Drug Discovery and Development

Oramed Pharmaceuticals (NSDQ:ORMP) announced today that it is forming a joint venture to develop novel oral COVID-19 vaccines. New York-based Oramed entered into definitive agreements to form Oravax Medical, which is based on Oramed’s proprietary POD (protein oral delivery) technology and Premas Biotech’s novel vaccine technology, according to a news release. Get the full story…

Emulate has debuted what it terms a “colon intestine chip” targeted at pharma and biotech companies, academics and other researchers. The company believes the system will accelerate the identification of drug candidates to treat inflammatory damage in the colon. The technology could be a boon for understanding inflammatory bowel disease, which approximately 1.6 million people in…

HRS Heat Exchangers announced that it received orders for pharmaceutical heat exchangers for use with the manufacturing of COVID-19 vaccines. Orders were placed by subcontractors working with Pfizer and Moderna, which both have vaccines authorized in the U.S., and Oxford/AstraZeneca, which has been approved across Europe but not yet in the U.S. The orders are…

Although no causal link has been found between blood clots and the AstraZeneca COVID-19 vaccine, several European nations have decided to suspend its use out of an abundance of caution. Germany, France, Italy, and Spain recently halted the use of the vaccine following reports of blood clots in vaccinated people’s brains. There have been 37…

MIT researchers are touting a new machine-learning technique called DeepBAR that can quickly calculate the binding affinities between drug candidates and their targets. DeepBAR produces precise calculations in a fraction of the time compared to conventional techniques, according to the researchers. They think the software could potentially accelerate drug discovery and protein engineering. “Our method…

Researchers have not found causal links between COVID-19 vaccination and deaths, but a handful of post-vaccine deaths are making headlines. One such case is the death of Kassidi Kurrill, a 39-year-old resident of Ogden, Utah, who recently passed away four days after receiving the second dose of Moderna COVID-19 vaccine. Before her death, Kurrill complained…

The Danish Medicines Agency announced that it is investigating the AstraZeneca COVID-19 vaccine after reports of blood clots. In collaboration with the European Medicines Agency, the Danish Medicines Agency launched the investigation as it considers there to be a reason to look into the circumstances further after cases in which citizens developed blood clots shortly…

President Joe Biden is reportedly set to announce plans to purchase an additional 100 million doses of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine. An NBC News report said that Biden is set to announce the purchase of the single-dose vaccines on Wednesday, according to two officials from his administration. The purchase of doses from Johnson &…

All of the COVID-19 vaccines authorized to date are delivered via intramuscular injection. But the intranasal vaccines that are now in development could lead to a more diverse vaccine landscape. The company Altimmune (Gaithersburg, Md.) recently launched a Phase 1 clinical trial to test its single-dose adCOVID intranasal vaccine in 180 adult volunteers. Bharat Biotech…

Merck (NYSE:MRK) today announced positive results from a Phase 1 study of its subdermal drug-eluting implant for preventing HIV-1 infection. The investigational implant has the potential for extended administration of islatravir for pre-exposure prophylaxis (PrEP) of HIV-1 infection, according to a news release. Get the full story at our sister site, Drug Delivery Business News.

Alzheimer’s disease has one of the highest financial burdens. The Alzheimer’s Association estimates that the cost of the disease in the U.S. will hit $355 billion in 2021. “Not only is Alzheimer’s one of the most expensive, it’s probably one of the most devastating diseases of humans,” said Dr. Allan Levey, professor and chairman of…

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…

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…

President Joe Biden is reportedly set to announce a partnership in which Merck (NYSE:MRK) will make Johnson & Johnson’s (NYSE:JNJ) recently approved COVID-19 vaccine. The Washington Post reported that the agreement between the two competitors will boost the supply of the single-dose vaccine from J&J’s Janssen subsidiary, which received FDA emergency use authorization last week. Get the full story at…

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…