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RSS FeedPosted by Michael Wonder on 01 Jul 2021
Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug
30 June 2021 - Former health secretary Donna Shalala called for a federal investigation into the FDA’s polarising approval of ...
Posted by Michael Wonder on 01 Jul 2021
FDA approves supplemental new drug application for Adhansia XR (methylphenidate hydrochloride) extended release capsules
1 June 2021 - Phase 3 adult laboratory classroom study confirmed that Adhansia XR provided rapid and sustained symptom relief ...
Posted by Michael Wonder on 01 Jul 2021
FDA approves dose escalation label update for Puma Biotechnology’s Nerlynx (neratinib) in HER2 positive early stage and metastatic breast cancer
1 June 2021 - Dose escalation of Nerlynx therapy demonstrated improved management and prevention of Grade 3 diarrhoea. ...
Posted by Michael Wonder on 01 Jul 2021
FDA approves component of treatment regimen for most common childhood cancer
30 June 2021 - Today, the U.S. FDA approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen ...
Posted by Michael Wonder on 01 Jul 2021
LEXEO Therapeutics receives rare paediatric disease designation and orphan drug designation for LX2006 for the treatment of Friedreich’s ataxia
30 June 2021 - Phase I/II clinical trial in patients with cardiomyopathy associated with Friedreich’s ataxia expected to initiate in 2021. ...
Posted by Michael Wonder on 01 Jul 2021
U.S. FDA accepts filing of Hutchmed's NDA for surufatinib for the treatment of advanced neuroendocrine tumours
1 July 2021 - U.S. FDA has assigned a target action date of 30 April 2022. ...
Posted by Michael Wonder on 01 Jul 2021
Additional treatment option – Tremfya – now available on the PBS for Australians with active psoriatic arthritis
1 July 2021 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that Tremfya (guselkumab) is now available on ...
Posted by Michael Wonder on 30 Jun 2021
Will Biogen’s new Alzheimer’s drug’s burden on Medicare be big, huge, or catastrophic?
28 June 2021 - The FDA’s decision to grant wide-ranging approval to the controversial, pricey new Alzheimer’s drug Aduhelm will ...
Posted by Michael Wonder on 30 Jun 2021
ICER to assess treatment for type 2 diabetes
30 June 2021 - Report will be subject of New England CEPAC meeting in January 2022; draft scoping document open ...
Posted by Michael Wonder on 30 Jun 2021
Sanofi’s Praluent provides solution for Korean dyslipidaemia patients
30 June 2021 - Sanofi Aventis is strengthening its position in the local dyslipidaemia treatment market with Praluent (alirocumab), a ...
Posted by Michael Wonder on 30 Jun 2021
Schedule of Pharmaceutical Benefits - 1 July 2021
1 July 2021 - The July 2021 issue of the Schedule of Pharmaceutical Benefits is out and now in ...
Posted by Michael Wonder on 30 Jun 2021
Eli Lilly CEO says drug maker will keep looking for ways to cut insulin costs as Walmart debuts lower price rival
29 June 2021 - Insulin has become a focal point in lawmakers’ debate over soaring drug prices — especially since it ...
Posted by Michael Wonder on 30 Jun 2021
In revised evidence report, ICER confirms judgment that evidence is insufficient to demonstrate net health benefit of aducanumab for patients with Alzheimer’s disease
30 June 2021 - Accepting the uncertainty associated with the positive estimate obtained from pooled data from both pivotal trials, ...
Posted by Michael Wonder on 30 Jun 2021
States step up push to regulate pharmacy drug brokers
30 June 2021 - Under pressure to rein in skyrocketing prescription drug costs, states are targeting companies that serve as conduits ...
Posted by Michael Wonder on 30 Jun 2021
Nurse prescribers now able to initiate Special Authority medicines
30 June 2021 - Joint media release with the Ministry of Health ...