Drug Discovery and Development

Dr. Jeremy Katzen, a clinical instructor of medicine at the University of Pennsylvania, has received the National Institutes of Health K08 Clinical Investigator Award. Katzen’s research aims to contribute to an improved scientific understanding of cell biology of the respiratory system while discovering new potential therapeutic possibilities for respiratory disorders. In particular, his work focuses on…

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 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…

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…

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…

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…

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…

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…

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…

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…

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…

As governments and health authorities worldwide gear up to deliver potentially billions of COVID-19 vaccine doses, artificial intelligence and data automation techniques could be a powerful tool combating one of the top hindrances to mass vaccination: vaccine hesitancy.   In particular, natural language processing (NLP) could help health authorities transform adverse event reports from COVID-19 vaccines…

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…

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…

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 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…

The pharmaceutical industry stands at a crossroads as Election Day nears in the U.S. The election could ultimately have sweeping implications for the sector, or it could yield only modest changes. While the presidential election could have a significant influence on the pharma sector, arguably more important is who gains control of Congress. A blue…

Biotech firm Gilead Sciences is on the defensive as its revenue surges thanks to the COVID-19 drug Veklury, better known as remdesivir. Several press outlets are skeptical of the promise of remdesivir, the first COVID-19 treatment to win FDA approval. This week, Healthline questioned whether FDA should have approved the drug. The New York Times…

Sanofi (NSDQ:SNY) and GSK (LON: GSK), which have teamed up to produce a COVID-19 vaccine candidate, have signaled their intent to work with the legal administrator of the COVAX Facility. The two companies have vowed to produce 200 million doses of a vaccine based on the protein subunit AS03 adjuvant.  Governments, businesses and health organizations…

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…

 Bayer (FRA: BAYN) announced today that it will acquire gene therapy startup AskBio for an upfront payment of $2 billion. The German life sciences giant could shell out an additional $2 billion if the startup meets specific criteria. Rather than folding AskBio’s operations into its own, Bayer stressed in a statement that the startup would operate independently…

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…

Moderna’s COVID-19 vaccine clinical trial has hit a roadblock. Moderna (NSDQ:MRNA) learned that contractors it had hired failed to recruit sufficient numbers of minorities for the 30,000-person study, according to a Reuters report. The lack of Black, Latinos and Native American patients led the company to tap academic researchers with ties to diverse communities. Moderna didn’t…

The pharma industry has put its weight behind Democratic presidential candidate Joe Biden, reversing a longstanding fundraising trend that has favored the GOP. Republican candidates have received 64% of pharma industry contributions since 1990, according to the Center for Responsive Politics’ Open Secrets. But the industry is shifting its support to Democrats in 2020. So far,…

Teknova (Hollister, Calif.) announced today that it has completed the FDA notification process for its CDC formulation viral transport medium (VTM). Notification process compilation means the VTM is in compliance with FDA’s COVID-19 Transport Media Policy, July 2020 guidelines. Teknova is now offering the VTM for commercial distribution after scaling up manufacturing within six months.…