Brian Buntz

Early data from a University of Oxford study indicates the COVID-19 vaccine it jointly developed with AstraZeneca is effective against the P.1 variant, which originated in Brazil.  The study has not yet been published, but Reuters confirmed its results.  South Africa recently paused the vaccine rollout, where a similar variant is circulating after early study data indicated…

The RCSB Protein Data Bank has announced that more than 1,000 SARS-CoV-2 proteins are available at no cost.  Headquartered at Rutgers University–New Brunswick, the RCSB Protein Data Bank released its first SARS-CoV-2 structure — the coronavirus main protease (PDB 6lu7) — on Feb. 5, 2020.  The database has helped drive the development of effective COVID-19 vaccines. It continues to shed…

For all of its promise in healthcare and elsewhere, deploying artificial intelligence is frequently a challenging endeavor. “Close collaboration between data science teams, other project team members and stakeholders is essential,” said Jennifer Bradford, director of data science at Phastar, the London-headquartered contract research organization. While input from computational, statistical or medical experts could be…

The antiparasitic drug ivermectin does not appear to be an efficacious COVID-19 treatment for mild COVID-19 cases, based on a randomized study recently published in JAMA. Ivermectin — which is widely used in veterinary medicine to get rid of worms and other parasites— emerged as a potential COVID-19 treatment, owing to its ability to inhibit…

While organ-on-a-chip technology has evolved tremendously over the past 15 years, adoption of the technology remains at an early stage. But as organ-chip technology advances and the R&D costs for pharma companies continue to hover near unsustainable levels, organ-on-a-chip technology has the promise to address what cell biologist and bioengineer Donald Ingber called the “broken”…

Novavax announced fourth-quarter earnings that fell below analysts’ projections, but the company could make more than 2 billion doses of its COVID-19 vaccine annually.   The company’s vaccine demonstrated 90% efficacy in a Phase 3 trial in the U.K. The company’s outlook for the rest of the year depends largely on FDA’s authorization of its…

The investigational drug brilacidin showed promise in a recent study published in the peer-reviewed journal Viruses. Researchers conclude that the synthetic small molecule from Innovation Pharmaceuticals exhibited “potent antiviral activity.” The scientists tested the drug in a human lung cell line and a monkey cell line. The researchers tested brilacidin against COVID-19 variants from Washington…

Amgen and AstraZeneca have announced that the experimental monoclonal antibody tezepelumab demonstrated a clinically meaningful reduction in annualized asthma exacerbation rate (AAER) in severe, uncontrolled asthma patients. In the NAVIGATOR Phase 3 trial, the drug led to a 56% reduction in AAER versus placebo over 52 weeks when used as part of the standard of…

One adverse event common to clinical trials for currently authorized COVID-19 vaccines is Bell’s palsy, an asymmetrical weakness or paralysis of the face that is often temporary. Two vaccine recipients in the Johnson & Johnson Phase 3 clinical trial developed Bell’s palsy, as did two people in the placebo group. Another patient developed facial swelling…

Americans will start receiving Johnson & Johnson‘s COVID-19 vaccine within the next 24 to 48 hours, J&J CEO Alex Gorsky told NBC’s Today this morning. FDA issued an EUA for J&J’s Ad26.COV2-S vaccine on Feb. 27, a day after an advisory panel unanimously recommended that the agency authorize the vaccine for adults 18 and over.…

Moderna posted mixed fourth-quarter results today with a larger-than-expected loss but beat the consensus forecast for revenue. The company boosted its outlook for the rest of the year, citing strong demand and maturing commercialization capabilities. The Cambridge, Mass.-based vaccine developer reported revenue of $570.7 million for the three months ended Dec. 31, 2020. That figure…

Today, an FDA advisory panel is convening to evaluate the Ad26.COV2.S COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ).  The vaccine has a favorable safety profile and significant efficacy after a single dose.  Here are several themes that are likely to be among the topics discussed in the Vaccines and Related Biological Products Advisory Committee meeting.  1. The…

Quantitative PCR (qPCR) is the mainstream molecular technology for in vitro diagnostic assays. The introduction of freeze-drying to create ambient-temperature stable qPCR tests has improved assay stability and consistency and has enabled diagnostic companies to reduce supply chain and shipping costs. However, lyophilization is a complex and expensive process that requires expertise and sophisticated equipment…

In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears. In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer. No placebo recipients developed the condition. J&J concluded that the tinnitus reports…

The diabetes drug Ozempic (semaglutide) could potentially enhance weight loss in overweight and obese patients without diabetes, according to a study recently published in JAMA and The New England Journal of Medicine. In December, Novo Nordisk (NYSE:NVO) submitted a new drug application to the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management. The drug won FDA…

Last year, herd immunity seemed like a comforting promise as researchers worked on dozens of COVID-19 vaccine candidates and a silver-lining to the rampant spread of the virus — the more people who got infected, the more natural immunity that would develop over time. There are now dissenting opinions about how the term relates to…

A segment of the population is wary of COVID-19 vaccines. One of the main reasons why is the rapid pace at which they were developed. But the mRNA vaccines FDA was able to authorize in late 2020 were years in the making, stressed Kizzmekia Corbett of the NIH at CDC’s National Forum on COVID-19 Vaccine…

Since the early 2000s, pundits have lamented that there is an innovation crisis in the pharmaceutical industry. One of the most common reasons given is the challenge of bringing new drugs to market. The U.S. Government Accounting Office concluded in 2006 that the “productivity of [the pharma industry’s] research and development expenditures has been declining.”…

Sanofi (NYSE:SNY) and Glaxo Smith Kline (NYSE:GSK) are moving forward with their development plans of a COVID-19 vaccine. In December, the two companies announced that their vaccine development efforts had been delayed after the product failed to mount a robust immune response in older adults. The two companies believe the setback resulted from an insufficient…

FDA has released updated guidance detailing its plans to streamline authorization of COVID-19 vaccines adapted to more-infectious variants, such as the U.K. variant B.1.1.7, which is now present in dozens of states. FDA’s guidance would require such companies to launch small clinical studies similar to those needed for annual flu vaccines. It also encourages sponsors…

The specialty biopharmaceutical company Redhill Biopharma (NSDQ:RDHL) recently announced that the first patient had been dosed in a Phase 2/3 investigating the potential of RHB-107 (upamostat) for mild-to-moderate COVID-19. The company is also testing the potential of a drug known as opaganib for hospitalized patients. In the following interview, Gilead Raday, COO at Redhill Biopharma,…

The EU recently added clauses to COVID-19 vaccine contracts to prioritize vaccines that are effective against emerging SARS-CoV-2 variants. Meanwhile, a U.S. House bill that would provide $1.75 billion for genomic sequencing of coronavirus samples is scheduled for floor debate and the Senate is considering similar legislation. The UK variant (B.1.1.7) that is spreading across…

The biopharmaceutical company IMV (NSDQ:IMV) has recently revealed promising data related to its lead immunotherapy as a potential ovarian cancer treatment. In the Phase 2 DeCidE1 trial, the immunotherapy DPX-Survivac with intermittent low-dose cyclophosphamide showed durable anti-tumor activity in patients with recurrent, advanced ovarian cancer. A recent analysis from three different clinical trials published in published…

The zebrafish, commonly found in aquariums, is widely tapped in drug development to understand disease mechanisms. The advent of CRISPR gene editing has given researchers more flexibility in developing disease models, thanks to its ability to create gene-edited zebrafish variants. To that end, the privately-held company ZeClinics (Barcelona) is using CRISPR-based techniques to make unique…

Mountain View, Calif.-based Aditx Therapeutics (NSDQ:ADTX) has recently introduced an offering known as AditxtScore, a lab-developed test that provides a comprehensive profile of the immune system. An initial focus area for the technology will be monitoring COVID-19 immunity.  The technology could also help inform the development of immunotherapies and reduce organ transplant rejection. One of…