Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2024
Blue Shield of California slashes cost of world's best selling drug
1 October 2024 - Non-profit health plan collaborates with Fresenius Kabi and Evio Pharmacy Solutions to purchase FDA approved Humira biosimilar ...
Posted by Michael Wonder on 26 Sep 2024
EMA recommends suspension of sickle cell disease medicine Oxbryta
26 September 2024 - The EMA’s CHMP has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta ...
Posted by Michael Wonder on 26 Sep 2024
Pfizer voluntarily withdraws all lots of sickle cell disease treatment Oxbryta (voxelotor) from worldwide markets
25 September 2024 - Pfizer announced today that it is voluntarily withdrawing all lots of Oxbryta (voxelotor) for the treatment of ...
Posted by Michael Wonder on 26 Sep 2024
Tepezza (teprotumumab) receives approval in Japan for the treatment of active thyroid eye disease
24 September 2024 - Amgen today announced Tepezza (teprotumumab) has been approved for the treatment of active or high clinical activity ...
Posted by Michael Wonder on 26 Sep 2024
Health Canada grants marketing authorisation of first CRISPR/Cas9 gene edited therapy, Casgevy (exagamglogene autotemcel), for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
25 September 2024 - First regulatory authorisation of a CRISPR-based gene-editing therapy in Canada. ...
Posted by Michael Wonder on 26 Sep 2024
Pfizer Canada and BioNTech receive Health Canada approval of Omicron KP.2 variant adapted COVID-19 vaccine
24 September 2024 - Omicron KP.2 variant adapted vaccine Comirnaty is now authorised in Canada for individuals 6 months of age ...
Posted by Michael Wonder on 25 Sep 2024
Moderna receives Health Canada approval for updated COVID-19 vaccine targeting KP.2 variant of SARS-COV-2 for ages six months and older
17 September 2024 - Spikevax is the first updated COVID-19 vaccine authorised in Canada for 2024-2025, offering a timely solution to ...
Posted by Michael Wonder on 25 Sep 2024
FDA approves new drug to treat Niemann-Pick disease, type C
24 September 2024 - Today, the US FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease ...
Posted by Michael Wonder on 25 Sep 2024
FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy
25 September 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage ...
Posted by Michael Wonder on 25 Sep 2024
Trifluridine with tipiracil hydrochloride in combination with bevacizumab for the treatment of patients with metastatic colorectal cancer after two systemic treatments (final guidance)
25 September 2024 - NICE has published final evidence-based recommendations on the use of trifluridine with tipiracil hydrochloride (Lonsurf) for ...
Posted by Michael Wonder on 25 Sep 2024
PhRMA scores a small win in legal challenge to Medicare’s drug price negotiation
20 September 2024 - An appeals court revived the case and sent it back to a lower court in Texas. ...
Posted by Michael Wonder on 25 Sep 2024
GSK’s Menveo meningococcal vaccine in new single-vial, fully liquid presentation receives positive European CHMP opinion
24 September 2024 - Marketing authorisation in EU expected by November 2024. ...
Posted by Michael Wonder on 25 Sep 2024
Santhera announces acceptance by Swissmedic of marketing authorisation application for Agamree (vamorolone) in Duchenne muscular dystrophy
24 September 2024 - Santhera Pharmaceuticals announces that Swissmedic, the Swiss Agency for Therapeutic Products, has accepted for review the ...
Posted by Michael Wonder on 25 Sep 2024
Lilly's Kisunla (donanemab-azbt) approved in Japan for the treatment of early symptomatic Alzheimer's disease
24 September 2024 - Japan is the second major market where Kisunla has received approval. ...
Posted by Michael Wonder on 25 Sep 2024
Takeda receives approval for Fruzaqla (fruquintinib) in Japan for the treatment of unresectable advanced or recurrent colorectal cancer
24 September 2024 - Approval based on results from positive, global, Phase 3 FRESCO-2 trial. ...
Posted by Michael Wonder on 25 Sep 2024
FDA accepts Arcutis’ supplemental new drug application for Zoryve (roflumilast) foam for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over
24 September 2024 - US FDA has set a PDUFA target action date of 22 May 2025. ...