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Vaccine developers call on FDA to offer clarity on COVID-19 trials
Comments from J&J and Pfizer made before FDA advisory committee meeting yesterday
FDA approves Gilead’s remdesivir for hospitalised COVID-19 patients
Antiviral drug initially scored emergency use authorisation in May
Purdue to pay over $8bn to settle opioid-related criminal claims
Claims relate to Purdue's involvement in fuelling the opioid addiction crisis
Independent consultant will review Lilly’s COVID-19 plant issues
COVID-19 antibody trial was paused last week due to safety issue
AZ’s US-based COVID-19 vaccine trial could restart this week
Sources briefed on the matter disclosed possible timeline to Reuters
Novartis scores CHMP backing for cholesterol drug Leqvio
Potential first-in-class treatment moves closer to EU approval
Pfizer CEO pushes back COVID-19 vaccine submission to November
Company previously said it would seek approval by October
Novartis’ MS therapy Mayzent approved by NICE
Agency approves drug after new cost-effectiveness proposal
Regeneron scores first FDA approval for Ebola antibody treatment
Treatment cut mortality rate in study based in the Democratic Republic of Congo
‘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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Biopharma industry encouraged by EMA’s COVID-19 transparency measuresIFPMA and EFPIA welcome new transparency measures for potential treatments and vaccines
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Mallinckrodt files for bankruptcy protection in the USBankruptcy filing will reduce debts related to legal liabilities
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Regeneron seeks US emergency use authorisation for COVID-19 antibody cocktailIf approved, the US government will make initial doses available at no cost
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Alkermes’ new antipsychotic clears FDA advisory committee hurdle Target action date for FDA decision is due on 15 November
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FDA publishes new guidelines for COVID-19 vaccine approvalNew rules mean a COVID-19 shot is unlikely to be approved pre-election in the US
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WHO’s director-general says COVID-19 vaccine may be available by year-endRemarks were made at a WHO executive board meeting earlier this week
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Pfizer and BioNTech’s COVID-19 vaccine begins EMA evaluationVaccine is the second to undergo EMA's 'rolling review' process after AstraZeneca/Oxford Uni's candidate
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
- Relief Therapeutics’ COVID-19 drug shows positive results ahead of trial readout
- GSK chief exec ‘optimistic’ COVID-19 vaccine could be available next year
- Pfizer CEO says COVID-19 vaccine efficacy data could come ‘soon’
- FDA sets November date for expert panel review of Biogen’s aducanumab
- Novartis weathers the COVID-19 storm in Q3, lifts outlook
- FDA approves Gilead’s remdesivir for hospitalised COVID-19 patients
- The science of the deal
- Live Webinar: Overcoming Behavioral Health Access Limitations Through Telemedicine
- Pfizer CEO says COVID-19 vaccine efficacy data could come ‘soon’
- Lilly’s Q3 earnings slump on COVID-19 development costs, pricing pressures
- Keytruda growth helps Merck to offset COVID-19 impact in Q3
- Celebrating the hard work and dedication of our wonderful Talent Manager
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