Brian Buntz

Initial data from a Moderna (NSDQ:MRNA) Phase 2 trial found two versions of its COVID-19 vaccine increased neutralizing titers against SARS-CoV-2 and two variants in previously vaccinated clinical trial volunteers. A third dose of the company’s existing mRNA-1273 appears to improve immune response against the B.1.351 variant that first emerged in South Africa. But a booster dose…

The COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) appears to be on the cusp of winning regulatory authorization for use in adolescents between the ages of 12 and 15, according to several media reports. FDA has authorized the vaccine for people aged 16 and up. In March, Pfizer submitted clinical trial results to FDA, suggesting the efficacy of the…

A recent study found that only 13.5% of recipients of the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) had systemic side effects after the first dose. That figure climbed to 22.0% after the second dose. Conversely, just over one-third (33.7%) of recipients of the first dose of vaccine from AstraZeneca (LON:AZN) had systemic side effects, according to the…

After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking authorization from the European Medicines Agency (EMA) to distribute the vaccine to that age group. BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries…

One of the most dangerous aspects of the novel coronavirus is its potential to cause pneumonia and acute respiratory distress syndrome (ARDS). Pandemic influenza A (H1N1) can cause similar problems. A team of researchers at Ohio State University has developed a potential treatment for ARDS stemming from COVID-19 or influenza. The inspiration for the therapy,…

A group of scientists from the U.S. and China injected human stem cells into 132 macaque embryos, which then developed for up to 20 days. While the research holds promise for organ transplants, studying disease and testing new drugs, it also prompts controversy. The research was published this month in Cell. The scientists began with blastocysts…

One dose of vaccine from Pfizer (NYSE:PFE) or AstraZeneca (LON:AZN) leads to a substantial reduction in infection risk in adults, according to a recent study published in BMJ.  The study organizers found that recipients of a single dose of either vaccine led to a 57% reduction in asymptomatic infections and a 74% drop in symptomatic disease at least…

Israel’s Health Ministry is researching “tens” of cases of myocarditis, or heart inflammation, in people who have received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). More than five million people in the country have received the vaccine. The agency, however, has not yet established a causal relationship between the events and the vaccine. Pfizer has…

Intelligence Squared, the organizers of a popular debate series, recently asked a panel of experts whether psychedelics should be legalized. There was considerable overlap between the factions arguing in favor and opposition of that motion, reflecting the growing interest in psychedelic compounds for therapeutic applications. But the two camps were split when it came to…

The rare disease biotech ProQR (NSDQ:PRQR) has a mission of reversing blindness from inherited retinal diseases. The company seems to be on track to realize that ambition, having recently announced promising data in treating a condition known as Leber congenital amaurosis type 10 in clinical studies. One patient with the childhood form of blindness gained…

Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab seemed to be a potential blockbuster until an FDA advisory committee voiced skepticism in November about the drug. FDA reviewers had previously assessed the drug’s prospects more positively. The company is preparing for the event of an FDA approval of the drug in June. Biogen’s CEO Michel Vounatsos said in…

The Swiss pharma giant Roche (OTCMKTS:RHHBY) has canceled two Phase 2 COVID-19 studies while looking to identify a new site to conduct a clinical study for the oral antiviral AT-527, which it is developing with Atea Pharmaceuticals (NSDQ:AVIR.O). The two companies were looking to launch a trial in the U.K., but falling COVID-19 cases there have…

Global pharma firm Novo Nordisk (NYSE:NVO) will launch a Phase 3a study to investigate the potential of oral Ozempic (semaglutide) to treat obesity.  The drug is currently indicated in a subcutaneous form in the U.S. for people with type 2 diabetes to improve glycemic control in conjunction with diet and exercise and to lower diabetics’…

Former HUD Secretary Dr. Ben Carson, Sr. will assist Galectin Therapeutics Inc. (NSDQ: GALT) with the development of its galectin-3 inhibitor, belapectin. The drug is a potential treatment for nonalcoholic steatohepatitis (NASH), which is also known as nonalcoholic fatty liver disease.  Galectin Therapeutics has an ongoing Phase 2b/3 trial to investigate belapectin’s potential in treating cirrhosis…

Ovid Therapeutics (NSDQ:OVID) has named MIT professor Robert Langer as the chair of its scientific advisory board. The biopharma company focuses on rare neurological diseases. “The neurosciences are on the cusp of a scientific and, hopefully, therapeutic revolution,” said Langer in a statement. “Ovid has an exciting approach to tackling the key questions that drive…

After the European Medicines Agency determined that the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, the company announced that it would unfreeze its European vaccinate rollout. But assessing demand for the J&J and AstraZeneca vaccines remains difficult. The possible link to rare blood clots could elevate the role of vaccines from…

A group of researchers in Israel has concluded that an mRNA-based vaccine could activate herpes zoster (shingles) in a limited number of people with rheumatic diseases. The viral infection, which can cause a painful rash, is caused by the varicella-zoster virus, which is also responsible for chickenpox. In a study focusing on individuals with autoimmune…

On April 16, Lilly announced that it was requesting FDA to revoke the emergency use authorization (EUA) for the monoclonal antibody bamlanivimab (LY-CoV555) when used alone. Hours after, the agency agreed to rescind the EUA on the grounds that bamlanivimab is potentially ineffective against some SARS-CoV-2 variants. Bamlanivimab, however, won’t be disappearing as a COVID-19…

For almost every major common disease, researchers have less understanding of the severe forms than milder cases. And as a result, people with severe forms of diseases often have few treatment options available.   Thus, the significant unmet medical need for many diseases ranging from multiple sclerosis to Alzheimer’s is to halt disease progression and treat severe…

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…