Blog
RSS FeedPosted by Michael Wonder on 22 Dec 2016
High-cost, high-value oral specialty drugs: more evidence on the impact of cost sharing in Medicare Part D
20 December 2016 - In the closing moments of a recent clinic visit, a patient with progressive chronic lymphocytic leukaemia let ...
Posted by Michael Wonder on 21 Dec 2016
Care for the vulnerable vs. cash for the powerful — Trump’s pick for HHS
21 December 2016 - Representative Tom Price of Georgia, an orthopaedic surgeon, will be President-elect Donald Trump’s nominee for Secretary of ...
Posted by Michael Wonder on 21 Dec 2016
FDA accepts supplemental new drug application for Pfizer’s Ibrance (palbociclib) in HR+, HER2- metastatic breast cancer
21 December 2016 - sNDA includes data from Phase 3 PALOMA-2 trial to support conversion from accelerated approval to regular ...
Posted by Michael Wonder on 21 Dec 2016
Trump is going after health care. Will Democrats push back?
21 December 2016 - Where should Democrats head after their recent electoral rout? ...
Posted by Michael Wonder on 21 Dec 2016
Janssen submits two applications to FDA seeking approval of Simponi Aria (golimumab) for the treatment of active psoriatic arthritis and active ankylosing spondylitis
20 December 2016 - Janssen Biotech announced today the submission of two supplemental biologics license applications to the U.S. FDA seeking ...
Posted by Michael Wonder on 21 Dec 2016
Senate aims to stop firms from ‘buying up drugs and jacking up prices’
21 December 2012 - On the heels of headline-grabbing price spikes on prescription drugs, a bipartisan Senate report on Wednesday ...
Posted by Michael Wonder on 21 Dec 2016
Tesaro announces priority review designation for niraparib NDA
20 December 2016 - Niraparib new drug application accepted for review by FDA with a PDUFA goal date of 30 ...
Posted by Michael Wonder on 21 Dec 2016
FDA extends review of application for Ocrevus (ocrelizumab)
20 December 2016 - Roche announced today that the U.S. FDA has extended the Prescription Drug User Fee Act date for ...
Posted by Michael Wonder on 21 Dec 2016
KemPharm granted "fast track" designation for KP201/IR
20 December 2016 - KP201/IR could be the first single entity (APAP-free), immediate release hydrocodone product for pain analgesia with ...
Posted by Michael Wonder on 21 Dec 2016
Apellis announces FDA fast track designation for APL-2 in PNH
20 December 2016 - C3 inhibitor is in development for the treatment of PNH, both in patients not previously treated ...
Posted by Michael Wonder on 20 Dec 2016
Juno Therapeutics' and Celgene Corporation's investigational drug JCAR017 granted breakthrough therapy designation from FDA and priority medicines eligibility from EMA for relapsed/refractory diffuse large B cell lymphoma
20 December 2016 - Early results recently announced with JCAR017 in non-Hodgkin lymphoma and pediatric acute lymphoblastic leukemia. ...
Posted by Michael Wonder on 20 Dec 2016
Faced with unaffordable drug prices, tens of millions buy medicine outside U.S.
20 December 2016 - As drug prices have spiralled upward in the past decade, tens of millions of generally law-abiding ...
Posted by Michael Wonder on 20 Dec 2016
Democrats seek Trump's cooperation on drug price reform
20 December 2016 - A group of Democratic senators took their plans to tackle rising drug costs to President-elect Donald ...
Posted by Michael Wonder on 20 Dec 2016
Novo Nordisk receives FDA approval of Tresiba (insulin degludec injection 100 U/mL, 200 U/mL) for use in children and adolescents with diabetes
19 December 2016 - Novo Nordisk today announced that the U.S. FDA approved an expanded indication for Tresiba (insulin degludec injection ...
Posted by Michael Wonder on 20 Dec 2016
Harnessing the U.S. taxpayer to fight cancer and make profits
19 December 2016 - Enthusiasm for cancer immunotherapy is soaring, and so is Arie Belldegrun’s fortune. ...