This 7 days, Eli Lilly LLY has utilized for the unexpected emergency use of its coronavirus antibody prospect and Pfizer PFE/BioNTech has commenced rolling submitting for their COVID-19 vaccine acceptance in Europe. AstraZeneca AZN resumed its COVID-19 vaccine research in Japan.
Recap of the Week’s Most Critical Stories
Lilly Files for EUA of Antibody Candidate, LYCoV555: Lilly applied to the Food and drug administration for Unexpected emergency Use Authorization (EUA) for its antibody treatment applicant, LYCoV555, as a monotherapy for the procedure of bigger-danger sufferers who have been recently identified with moderate-to-average COVID-19. The firm also introduced promising facts from the combination cohort of the period II BLAZE-1 research which confirmed that an antibody mix, LYCoV555 and LY-CoV016, decreased viral load signs and COVID-19 associated hospitalization and crisis space visits.
The ask for for EUA was dependent on this twin therapy info as properly knowledge from the monotherapy cohort which was launched past thirty day period. Lilly will file a independent request for EUA for the combination therapy in November.
Lilly, meanwhile, entered into an agreement with Monthly bill & Melinda Gates Basis for the supply of its potential COVID-19 antibody remedy for lower- and center-money nations. The offer is section of the foundation’s COVID-19 Therapeutics Accelerator (CTA) philanthropic method, which aims to quickly provide successful COVID-19 medications to the market place. Business producing of the prospect will start off at CTA’s reserved producing facility in Denmark from April 2021.
EMA Starts off Rolling Overview of Pfizer’s Coronavirus Vaccine: Pfizer/BioNTech began rolling submission of their mRNA-centered coronavirus vaccine candidate, BNT162b2, to the European Medicines Agency (EMA). The EMA acknowledged rolling assessment on the candidate centered on accessible preclinical and clinical facts.
As section of the rolling evaluate method, the EMA’s Committee for Medicinal Products for Human Use has begun assessing the pre-clinical details. After the rolling overview system is complete, the remaining/official marketing and advertising software will be submitted after the EMA is satisfied that the submitted details are suitable and demonstrates the vaccine’s efficacy and protection.
Meanwhile, Pfizer alongside with associate OPKO Health declared favorable top-line info from a phase III examine assessing somatrogon dosed the moment-weekly in kids 3 to <18 years of age with growth hormone deficiency. The study met its primary endpoint by showing improved treatment burden with somatrogon injection compared to somatropin injection (current standard of care) administered once daily, as measured by mean overall Life Interference total score. The efficacy of somatrogon seen in the study demonstrates its potential to reduce lifestyle interference, support patient preference, and improve adherence compared to somatropin.
Meanwhile, Pfizer and partner Sangamo announced initiation of a phase III study evaluating giroctocogene fitelparvovec/SB-525, an investigational gene therapy in patients with severe hemophilia A.
AstraZeneca Re-Starts COVID-19 Vaccine Study in Japan: AstraZeneca resumed the phase I/II clinical study on its COVID-19 vaccine candidate, AZD1222, in Japan following re-start of studies in UK, Brazil, South Africa and India. Last month, AstraZeneca temporarily paused all its global late-stage studies on AZD1222, which it is developing in partnership with Oxford University, as a patient in U.K. suffered an unspecified illness. However, while the international studies have now resumed, the study in the United States remains on hold and the company is in discussion with the FDA to provide the necessary information to re-start the studies.
Glaxo/Vir Biotech’s COVID-19 Antibody Drug Enters Phase III: Glaxo GSK and partner Vir Biotech announced the global expansion to phase III of the COMET-ICE study on their monoclonal antibody, VIR-7831, for the early treatment of COVID-19 in patients who are at high risk of hospitalization. The study continued to phase III on the recommendation of an Independent Data Monitoring Committee based on positive data from the lead in portion of the phase II COMET-ICE study. Initial data from the phase III study are expected by the end of 2020 while results for the primary endpoint are expected in the first quarter of 2021.
The COMET program also includes two other studies, one for the treatment of hospitalised patients and another for the prevention of symptomatic infection. The study is part of a collaboration agreement between Glaxo and Vir Biotechnology signed in April to develop antibody treatments for coronaviruses including SARS-CoV-2.
J&J Agrees to Supply 200M Doses of Coronavirus Vaccine to European Countries: J&J JNJ announced an agreement with the European Commission to supply 200 million doses of its investigational COVID-19 vaccine candidate, following approval, to European countries. The agreement also includes an option for EU member states to secure up to 200 million additional doses.
J&J has begun a large pivotal phase III study to evaluate the safety and efficacy of a single dose of its investigational COVID-19 vaccine candidate, JNJ-78436735, this month. J&J has signed a similar advance supply agreement to provide 100 million doses of its candidate to the U.S. government. J&J has a goal to supply more than one billion doses globally, if the vaccine is approved.
EMA Accepts Sanofi’s Application for Pompe Disease Candidate: The European Medicines Agency accepted Sanofi’s SNY application seeking approval of its investigational enzyme replacement therapy, avalglucosidase alfa, for the treatment of late-onset Pompe disease, for review. The marketing authorization application is based on data from two studies which include both infantile-onset and late-onset Pompe disease patients. The EMA is expected to give its decision in the second half of 2021.
Novo Nordisk Raises 2020 Outlook: Novo Nordisk NVO raised its previously issued sales and operating profit growth outlook for 2020 due to lower-than-anticipated negative impacts from COVID-19. It expects sales growth at constant exchange rate (CER) in the range of 5-8% versus prior expectation in the range of 3-6%. Operating profit growth expectations were raised from 2-5% to 5-8%. The company also issued preliminary third-quarter sales and operating profit growth rate. Novo Nordisk’s sales increased by 7% and operating profit increased by 7%, both at CER, in the third quarter.
The NYSE ARCA Pharmaceutical Index rose 1.13% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, Lilly recorded the maximum increase (6.3%) while Merck declined the most (1.5%).
In the past six months, AstraZeneca has risen the most (21.1%) while Merck declined the most (2.5%).
(See the last pharma stock roundup here: FDA Approves New Uses of PFE, JNJ & GSK’s Drugs)
What’s Next in the Pharma World?
Watch out for J&J’s third quarter earnings results and regular pipeline and regulatory updates next week.
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