Blog
RSS FeedPosted by Michael Wonder on 04 Mar 2019
Drug companies and doctors battle over the future of faecal transplants
3 March 2019 - As pharmaceutical companies seek to profit from the curative wonders of human faeces, doctors worry about new ...
Posted by Michael Wonder on 04 Mar 2019
Senators tell FDA to speed up approvals of generic insulin
1 March 2019 - A bipartisan group of senators want the Food and Drug Administration (FDA) to change its policy ...
Posted by Michael Wonder on 04 Mar 2019
Novo Nordisk files for a label update for Fiasp to the EMA and the FDA seeking approval for use in children and adolescents
1 March 2019 - Novo Nordisk today announced that it has submitted label updates to the EMA and the US FDA ...
Posted by Michael Wonder on 02 Mar 2019
Treatment effects in multi-centre randomised clinical trials
1 March 2019 - It is common for treatments to be evaluated in clinical trials that involve many sites or centres, ...
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 28 Feb 2019
U.S. Senator Sanders urges FDA to allow older versions of $375,000 drug
28 February 2019 - U.S. Senator Bernie Sanders this week urged regulators to allow pharmacies and manufacturers to resume distributing unbranded, ...
Posted by Michael Wonder on 28 Feb 2019
FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers
28 February 2019 - Genentech today announced the U.S. FDA has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous injection for ...
Posted by Michael Wonder on 28 Feb 2019
FDA expands indication for Soliqua 100/33
27 February 2019 - Soliqua 100/33 now approved as an add-on to diet and exercise for adults with type 2 diabetes. ...
Posted by Michael Wonder on 28 Feb 2019
Janssen announces U.S. FDA approval of novel Tremfya (guselkumab) one-press patient-controlled injector for adults with moderate-to-severe plaque psoriasis
27 February 2019 - Nearly 99% of patients using One-Press for the first time completed a successful injection. ...
Posted by Michael Wonder on 27 Feb 2019
Patient experience data and bias — what ratings don’t tell us
28 February 2018 - Although patient-experience data are important to U.S. health care organisations, the best way to interpret them remains ...
Posted by Michael Wonder on 27 Feb 2019
Bayer completes rolling submission for darolutamide in U.S.
27 February 2019 - Bayer today announced the completion of the rolling submission of a new drug application for darolutamide to ...
Posted by Michael Wonder on 27 Feb 2019
Celgene Corporation announces key regulatory update for Revlimid in lymphoma
26 February 2019 - U.S. FDA grants priority review for Revlimid (lenalidomide) in combination with rituximab for previously treated follicular and ...
Posted by Michael Wonder on 27 Feb 2019
Heron announces FDA approval of supplemental new drug application to expand Cinvanti label for IV push
26 February 2019 - Heron Therapeutics today announced that the U.S. FDA has approved Heron's supplemental new drug application for ...
Posted by Michael Wonder on 27 Feb 2019
Iovance Biotherapeutics was granted fast track designation for LN-145 for cervical cancer
26 February 2019 - Iovance Biotherapeutics today announced that the U.S. FDA has granted fast track designation for LN-145 for the ...
Posted by Michael Wonder on 26 Feb 2019
Former Novartis executive wins $1.5 million after claiming she was fired for complaining about a study
26 February 2019 - Min Amy Guo, who had been executive director of the Health Economics and Outcomes Research Group, objected ...