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RSS FeedPosted by Michael Wonder on 22 Sep 2023
PMPRB report shows increased plan costs, promising pharmaceutical innovation: expert
20 September 2023 - A recent report by the Patented Medicine Prices Review Board shows increased growth for private drug ...
Posted by Michael Wonder on 19 Sep 2023
UCB provides update on US regulatory review of bimekizumab
19 September 2023 - UCB today provided an update on the biologics license application for bimekizumab for the treatment of ...
Posted by Michael Wonder on 19 Sep 2023
How IQWiG assesses – version 7.0 of the method paper comes into force
19 September 2023 - Fundamental revision of the cost benefit assessment and addition of the concept of application-accompanying data collection. ...
Posted by Michael Wonder on 19 Sep 2023
Altuviiio supplemental biologics license application based on positive final results from Phase 3 XTEND-Kids study accepted by FDA
12 September 2023 - Final results from XTEND-Kids study were submitted for review, potentially expanding on the interim data included in ...
Posted by Michael Wonder on 19 Sep 2023
FDA accepts for priority review Merck’s supplemental new drug application for Welireg (belzutifan) in certain previously treated patients with advanced renal cell carcinoma
19 September 2023 - Acceptance based on results from the Phase 3 LITESPARK-005 trial, which showed a statistically significant and clinically ...
Posted by Michael Wonder on 19 Sep 2023
MHRA approves Moderna’s adapted COVID-19 vaccine (Spikevax) that targets Omicron XBB.1.5
15 September 2023 - The vaccine was approved after it was found to meet the MHRA’s standards of safety, quality and ...
Posted by Michael Wonder on 19 Sep 2023
Orchard Therapeutics announces acceptance of biologics license application for OTL-200 in MLD and receives priority review
18 September 2023 - PDUFA date set for 18 March 2024. ...
Posted by Michael Wonder on 19 Sep 2023
Cellectar Biosciences receives European Medicines Agency Priority Medicines (PRIME) designation for iopofosine for Waldenstrom’s macroglobulinaemia
18 September 2023 - The EMA’s PRIME status is granted to drug candidates that may offer a major therapeutic advantage over ...
Posted by Michael Wonder on 19 Sep 2023
Ebglyss (lebrikizumab) receives positive CHMP opinion for moderate to severe atopic dermatitis
15 September 2023 - Positive opinion is based on Phase 3 studies which showed long-term response in skin clearance and itch ...
Posted by Michael Wonder on 18 Sep 2023
Kymera Therapeutics receives US FDA fast track designation for KT-333, a first in class, investigational STAT3 degrader for the treatment of relapsed/refractory cutaneous T-cell lymphoma and relapsed/refractory peripheral T-cell lymphoma
18 September 2023 - KT-333 Phase 1 oncology trial ongoing with an update including initial evaluation of its clinical anti-tumour activity ...
Posted by Michael Wonder on 18 Sep 2023
Australian made cancer drug gets billion dollar US FDA approval
19 September 2023 - A drug invented in Melbourne to treat a lethal bone marrow cancer is set to become ...
Posted by Michael Wonder on 18 Sep 2023
Orexo submits new drug application to FDA for OX124, a high-dose rescue medication for opioid overdose
18 September 2023 - OX124 is based on Orexo´s world-class drug delivery platform amorphOX and is designed to reverse the effect ...
Posted by Michael Wonder on 18 Sep 2023
BioMarin receives positive CHMP opinion in Europe to expand use of Voxzogo (vosoritide) to treat children aged 4 months and older with achondroplasia
15 September 2023 - BioMarin today announced that the EMA's CHMP has adopted a positive opinion recommending marketing authorisation to expand ...
Posted by Michael Wonder on 18 Sep 2023
Ascendis Pharma receives positive CHMP opinion for TransCon PTH (palopegteriparatide) for adults with chronic hypoparathyroidism
14 September 2023 - Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union ...
Posted by Michael Wonder on 18 Sep 2023
Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab
18 September 2023 - Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical data. ...
Posted by Michael Wonder on 18 Sep 2023
COVID-19 vaccine contract summary
18 September 2023 - The Ministry of Health has released a summary of the New Zealand Government’s procurement process for ...