Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received $1.1 billion in deposits for the shot. The figure was revealed by CEO Stéphane Bancel in Moderna’s third-quarter results call… Read More »Moderna banks $1.1bn in COVID-19 vaccine deposits, signs Japan supply deal
Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial. It’s also revealed that more than 25,000 of them have already received the second dose of the shot in the COVE… Read More »Moderna nears COVID-19 vaccine finish line as it wraps up study enrolment
Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety data to become available. The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late… Read More »Pfizer to wait until after election to file COVID-19 vaccine in US
Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint… Read More »PharmaShots Weekly Snapshot (Oct 12-16, 2020)
Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi 2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses… Read More »PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)
Shots: Moderna reported the publication of the second interim analysis of the open-label P-I study of mRNA-1273 in the NEJM. The study evaluated a 2dose vaccination schedule of mRNA-1273 given 28 days apart in 40 adults across two dose levels (25/100µg) in two age cohorts… Read More »Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults
Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data
The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.
Moderna has said that its coronavirus vaccine stimulated an immune response in older people in phase 1 trials, suggesting that the jab is effective in the age groups most susceptible to COVID-19. An analysis of the latest data from a phase 1 trial showed that… Read More »Moderna’s COVID vaccine works in older people, according to new data
Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s… Read More »Is COVID the Rx for the Pharmaceutical Industry’s Reputation?
The biotech company reached a deal with the European Commission to supply an initial 80 million doses, while European Union member states will have the option to purchase 80 million more.
The US government has signed another big coronavirus vaccine supply deal, snapping up 100 million doses of Moderna’s mRNA jab for a little over $1.5 billion –around $15 per dose or $30 per course. That’s a steep discount on the $32 to $37 price per… Read More »Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine
The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.
Shots: For smaller volume agreements, the company has priced its COVID-19 vaccine ranging from $32-$37/ dose, higher than the price of Pfizer’s vaccine candidate The company is in talks with several countries for supply agreements of its vaccine, adding that it had already received about… Read More »Moderna Prices its COVID-19 Vaccine at $32-$37 per Dose for Smaller Volume Agreements
1. Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease 2. Johnson & Johnson Initiates P-I/IIa Study… Read More »PharmaShots Weekly Snapshot (Jul 27- 31, 2020)
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019”… Read More »Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020
The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named… Read More »Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial
A US government agency is to give a further $472 million to biotech Moderna, after it announced plans to expand a phase 3 trial for its potential COVID-19 jab. The latest funding from the Biomedical Advanced Research and Development Authority follows a tranche worth $483… Read More »Moderna gets further $472m as expanded phase 3 COVID-19 trial begins
1. Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion, Moderate, Severe, Rheumatoid Arthritis 2. Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore… Read More »PharmaShots Weekly Snapshot (Jul 20- 24, 2020)
Concerns have emerged about access to some potential COVID-19 vaccines after pharma executives from three companies said they expect to make profits from their products in evidence to a US Congressional panel. Moderna, Merck & Co, and Pfizer said they expect to profit from coronavirus… Read More »Controversy as pharma execs predict profits from COVID-19 vaccines
JP Morgan has downgraded its valuation of Moderna, saying its $37 billion market cap is way too high even if its COVID-19 vaccine mRNA-1273 succeeds in clinical trials. Moderna’s share price has rocketed 385% this year, driven by the development of mRNA-1273, but the analysts… Read More »Moderna’s $37B market cap is too high, despite COVID-19 vaccine; analyst
1. Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis Published: Jul 17, 2020 | Tags: Eli Lilly, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis 2. Oncorus Initiates P-I Study of ONCR-177 in Patients… Read More »PharmaShots Weekly Snapshot (Jul 13- 17, 2020)
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.
Evaluation of durability is still under evaluation, but the responses to mRNA-1273 show neutralizing antibody titers multiple times higher than those of recovered patients. Additionally, T-cell responses suggest potentially lower risk of enhanced respiratory disease.
The company said it is on track to start its 30,000-participant Phase III trial this month and has finished manufacturing enough supplies of the vaccine to do so.