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RSS FeedPosted by Michael Wonder on 24 Sep 2020
'Pharma resistance’ to battle superbugs
24 September 2020 - A group of pharmaceutical giants, biotech companies, industry peak bodies and the CSIRO have banded together ...
Posted by Michael Wonder on 24 Sep 2020
FDA grants AT-007 paediatric rare disease designation and orphan designation for treatment of PMM2-CDG
24 September 2020 - Applied Therapeutics announced today that the U.S. FDA has granted AT-007 both paediatric rare disease designation and ...
Posted by Michael Wonder on 24 Sep 2020
Leap Therapeutics announces FDA fast track designation granted to DKN-01 for the treatment of gastric and gastro-esophageal junction cancer
24 September 2020 - Leap Therapeutics today announced that the U.S. FDA has granted fast track designation to DKN-01 for the ...
Posted by Michael Wonder on 24 Sep 2020
Guideline on registry-based studies - launch of public consultation
24 September 2020 - EMA has published its draft Guideline on registry-based studies for a three-month public consultation today. ...
Posted by Michael Wonder on 24 Sep 2020
Stage 2 PBS process improvement information forum – webinar recording and resources available
24 September 2020 - On 21 September 2020, the department hosted a webinar to provide information to industry on the Stage ...
Posted by Michael Wonder on 24 Sep 2020
GW Pharmaceuticals receives Australian Therapeutic Goods Administration approval for Epidyolex (cannabidiol) for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy
23 September 2020 - This represents the third successful regulatory approval globally for GW’s plant-derived cannabis-based medicine. ...
Posted by Michael Wonder on 23 Sep 2020
SMC plays key role in helping to secure access to COVID-19 treatments
15 September 2020 - The Scottish Medicines Consortium is part of a UK-wide multi-agency initiative to secure access to potential ...
Posted by Michael Wonder on 23 Sep 2020
NICE board agrees to stimulate action following publication of Independent Medicines and Medical Devices Safety Review report
23 September 2020 - NICE to reinforce the importance of collaborative working with system partners to ensure a more integrated approach ...
Posted by Michael Wonder on 23 Sep 2020
NICE publishes final guidance for another Roche cancer medicine
23 September 2020 - This time it is for polatuzumab vedotin (Polivy) for patients with non-Hodgkin's lymphoma. ...
Posted by Michael Wonder on 23 Sep 2020
More patients will have access to medicines within the high-cost protection
23 September 2020 - From 2 June 2020, patients who pick up prescription drugs at pharmacies can switch to an ...
Posted by Michael Wonder on 23 Sep 2020
ICER issues final report and policy recommendations on treatments for cystic fibrosis
23 September 2020 - Independent appraisal committee unanimously concludes that Trikafta delivers substantial benefits for patients, family members, and society. ...
Posted by Michael Wonder on 23 Sep 2020
How incidents with medicines are managed in the EU – a ten year analysis
23 September 2020 - The EU medicines network is supported by a robust regulatory framework with defined processes and clear ...
Posted by Michael Wonder on 23 Sep 2020
FDA accepts supplemental new drug application for Pfizer’s Xalkori (crizotinib) for the treatment of paediatric ALK positive anaplastic large cell lymphoma
23 September 2020 - If approved, Xalkori would be the first biomarker driven therapy for paediatric ALK positive anaplastic large cell ...
Posted by Michael Wonder on 23 Sep 2020
Eisai receives positive opinion from EMA's CHMP on use of anti-epileptic agent Fycompa in paediatric patients
23 September 2020 - Eisai announced that it has received a positive opinion from the EMA’s CHMP on the license extension ...
Posted by Michael Wonder on 23 Sep 2020
UCB achieves important regulatory milestone for bimekizumab
22 September 2020 - The U.S. FDA and EMA have accepted marketing application submissions for bimekizumab for the treatment of adults ...