U.S. Health and Human Services Dept. Secretary Alex Azar confirmed that HHS is working with president-elect Joe Biden on a presidential transition. Speaking during a press briefing, Azar said HHS is in contact with the transition team after the General Services Administration formally recognized Biden as the president-elect, having previously sidestepped questions regarding the potential…
BREAKING: AstraZeneca says its COVID vaccine up to 90% effective
AstraZeneca (NYSE:AZN) announced today that one of its COVID-19 vaccine candidate dosing regimens is up to 90% effective in preventing the virus. Cambridge, United Kingdom-based AstraZeneca, working in collaboration with Oxford University, found the vaccine to be highly effective in preventing COVID-19 for subjects in the UK and Brazil, with no hospitalizations or severe cases of…
FDA OKs first COVID-19 test that people can use on themselves at home
The FDA announced that it issued emergency use authorization (EUA) for the first at-home, rapid COVID-19 diagnostic test. A diagnostic designed for self-testing in the home, the Lucira COVID-19 all-in-one test kit is a molecular (real-time loop-mediated amplification reaction) single-use test designed to detect SARS-CoV-2, according to an FDA news release. Get the full story…
Report: Fauci expects Moderna COVID-19 vaccine data within a week
Dr. Anthony Fauci is reportedly expecting that early data from Moderna’s (NSDQ:MRNA) COVID-19 vaccine candidate is not far away. Following Monday’s news that the candidate being developed by Pfizer and BioNTech has proven to be 90% effective at preventing infection, the nation’s top infectious disease official expressed optimism over Moderna’s potential, according to a Forbes report. Get the full…
Tandem Diabetes slides after hours on mixed bag Q3
Tandem Diabetes Care (NSDQ:TNDM) shares took a hit after hours today on third-quarter results that were mixed compared to the consensus forecast. The San Diego-based insulin delivery and diabetes technology company posted losses of -$9.4 million, or -15¢ per share, on sales of $123.6 million for the three months ended Sept.30, 2020, for a bottom-line slide […]
Report: Oxford chief says there’s ‘small chance’ COVID-19 vaccine is ready by Christmas
The director of the group developing a COVID-19 vaccine candidate at Oxford University says it’s possible that the vaccine could be ready by Christmas. According to a Reuters report, Oxford vaccine trial chief investigator Andrew Pollard said he’s optimistic that the university, which is collaborating with AstraZeneca on the vaccine, will present trial results by…
Johns Hopkins researchers tout medicine-delivering microdevices
Johns Hopkins researchers are touting microdevices that can latch onto intestinal mucosa and release drugs into the body. Led by engineering professor David Gracias and gastroenterologist Dr. Florin Selaru, the team of researchers and biomedical engineers designed and tested shape-changing microdevices that they say can mimic the way the parasitic hookworm affixes itself to an…
Pfizer dips on bottom-line slide, missed revenue projections
Pfizer (NYSE:PFE) shares fell today on third-quarter results that came up short of the consensus revenue forecast. The New York-based company posted profits of $2.2 billion, or 39¢ per share, on sales of $12.1 billion for the three months ended Sept. 30, 2020, for a -71.4% bottom-line slide on a sales decline of -4.3. Adjusted to…
FDA approves remdesivir as a COVID-19 treatment
The FDA announced that it fully approved the use of remdesivir as a treatment for COVID-19 requiring hospitalization in all adult and some pediatric patients. Remdesivir is only to be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care. The drug, also referred to by the FDA…
NIH launches drug trial for deadly cytokine storm
The National Institutes of Health today launched a Phase 3 clinical trial to evaluate three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes proteins that trigger inflammation, otherwise known as a cytokine storm, which can lead to acute respiratory distress syndrome, multiple…
Pfizer expects to apply for COVID-19 vaccine EUA in late November, CEO says
Pfizer (NYSE:PFE) chairman & CEO Albert Bourla penned an open letter today setting an expected timeline for the company’s COVID-19 vaccine candidate. The vaccine candidate, being developed in collaboration with BioNTech (NSDQ:BNTX), is among the top COVID-19 vaccines currently undergoing Phase 3 clinical trials and nearing potential regulatory authorization, should they prove safe and effective. Once the…
FDA approves first Ebola virus treatment
The FDA granted approval to Inmazep, a mixture of three monoclonal antibodies, making it the first FDA-approved treatment for Ebola virus. Regeneron Pharmaceuticals (NSDQ:REGN) received the approval, having recently been in the news for providing its investigational COVID-19 therapeutic to President Donald Trump. Inmazeb targets the glycoprotein that is on the surface of the Ebola virus.…
Sanofi to launch COVID-19 vaccine trial in Q4
Sanofi (NYSE:SNY) and Translate Bio (NSDQ:TBIO) announced today that a Phase 1/2 clinical trial for its COVID-19 vaccine candidate is set for the fourth quarter of 2020. Preclinical results for MRT5500, the COVID-19 vaccine candidate under development by the two companies, demonstrated a favorable immune response profile against SARS-CoV-2, the virus causing coronavirus, which supports the selection…
Report: Eli Lilly halts COVID-19 treatment trial
Eli Lilly (NYSE:LLY) reportedly paused a clinical trial testing its COVID-19 antibody treatment candidate because of a “potential safety concern.” The New York Times reported that Eli Lilly’s testing site researchers were notified of the pause by emails sent by government officials (it is a government-sponsored trial) and the company later confirmed it. A spokesperson from…
J&J halts COVID-19 vaccine trial due to illness
Johnson & Johnson (NYSE:JNJ) announced that it temporarily paused further dosing in its COVID-19 vaccine candidate clinical trials. The pause in the trials conducted by J&J’s Janssen Pharmaceuticals subsidiary follows an unexplained illness arising in a study participant, according to a news release. Under the company’s guidelines, the illness is being reviewed and evaluated by internal…
FDA funds studies of 6 rare-disease drugs
The FDA announced that it awarded six new clinical trial research grants to principal investigators totaling more than $16 million over four years. Awarded through the Congressionally-funded Orphan Products Grants Program, the research grants seek to enhance the development of medical products for patients with rare diseases, according to a news release. More than 90…
EU orders 200M J&J COVID-19 vaccine doses
Johnson & Johnson (NYSE:JNJ) announced today that its set to provide 200 million doses of its COVID-19 vaccine candidate to Europe. The European Commission, on behalf of the European Union, approved an advance purchase agreement in which J&J subsidiary Janssen Pharmaceutical, which is developing the vaccine candidate, would supply the doses to EU member states following…
J&J closes $6.5B Momenta buy
Johnson & Johnson (NYSE:JNJ) announced today that it successfully completed its $6.5 billion acquisition of Momenta Pharmaceuticals (NSDQ:MNTA). After the all-cash acquisition was agreed upon in August, it officially closed today through a merger of Vigor with and into Momenta, which now operates as a wholly-owned subsidiary of Johnson & Johnson. In connection with the merger, shares…
Report: AstraZeneca Phase III COVID-19 vaccine remains on hold in U.S.
AstraZeneca (NYSE:AZN) is reportedly keeping its COVID-19 vaccine trial in the U.S. on hold as questions remain over patient safety. U.S. Health and Human Services Dept. Secretary Alex Azar told CNBC yesterday that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based…
J&J launches fourth large-scale COVID-19 vaccine trial
Johnson & Johnson (NYSE:JNJ) has begun enrollment of adult volunteers for a fourth Phase 3 clinical trial of a COVID-19 vaccine candidate. The National Institutes of Health announced today that J&J’s Janssen Pharmaceuticals COVID-19 vaccine candidate (JNJ-78436725) has begun the Phase 3 trial to evaluate if it can prevent symptomatic COVID-19 after a single dose regimen. Get the…
Canada lining up millions of doses of COVID-19 vaccines
Sanofi (NYSE:SNY), GlaxoSmithKline (NYSE:GSK) and Moderna (NSDQ:MRNA) have all agreed to supply Canada with a total of more than 90 million doses of a COVID-19 vaccine. Beginning in 2021, Government of Canada is set to receive up to 72 million doses of an adjuvanted COVID-19 vaccine from Sanofi and GSK, while the country also increased its confirmed…
BARDA awards $12.9M to Ortho Clinical for coronavirus antigen test
Ortho Clinical Diagnostics announced that it received a nearly $12.9 million award from BARDA to support the development of its COVID-19 antigen test. Raritan, N.J.-based Ortho Clinical Diagnostics and the Biomedical Advanced Research and Development Authority (BARDA) are working together under a new contract as part of the government’s ongoing COVID-19 medical countermeasure development efforts,…
Pfizer touts animal trial results for COVID-19 vaccine candidate
Pfizer (NYSE:PFE) announced today that its COVID-19 vaccine candidate protected against infection in preliminary non-human trials. The vaccine, being developed in collaboration with BioNTech (NSDQ:BNTX), was tested in mouse and non-human primate models. In the non-human primate study, the BNT162b2 mRNA-based vaccine candidate protected rhesus macaques against SARS-CoV-2 infection, according to a news release. In a viral…
AstraZeneca puts COVID-19 vaccine trial on hold
AstraZeneca (NYSE:AZN) announced today that it voluntarily paused the trials for its COVID-19 vaccine candidate after an unexplained illness. The company said in a news release that a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III…
Drug companies agree not to release COVID-19 vaccine until it’s ready
Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine. The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as…