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Pharmafile.com’s top 10 news stories of the week

pharmafile | January 8, 2021 | News story | Medical Communications  

Almost all of Pharmafile.com’s most popular stories this week focused on developments in the global mission to vaccinate against COVID-19. The EU has ramped up its vaccination programme by securing 100m extra doses of the Pfizer jab, before approving Moderna’s vaccine candidate – which this week achieved over 90% efficacy in Phase III trials – just days after.

In oncology news, Genentech’s novel cancer immunotherapy has been granted Breakthrough Therapy Design by the FDA, while scientists in the UK have developed a new drug that effectively targets the KRAS mutations found in a number of hard-to-treat cancers.

 1. Genentech’s cancer drug gets Breakthrough Therapy Designation from FDA – Published 05/01/2021

Genentech has announced that tiragolumab, a novel cancer immunotherapy designed to bind to T cell immunoreceptor with Ig and ITIM domains (TIGIT), has been granted Breakthrough Therapy Designation (BTD) by the FDA, in combination with Tecentriq (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations.

2.  AstraZeneca’s Farxiga granted Priority Review by FDA – Published 06/01/21

AstraZeneca’s Farxiga (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type-2 diabetes.

3. WHO recommends against 12-week delay for COVID-19 vaccine doses – Published 06/01/21

The WHO has recommended against the UK’s plans to delay second doses of the COVID-19 vaccine by 12 weeks, saying people should receive the second dose within 21 to 28 days of the first jab.

4. EU approves Moderna’s COVID-19 vaccine – Published on 07/01/21

The European Commission has granted a Condition Marketing Authorisation (CMA) for Moderna’s COVID-19 vaccine, meaning the jab will soon be rolled out across the EU’s 27 states as part of its vaccination programme.

5. EU states to receive 100m extra doses of Pfizer-BioNTech vaccine – Published 04/01/21

Pfizer and BioNTech have announced they will supply an additional 100 million doses of their COVID-19 vaccine, COMIRNATY, to the EU’s 27 member states in 2021.

6. RedHill announces positive top-line data for COVID-19 pneumonia drugPublished on 04/01/21

RedHill Biopharma has announced that preliminary top-line data from its US Phase II study with orally-administered opaganib (Yeliva) in patients hospitalised with COVID-19 pneumonia demonstrated positive safety and efficacy signals.

7. Scientists develop new drug to target KRAS mutations in cancerPublished on 05/01/21

In a study funded by Cancer Research UK and Wellcome, scientists have developed a new drug that effectively targets the KRAS mutation found in several hard-to-treat cancers.

8. Concern as India approves COVID-19 vaccine before trial completionPublished on 04/01/21

Experts have expressed concern over India’s emergency approval of its homegrown COVID-19 vaccine, Covaxin, before studies have been completed.

9. Moderna’s COVID-19 vaccine achieves over 90% efficacy in Phase III trialPublished on 04/01/21

Moderna’s COVID-19 vaccine has achieved over 90% efficacy in interim safety and primary efficacy results following its Phase III trial.

10. UK becomes first country to roll out Oxford University-AstraZeneca COVID-19 vaccinePublished on 04/01/21

The UK has become the first country to administer the Oxford University-AstraZeneca COVID-19 vaccine to its population as coronavirus case numbers across the nation continue to rise.

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