Pharmafile.com’s top 10 news stories of the week
pharmafile | June 4, 2021 | News story | Medical Communications |
Among our ten most-read stories this week: NICE rejects risdiplam for treating spinal muscular atrophy; The EU wants to Fine AstraZeneca €10 per dose for COVID-19 vaccine delay; Organon launches as women’s health company; elsewhere, a vaccine patch outperforms needle-and-syringe jabs in pre-clinical study.
1. NICE rejects risdiplam for treating spinal muscular atrophy – Published 02/06/21
NICE has issued draft guidance today which does not recommend Roche’s risdiplam (Evrysdi) for treating the rare genetic disorder spinal muscular atrophy (SMA).
2. EU: Fine AstraZeneca €10 per dose for COVID-19 vaccine delay – Published 28/06/21
The EU is suing AstraZeneca in a Brussels court over its failure to deliver on its vaccine contract.
EU member states and European Commission are suing the pharmaceutical company after it delivered only 30 million doses in the first quarter of 2021 out of the 120 million it was contracted to supply.
3. Organon launches as women’s health company – Published 03/06/21
Organon today launched through a spinoff from Merck as a global company focusing on women’s health.
The new team will be majority women and the company will be headquartered in the US, with offices across the globe, including one in Shoreditch, London.
4. Vaccine patch outperforms needle-and-syringe jabs in pre-clinical study– Published 03/06/21
Vaxxas, an Australian clinical-stage biotechnology company, has announced positive results from pre-clinical trials into its novel high-density microarray patch (HD-MAP) for vaccination against COVID-19
5. Biosimilars and Brexit: What’s in store for UK’s biosimilar market? – Published 02/06/21
It’s been 15 years since the first biosimilar entered the market, and the impact of these drugs on the healthcare industry has been immense. Now the UK has officially left the EU, what effect will Brexit have on the booming biosimilar market in the UK? Kat Jenkins takes a look at the new regulatory landscape post-Brexit, speaking with British Biosimilar Association’s Technical Director, Paul Fleming
6. FDA approves Novartis’s Cosentyx for severe plaque psoriasis – Published 02/06/21
The FDA has approved Novartis’s Cosentyx for the treatment of children and adolescents with moderate to severe plaque psoriasis.
The approval is based on pivotal Phase III trial data showing that Cosentyx demonstrated superior improvements of skin symptoms compared to placebo.
7. DMD study in vamorolone reports positive results – Published 01/06/21
Santhera Pharmaceuticals and ReveraGen BioPharma have announced positive results from their Phase IIb VISION-DMD study, evaluating the efficacy and safety of vamorolone compared to placebo and prednisone (active control) in the treatment of Duchenne muscular dystrophy (DMD).
8. FDA approves BMS’s Zeposia for chronic inflammatory bowel disease – Published 28/05/21
The FDA has approved Approves Bristol Myers Squibb’s Zeposia for adults with moderately to severely active ulcerative colitis (UC).
UC is a chronic inflammatory bowel disease and Zeposia is the first and only oral sphingosine 1-phosphate receptor modulator approved to treat it.
9. NICE recommends Janssen’s active psoriatic arthritis drug– Published 28/05/21
NICE have released a Final Appraisal Document (FAD) recommending Janssen’s tremfya (guselkumab) as a new option for treating active psoriatic arthritis (PsA) in adults who have not responded well to disease-modifying antirheumatic drug (DMARD) therapy or who cannot tolerate them.
10. Novartis report longest median OS in breast cancer study – Published 03/06/21
Novartis has announced updated median overall survival (OS) results for Kisqali (ribociclib), in combination with fulvestrant, in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer.
