Blog
RSS FeedPosted by Michael Wonder on 04 Jun 2017
Merck receives accelerated approval of Keytruda (pembrolizumab), the first FDA approved anti-PD-1 therapy
4 September 2014 - Merck today announced that the US FDA has approved Keytruda (pembrolizumab) at a dose of 2 ...
Posted by Michael Wonder on 04 Jun 2017
FDA approves expanded indication for Merck’s Keytruda (pembrolizumab) for the treatment of patients with advanced melanoma
18 December 2015 - Keytruda is now the first and only anti-PD-1 therapy to achieve superior overall survival compared to ipilimumab. ...
Posted by Michael Wonder on 04 Jun 2017
FDA approves Merck’s Keytruda (pembrolizumab) for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy
5 August 2016 - Merck today announced that the U.S. FDA has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death ...
Posted by Michael Wonder on 03 Jun 2017
Pfizer announces acceptance of regulatory submissions by U.S. FDA and EMA for Sutent (sunitinib) for adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma after surgery
31 May 2017 - Applications seek to expand approved use of Sutent based on data from the Phase 3 S-TRAC trial. ...
Posted by Michael Wonder on 02 Jun 2017
Express Scripts sues maker of overdose drug, intensifying feud
31 May 2017 - A company that manages prescription drug plans for tens of millions of Americans has sued a ...
Posted by Michael Wonder on 02 Jun 2017
Roche announces FDA approval of companion diagnostic to identify ALK positive non-small-cell lung cancer patients
1 June 2017 - The Ventana ALK CDx assay identifies ALK positive non-small-cell lung cancer patients eligible for treatment with the ...
Posted by Michael Wonder on 01 Jun 2017
More new cancer drugs mean higher costs but also longer lives
1 June 2017 - Spending on cancer treatments has spiked past the $100 billion mark globally over the past five ...
Posted by Michael Wonder on 01 Jun 2017
Health policy trials
31 May 2017 - Clinical trials are most commonly associated with drugs and devices, but there are notable examples of trials ...
Posted by Michael Wonder on 01 Jun 2017
Novo Nordisk receives US FDA approval of Rebinyn (nonacog beta pegol; N9-GP)
31 May 2017 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Rebinyn ...
Posted by Michael Wonder on 01 Jun 2017
Nicox receives FDA approval of Zerviate (cetirizine ophthalmic solution) 0.24%
31 May 2017 - U.S. patent protection until at least 2030. ...
Posted by Michael Wonder on 01 Jun 2017
Jazz Pharmaceuticals announces FDA acceptance of NDA for Vyxeos (CPX-351), an investigational treatment for acute myeloid leukaemia, with priority review status
31 May 2017 - Jazz Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently ...
Posted by Michael Wonder on 31 May 2017
ProQR receives fast track designation from the FDA for QR-110 for Leber’s congenital amaurosis type 10
31 May 2017 - QR-110 is currently in clinical development with the planned Phase 1/2 open-label trial (PQ-110-001) that will assess ...
Posted by Michael Wonder on 31 May 2017
FDA grants breakthrough therapy designation for Alnylam's givosiran for the prophylaxis of attacks in patients with acute hepatic porphyria
31 May 2017 - Company plans to initiate Phase 3 clinical program in late 2017. ...
Posted by Michael Wonder on 31 May 2017
Indivior submits new drug application to U.S. FDA for RBP-6000 buprenorphine monthly depot
30 May 2017 - A potential novel long-acting, sustained release product candidate for treatment of opioid use disorder. ...
Posted by Michael Wonder on 31 May 2017
Merck receives FDA approval of Isentress HD (raltegravir), a new once daily option, in combination with other anti-retroviral agents, for the treatment of HIV-1 infection in appropriate patients
30 May 2017 - Merck today announced that the U.S. FDA has approved Isentress HD, a new 1200 mg once-daily dose ...