Nivolumab in skin cancer: additional benefit upgraded on the basis of an indirect comparison

16 September 2021 - For nivolumab (Opdivo), the pharmaceutical company was able to achieve a significantly better result in a second ...

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PBAC Public Summary Documents (first time decisions not to recommend, deferrals and other matters) – May 2021 meeting

10 September 2021 - The Public Summary Documents (first time decisions not to recommend, deferrals and other matters) from the May ...

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Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study

9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval ...

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Decibel Therapeutics receives orphan drug and rare paediatric disease designations for DB-OTO for the treatment of otoferlin related congenital hearing loss

9 September 2021 - Decibel Therapeutics today announced that the U.S. FDA has granted both orphan drug designation and rare paediatric ...

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FDA grants breakthrough device designation to the NovoTTF-200T system for advanced liver cancer

9 September 2021 - Novocure today announced the United States FDA has granted breakthrough designation to the NovoTTF-200T System, a Tumour ...

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VOR33 granted U.S. FDA fast track designation for AML

9 September 2021 - Vor Biopharma today announced that the U.S. FDA has granted fast track designation to VOR33, the ...

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Senate considers pegging Medicare drug prices to deeply discounted Veterans Affairs rates

9 September 2021 - Senate lawmakers are actively considering pegging the prices Medicare pays for drugs to those drug makers ...

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Biden Administration unveils plan to cut prescription drug prices

9 September 2021 - The Department of Health and Human Services plan supports legislation to empower the government to negotiate Medicare ...

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Insurance benefits for Pfizer’s heart drug Vyndamax uncertain

9 September 2021 - Pfizer’s Vyndamax (tafamidis), a treatment for transthyretin amyloid cardiomyopathy, got in the European Society of Cardiology’s ...

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Professor Gillian Leng to retire from NICE

9 September 2021 - Professor Leng has spent more than 20 years working at NICE. ...

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Eloxx Pharmaceuticals announces fast track designation for ELX-02 for the treatment of cystic fibrosis patients with nonsense mutations

9 September 2021 - Eloxx Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for ELX-02, a ...

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Myovant Sciences and Pfizer announce FDA acceptance of supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis

9 September 2021 - FDA PDUFA target action date is 6 May 2022. ...

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FDA grants Jardiance breakthrough therapy designation for heart failure with preserved ejection fraction

9 September 2021 - Designation is based on results from the EMPEROR-Preserved Phase 3 trial, which established Jardiance as the first ...

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NICE recommends treatment for people with juvenile idiopathic arthritis

9 September 2021 - NICE has today published final draft guidance which recommends tofacitinib (Xeljanz; Pfizer) as an option for treating ...

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Health funds reject claims hospitals hit by prostheses reforms

9 September 2021 - Health insurers say private hospital operators will not be left out of pocket, rejecting claims they ...

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Merck’s Keytruda (pembrolizumab) approved in China in combination with chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic oesophageal or gastro-oesophageal junction carcinoma

7 September 2021 - Keytruda is now approved for eight indications across five different types of cancer in China. ...

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