Blog
RSS FeedPosted by Michael Wonder on 07 Dec 2023
Evolving our approach to COVID-19 vaccines and treatments
6 December 2023 - As New Zealand’s response to the COVID-19 pandemic has evolved, so has ours. ...
Posted by Michael Wonder on 07 Dec 2023
Dupilumab for the treatment of patients with eosinophilic oesophagitis
7 December 2023 - NICE is unable to make a recommendation on the use of dupilumab (Dupixent) for the treatment of ...
Posted by Michael Wonder on 06 Dec 2023
Secukinumab for the treatment of patients with moderate to severe hidradenitis suppurativa (final guidance)
6 December 2023 - NICE has published final evidence-based recommendations on the use of secukinumab (Cosentyx) for the treatment of ...
Posted by Michael Wonder on 06 Dec 2023
BridgeBio Pharma announces submission of new drug application to US FDA for acoramidis for the treatment of patients with transthyretin amyloid cardiomyopathy
5 December 2023 - NDA submission is based on positive results from ATTRibute-CM Phase 3 study. ...
Posted by Michael Wonder on 06 Dec 2023
FDA grants priority review of ImmunoGen’s supplemental biologics license application for Elahere (mirvetuximab soravtansine-gynx) in platinum-resistant ovarian cancer
5 December 2023 - Priority review granted with PDUFA date of 5 April 2024. ...
Posted by Michael Wonder on 06 Dec 2023
Novartis receives FDA approval for Fabhalta (iptacopan), offering superior haemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH
6 December 2023 - Approval based on APPLY-PNH trial in adults with PNH and anaemia despite prior anti-C5 treatment, and supported ...
Posted by Michael Wonder on 06 Dec 2023
Neurocrine Biosciences receives breakthrough therapy designation from US FDA for crinecerfont in congenital adrenal hyperplasia
5 December 2023 - Crinecerfont new drug application submission planned in 2024. ...
Posted by Michael Wonder on 05 Dec 2023
Osteal Therapeutics’ VT-X7 receives FDA’s breakthrough therapy designation for the treatment of periprosthetic joint infection of the hip and knee
5 December 2023 - The US FDA granted breakthrough therapy designation for VT-X7, Osteal Therapeutics’ investigational drug therapy for periprosthetic joint ...
Posted by Michael Wonder on 05 Dec 2023
Relaunched EMA website now live
5 December 2023 - EMA has relaunched its website: www.ema.europa.eu. ...
Posted by Michael Wonder on 05 Dec 2023
ICER releases draft evidence report on treatment for paroxysmal nocturnal haemoglobinuria
5 December 2023 - Public comment period now open until 9 January 2024; requests to make oral comment during public ...
Posted by Michael Wonder on 05 Dec 2023
Government sends mixed message to global life science investors
5 December 2023 - The Government has published new terms for the Statutory Scheme for branded medicines, maintaining sales rebates ...
Posted by Michael Wonder on 05 Dec 2023
Zepbound (tirzepatide) is now available in US pharmacies for adults living with obesity
5 December 2023 - Express Scripts to add Zepbound to National Preferred Formulary. ...
Posted by Michael Wonder on 05 Dec 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
5 December 2023 - The US FDA assigned a target action date of 5 April 2024. ...
Posted by Michael Wonder on 05 Dec 2023
CVS plans to overhaul how much drugs cost
5 December 2023 - The nation’s biggest drugstore chain to get paid based on the amount it pays for drugs, plus ...
Posted by Michael Wonder on 05 Dec 2023
Vanda Pharmaceuticals announces that US FDA accepts new drug application for tradipitant for the treatment of gastroparesis
4 December 2023 - Vanda Pharmaceuticals today announced that the US FDA has accepted the filing of Vanda's new drug ...