Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 03 Feb 2021
First COVID-19 vaccine approved for NZ: How did we get here and what comes next
3 February 2021 - The medicines safety authority has approved the first COVID-19 vaccine for use in New Zealand. ...
Posted by Michael Wonder on 02 Feb 2021
If 2021 is to be the year of U.S. drug price controls, how should biopharma companies respond?
2 February 2021 - As the Biden administration assumes leadership in Washington and former President Donald Trump’s most favoured nation ...
Posted by Michael Wonder on 02 Feb 2021
Biden freeze hits two Trump drug price rules
1 February 2021 - A freeze by the new Biden administration on Trump era regulations will hit at least two rules ...
Posted by Michael Wonder on 02 Feb 2021
VBI Vaccines announces U.S. FDA acceptance of BLA filing for VBI’s 3 antigen prophylactic hepatitis B vaccine
2 February 2021 - FDA sets a target action date of 30 November 2021. ...
Posted by Michael Wonder on 02 Feb 2021
Cystic fibrosis sufferer Bella Powell hits out at drug company for stalling PHARMAC funding
2 February 2021 - A cystic fibrosis patient is calling out American drug company Vertex, for not achieving PHARMAC funding. ...
Posted by Michael Wonder on 02 Feb 2021
Novo Nordisk receives positive opinion from the European regulatory authorities for once-weekly Sogroya (somapacitan) for the treatment of adult growth hormone deficiency
29 January 2021 - Novo Nordisk announced today that the CHMP, under the EMA, adopted a positive opinion for the use ...
Posted by Michael Wonder on 02 Feb 2021
Bayer receives approval in the UK for Xarelto (rivaroxaban) to treat children with venous thromboembolism and to prevent recurrence
1 February 2021 - Paediatric use of rivaroxaban is based on data from the phase III paediatric thromboembolism programme, EINSTEIN-Junior. ...
Posted by Michael Wonder on 02 Feb 2021
Janssen announces CAR-T therapy ciltacabtagene autoleucel (cilta-cel) accepted for accelerated assessment in Europe for the treatment of patients with heavily pretreated multiple myeloma
1 February 2021 - Janssen announced today that the CHMP of the EMA will perform an accelerated assessment of the ...
Posted by Michael Wonder on 02 Feb 2021
Precision medicine helping to change the prognosis of a rare subtype of bowel cancer
2 February 2021 - Australians with a specific type of bowel cancer are no longer subject to a ‘one-size fits ...
Posted by Michael Wonder on 02 Feb 2021
Investigation reveals no specific risk of COVID-19 vaccinations in elderly patients
2 January 2021 - On 14 January 2021 the TGA received reports of about 30 deaths in over 40,000 elderly ...
Posted by Michael Wonder on 02 Feb 2021
Chiesi Group receives the European Marketing authorization for the extrafine triple-combination therapy for the treatment of moderate to severe asthma
1 February 2021 - It is the first extrafine fixed triple combination therapy in a single inhaler to be approved for ...
Posted by Michael Wonder on 02 Feb 2021
Is it time to stop using statistical significance?
1 February 2021 - The important first step in the critical appraisal of a randomised trial is not an evaluation ...
Posted by Michael Wonder on 02 Feb 2021
COVID‑19 vaccines – are we there yet?
1 February 2021 - The novel coronavirus SARS-CoV-2, the cause of the COVID-19 pandemic, is a highly infectious human respiratory ...
Posted by Michael Wonder on 02 Feb 2021
Mirum Pharmaceuticals announces completion of rolling NDA submission for maralixibat in Alagille syndrome
1 February 2021 - Maralixibat U.S. launch expected in second half of 2021, if approved. ...
Posted by Michael Wonder on 02 Feb 2021
Bristol Myers Squibb application for Zeposia (ozanimod) for the treatment of ulcerative colitis accepted for filing with priority review by U.S. FDA
1 February 2021 - U.S. Food and Drug Administration assigned an action date of 30 May 2021. ...