PRAC confirms four-week limit for use of high-strength estradiol creams

Europe – PRAC confirms four-week limit for use of high-strength estradiol creams

EMA’s safety committee (PRAC) has confirmed its recommendation to limit the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single...
Ibrance given NICE green light in breast cancer

UK – Ibrance given NICE green light in breast cancer

The potentially life-extending drug will now be available for patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced breast cancer, who...
Vitrakvi deemed ‘not cost-effective’ by NICE

UK – Vitrakvi deemed ‘not cost-effective’ by NICE

The guidance service published the decision in regards to the drug being used in advanced neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in...
NICE ‘OK’ for Lynparza

UK – NICE ‘OK’ for Lynparza

The decision was based on a clinical trial in which the drug stalled growth of the cancer for around 13.6 months compared to placebo. The...
Study: Speedier reviews might have compromised rigor of FDA approval

USA – Study: Speedier reviews might have compromised rigor of FDA approval

Changes in U.S. Food and Drug Administration (FDA) procedures meant to speed approvals for medications may have resulted in less exacting standards, a new...
DM et Phtalates

International – DM et Phtalates

Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR)...
Pediatric Study Plans for Oncology Drugs : Q & A

USA – Pediatric Study Plans for Oncology Drugs : Q & A

The purpose of this guidance is to provide information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by...
3 More NDAs Will Become BLAs

USA – 3 More NDAs Will Become BLAs

As some insulin, human growth hormone and other products transition on 23 March from new drug applications (NDAs) to biologics license applications (BLAs), the...
Mandatory use of international standard for the reporting of side effects to improve safety of medicines

Europe – Mandatory use of international standard for the reporting of side effects to...

At its December 2019 meeting, EMA's Management Board agreed to the mandatory use of a consistent international format, the ISO ICSR format, for reporting individual cases...
NICE rejects Keytruda, asks for more info

UK – NICE rejects Keytruda, asks for more info

The organisation is calling for an urgent reassessment of the evidence for the drug’s benefit, and has asked for more clinical and cost-effectiveness evidence...

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