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 FDA announced today that it approved Opdivo (nivolumab) in combination with chemotherapy to treat gastric cancer, among other diseases. Opdivo, developed by Bristol-Myers Squibb, when used in combination with certain types of chemotherapy is designed to treat advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. It is now the first FDA-approved…

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…

Thermo Fisher Scientific (NYSE:TMO) announced today that it agreed to acquire PPD (NSDQ:PPD) for $17.4 billion. The boards of directors for both companies approved the definitive agreement which will see Thermo Fisher buy PPD at a price of $47.50 per share, totaling the $17.4 billion, plus the assumption of approximately $3.5 billion of net debt,…

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…

Reports from Italy claim that the European Union Commission won’t renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson. According to Reuters, Italian outlet La Stampa reported that sources from the Italian health ministry have said the commission does not want to pursue contract renewals with those two companies once those encompassing the…

Pfizer will deliver 10% more of its COVID-19 vaccine to the U.S. by the end of May than originally planned, its CEO tweeted yesterday. The tweet follows the federal government’s decision to recommend a temporary halt in the distribution of Johnson & Johnson’s single-dose vaccine, which has been tied to rare instances of blood clot…

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…

The FDA and CDC issued a joint statement today recommending the pause in the administration of the Johnson & Johnson COVID-19 vaccine. As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood…

The co-administration of drugs is commonplace for therapeutic proteins (TP). Yet, drug developers may face delays or ambiguity in preparing for clinical trials if they don’t plan for preliminary analysis of drug-drug interactions (DDI). Fortunately, the U.S. Food and Drug Administration (FDA) released in August 2020 new draft guidance for DDI assessment of TPs. The…

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…

The NIH today announced that a clinical trial is underway to study whether people who are highly allergic or have a mast cell disorder are more likely to develop an allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines. Reports of severe allergic reactions to COVID-19 vaccines have made headlines since the rollout to the…

Intravacc is today touting positive pre-clinical results of its SARS-CoV-2 nasal spray vaccine candidate in non-human subjects. Bilthoven, Netherlands-based Intravacc’s SARS-CoV-2 outer membrane vesicle (OMV)-based recombinant spike protein (rSp) nasal spray candidate was observed in four groups of mice and four groups of hamsters, all of which received two intranasal immunizations on day one and day…

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…

Scientists in Cambridge, Mass. and Chennai, India, are touting self-organizing brain tissue growth in a 3D-printed system. Published results in Biomicrofluidics highlight the work of the Massachusetts Institute of Technology (MIT) and Indian Institute of Technology Madras scientists, who have grown small amounts of the self-organizing brain tissue, known as organoids, in a tiny 3D-printed system that…