Covid-19 delta outbreak: major PHARMAC review report delayed by lockdown

22 September 2021 - Act says it is "not good enough" an interim report for a much touted independent PHARMAC ...

Read more →

COVID-19 vaccine weekly safety report (16 September 2021)

16 September 2021 - To 12 September 2021, approximately 22.8 million vaccine doses have been given in Australia – 14 million ...

Read more →

Sage Therapeutics receives fast track designation for SAGE-718 for the treatment of Huntington’s disease

15 September 2021 - Sage Therapeutics today announced that the U.S. FDA has granted fast track designation to SAGE-718 for development ...

Read more →

PHARMAC funds tocilizumab to treat cases of COVID-19

16 September 2021 - PHARMAC is widening funded access to tocilizumab, an immunosuppressive drug used mainly to treat arthritis, to treat ...

Read more →

PHARMAC funds new treatment for rheumatoid arthritis to support people impacted by tocilizumab stock shortage

16 September 2021 - PHARMAC has funded upadacitinib tablets as an alternative treatment for New Zealanders with severe rheumatoid arthritis, ...

Read more →

Takeda’s Exkivity (mobocertinib) approved by U.S. FDA as the first oral therapy specifically designed for patients with EGFR exon 20 insertion positive NSCLC

15 September 2021 - Next generation sequencing companion diagnostic test approved simultaneously to support identification of patients with EGFR exon 20 ...

Read more →

Pulmocide’s lead drug candidate opelconazole (PC945) granted orphan drug, fast track and qualified infectious disease product designations by US FDA

15 September 2021 - Pulmocide today announced that the US FDA has granted orphan drug, fast track and qualified infectious disease ...

Read more →

FDA, EMA launch complex generic, hybrid product advice pilot

15 September 2021 - The US FDA and the EMA on Wednesday launched a new pilot aimed at giving parallel ...

Read more →

Lilly to supply 388,000 doses of etesevimab to U.S. Government for treatment of COVID-19

15 September 2021 - Additional doses of etesevimab will be paired with existing bamlanivimab purchased by the U.S. Government ...

Read more →

FDA advances data, IT modernisation efforts with new Office of Digital Transformation

15 September 2021 - FDA prioritises effective and efficient use of data by reorganising IT, data and cybersecurity functions to ...

Read more →

Drug prices measure blocked in House Committee as Democrats splinter

15 September 2021 - Provision of $3.5 trillion budget package would allow Medicare to negotiate over the cost of prescriptions. ...

Read more →

Venetoclax in acute myeloid leukaemia: indication of a considerable added benefit

15 September 2021 - Third new area of ​​application/those affected still live a good year on average - and thus ...

Read more →

U.S. FDA grants Brukinsa (zanubrutinib) accelerated approval in relapsed or refractory marginal zone lymphoma

15 September 2021 - This marks the third FDA approval for Brukinsa and first approval in marginal zone lymphoma. ...

Read more →

NICE backs Opdivo for head and neck cancer

15 September 2021 - NICE has recommended Bristol Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for routine use on the NHS ...

Read more →

Aduhelm backlash threatens to reverse progress in FDA’s reviews of rare and ultra-rare disease drugs

14 September 2021 - The FDA’s approval of Aduhelm to treat Alzheimer’s disease has unleashed criticism about the decision and ...

Read more →

ObsEva announces submission of new drug application to U.S. FDA for linzagolix for the treatment of uterine fibroids

15 September 2021 - NDA submission includes positive data from Phase 3 PRIMROSE trials up to 52 weeks on treatment and ...

Read more →