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RSS FeedPosted by Michael Wonder on 07 Oct 2020
Swissmedic reviewing AstraZeneca’s COVID-19 vaccine
6 October 2020 - Swiss drug authority Swissmedic has begun evaluating the so-called “Covid-19 Vaccine AstraZeneca”. ...
Posted by Michael Wonder on 07 Oct 2020
Samsung Bioepis and Biogen announce EMA filing acceptance of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
6 October 2020 - Samsung Bioepis and Biogen today announced that the EMA has accepted for review the marketing authorisation Application ...
Posted by Michael Wonder on 06 Oct 2020
Y-mAbs provides regulatory update on omburtamab for the treatment of patients with neuroblastoma
5 October 2020 - Y-mAbs Therapeutics today announced that Y-mAbs has received a Refusal to File letter from the U.S. FDA ...
Posted by Michael Wonder on 06 Oct 2020
FDA discloses vaccine guidelines blocked by White House
7 October 2020 - The FDA has laid out its safety standards for developers of COVID-19 vaccines after the White House ...
Posted by Michael Wonder on 06 Oct 2020
Demystifying the estimand framework: a case study using patient-reported outcomes in oncology
1 October 2020 - Patient-reported outcome measures describe how a patient feels or functions and are increasingly being used in benefit–risk ...
Posted by Michael Wonder on 06 Oct 2020
EMA starts second rolling review of a COVID-19 vaccine
6 October 2020 - EMA’s CHMP has started a ‘rolling review’ of data on a vaccine for COVID-19 known as BNT162b2, ...
Posted by Michael Wonder on 06 Oct 2020
FDA announces all time low rates for FY2021 priority review vouchers
5 October 2020 - The US FDA has announced historic low rates for the fiscal year 2021 fees to use ...
Posted by Michael Wonder on 06 Oct 2020
FDA grants GlycoMimetics rare paediatric disease designation for rivipansel for treatment of sickle cell disease
5 October 2020 - GlycoMimetics today announced that the U.S. FDA has granted the Company a rare paediatric disease designation for ...
Posted by Michael Wonder on 06 Oct 2020
PixCell Medical announces regulatory approval from Australian TGA for HemoScreen point of care hematology analyser
5 October 2020 - PixCell Medical announced today that it has received regulatory approval from the Australian TGA for the ...
Posted by Michael Wonder on 05 Oct 2020
Moderna CEO says COVID-19 vaccine will be ready for FDA submission in late November
5 October 2020 - Company will seek emergency use authorisation for experimental vaccine. ...
Posted by Michael Wonder on 05 Oct 2020
ImmunoGen announces FDA breakthrough therapy designation for IMGN632 in relapsed or refractory blastic plasmacytoid dendritic cell neoplasm
5 October 2020 - ImmunoGen today announced that the U.S. FDA has granted breakthrough therapy designation for IMGN632 for the ...
Posted by Michael Wonder on 05 Oct 2020
EU regulator starts safety review of coronavirus drug
3 October 2020 - The European Medicines Agency says it has started a safety review after some patients taking the ...
Posted by Michael Wonder on 05 Oct 2020
CDER proposes withdrawal of approval for Makena
5 October 2020 - Today, the U.S. FDA’s Center for Drug Evaluation and Research proposed that Makena (hydroxyprogesterone caproate injection) ...
Posted by Michael Wonder on 05 Oct 2020
Real world evidence from a narrow therapeutic index product (levothyroxine) reflects the therapeutic equivalence of generic drug product
5 October 2020 - The National Institute of Diabetes and Digestive and Kidney Diseases reports that almost 5% of the U.S. ...
Posted by Michael Wonder on 05 Oct 2020
EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
5 October 2020 - The EMA has re-affirmed today that it will uphold its long-standing commitment to independence and transparency ...