Drug Discovery and Development

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…

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…

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…

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…

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…

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…

Dialectic Therapeutics issued an SEC Form D to confirm the sale of nearly $6.4 million in debt, options, warrants and/or other rights to purchase securities. According to the filing, the Dallas-based cancer treatment technology developer made the first sale in its offering of $6.35 million on Dec. 15, 2020. The $6.35 million already sold is…

Pfizer (NYSE:PFE) is reportedly expecting to trim the time needed to produce COVID-19 vaccine batches to speed up production. The company, which along with BioNTech (NSDQ:BNTX) developed one of two COVID-19 vaccines currently authorized in the U.S., is slated to cut the amount of time it takes to produce a batch of the vaccine from 110…

The FDA announced that it issued emergency use authorization (EUA) for monoclonal antibodies developed by Eli Lilly (NYSE:LLY) for treating COVID-19. Eli Lilly’s bamlanivimab and etesevimab received authorization to be administered together for treating mild to moderate COVID-19 in adults and pediatric patients over 12 years old and weighing at least 40 kilograms (about 88 pounds),…

Cardiology trials often adopt composite endpoints that combine several events of clinical interest as the primary efficacy outcome. Time-to-first-event approaches follow the recommendations of regulatory agencies. But composite outcomes that only consider the first event are suboptimal for a chronic disease such as heart failure (HF), which is characterized by recurrent HF hospitalizations since repeat…

Reality is beginning to sink in. Despite the availability of a growing number of COVID-19 vaccines and other therapies, the SARS-CoV-2 virus is likely to become endemic in the medium term, if not longer. A handful of coronaviruses — among them strains of NL63, OC43, 229E and HKU1 — are already endemic. For drug developers,…

Johnson & Johnson (NYSE:JNJ) announced that it submitted an FDA emergency use authorization (EUA) application for its COVID-19 vaccine candidate. New Brunswick, N.J.-based J&J’s Janssen Biotech subsidiary submitted the application for its investigational single-dose Janssen COVID-19 vaccine candidate, based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its…

Late last year, GlaxoSmithKline (NYSE:GSK) and Sanofi (NYSE:SNY) announced that their joint COVID-19 vaccine was delayed. Now, GlaxoSmithKline is hooking up with Germany-headquartered CureVac (NSDQ:CVAC) to develop a COVID-19 vaccine that can target multiple variants of the virus simultaneously. GSK plans on spending €150 million on the project, paying the first half to CureVac initially and the latter half…

In 2014, FDA approved two medications for idiopathic pulmonary fibrosis (IPF) — nintedanib from Boehringer Ingelheim and pirfenidone from Roche (OTCMKTS:RHHBY). “That was a huge success for our community but certainly, it’s the beginning of what we need to be doing for our patients,” said Dr. Joyce Lee, a senior medical advisor for the Pulmonary…

Idiopathic pulmonary fibrosis (IPF) is frequently a debilitating disease associated with significant morbidity and mortality. Although a rare disease, its incidence has increased in recent decades, and it leads to more deaths than some cancers.  The treatment landscape for the condition changed in 2014 when FDA approved the first drugs indicated for IPF, nintedanib from Boehringer…

Highly-transmissible COVID-19 variants have likely been circulating undetected for months in places like the U.K., South Africa and Brazil. They then seemed to burst onto the scene, fueling large outbreaks that dwarfed preceding ones. While the variants aren’t well understood, they suggest that SARS-CoV-2 is mutating in ways that confer an evolutionary advantage. They thus…