Drug Discovery

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…

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…

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,…

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…

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 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…

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…

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…

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…

Study power is the holy grail of clinical trials, setting drug developers on the quickest path to market — but nonadherence causes costly detours. When participants do not take their medication as specified in the study protocol, it can result in underestimated drug efficacy, delay the approval of investigational products, and contribute to rising costs.…

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…

MedTech Innovator announced today that its new BioTools Innovator accelerator program has launched. BioTools Innovator is intended to advance life science tools innovation and improve human health by accelerating the growth of startups developing and commercializing a wide range of biotech products, platforms and services, according to a news release. Across a three-month accelerator program,…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that their COVID-19 vaccine produced 100% efficacy among adolescents. In adolescents aged 12 to 15 years old with or without prior evidence of SARS-CoV-2 infection, the BNT162b2 vaccine demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants between 16 and 25. The vaccine…

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,…

Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature. Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures,…