Blog
RSS FeedPosted 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
“Repurposing” off-patent drugs offers big hopes of new treatments
28 February 2019 - Towards the end of 2014 a 66-year-old British man named Alistair had a seizure. A scan ...
Posted by Michael Wonder on 28 Feb 2019
First guidance on new rules for certain medical devices
28 February 2019 - EMA has published today the first of a series of guidance documents to help applicants prepare ...
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
EMA publishes agenda for 25-28 February 2019 CHMP meeting
25 February 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 ...
Posted by Michael Wonder on 26 Feb 2019
Spero Therapeutics receives QIDP designation from the U.S. FDA for the development of SPR720
26 February 2019 - Phase 1 top-line data readout for oral SPR720 expected in second half of 2019. ...
Posted by Michael Wonder on 26 Feb 2019
'Wacky' drug price system keeps costs high for patients paying for prescriptions, FDA chief says
26 February 2019 - "The sick people are helping to subsidise the healthy people. That's not how insurance is supposed to ...
Posted by Michael Wonder on 26 Feb 2019
A small drug maker settles charges for paying others to submit its FDA applications
26 February 2019 - A small drug maker was fined $4 million for striking deals with two tiny companies to ...