newsFirst patients receive Moderna’s modified COVID-19 vaccine candidates11 March 2021 | By Hannah Balfour (European Pharmaceutical Review)Moderna has begun testing two new mRNA COVID-19 vaccines, one specifically targeting the B.1.351 variant and the other a multivalent candidate.
newsBamlanivimab and etesevimab prevent COVID-19 related deaths11 March 2021 | By Hannah Balfour (European Pharmaceutical Review)In a high-risk patient cohort, treatment with the combination of bamlanivimab and etesevimab reduces COVID-19 related hospitalisation and death by 87 percent.
newsFDA grants Emergency Use Authorisation to Abott’s SARS-CoV-2, influenza and RSV test9 March 2021 | By Hannah Balfour (European Pharmaceutical Review)The PCR based Alinity™ m Resp-4-Plex molecular assay can detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV).
newsCOVID-19 T cell test submitted for emergency use authorisation8 March 2021 | By Hannah Balfour (European Pharmaceutical Review)In clinical testing, the T-SPOT.COVID test was found to agree with PCR test results in over 96 percent of samples taken within first 60 days of infection.
newsExperimental immunotherapy significantly delays onset of type 1 diabetes4 March 2021 | By Hannah Balfour (European Pharmaceutical Review)If approved for use, teplizumab could be the first drug able to delay the onset or completely prevent type 1 diabetes in at-risk groups.
newsMerck to manufacture Janssen’s COVID-19 vaccine3 March 2021 | By Hannah Balfour (European Pharmaceutical Review)Merck has entered into multiple agreements to support the expansion of the supply of COVID-19 medicines and vaccines.
newsFDA approves the Janssen COVID-19 Vaccine for emergency use1 March 2021 | By Hannah Balfour (European Pharmaceutical Review)The FDA has issued an Emergency Use Authorization for the single-dose Janssen COVID-19 Vaccine, making it the third COVID-19 vaccine available for use in the US.
newsTezepelumab significantly reduces exacerbations of severe asthma1 March 2021 | By Hannah Balfour (European Pharmaceutical Review)In a Phase III trial, tezepelumab was shown to meaningfully reduce annualised asthma exacerbation rates in a range of patients with severe, uncontrolled asthma.
newsNovel nanocarrier enables targeted treatment of gliomas in vivo1 March 2021 | By Hannah Balfour (European Pharmaceutical Review)The new nanoparticle formulation enabled researchers to selectively target glioma cells with Dp44mT, a potent chelator and promising anti-cancer therapeutic, for the first time.
newsLeukine® significantly improves lung function in hospitalised COVID-19 patients26 February 2021 | By Hannah Balfour (European Pharmaceutical Review)In the trial Leukine® (sargramostim, rhuGM-CSF) improved oxygenation in COVID-19 patients with acute respiratory failure by at least a third in over half of those treated.
newsTreatment for rare Duchenne muscular dystrophy mutation approved by FDA26 February 2021 | By Hannah Balfour (European Pharmaceutical Review)The FDA conditionally approved Sarepta’s Amondys 45 (casimersen) after interim Phase III results indicated the treatment is reasonably likely to be of clinical benefit.
newsFDA approves more flexible transportation conditions for Pfizer-BioNTech COVID-19 vaccine26 February 2021 | By Hannah Balfour (European Pharmaceutical Review)Based on new stability data, the US regulator will allow COMIRNATY® to be transported and stored at standard pharmaceutical freezer temperatures for up to two weeks.
newsIde-cel provides lasting remissions in multiply-relapsed myeloma25 February 2021 | By Hannah Balfour (European Pharmaceutical Review)BMS and bluebird bio have applied to the FDA for approval of ide-cel as a standard therapy for relapsed or refractory multiple myeloma based on positive Phase II trial results.
newsFDA grants Priority Review to Pfizer’s tick-borne encephalitis vaccine TicoVac™25 February 2021 | By Hannah Balfour (European Pharmaceutical Review)If approved, TicoVac would be the first vaccine in the US to help protect adults and children from tick-borne encephalitis.
newsFDA receives new stability data on Pfizer’s COVID-19 vaccine24 February 2021 | By Hannah Balfour (European Pharmaceutical Review)New stability data could allow Pfizer and BioNTech’s COMIRNATY® COVID-19 vaccine to be stored at normal refrigerated temperatures for up to two weeks.