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RSS FeedPosted by Michael Wonder on 01 Sep 2020
FDA approves Onureg (azacitidine tablets) for acute myeloid leukaemia
1 September 2020 - Today, the FDA approved azacitidine tablets (Onureg, Celgene) for continued treatment of patients with acute myeloid ...
Posted by Michael Wonder on 01 Sep 2020
FDA accepts Vertex’s supplemental new drug applications for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for additional CFTR mutations
1 September 2020 - More than 600 people with certain rare cystic fibrosis mutations could become newly eligible for Trikafta, Symdeko ...
Posted by Michael Wonder on 01 Sep 2020
New formulation of Entyvio is included in the high-cost protection with limitation
1 September 2020 - Entyvio (vedolizumab) in the new dosage form of a solution for subcutaneous injection is included in the ...
Posted by Michael Wonder on 01 Sep 2020
Athenex announces FDA acceptance for filing of U.S. NDA for oral paclitaxel and encequidar in metastatic breast cancer with priority review
1 September 2020 - FDA grants priority review and sets PDUFA target action date of 28 February 2021. ...
Posted by Michael Wonder on 01 Sep 2020
Imfinzi approved in the EU for the treatment of extensive-stage small cell lung cancer
1 September 2020 - Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit and improved response rate in combination with a ...
Posted by Michael Wonder on 01 Sep 2020
Health Canada authorises Enspryng for Canadians living with neuromyelitis optica spectrum disorder
31 August 2020 - Roche Canada announced today that Health Canada has granted market authorisation for Enspryng (satralizumab) as monotherapy ...
Posted by Michael Wonder on 31 Aug 2020
ICER posts draft scoping document on lupus nephritis
31 August 2020 - Document open to public comment until 21 September 2020. ...
Posted by Michael Wonder on 31 Aug 2020
Mezzion shares tumble on FDA’s return of heart disease med NDA
31 August 2020 - Mezzion has announced it has received a complete response letter from the U.S. FDA over its submitted ...
Posted by Michael Wonder on 31 Aug 2020
A new biosimilar to NovoRapid is included in the high-cost protection
28 August 2020 - Insulin aspart Sanofi (insulin aspart) solution for injection for the treatment of diabetes is included in ...
Posted by Michael Wonder on 31 Aug 2020
FDA approves Xaracoll (bupivacaine hydrochloride) implant, a non-opioid, drug-device treatment option for acute post-surgical pain relief for up to 24 hours following open inguinal hernia repair in adults
31 August 2020 - Xaracoll is a first-of-its-kind, fully bioresorbable collagen implant that delivers bupivacaine hydrochloride directly to the surgical site ...
Posted by Michael Wonder on 31 Aug 2020
CMS acts to spur innovation for America’s seniors
31 August 2020 - Today, under President Trump’s leadership, the Centers for Medicare & Medicaid Services issued a proposed rule that ...
Posted by Michael Wonder on 31 Aug 2020
VelosBio announces FDA fast track and orphan drug designations for VLS-101 in patients with mantle cell lymphoma
31 August 2020 - VelosBio today announced that the U.S. FDA has granted the company fast track and orphan drug designation ...
Posted by Michael Wonder on 31 Aug 2020
CorMedix announces FDA acceptance for filing and priority review of new drug application for Defencath
31 August 2020 - FDA sets PDUFA goal date of 28 February 2021. ...
Posted by Michael Wonder on 31 Aug 2020
Schedule of Pharmaceutical Benefits - 1 September 2020 update
1 September 2020 - The September 2020 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 Aug 2020
‘Korea should introduce indication-specific drug pricing’
31 August 2020 - “Korea must introduce a system to apply different prices for a drug’s multiple indications, to guarantee ...