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FDA sets January decision date for Xalkori in ALK-positive lymphoma
FDA submission is based on results from ADVL0912 and A8081013 studies
EMA fast-tracks review of bluebird bio’s LentiGlobin for sickle cell disease
Gene therapy has been given a PRIME designation
Relief Therapeutics seeks US emergency approval for COVID-19 drug
If granted, EUA would give approval for use in severely ill patients with no other treatment options
Shionogi's Gram-negative antibiotic launches in the UK
Novel antibiotic is indicated for use against Gram-negative bacterial infections
Roche plans to launch rapid COVID-19 antigen test later this month
Swiss pharma also intends to file for emergency approval in the US
American Medical Association calls for COVID-19 vaccine development transparency
Organisation asks FDA to provide transparent information on review plans
US charges Teva for generic drug price-fixing plot
Company maintains it has not committed any wrongdoing
FDA grants emergency approval for blood plasma treatments for COVID-19
Emergency approval granted despite concerns from top US health officials
Vertex’s triple combination CF therapy to become available on the NHS
The drug will immediately become available to thousands of cystic fibrosis patients
‘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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Janssen scores another expansion for new Darzalex combination in the USMyeloma med approved in combination with Amgen's Kyprolis
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Novartis wins FDA approval for relapsing MS drug KesimptaSwiss pharma company is expecting EU approval for treatment next year
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Pifzer, BioNTech eye October approval for mRNA-based COVID-19 vaccineCompanies share additional phase 1 safety and tolerability data
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NICE recommends Roche’s Polivy for B-cell lymphomaCost-effectiveness agency approves drug following initial rejection earlier this year
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US states claim Purdue Pharma owes $2.2 trillion over opioid crisis Company faces new accusations of dishonest marketing tactics
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AZ scores FDA priority review for new Imfinzi fixed-dose regimen Four-week dosing schedule offers new flexibility for patients
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Roche’s Soliris rival Enspryng bags FDA approvalDrug is second to be approved for the treatment of NMOSD
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
Featured jobs
- New study identifies drugs that are safe to use in COVID-19 treatment
- How COVID-19 is accelerating the threat of antimicrobial resistance
- Novacyt launches diagnostic test to differentiate between COVID-19 and flu
- Relief Therapeutics seeks US emergency approval for COVID-19 drug
- Gavi says 76 wealthy countries have committed to COVAX vaccine facility
- Keytruda doubles five-year survival rate in NSCLC
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