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RSS FeedPosted by Michael Wonder on 30 Mar 2023
EMA recommends approval of Bimervax as a COVID-19 booster vaccine
30 March 2023 - The EMA’s CHMP has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a ...
Posted by Michael Wonder on 29 Mar 2023
Libtayo (cemiplimab) in combination with chemotherapy approved by European Commission for the first-line treatment of advanced PD-L1 positive non-small-cell lung cancer
29 March 2023 - Approval marks second first-line indication in non-small-cell lung cancer and fifth indication for Libtayo in the ...
Posted by Michael Wonder on 28 Mar 2023
DARWIN EU has completed its first studies and is calling for new data partners
28 March 2023 - DARWIN EU, the Data Analysis and Real World Interrogation Network, has accomplished its first year of establishment. ...
Posted by Michael Wonder on 28 Mar 2023
Amicus Therapeutics announces European Commission approval for Pombiliti in patients with late-onset Pompe disease
27 March 2023 - CHMP opinion for miglustat, the oral enzyme stabiliser component of AT-GAA, on track for 2Q, 2023. ...
Posted by Michael Wonder on 27 Mar 2023
EMA validates marketing authorisation application for Henlius' Hansizhuang (serplulimab)
23 March 2023 - Hansizhuang (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer. ...
Posted by Michael Wonder on 22 Mar 2023
Advancing regulatory science in the EU – mid-point report published
22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...
Posted by Michael Wonder on 22 Mar 2023
Dupixent (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis
21 March 2023 - Milestone marks third Dupixent European Commission approval in the past four months. ...
Posted by Michael Wonder on 15 Mar 2023
EMA-FDA parallel scientific advice program has ‘limited’ uptake
14 March 2023 - A review of the last five years of the parallel scientific advice program between the FDA ...
Posted by Michael Wonder on 08 Mar 2023
Genethon given PRIME status by EMA for gene therapy to treat Crigler-Najjar syndrome, a rare liver disease
7 March 2023 - Genethon today announced that the EMA has granted PRIME (Priority Medicines) status to the gene therapy, ...
Posted by Michael Wonder on 08 Mar 2023
In Amsterdam, EU drugs regulator doesn’t want brothel moving in next door
7 March 2023 - Sex and drugs don’t mix, argues the EMA. ...
Posted by Michael Wonder on 06 Mar 2023
Bristol Myers Squibb receives European Commission approval of Reblozyl (luspatercept) for anaemia in adult patients with non-transfusion-dependent beta thalassaemia
3 March 2023 - Third authorised indication in Europe for Reblozyl, a first in class treatment for patients with diseases ...
Posted by Michael Wonder on 05 Mar 2023
Replacing RCTs with real world data for regulatory decision-making: a self-fulfilling prophecy?
2 March 2023 - Real world data are advocated as an alternative approach to randomised clinical trials for closing knowledge gaps ...
Posted by Michael Wonder on 03 Mar 2023
Nubeqa (darolutamide) receives EU approval for additional indication in prostate cancer
1 March 2023 - Approval is based on Phase 3 ARASENS trial data. ...
Posted by Michael Wonder on 28 Feb 2023
US FDA accepts Bristol Myers Squibb’s supplemental biologics license application and EMA validates application for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma
28 February 2023 - The applications are based on results from the Phase 3 CheckMate-76K trial, in which Opdivo demonstrated a ...
Posted by Michael Wonder on 27 Feb 2023
EMA pilots scientific advice for certain high risk medical devices
27 February 2023 - The EMA has launched a pilot to give scientific advice on the intended clinical development strategy ...