Potential COVID-19 treatment LAM-002A to enter Phase II clinical trial
Yale University and AI Therapeutics will collaborate on a Phase II trial to study LAM-002A as a COVID-19 treatment for newly diagnosed patients.
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EMA initiates review of dexamethasone for treating COVID-19
The EMA has begun to review dexamethasone to provide an opinion on the results of the RECOVERY study for the treatment of adults admitted to hospital with COVID-19.
Pfizer and BioNTech COVID-19 vaccine candidate enters Phase II/III trials
The BNT162b2 mRNA-based vaccine produced by Pfizer and BioNTech will enter Phase have II/III clinical trials to test its safety and efficacy against COVID-19.
Sandoz and Austrian government to invest in European antibiotic manufacturing
Sandoz plans to invest €150 million and the Austrian government €50 million into integrated antibiotic manufacturing operations at Kundl.
UK government invests £100 million into COVID-19 vaccine manufacturing
The UK government has committed £100 million to establish a centre to scale up COVID-19 vaccine and gene therapy manufacturing.
EMA recommends 11 new medicines for approval following July meeting
Dapivirine Vaginal Ring (dapivirine) and Blenrep (belantamab mafodotin) have been recommended for approval by the EMA's CHMP, along with nine other medicines.
FUJIFILM Diosynth Biotechnologies to manufacture Novavax COVID-19 vaccine candidate
Novavax and FUJIFILM Diosynth Biotechnologies have agreed for FDB to make the bulk drug substance for NVX-CoV2373, the Novavax COVID-19 vaccine candidate.
FDA orders update of label change for opioid pain medications
The FDA is requiring that labels for opioid pain medicine and medicines to treat opioid use disorder recommend healthcare professionals discuss the availability of naloxone with patients to reduce overdoses.
Study suggests some excipients in common drugs are biologically active
Preliminary research has revealed that some excipients used in common medications may interact with important human enzymes and receptors.
EMA to monitor real world use of COVID-19 treatments and vaccines
The EMA has built up an infrastructure to allow for the monitoring of COVID-19 treatments and vaccines used in clinical practice.
UK MHRA announces two Class 2 medicine recalls
A batch of Nitrofurantoin and all unexpired stock of Desmopressin nasal spray are being recalled in the UK, the MHRA has announced.
Pfizer and BioNTech to supply up to 600 million doses of COVID-19 vaccine to US
An agreement between the US government and Pfizer and BioNTech will have the companies produce an initial 100 million doses of their COVID-19 vaccine candidate, with the potential for 500 million more.
Novel anti-amyloid drug BAN2401 enters Phase III trial in Alzheimer’s patients
BAN2401 will be tested in various stages of Alzheimer’s disease progression to assess if it can slow the progression of cognitive decline.
Plant-based COVID-19 vaccine enters Phase I trials
The vaccine containing a recombinant coronavirus virus-like particles (CoVLP) will be tested in three different doses and with two different adjuvants.
UK’s SARS-CoV-2 vaccine candidate is safe and induces antibody and T cell response
Data released from the Phase I/II trial of the ChAdOx1 COVID-19 vaccine candidate suggests it elicits an immune response with no adverse effects.
