Blog
RSS FeedPosted by Michael Wonder on 26 May 2021
Varian receives FDA breakthrough device designation for its cardiac radioablation system for treatment of refractory ventricular tachycardia
26 May 2021 - Varian's CRA system has been designated a "breakthrough device" by the FDA because of its potential to ...
Posted by Michael Wonder on 09 Mar 2021
Roche receives FDA approval for Ventana ALK (D5F3) CDx assay to identify lung cancer patients eligible for targeted treatment with Lorbrena (lorlatinib)
9 March 2021 - The Ventana ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted ...
Posted by Michael Wonder on 22 Oct 2020
Oxford developed COVID-19 vaccine, then scholars clashed over money
21 October 2020 - Early deal with Merck was scotched for fear poor countries would be left out; now university could ...
Posted by Michael Wonder on 19 Oct 2020
All eyes on a hurdle race for a SARS-CoV-2 vaccine
19 October 2020 - Leading COVID-19 vaccine candidates have progressed through laboratory tests at record speed. ...
Posted by Michael Wonder on 12 May 2020
Investigators propose different measures for biosimilar equivalence
12 May 2020 - Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence ...
Posted by Michael Wonder on 14 Apr 2020
COVID-19: world needs a global approach to fight: Bill Gates
12 April 2020 - Over the past few weeks, I’ve spoken to dozens of experts about COVID-19, and there’s clear ...
Posted by Michael Wonder on 09 Feb 2020
Biosimilars and interchangeable biosimilars: licensure for fewer than all conditions of use for which the reference product has been licensed guidance for industry
5 February 2020 - This guidance provides recommendations to applicants seeking licensure under section 351(k) of the Public Health Service Act ...
Posted by Michael Wonder on 18 Dec 2019
Bristol-Myers Squibb announces submission of biologics license application for CAR T-Cell therapy lisocabtagene maraleucel (liso-cel) to FDA
18 December 2019 - Submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory ...
Posted by Michael Wonder on 18 Aug 2019
Roche cancer treatment priced at $17,050 a month, lower than rival Vitrakvi
17 August 2019 - Roche has priced its personalised cancer treatment, Rozlytrek, at about $17,050 per month, nearly half of ...
Posted by Michael Wonder on 19 Jul 2019
Was it really a smart move for the FDA to approve a ‘smart pill’ for treating schizophrenia?
18 July 2019 - In late 2017, the FDA approved the first so-called smart pill, ushering in a new era ...
Posted by Michael Wonder on 23 Apr 2019
FDA approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma
22 April 2019 - Approval based on results of KEYNOTE-426, where Keytruda in combination with axitinib reduced the risk of death ...
Posted by Michael Wonder on 18 Mar 2019
CytoDyn reaches historical milestone, submits first of three sections of BLA to FDA for leronlimab (PRO 140) as a combination therapy for HIV
18 March 2019 - FDA previously granted rolling review for BLA. ...
Posted by Michael Wonder on 13 Mar 2019
Janssen submits application to U.S. FDA seeking approval of Darzalex (daratumumab) combination therapy for patients with newly diagnosed multiple myeloma who are transplant ineligible
12 March 2019 - Application supported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot ...
Posted by Michael Wonder on 01 Mar 2019
Esperion announces submissions of two NDAs and official completion of two MAA validations for both bempedoic acid and the bempedoic acid/ezetimibe combination tablet
28 February 2019 - Esperion today announced that the company has successfully completed important and key global marketing applications including ...
Posted by Michael Wonder on 05 Dec 2018
FDA grants fast track designation for AMG 420
3 December 2018 - Amgen today announced the first clinical results from studies evaluating investigational novel bi-specific T cell engager (BiTE) ...