The U.S. is poised to have three vaccines available after an FDA advisory panel unanimously recommended that the agency authorize the Ad26.COV2-S vaccine from Johnson & Johnson for adults 18 and over. Although the recommendations of the independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) are nonbinding, the agency almost always heeds them. There are 22…

Health Canada today authorized the COVID-19 vaccine developed by AstraZeneca and Oxford University — the third vaccine for the novel coronavirus authorized in Canada. “This is very encouraging news. It means more people vaccinated, and sooner. Because for AstraZeneca, just like we were for Pfizer and Moderna, we are ready to get doses rolling,” said…

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…

Pfizer/BioNTech and Moderna are testing whether a third dose of their COVID-19 vaccines could better protect against new virus variants. Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that participants from their Phase 1 study will be offered the opportunity to receive a 30-µg booster of the current vaccine 6 to 12 months after receiving their initial two…

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…

Kala Pharmaceuticals (NSDQ:KALA) shares dipped this morning on fourth-quarter results that came up short of the consensus forecast. The Watertown, Mass.-based company posted losses of -$31.1 million, or -55¢ per share, on sales of $2.2 million for the three months ended Dec. 31, 2020, for a more than $10 million bottom-line slide on sales growth of…

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…

An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted…

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…

Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which…

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…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women. The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the…

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…

Thermo Fisher Scientific (NYSE:TMO) announced today that it acquired cell sorting technology assets from SIDIS Corp. subsidiary Propel Labs. Waltham, Mass.-based Thermo Fisher’s agreement with Propel Labs stipulates that the recently introduced Bigfoot spectral cell sorter and approximately 40 employees will become part of Thermo Fisher’s biosciences business unit, while Propel Labs will continue to operate…

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…

Johnson & Johnson (NYSE:JNJ) announced today that it submitted a conditional marketing authorization application (cMAA) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s cMAA application with the European Medicines Agency (EMA) is seeking authorization for the investigational, single-dose COVID-19 vaccine candidate developed by its Janssen subsidiary, according to a news release. The submission is based on…

PerkinElmer (NYSE:PKI) announced today that it launched the first cell painting kit as part of its PhenoVue cellular imaging reagent portfolio. Waltham, Mass.-based PerkinElmer’s new range of reagents utilizes the company’s expertise in cellular imaging and high-content screening while working with its microplates, automation offerings and software to allow researchers to better understand diseases and develop…

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…