Merck (NYSE: MRK) recently announced that it will pay $425 million in cash to acquire privately-held biopharmaceutical company OncoImmune and its potential COVID-19 treatment. OncoImmune’s CD24Fc is a first-in-class recombinant fusion protein that targets the innate immune system. OncoImmune recently announced positive top-line findings from an interim efficacy analysis of a Phase 3 study evaluating…
HHS confirms involvement in presidential transition process
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…
Regeneron antibody cocktail wins emergency use authorization
Regeneron Pharmaceuticals (NSDQ:REGN) has announced that the FDA has granted emergency use authorization (EUA) for the combination of casirivimab and imdevimab to treat COVID-19. The monoclonal antibody cocktail is reportedly the first treatment to show “statistically significant anti-viral activity” against COVID-19, according to its developer. In a trial, the combination of drugs cut hospitalization or emergency…
How COVID-19 has affected Big Pharma and biotech
Biotechnology traces its roots to the Neolithic era when early civilizations discovered how to ferment grains to prepare alcoholic brews and bread. It wasn’t until genetic engineering became mainstream in the mid-1970s, however, that biotechnology, as we know it today, was launched. The field continues to evolve today. The advent of new technology has revolutionized the market…
How U.S. government bolstered Moderna’s COVID-19 vaccine candidate
Until recently, the most rapidly developed vaccine was for mumps, which took four years. Now, Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) appear to be on the cusp of commercializing COVID-19 vaccines under emergency use authorization. It was only a year ago that physicians in China identified unusual pneumonia cases that would later be associated with the novel coronavirus. As impressive…
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…
BREAKING: Pfizer, BioNTech submit FDA EUA request for COVID-19 vaccine
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced that they will submit a request today with FDA for an EUA of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2. If all goes as planned, the companies predict that high-risk populations in the U.S. could start receiving the vaccine by mid- to late-December. Vaccine distribution could start within…
Pfizer’s COVID-19 vaccine could have fewer side effects than Moderna’s
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have announced that their coronavirus vaccine was 95% effective, putting it in line with the preliminary results from rival Moderna (NSDQ:MRNA). Pfizer’s BNT162b2 vaccine candidate appears to have an advantage over Moderna’s mRNA-1273 vaccine in terms of its low adverse event rate. Out of a randomized pool of at least 8,000…
Thermo Scientific unveils lower-cost cryo-transmission electron microscope
Thermo Fisher Scientific (NYSE: TMO) has debuted a cryogenic transmission electron microscope (cryo-TEM) that it claims “democratizes” the technique. In 2017, a trio of international researchers won the Nobel Prize in Chemistry for the microscopy method, which enables high-resolution imaging of biomolecules in a solution. The technique enables researchers to see proteins in high resolution…
ProBioGen teams up with Asahi Kasei
Berlin-based ProBioGen has closed a deal with Asahi Kasei Pharma (TYO:2502) to collaborate on biologics. The German company said it will use its proprietary cell line development platform and transposase technology to support Tokyo-based Asahi Kasei’s biologics pipeline development. “We are enchanted to work with Asahi Kasei Pharma on one of their key projects and…
How Dolly Parton helped support Moderna’s COVID-19 vaccine
Buried in a preliminary report on Moderna’s COVID-19 vaccine is a list of financial backers that includes the famed singer Dolly Parton. Parton was unaware that her $1 million donation to COVID research at Vanderbilt University in April would be used to advance the vaccine candidate from Moderna (NSDQ: MRNA), according to CNN. The singer…
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…
Researchers aim to speed drug discovery with human-understandable ML models
Researchers at Purdue University have devised chemical reactivity flowcharts and novel machine learning models that could accelerate drug discovery. Although the use of machine learning for drug development has grown, researchers’ ability to understand machine learning recommendations has been limited. In a paper published in Organic Letters, Purdue professor Gaurav Chopra noted that the machine…
Amylyx Pharmaceuticals wins orphan drug designation from FDA
The neurodegenerative-diseased-focused biotech Amylyx Pharmaceuticals announced that it had received orphan drug designation for AMX0035, a proprietary blend of sodium phenylbutyrate and tauroursodeoxycholic acid. The Cambridge, Mass.-based company won that designation to treat Wolfram syndrome, a rare genetic disease associated with diabetes, progressive optic atrophy, hearing loss and severe neurological disabilities. The prognosis for patients…
Why the COVID-19 vaccine market won’t be ‘winner take all’
There are a dozen Phase 3 COVID-19 vaccine candidates with more than 50 in either Phase 1 or Phase 2 trials. But the fact that Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have vaccine candidates with efficacy greater than 90% could ultimately narrow the playing field. “Efficacy matters, but I don’t think [Pfizer’s and Moderna’s efficacy rate of] greater…
Medicago and GSK partner on COVID-19 vaccine trial
The Canadian biotech firm Medicago (CVE:MDG) is hooking up GlaxoSmithKline (NYSE:GSK) on a study involving 30,000 participants. The Quebec City-based Medicago had recently announced promising data concerning its plant-based vaccine candidate. Medicago’s vaccine is unique in that it uses virus-like particles that resemble the structure of the novel coronavirus but contain no genetic material from the virus. …
Moderna and Pfizer COVID-19 vaccines set a high bar for competitors
Moderna (NSDQ:MRNA) is now the second company to release positive preliminary results from a Phase 3 trial of a COVID-19 vaccine candidate — and it appears to be more good news. Last week, Pfizer (NYSE:PFE) announced that early data suggested its BNT162 mRNA-based vaccine was more than 90% effective at reducing symptomatic COVID-19 infections. Today,…
Moderna readies interim analysis for its COVID-19 vaccine trial
Pfizer (NYSE:PFE) and Moderna (NYSE:MRNA) are likely to be among the first companies to commercialize COVID-19 vaccines. But while the former has announced positive results from its interim analysis of its clinical study, the status of Moderna’s Phase 3 COVE trial remains a mystery. The company announced that it remains blinded to whether the Phase 3…
Trump accuses FDA of delaying Pfizer’s COVID-19 vaccine announcement
In the aftermath of Pfizer’s (NYSE: PFE) announcement that its COVID-19 vaccine promises to be 90% effective, President Trump is faulting the FDA for its role allegedly delaying the announcement until after Election Day. The President has pointed to the episode as evidence for a ‘medical deep state,” according to the Washington Post. Already, HHS…
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…
Eli Lilly wins FDA nod for COVID-19 antibody treatment
The FDA issued an emergency use authorization (EUA) yesterday for the investigational monoclonal antibody therapy bamlanivimab (LY-CoV555) to treat COVID-19. The drug from Eli Lilly (NYSE:LLY) is intended to reduce the risk of severe COVID-19 infections when administered within 10 days of developing symptoms. The manufacturer indicates the drug for mild-to-moderate COVID-19 infections in adult…
7 things to know about COVID-19 vaccines
Enthusiasm surrounding COVID-19 vaccines is on the upswing after Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) announced preliminary data suggesting their vaccines could be more than 90% effective at preventing COVID-19 infections. Health and Human Services (HHS) Secretary Alex Azar said today in an NBC interview that he believes a COVID-19 vaccine would be available to the general public…
Pfizer claims its COVID-19 vaccine could be 90% effective
Pfizer (NYSE:PFE) has announced its vaccine candidate promises to be 90% effective in protecting against COVID-19 infections. The announcement included the interim analysis results of its Phase 3 trial. Pfizer had earlier suggested that it would announce those results in late October. The promising data clears the way for Pfizer to apply for emergency-use authorization from…
Biogen’s controversial Alzheimer’s drug hits snag
Aducanumab from Biogen (NSDQ:BIIB) seemed to be on the verge of becoming the first new Alzheimer’s drug to hit the market in almost two decades. Now, its potential fate is murkier given skepticisms voiced during an FDA advisory committee meeting today. BIIB shares skidded 28% in afternoon trading on Nov. 9. Eight of the experts…
Oxford Gene Technology expands next-generation sequencing line
Oxford Gene Technology (OGT) has expanded its SureSeq line of next-generation sequencing (NGS) panels to detect genetic variants associated with breast and ovarian cancer and myeloid disorders. One of the offerings is a myeloid panel that can detect abnormalities in 70 genes associated with a range of diseases, including acute myeloid leukemia, myelodysplastic syndrome and…