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…

What can the pharma industry do about the critical shortage of contract manufacturing organization (CMO) and contract development and manufacturing company (CDMO) facilities? For a growing number of young entrepreneurial drug companies, the answer is a middle ground between building their own facilities and outsourcing to the saturated CMO/CDMO market. This middle ground lies 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…

Human Factors + (HF+) is a natural extension of Noble’s deep understanding of the patient experience relative to self-administering drug therapies By Tim McLeroy, Executive Director of Marketing & Patient Services The global market for medical devices is approximately $436 billion, bolstered by an aging population, according to data from hfMEDIC, the University of Utah-led […]

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,…

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…

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,…

Influenza viruses are a moving target, forcing drug developers to modify their products annually based on the strains most likely to dominate a given season. SARS-CoV-2 could follow a similar trajectory in the first few years of the pandemic, according to a study published in Virus Evolution. SARS-CoV-2 is likely to continue to accumulate changes…

The World Health Organization has a leading theory regarding the origins of the COVID-19 pandemic but is considering three others in a forthcoming report, according to a recent AP article. The most likely scenario is that the virus, which many scientists believe first appeared in bats, infected humans through an intermediary animal. Less likely is that…

Following allegations of sexual harassment, former head of Operation Warp Speed Moncef Slaoui has left roles at two more companies. Yesterday, Slaoui was terminated as the Galvani board of directors’ chair, GlaxoSmithKline’s board of directors announced. The same day, Vaxcyte confirmed in an SEC filing that it had axed Slaoui as its chairman of the…

The Korean biopharma Medytox and Jupiter, Fla.–based Dyadic International are partnering to develop vaccines that would protect against multiple COVID-19 variants. The companies plan on using Dyadic’s C1-cell protein production platform in the development of the vaccines. The vaccines would use a similar strategy to flu vaccines, which are often trivalent or quadrivalent. The former…

Some of the first commercially available doses of Pfizer-BioNTech COVID-19 vaccine had lower levels of intact mRNA than anticipated, according to leaked documents reviewed by BMJ. The documents in question relate to a December breach of the European Medicines Agency (EMA), which was one of the many victims of pharma-related cyber breaches in 2020. The cybercriminals…

A multicenter study involving a substantial number of minorities indicated that remdesivir supported clinical improvement in the majority of patients. The hospitalized remdesivir group had an average time to clinical improvement of five days versus seven days for those not receiving the drug. Remdesivir recipients had a 28-day mortality rate of 7.7% compared with a…

The duration of immunity from COVID-19 infections is still not well understood. But a recent longitudinal study indicates that the presence of SARS-CoV-2 neutralizing antibodies could range from about 40 days to decades, depending on the severity of infection. The study followed 164 patients infected with the novel coronavirus for up to 180 days after…

In a complaint filed in Illinois federal court, AbbVie alleges that the Icelandic biopharma company Alvotech sought to copy its blockbuster biologic Humira (adalimumab).  The lawsuit accuses Alvotech of hiring a former AbbVie employee, Rongzan Ho, to help it develop a copycat version of Humira.  Ho, a team leader of upstream manufacturing for Humira, was…

  GlaxoSmithKline’s board of directors announced today that it terminated Moncef Slaoui as the chair of the Galvani board of directors. Slaoui, who served as the head of Operation Warp Speed — the Trump administration’s program to accelerate COVID-19 vaccine development — was terminated effective immediately, according to a news release from GSK, the majority…

An experimental oral antiviral from Pfizer will be the focus of a Phase 1 study involving healthy adults. Known as PF-07321332, the drug has shown promise during in vitro studies against SARS-CoV-2. PF-07321332 belongs to a class of drugs known as protease inhibitors, which are commonly used to treat HIV/AIDS and hepatitis C. Protease inhibitors bind to…