Brian Buntz

The magic mushroom compound psilocybin appeared to be slightly more effective than the selective serotonin-reuptake inhibitor escitalopram (Lexapro) in a small study recently published in NEJM.   In the Phase 2 study, which tracked 59 patients over six weeks, the psilocybin group had an approximately 8-point average drop in the Quick Inventory of Depressive Symptomatology (Self-Report) questionnaire…

Johnson & Johnson (NYSE:JNJ) privately contacted other COVID-19 vaccine makers last week to gauge their interest in studying blood clot risks, according to a Wall Street Journal report. Specifically, the company asked whether its rivals — AstraZeneca, Moderna and Pfizer— had new information about blood clots following vaccination and if they were interested in forming an external panel…

Regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), causing some to wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events. Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s…

The public may require annual vaccines to protect against SARS-CoV-2, Pfizer (NYSE:PFE) CEO Albert Bourla said today.  “It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said in a CNBC interview.  While the details of Pfizer-BioNTech boosters are not yet clear, COVID-19 boosters will likely be based…

A CDC advisory committee decided not to vote on how Johnson & Johnson’s COVID-19 vaccine should be deployed, reasoning that it needs more time to review data related to rare blood clots potentially linked to the vaccine. The CDC and FDA announced on April 13 their recommendation to pause the vaccine’s use on safety grounds.…

There have multiple surges in malpractice claims following each wave of COVID-19 infections. According to Victor Bornstein, CEO of Justpoint (New York City), the vast majority of those claims have targeted medical malpractice, an AI company specializing in malpractice. “The healthcare system was under a lot of stress, and more mistakes tend to happen,” Borstein…

Peripheral cytokines from COVID-19 vaccines could cause or exacerbate tinnitus, or ringing in the ears, theorized Shaowen Bao, an associate professor of neuroscience and physiology at the University of Arizona.  Recent articles on Drug Discovery & Development on the possible link between tinnitus and COVID-19 vaccines have attracted hundreds of comments.  Some 0.65% of COVID-19 vaccine recipients who…

With COVID-19 cases surging in many parts of the world, the need is high for multiple vaccines to slow the virus. But the fate of adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson has become murky after a limited number of people receiving those vaccines have developed severe blood clot disorders. Officials in both the…

Developing disease-modifying therapies for neurodegenerative diseases remains a pressing need. The incidence of neurodegenerative disease is ramping up in the U.S. and elsewhere as much of the global population ages. One out of three seniors dies with Alzheimer’s disease or another form of dementia, according to the Alzheimer’s Association. Parkinson’s disease is also becoming more…

Pfizer (NYSE:PFE) and its German partner BioNTech (NSDQ:BNTX) have asked FDA to extend the authorization of their COVID-19 vaccine to the ages of 12 to 15.  FDA authorized the vaccine for people 16 and older on Dec. 11, 2020.  The agency will likely extend its prior authorization to younger adolescents “if the data submitted support…

The European Medicines Agency (EMA) announced that it is beginning a review of blood clots appearing in a handful of recipients of the Johnson & Johnson COVID-19 vaccine.  EMA recently concluded that blood clots associated with low blood platelet levels were a “very rare” side effect of Vaxzevria, the vaccine from AstraZeneca.  Four recipients of…

The need for therapies that change the course of Parkinson’s disease is considerable. “There are zero disease-modifying treatments for Parkinson’s,” said Dr. Allan Levey, professor and chairman of Emory University’s department of neurology.  Parkinson’s disease affects some 10 million people worldwide, according to the Parkinson’s Foundation.  Current drugs for Parkinson’s make it possible to “reverse…

The pandemic has forced a rethink of clinical research, but the pharma industry continues to rely on animal testing. While pundits have observed that computer modeling and techniques such as microdosing can reduce animal testing, animal testing continues to be integral in preclinical studies.  But computer models are now sufficiently accurate to predict many drugs’ response, said…

Virus-like particle (VLP) technology specialist Icosavax has closed $100 million in Series B financing, which it will use for clinical studies and continued development of a SARS-CoV-2 vaccine candidate. One focus of the clinical research will be clinical trials for its bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine. RSV is a common…

An experimental oral antiviral from Pfizer that recently became the focus of a Phase 1 study was featured at the American Chemical Society Spring 2021 meeting. Known as PF-07321332, the compound is a protease inhibitor. It works by binding to a viral enzyme known as protease to block viral replication. Protease inhibitors are used to treat HIV/AIDS…

European Medicines Agency (EMA) official Marco Cavaleri said there was a link between AstraZeneca’s COVID-19 vaccine and rare reports of blood clots, including pulmonary embolism, deep vein thrombosis and thrombocytopenia, according to a Reuters report. Two separate research groups in Europe had reached similar conclusions regarding the blood clots in March. AstraZeneca had previously downplayed the possibility that…

A patient with childhood blindness has gained vision after a single injection of sepofarsen, an investigational RNA therapy. The patient had a rare genetic disorder known as Leber congenital amaurosis (LCA) that affects the retina and often causes severe visual impairment. Injection of sepofarsen led to measurable changes in the fovea, a depression in the…

Mass-vaccination efforts are ramping up, and prominent COVID-19 vaccine developers are working to lower the eligibility age for their products. Johnson & Johnson (NYSE:JNJ), for instance, has begun vaccinating adolescents in a Phase 2a clinical trial for its COVID-19 vaccine candidate.  Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) recently announced that their vaccine was 100% effective in…

Moderna (NSDQ:MRNA) is beginning a new Phase 1 study to test the effectiveness of a new version of its COVID-19 vaccine designed to enhance protection against the B.1.351 first detected in South Africa.  The recent study will help Moderna and its partner, the National Institute of Allergy and Infectious Diseases determine whether to update the…

The number of concerning SARS-CoV-2 variants continues to increase. One notable example is a variant known as a ‘double mutant’ that arose in India. The variant has two mutations that could make the virus more virulent and resistant to antibodies, according to a preprint on bioRxiv. Researchers at the Stanford Clinical Virology Lab recently confirmed the…

COVID-19 has complicated oncology trials and care, slowing down the success seen against cancer. While the cancer death rate fell 29% between 1991 and 2017, according to the American Cancer Society, the coronavirus pandemic has threatened to interfere with oncology drug development trials. COVID-19’s disproportionate impact on oncology “Cancer patients have been disproportionately negatively affected…

The first COVID-19 vaccine to win emergency use authorization in the U.S. is highly effective for at least six months after the second dose. Developed jointly by Pfizer (NYSE: PFE) and BioNTech (NSDQ: BNTX), the BNT162b2 vaccine   The durability of COVID-19 vaccines had been something of an open question, although early clinical data suggested that Moderna’s…

Biotech firm AbCellera (NASDAQ:ABCL) announced its full-year 2020 business results, which were dramatically higher than the previous year. The company pulled in $233 million in total revenue last year compared with $11.6 million in 2019. Net earnings for 2020 were $119 million compared to a $2 million loss in 2019. “AbCellera had a breakthrough year,…

A single dose of Pfizer or Moderna vaccine is about 80% effective at preventing COVID-19 infection at least two weeks after injection. The efficacy level rises to 90% two weeks after the second dose of either mRNA vaccine, according to a recent CDC study involving roughly 4,000 essential workers. In contrast to the Phase 3 trials from…

GlaxoSmithKline and Vir Biotechnology have filed for emergency use authorization (EUA) for VIR-7831 (GSK4182136), a dual-action SARS-CoV-2 monoclonal antibody. VIR-7831 is designed to stop SARS-CoV-2 viral entry into cells and accelerate the clearing of infected cells. VIR-7831 would have a similar indication to other monoclonal antibodies that have won an EUA. It is intended for…