clinical trials

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…

As clinical trials have become more decentralized, there has been an increased focus on the need for more patient-centric drug development. This focus has led to a variety of eClinical applications. Electronic patient-reported outcomes (ePRO) and other electronic clinical outcome assessment (eCOA) approaches can transform trials to make them more pragmatic, patient-centric and efficient. Such…

Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine. Speaking during the company’s first-quarter earnings call yesterday, transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is…

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…

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…

AI-powered drug discovery company Exscientia announced that it completed a $225 Series D funding round. SoftBank Vision Fund 2 led the funding round, while previous lead investors, Novo Holdings and funds managed by Blackrock, contributed. Other investors included Mubadala Investment Company, Farallon Capital, Casdin Capital, GT Healthcare Capital, Marshall Wace, Pivotal bioVenture Partners, Laurion Capital,…

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…

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’…

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…

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…

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…

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 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…

A patient with childhood blindness has gained durable vision improvement 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…

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…