Blog
RSS FeedPosted by Michael Wonder on 23 Oct 2024
FDA approves NGS based companion diagnostic for first targeted therapy for patients with grade 2 IDH mutant glioma
21 October 2024 - Oncomine Dx target test to identify patients eligible for Servier’s Voranigo (vorasidenib) tablet, the only FDA ...
Posted by Michael Wonder on 23 Oct 2024
US FDA approves Pfizer’s RSV vaccine Abrysvo for adults aged 18 to 59 at increased risk for disease
22 October 2024 - Approval based on data from pivotal Phase 3 trial in adults at increased risk of lower ...
Posted by Michael Wonder on 23 Oct 2024
Lilly's Kisunla (donanemab-azbt) receives marketing authorisation in Great Britain for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease in adult patients who are apolipoprotein E Ε4 heterozygotes or non-carriers
23 October 2024 - Donanemab was first approved in the United States in July 2024 and then approved in Japan ...
Posted by Michael Wonder on 23 Oct 2024
New Alzheimer’s treatment donanemab does not currently demonstrate value for the NHS says NICE
23 October 2024 - More evidence is needed on the clinical and cost effectiveness of donanemab, a new treatment for mild ...
Posted by Michael Wonder on 23 Oct 2024
Danicopan in combination with ravulizumab or eculizumab for the treatment of patients with paroxysmal nocturnal haemoglobinuria (final guidance)
23 October 2024 - NICE has published final evidence-based recommendations on the use of danicopan (Voydeya) in combination with ravulizumab ...
Posted by Michael Wonder on 23 Oct 2024
Health Canada approves first and only oral targeted treatment for brain cancer
22 October 2024 - Pivotal Phase 3 study shows significant improvement in progression-free survival with a favourable safety profile. ...
Posted by Michael Wonder on 22 Oct 2024
ICER publishes final evidence report on treatments for transthyretin amyloid cardiomyopathy
21 October 2024 - Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ...
Posted by Michael Wonder on 22 Oct 2024
Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly
22 October 2024 - The FDA issues a complete response letter for CAM2029 pending FDA’s assessment of responses from a third ...
Posted by Michael Wonder on 22 Oct 2024
CHMP recommends the approval of Dong-A ST’s Imuldosa, a biosimilar to Stelara
21 October 2024 - Dong-A ST announced on 18 October 2024 that its biosimilar Imuldosa (ustekinumab, development code DMB-3115), referencing ...
Posted by Michael Wonder on 22 Oct 2024
Highlights from the 14-17 October 2024 CHMP meeting
18 October 2024 - The CHMP recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of ...
Posted by Michael Wonder on 21 Oct 2024
Wainzua (eplontersen) recommended for approval in the EU by CHMP for the treatment of adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis
21 October 2024 - Recommendation based on NEURO-TTRansform Phase 3 results showing Wainzua demonstrated consistent and sustained benefit improving neuropathy ...
Posted by Michael Wonder on 20 Oct 2024
Prostate cancer: significant additional benefit for PSMA diagnostics with gozetotide
15 October 2024 - Because of the direct link between diagnosis and therapy, the data from the early benefit assessment ...
Posted by Michael Wonder on 20 Oct 2024
Avadel Pharmaceuticals announces FDA approval of Lumryz (sodium oxybate) extended release oral suspension for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy
17 October 2024 - Granted orphan drug exclusivity in paediatric narcolepsy patients 7 years and older through 16 October 2031. ...
Posted by Michael Wonder on 19 Oct 2024
Arcutis announces Health Canada approval of Zoryve (roflumilast) foam 0.3% to treat seborrheic dermatitis in individuals 9 years of age and older
18 October 2024 - Zoryve foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved ...
Posted by Michael Wonder on 19 Oct 2024
FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastro-oesophageal junction adenocarcinoma
18 October 2024 - Today, the FDA approved zolbetuximab-clzb (Vyloy, Astellas Pharma), a claudin 18.2 (CLDN18.2) directed cytolytic antibody, with ...