex (teduglutide) for children 1 year of age and older with short bowel syndrome

17 May 2019 - Gattex is the only glucagon-like peptide-2 analogue approved that improves intestinal absorption in patients with SBS who ...

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NICE recommends Revlimid as multiple myeloma alternative

17 May 2019 - NICE has recommended Revlimid (lenalidomide), a drug that helps to support the immune system to fight ...

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Celgene receives European Commission approvals for Revlimid (lenalidomide) and Imnovid (pomalidomide)-based triplet combination regimens for patients with multiple myeloma

16 May 2019 - The European Commission has approved two of Celgene’s IMiD based combination regimens. ...

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Health Canada approves injectable hydromorphone to treat opioid addiction

16 May 2019 - Canada is first country to approve the pain drug for severe opioid use disorder, says Health ...

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FDA approves first anticoagulant (blood thinner) for paediatric patients to treat potentially life-threatening blood clots

16 May 2019 - The U.S. FDA today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of ...

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Nivolumab and ipilimumab: drug combination has added benefit in advanced renal cell carcinoma

15 May 2019 - There are no serious disadvantages in terms of overall survival. ...

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Novartis gets approval to sell Kymriah in Japan for $306,000

15 May 2019 - A Japanese government panel approved on Wednesday a price of 33.5 million yen ($305,800) for Novartis’ cancer ...

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AbbVie announces US FDA approval of Venclexta (venetoclax) as a chemotherapy-free combination regimen for previously untreated chronic lymphocytic leukaemia patients

15 May 2019 - FDA reviewed the submission under the real-time oncology review pilot program. ...

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NICE recommends first ever treatment for children with rare muscle wasting condition

15 May 2019 - Children with the rare genetic disorder spinal muscular atrophy can now be treated with nusinersen after NICE ...

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FDA approves Bavencio (avelumab) plus axitinib combination for patients with advanced renal cell carcinoma

14 May 2019 - Phase III study showed combination significantly lowered risk of disease progression or death by 31% and extended ...

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FDA approves Eylea (aflibercept) injection for diabetic retinopathy

13 May 2019 - Eylea improves diabetic retinopathy and prevents worsening disease that can lead to blindness. ...

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FDA approves broadened indication for Xeomin (incobotulinumtoxinA) as first-line treatment for blepharospasm (involuntary blinking) in adult patients

13 May 2019 - Merz Americas announced today that the U.S. FDA has approved the supplemental biologics license application for Xeomin ...

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New cancer drugs approved for NHS use in Scotland

13 May 2019 - The Scottish Medicines Consortium accepted the use of new medicines to treat patients with breast and skin ...

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