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RSS FeedPosted by Michael Wonder on 16 Sep 2020
FDA granted paediatric disease designation for OXi-4503
16 September 2020 - Treatment of acute myeloid leukaemia due to genetic mutations that disproportionately affect paediatric patients. ...
Posted by Michael Wonder on 16 Sep 2020
The road ahead: 'What two more years of life could mean'
16 September 2020 - In May 2018, Mulholland was diagnosed with breast cancer. ...
Posted by Michael Wonder on 16 Sep 2020
Orphazyme announces U.S. FDA acceptance and priority review of new drug application for arimoclomol for Niemann-Pick disease Type C
16 September 2020 - If approved, arimoclomol would become the first approved therapy in the U.S. for people with Niemann-Pick disease ...
Posted by Michael Wonder on 16 Sep 2020
MediWound announces FDA acceptance of biologics license application for NexoBrid for the treatment of severe thermal burns
16 September 2020 - MediWound today announced that the U.S. FDA has accepted for review its recently submitted biologics license application ...
Posted by Michael Wonder on 16 Sep 2020
National's health policy - more money for PHARMAC, elective surgery guarantees
16 September 2020 - The National Party is promising record funding increases for PHARMAC, a new cancer agency, faster elective surgeries ...
Posted by Michael Wonder on 16 Sep 2020
Simplified chemotherapy prescribing arrangements
16 September 2020 - The Department of Health has simplified the way PBS medicines can be prescribed for chemotherapy patients ...
Posted by Michael Wonder on 16 Sep 2020
EMA validates Bristol Myers Squibb’s type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of malignant pleural mesothelioma
15 September 2020 - Opdivo plus Yervoy would potentially be the first immunotherapy option for the first-line treatment of this cancer ...
Posted by Michael Wonder on 16 Sep 2020
Brenzys (etanercept injection) now indicated for the treatment of plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis
15 September 2020 - Brenzys is a biosimilar biologic drug authorised based on its similarity to Enbrel, which is already approved ...
Posted by Michael Wonder on 15 Sep 2020
Gilead’s magrolimab, an investigational anti-CD47 monoclonal antibody, receives FDA breakthrough therapy designation for treatment of myelodysplastic syndrome
15 September 2020 - On-going clinical program includes the Phase 3 ENHANCE trial in myelodysplastic syndrome. ...
Posted by Michael Wonder on 15 Sep 2020
Estimating risk ratios and risk differences: alternatives to odds ratios
15 September 2020 - The goal of many medical research studies is to estimate the direction and magnitude of the effect ...
Posted by Michael Wonder on 15 Sep 2020
PhRMA statement on most favoured nation executive order
13 September 2020 - Pharmaceutical Research and Manufacturers of America president and CEO Stephen J. Ubl issued the following statement: ...
Posted by Michael Wonder on 15 Sep 2020
Trump advisor Kushner defends plan to cut drug prices, says Americans should pay the same as Europeans
15 September 2020 - Kushner’s comments to CNBC came two days after Trump announced that he signed an executive order that ...
Posted by Michael Wonder on 15 Sep 2020
Apellis announces submission of pegcetacoplan marketing applications to FDA and EMA for patients with PNH
15 September 2020 - -- Apellis Pharmaceuticals today announced that the company has submitted a new drug application to the ...
Posted by Michael Wonder on 15 Sep 2020
Plus Therapeutics receives fast track designation from FDA for its novel glioblastoma treatment
15 September 2020 - Plus Therapeutics today announced that the U.S. FDA has granted the Company fast track designation for its ...
Posted by Michael Wonder on 15 Sep 2020
US FDA grants fast track designation to Jardiance (empagliflozin) to improve outcomes following a heart attack
15 September 2020 - This fast track designation for empagliflozin emphasises the urgent need for potential treatments that may improve outcomes ...