clinical trials

OncoSec (NASDAQ: ONCS), a cancer immunotherapy company currently focused on R&D, is planning U.S. promotion of its tavokinogene telseplasmid (TAVO) drug for a type of metastatic melanoma — and eventually other cancers. “We don’t currently have a sales force. If successful, we’re going to need to have a sales and marketing team embedded in the…

In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). To date, it has analyzed data from 13 of those individuals. The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly…

The contract research organization Phastar (London) plans to expand its statistics and data science services with funding from Charterhouse Capital Partners, a European private equity firm. Phastar will also use the funds to expand its international footprint, opening an office in China. “We continue to see strong growth across pharma and biotech services,” said Kevin Kane,…

Patients with dermal fillers have a small potential risk of developing facial swelling after obtaining mRNA vaccines. To date, the FDA has noted the problem in three clinical trial recipients of the COVID-19 vaccine from Moderna (NSDQ:MRNA). The agency hasn’t observed facial swelling in the Phase 3 clinical trial for the COVID-19 vaccine from Pfizer…

Engineered microchips with living human cells have the potential to accelerate drug development and replace animal testing, said Dr. Donald Ingber, the founding director of the Wyss Institute for Biologically Inspired Engineering at Harvard University. The organ-on-a-chip technology could also enable the industry to rethink its business model, Ingber said in a webinar from the…

Researchers at privately-held Genuity Science and Yale University Medical School have revealed why aortic aneurysms form. The scientists discovered that an expansion in abnormal cells in smooth muscle tissue of the aorta can contribute to aortic aneurysm. The researchers came to that conclusion by using a combination of generative artificial intelligence, single-cell biology and RNA sequencing to…

The European Union has authorized the mRNA-1273 COVID-19 vaccine from Moderna (NSDQ:MRNA) ahead of schedule, responding to criticism that it had been too slow in its mass vaccination plans. The E.U. drug regulator had planned on meeting later in the month to discuss the vaccine.  “This vaccine provides us with another tool to overcome the current emergency,”…

AstraZeneca (LON:AZN) inadvertently discovered halving the first dose of its COVID-19 vaccine could boost its efficacy. Researchers at the National Institutes of Health (NIH) and Moderna (NSDQ:MRNA) are examining vaccine data to determine whether they can halve the 100-microgram dose to vaccinate twice as many people. Some data from Moderna’s clinical trial support that possibility,…

An inexpensive investigational vaccine known as AKS-452 is stable for weeks at room temperature and can potentially be used for both prime and boost vaccination. The vaccine developer, Akston Biosciences (Beverly, Mass.), has hooked up with LakePharma, a San Carlos, Calif.-based contract research, development and manufacturing outsourcing organization, to manufacture the vaccine. Phase 1/2 clinical…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have decided to offer to inform clinical trial volunteers in its COVID-19 vaccine whether they received a vaccine or placebo. Those who received a placebo will be eligible to receive the first dose of vaccine by March 1 and stay in the study. A second dose will be administered roughly three weeks…

The National Health Service in the U.K. is increasing the maximum interval between shots for recipients of the Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) vaccine to 12 weeks. In a letter to hospitals, NHS advised that patients scheduled to receive the second dose of the vaccine on Jan. 4 should receive it nine weeks later.  The developers of…

Chinese health authorities have authorized a SARS-CoV-2 vaccine from state-owned Sinopharm (OTCMKTS: SHTDY). The vaccine has an efficacy of 79% based on an interim analysis of a Phase 3 study.  China plans to distribute the BBIBP-CorV vaccine to citizens at no cost and distribute it to other countries that test Chinese vaccine candidates.  The country has…

An inexpensive COVID-19 vaccine from AstraZeneca (LON:AZN) — now authorized in the U.K. — could go on to become the most widely used in the world. It is inexpensive and easy to produce.  But a major hurdle that could slow its rollout in the U.K. after yesterday’s approval is the question of how to best…

Molnupiravir, an experimental antiviral drug developed by Emory University, Merck (NYSE:MRK) and Ridgeback Biotherapeutics, has promise in the battle against COVID-19 based on an animal trial published in Nature from Georgia State University researchers.   Also known as MK-4482 or EIDD-2801, the oral drug Molnupiravir has an advantage over SARS-CoV-2 therapies such as remdesivir and reconvalescent serum that require infusion.…

Vaccines are playing a central role in the fight against COVID-19. They also may hold promise to help relieve the opioid overdose crisis that has worsened along with the pandemic. That’s the argument that two psychiatrists make in a recent JAMA article, “The Hidden Epidemic of Opioid Overdoses During the Coronavirus Disease 2019 Pandemic.” Antifentanyl vaccines…

Like most things in healthcare, clinical trials have been slow to evolve in recent decades. But the COVID-19 pandemic has forced clinical trial research teams to become more efficient, patient-centered and inclusive.   Much is at stake as the pandemic has already caused significant clinical trial disruption. EY estimates that the COVID-19 impact on Phase 3…

After receiving emergency use authorization (EUA) for the combination of casirivimab and imdevimab to treat COVID-19, Regeneron Pharmaceuticals (NSDQ:REGN) has announced promising early results in an ongoing trial involving hospitalized patients needing low-flow oxygen.  Focusing on patients who had not yet developed an immune response to SARS-CoV-2, the trial found that patients who received the antibody cocktail…

A vaccine jointly developed by Oxford University and AstraZeneca (LON:AZN) recently won authorization in the U.K. Meanwhile, health officials in Turkey and Brazil have indicated that a vaccine from the Chinese firm Sinovac is safe and effective. But one factor that could slow the deployment of both vaccines globally is confusing clinical trial results. Sinovac’s CoronaVac product…

New macular degeneration treatments could offer superior durability to current anti-vascular endothelial growth factor therapy (anti-VEGF). But new drugs must have a similar safety profile to existing therapies to be competitive, according to a UBS briefing note.  The macular degeneration treatment landscape changed significantly in 2005 when FDA approved Macugen (pegaptanib sodium injection) from Pfizer (NYSE:PFE) to…

Merck (NYSE:MRK) has agreed to supply the U.S. government with the biological therapeutic CD24Fc if FDA authorizes the use of the drug.   The drug played a central role in Merck’s decision to acquire privately held OncoImmune, which had touted CD24Fc as its “lead compound.”  Merck plans on renaming the CD24Fc therapy MK-7110. (We recently profiled the…

The pharmaceutical industry launched a herculean effort to battle the COVID-19 pandemic early in 2020, developing an array of vaccines and other therapeutics while also identifying existing drugs suitable for treating patients sick with severe coronavirus infections. FDA recently granted emergency authorization to two SARS-CoV-2 vaccines and several other treatments. Here are 11 of the…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that they received conditional authorization from European regulators. The European Commission confirmed that it granted a conditional marketing authorization for the vaccine developed by the two companies, making it the first available COVID-19 vaccine in the European Union. The news follows an earlier announcement that the companies had received…

FDA has decided to permit emergency use of Moderna’s (NSDQ:MRNA) mRNA-1273 COVID-19 vaccine. A week ago, FDA granted the same designation for the vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).  The U.S. government will collaborate with the company to distribute the vaccine. Although the EUA permits the vaccine to be used in individuals 18 and older, medical workers…

Novartis (NYSE:NVS) has agreed to acquire Cadent Therapeutics, a privately owned neuroscience company based in Cambridge, Mass. Novartis plans to spend $210 million upfront with another $560 million in milestone payments.  The acquisition would give Novartis two neuroscience drugs in clinical development — one for schizophrenia and another for movement disorders. The transaction also includes a…

A week after supporting the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), an FDA advisory committee endorsed the mRNA-1273 vaccine from Moderna (NSDQ:MRNA). A total of 20 panel members voted in favor of the vaccine, and one member abstained.  After releasing an upbeat assessment of the vaccine earlier this week, FDA is likely to grant emergency use authorization…