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Novartis and NHS England reach ‘landmark’ deal for Zolgensma gene therapy for SMA
Children born with SMA type 1 typically have a life expectancy of around two years
EMA recommends use of Lilly’s COVID-19 antibody cocktail
Agency concludes bamlanivimab and etesevimab can be used to treat certain COVID-19 patients
Germany backs use of AZ/Oxford COVID-19 vaccine in over-65s
Country's Health Ministry also recommended extending gap between doses to 12 weeks
EMA begins rolling review process for Sputnik V COVID-19 vaccine
Late-stage trial results found vaccine gives 91.6% protection against COVID-19
Pfizer’s ALK inhibitor Lorbrena scores expanded FDA approval for first-line NSCLC
The European Medicines Agency is also reviewing an application for the drug
MHRA to fast-track vaccines modified for new COVID-19 variants
Pfizer, Moderna and AstraZeneca are all working on modified vaccines
Novavax seeks FDA emergency approval for COVID-19 vaccine by May
Company is hoping FDA will review data from a UK-based trial
MSD withdraws Keytruda’s US indication for small cell lung cancer
Checkpoint inhibitor gained accelerated approval in 2019
J&J’s one-dose COVID-19 vaccine granted emergency use approval by FDA
Company has already started shipping doses of the vaccine to the US
‘Post-Brexit landscape for EU-wide IP Rights: The Story So Far’
Brexit means pharma must review its intellectual property rights across Europe
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Moving timesContinuity and stability are vital when it comes to the EMA's relocation when it leaves London
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SMC gives green light for Amgen’s KyprolisThe committee also gives verdict on three other products
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FDA authorises flexible storage for Pfizer/BioNTech COVID-19 vaccineVaccine can be transported/stored at standard pharmaceutical freezer temperatures
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FDA briefing document backs J&J’s one-dose COVID-19 vaccineCompany is seeking an emergency use authorisation in the US
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FDA updates guidance for COVID-19 vaccine makers addressing new variantsFDA said that it expects manufacturing information for modified vaccines to remain generally the same
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J&J submits one-dose COVID-19 vaccine to WHO for emergency use listing
In phase 3, J&J's vaccine was 66% effective overall at preventing moderate-to-severe COVID-19
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Sanofi, Regeneron’s Libtayo scores first-line NSCLC approval in the US
New approval will see Libtayo compete with blockbuster immunotherapy Keytruda
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FDA fast-tracks review of Incyte’s Jakafi for chronic GVHDSubmission is based on results from the pivotal REACH3 study
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WHO agrees to no-fault compensation for rare serious side effects from COVAX-distributed vaccinesThe no-fault compensation fund will be accessible via a web portal by 31 March 2021
Latest regulatory appointments
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ABPI appoints industry veteran Richard Torbett as new chief executiveTorbett initially joined the pharma association in March 2016
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Professor Carole Longson moves from NICE to the ABPIShe joins the UK pharma body as its chief scientific officer
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MedTech Europe appoints new board of directors
Chair of the board Michelle Brennan is among those newly elected
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Greg Perry joins IFPMA as assistant director generalWill move to the global industry body from the Medicines Patent Pool
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AVEO appoints Nikhil Mehta as its senior VP, regulatory and quality assurance
He joins the biopharma from Tang Capital Management
COVID-19 Updates and Daily News
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- Bayer’s finerenone scores FDA priority review for chronic kidney disease
- Sinopharm’s COVID-19 vaccine scores approval in China
- Categories - Communiqué Awards
- Inovio plans late-stage COVID-19 vaccine study in second quarter 2021
- The role of women in science and technology
- Syneos Health Communications announces senior hires to Europe-based team
- IWD2021: #ChooseToChallenge Interview with Dennis O’Brien, Lucid Group CEO
- Lilly’s tirzepatide shows superiority over Novo’s semaglutide in type 2 diabetes trial
- Novartis and NHS England reach ‘landmark’ deal for Zolgensma gene therapy for SMA
- EMA recommends use of Lilly’s COVID-19 antibody cocktail
- Merck & Co, Ridgeback Biotherapeutics’ COVID-19 drug shows early promise
- ZENO GROUP HIRES AVRIL LEE AS HEAD OF HEALTHCARE, U.K. AND EUROPE
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