Blog
RSS FeedPosted by Michael Wonder on 24 Jul 2021
COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU
23 July 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously COVID-19 Vaccine ...
Posted by Michael Wonder on 22 Jul 2021
Bayer’s new symptomatic chronic heart failure treatment Verquvo (vericiguat) approved in EU
21 July 2021 - Approved for adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring ...
Posted by Michael Wonder on 22 Jul 2021
bluebird bio receives EC approval for Skysona (elivaldogene autotemcel, Lenti-D) gene therapy for patients less than 18 years of age with early cerebral adrenoleukodystrophy without matched sibling donor
21 July 2021 - Skysona is the first and only gene therapy approved in the European Union to treat early CALD. ...
Posted by Michael Wonder on 21 Jul 2021
Myovant Sciences announces European Commission approval for Ryeqo for the treatment of women with uterine fibroids
20 July 2021 - Ryeqo is the first and only once-daily long-term treatment for uterine fibroids in Europe. ...
Posted by Michael Wonder on 20 Jul 2021
Kyowa Kirin announces EU approval for the self administration of Crysvita (burosumab) to treat X-linked hypophosphataemia
19 July 2021 - An additional option is now available to healthcare professionals to meet the needs of X-linked hypophosphataemia patients and ...
Posted by Michael Wonder on 20 Jul 2021
Albireo receives European marketing authorisation of Bylvay (odevixibat), the first drug treatment for progressive familial intrahepatic cholestasis
19 July 2021 - First approval in the world of Bylvay for the treatment of progressive familial intrahepatic cholestasis. ...
Posted by Michael Wonder on 20 Jul 2021
Almirall receives European Commission approval of Klisyri (tirbanibulin), an innovative topical treatment for actinic keratosis
19 July 2021 - Klisyri (tirbanibulin) is a topical first in class microtubule inhibitor indicated for the treatment of actinic keratosis ...
Posted by Michael Wonder on 30 Jun 2021
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy for certain patients with oesophageal cancer or HER2 negative gastro-oesophageal junction adenocarcinoma
29 June 2021 - Keytruda is first anti-PD-1 therapy approved in Europe in combination with chemotherapy for first-line treatment of ...
Posted by Michael Wonder on 29 Jun 2021
Roche’s Enspryng approved by European Commission as first and only at home subcutaneous treatment for neuromyelitis optica spectrum disorder
28 June 2021 - In Phase 3 trials, ENSPRYNG significantly reduced the number and severity of relapses in people with AQP4-IgG ...
Posted by Michael Wonder on 28 Jun 2021
UCB receives positive CHMP opinion recommending approval of Bimzelx (bimekizumab) in the EU for the treatment of adults with moderate to severe plaque psoriasis
25 June 2021 - The positive CHMP opinion is supported by data from three Phase 3 trials where bimekizumab demonstrated superior ...
Posted by Michael Wonder on 28 Jun 2021
Incyte and MorphoSys announce positive CHMP opinion for tafasitamab in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma
25 June 2021 - The positive opinion from the CHMP is based on data from the Phase 2 L-MIND study evaluating ...
Posted by Michael Wonder on 28 Jun 2021
Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease
26 June 2021 - If approved, Forxiga has the potential to change the treatment paradigm for millions of people in ...
Posted by Michael Wonder on 28 Jun 2021
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) as adjuvant treatment for oesophageal or gastro-oesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy
25 June 2021 - Recommendation based on positive results from the Phase 3 CheckMate -577 trial in which Opdivo doubled disease-free ...
Posted by Michael Wonder on 28 Jun 2021
Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma
25 June 2021 - Approval based on data from the largest trial to date in patients with advanced basal cell carcinoma ...
Posted by Michael Wonder on 28 Jun 2021
Libtayo (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ≥50% PD-L1 expression
25 June 2021 - Approval based on a Phase 3 trial demonstrating Libtayo significantly improved overall survival compared to chemotherapy in ...