BioPharm Insight

Given the scarcity of treatment options for marginal zone lymphoma (MZL) patients, all eyes are on $TGTX highly anticipated #FDA approval for #umbralisib in relapsed/refractory MZL biopharminsight.com/tg-therapeutic…

University of Oxford prepares study blueprint to test combinations of UK-authorised #COVID19 vaccines, source says- pharmaceutical-technology.com/comment/univer…

The highly anticipated pivotal Phase III FORTRESS results for $POLN balixafortide in HER2-negative HR+ breast cancer look extra promising given the synergy provided by the choice of trial comparator pharmaceutical-technology.com/comment/polyph…

Despite strong evidence that favors the extrapolation of adult data in #COVID-19 vaccine trials to adolescents over 12, experts believe their use in children under 12 requires more clinical support before the #FDA considers approval in this age group pharmaceutical-technology.com/comment/covid-…

Although $ARWR gained a whopping stock boost after releasing ARO-AAT interim data at the #AASLD Digital Liver Meeting, experts are cautious to show excitement as fibrosis approval is a slow process biopharminsight.com/arrowhead%E2%8…

While the failure of $BIIB to win the support of the #FDA Advisory Committee for #aducanumab does not translate to a zero chance of approval, it does mean that the drug may face tremendous barriers to coverage by payers clinicaltrialsarena.com/comment/biogen…

Until #COVID19 vaccines are rolled out, treatments like $LLY mAb bamlanivimab will reap the benefits in terms of payer acceptance, despite broad labels, given the potential therapeutic and societal impact on stemming hospitalisations. clinicaltrialsarena.com/comment/eli-li…

Despite $PFE and $BNTX developing a #COVID-19 vaccine without the help of #OperationWarpSpeed, their success should be viewed with caution given the many unknowns of lasting immunity in different patient populations clinicaltrialsarena.com/comment/pfizer…

With early evidence of $CMRX DSTAT's efficacy in #COVID-19 patients, experts agree that its unique structural differences from heparin may allow it to block inflammatory responses through a more effective approach clinicaltrialsarena.com/comment/chimer…

Despite physician enthusiasm, #COVID19 #hIVIG development from the likes of #Takeda, $GRF and CSL Behring may be hampered by competition with authorized #convalescentplasma and the reliance on its supplies. clinicaltrialsarena.com/comment/hivig-…

Although $AUPH presented at #ACR20 positive efficacy analysis of voclosporin in lupus nephritis, the drug has potential long-term nephrotoxicity concerns biopharminsight.com/aurinia%E2%80%…

Despite the $LLY mAb news, experts are cautious on how limited data could hamper ongoing investigations needed to solidify efficacy and utility insight $REGN

With #ASH20 just around the corner, $FATE ’s CAR NK therapeutic approach poses excitement as it could address gaps left by single-target CAR-T therapies in B cell malignancies and #CLL biopharminsight.com/fate%E2%80%99s…

Frenetic attention is on the #COVID19 vaccine frontrunners $PFE $BNTX $MRNA but on their heels are a second wave of vaccines $JNJ $GSK $SAN $NVAX $INO, which are unlikely to require a higher or even matching efficacy bar clinicaltrialsarena.com/comment/covid-…

Researchers in the UK are set to run the first #COVID19 challenge trial in early 2021. Experts this news service spoke to said operational hurdles could well undercut the speed advantages

Despite the groundbreaking success of CAR-T therapies, $FATE and $CYAD have developed CAR-NK products that have experts optimistic about their advantages in treating cancer pharmaceutical-technology.com/comment/fate-t…

First $AZN and now $JNJ... following trial halt whiplash, $AZN #COVID19 vaccine AZD1222 splits experts as to whether its trials restarted too quickly on the heels of a second volunteer having a neurological event clinicaltrialsarena.com/comment/azd122…

Following intense political and media coverage, $LLY and $REGN #mABs' potential EUAs evoked caution due to limited clinically relevant data and the possible negative knock-on effect on ongoing trials clinicaltrialsarena.com/comment/eli-li…

In the race for a #COVID19 vaccine, $PFE $BNTX vaccine BNT162b2 has a speedier design but utility conclusions are dubious from either trial’s interim analysis. biopharminsight.com/pfizerbiontech…

In the notoriously difficult #dryeye space and following a CRL last year, $KALA steroid Eysuvis has high probability of approval with a 30 October PDUFA date, but mixed potential on uptake clinicaltrialsarena.com/comment/kala-b…