Novo Nordisk gets Refusal to File letter for 1/weekly type 2 diabetes treatment

 Novo Nordisk today announced that the US Food and Drug Administration (FDA) has issued a Refusal to File letter covering the label expansion application for once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes which was filed on 20 January 2021. A refusal to file letter is received when the FDA determines additional information is required to review a complete application.

In the letter, FDA has requested additional information including data relating to a proposed new manufacturing site. While additional information needs to be included in the resubmission, Novo Nordisk believes the already completed clinical trial programme will be sufficient for approval of the label expansion application.

Novo Nordisk expects to resubmit the application to FDA during the second quarter of 2021.

https://finance.yahoo.com/news/novo-nordisk-receives-refusal-file-214500301.html

Frequency Therapeutics sees no benefit in 4-dose hearing loss regimen

 Interim FX-322 Phase 2a Results Show Four Injection Schedule Had No Discernible Hearing Benefit

Separate FX-322 Phase 1b Study Confirms Hearing Improvement from Single Injection

Conference call at 8:30am ET today

Webcast details can be found on the Frequency Therapeutics’ investor relations site at https://investors.frequencytx.com/events-and-presentations, or by clicking here to enter the webcast directly.

https://finance.yahoo.com/news/frequency-therapeutics-releases-data-two-110000818.html

Pfizer to make other vaccines using technology behind its COVID-19 shot

 Pfizer Inc will develop new vaccines targeting other viruses and pathogens using the messenger RNA technology behind its COVID-19 shot, the Wall Street Journal reported on Tuesday, citing the drugmaker’s chief executive officer, Albert Bourla.

The drugmaker declined to say which viruses it is pursuing, the Journal reported.

https://www.reuters.com/article/us-health-coronavirus-pfizer/pfizer-to-make-other-vaccines-using-technology-behind-its-covid-19-shot-wsj-idUSKBN2BF13R

Pacira: FDA OKs application for pediatric Exparel

-- EXPAREL is the first and only FDA-approved long-acting local analgesic for children aged six and over –
-- Conference call tomorrow at 8:30 a.m. ET --

The Pacira management team will host a conference call to discuss the contents of this press release Tuesday, March 23rd, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 1185087. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the “Events” page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 1185087. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

https://finance.yahoo.com/news/pacira-announces-fda-approval-supplemental-224200070.html

Evelo Bio in collaboration for antiinflammatory, Covid therapy

  Evelo Biosciences (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, and Abdul Latif Jameel Health, a company focused on accelerating access to affordable modern medical care while addressing unmet medical needs in developing markets around the world, and part of Abdul Latif Jameel, today announced that the companies have entered into a strategic collaboration to develop and commercialize Evelo’s lead inflammation product candidate EDP1815 in the Middle East, Turkey, and Africa.

https://finance.yahoo.com/news/evelo-biosciences-abdul-latif-jameel-070000075.html

Reduced BNT162b2 mRNA vaccine response in SARS-CoV-2-naive nursing home residents

 David H. Canaday, Lenore Carias, Oladayo Oyebanji, Debbie Keresztesy, Dennis Wilk, Michael Payne, Htin Aung, Kerri St. Denis, Evan C. Lam, Brigid Wilson, Christopher F. Rowley, Sarah D. Berry, Cheryl M. Cameron, Mark J. Cameron,  

View ORCID ProfileAlejandro Benjamin Balazs, Stefan Gravenstein, Christopher L. King

doi: https://doi.org/10.1101/2021.03.19.21253920

This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

PDF: https://www.medrxiv.org/content/10.1101/2021.03.19.21253920v1.full.pdf

Abstract

The SARS-CoV-2 pandemic impact on nursing home (NH) residents prompted their prioritization for early vaccination. To fill the data gap for vaccine immunogenicity in NH residents, we examined antibody levels after BNT162b2 mRNA vaccine to spike, receptor binding domain (RBD) and for virus neutralization in 149 NH residents and 111 health care worker controls. SARS-CoV-2-naive NH residents mount antibody responses with nearly 4-fold lower median neutralization titers and half the anti-spike level compared to SARS-CoV-2-naive healthcare workers. By contrast, SARS-CoV-2-recovered vaccinated NH residents had neutralization, anti-spike and anti-RBD titers similar to SARS-CoV-2-recovered vaccinated healthcare workers. NH residents blunted antibody responses have important implications regarding the quality and durability of protection afforded by neoantigen vaccines. We urgently need better longitudinal evidence on vaccine effectiveness specific to NH resident populations to inform best practices for NH infection control measures, outbreak prevention and potential indication for a vaccine boost.

Competing Interest Statement

SG and DC are recipients of investigator-initiated grants to their universities from Pfizer to study pneumococcal vaccines and Sanofi Pasteur and Seqirus to study influenza vaccines. SG also does consulting for Seqirus, Sanofi, Merck, and Janssen. SG has spoken for Seqirus.

Funding Statement

Support from NIH (AI129709-03S1, 3P01AG027296-11S1, and U01 CA260539-01) and VA.

https://www.medrxiv.org/content/10.1101/2021.03.19.21253920v1

Repeated pulses of methyl-prednisolone in COVID-19 pneumonia and acute respiratory distress syndrome

 MichelleEspinosa-Solanoa1DemetrioGonzalez-Vergaraa1MartaFerrer-Galvana1Maria IsabelAsensio-Cruzab1Jose MLomascCristinaRoca-OportocMaria DoloresNavarro-AmuedocMariaPaniagua-GarciacCesarSotomayorcNuriaEspinosacManuelGarcia-GutierrezcJose MolinaGil-BermejocManuelaAguilar-GuisadocManuelPoyatocJuliaPraena-SegoviacAlejandroPalomodMacarenaBorrero-RodriguezdElisaCorderoc…LuisJara-Palomaresab2

https://doi.org/10.1016/j.opresp.2021.100086

PDF: https://www.sciencedirect.com/science/article/pii/S2659663621000059/pdf?md5=994bc456b733cfd84dedf935e3a1f2c9&pid=1-s2.0-S2659663621000059-main.pdf

Abstract

Introduction

The use of systemic corticosteroids in severely ill patients with coronavirus disease 2019 (COVID-19) is controversial. We aimed to evaluate the efficacy and safety of corticosteroid pulses in patients with COVID-19 pneumonia.

Methods

A quasi-experimental study, before and after, was performed in a tertiary referral hospital, including admitted patients showing COVID-19-associated pneumonia. The standard treatment protocol included targeted COVID-19 antiviral therapy from 23th March 2020, and additionally pulses of methylprednisolone from 30th March 2020. The primary outcome was a composite endpoint combining oro-tracheal intubation (OTI) and death within 7 days.

Results

A total of 24 patients were included. Standard of care (SOC) (before intervention) was prescribed in 14 patients, while 10 received SOC plus pulses of methylprednisolone (after intervention). The median age of patients was 64.5 years and 83.3% of the patients were men. The primary composite endpoint occurred in 13 patients (92.9%) who received SOC vs. 2 patients (20%) that received pulses of methylprednisolone (odds ratio, 0.02; 95% confidence interval, 0.001 to 0.25; P = 0.019). Length of hospitalization in survivors was shorter in the corticosteroids group (median, 14.5 [8.5 to 21.8] days vs. 29 [23 to 31] days, P = 0.003). There were no differences in the development of infections between both groups. There were 3 deaths, none of them in the corticosteroids group.

Conclusions

In patients with severe pneumonia due to COVID-19, the administration of methylprednisolone pulses was associated with a lower rate of OTI and /or death and a shorter hospitalization episode.

https://www.sciencedirect.com/science/article/pii/S2659663621000059