Brian Buntz

Pharmasol (Kaiserslautern, Germany), a provider of pharmacovigilance software and services, has launched psiXchange version 2.4. The software automates the safety document distribution process within clinical trials.  The company created psiXchange software to manage documentation related to drug safety. The latest version of the software includes expanded site views, improved support of clinical operations and site-based teams. PsiXchange version…

CureVac (NSDQ:CVAC) has announced that its first-generation COVID-19 vaccine has passed its first interim analysis but has chosen not to share efficacy data until a statistically significant efficacy analysis is ready. The Tübingen, Germany–headquartered company is developing two mRNA-based vaccines. The mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) are currently two of the most popular…

An article recently published in JAMA concluded that two inactivated COVID-19 vaccines from Sinopharm (OTCMKTS: SHTDY) were 72.8% and 78.1% effective, respectively, based on interim Phase 3 study results.   The lower figure refers to the protection from a COVID-19 vaccine based on two 5-µg doses based on the SARS-CoV-2 isolate WIV04 complete genome. The second vaccine in the…

While the question of when the vaccinated public will require a COVID-19 booster remains unclear, some long-term care advocates are pushing for guidance to avoid a potential resurgence in infections in the fall and winter.  Nursing home residents were among the first to receive COVID-19 vaccines. Providing boosters to the demographic is vital to prevent…

The U.S. Department of Health and Human Services (HHS) has recommended pausing the combination of Eli Lilly’s (NYSE:LLY) bamlanivimab/etesevimab in eight states, including Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon and Washington.  The agency’s reasoning for the decision is grounded in lab data that found the antibody cocktail is not effective against P.1 (Brazilian) or B.1.351…

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research. The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries. To get a sense of which pharmaceutical companies…

Healthcare workers have administered almost 288 million doses of COVID-19 vaccines in the U.S., which now has more than enough vaccine for the present demand.  Against that backdrop, FDA has released updated emergency use authorization (EUA) guidelines for COVID-19 vaccines that state the agency could decline some future EUA requests. “For the remainder of the current pandemic,…

The speed that pharmaceutical companies developed COVID-19 treatments and vaccines was “seemingly miraculous,” said Dr. George Yancopoulos, co-founder of Regeneron (NSDQ: REGN), in remarks when receiving a Titans of Global Health award. “But these miracles were actually born many decades earlier,” he said at the virtual event ceremony from the American Friends of the Hebrew University.…

Moderna (NSDQ:MRNA) has joined Pfizer (NYSE:PFE) in announcing that its vaccine was 100% effective in a Phase 2/3 study involving adolescents. It will seek regulatory authorization to expand the use of its vaccine to adolescents as young as 12 in early June. In the TeenCOVE study, no participants who received two doses of the mRNA-1273…

The COVID-19 pandemic has led to fundamental changes in how pharmaceutical companies and physicians interact with patients. And yet — for all of the talk about digital transformation, artificial intelligence (AI) and decentralized clinical trials in medicine in recent years — the adoption of those concepts has lagged. “The reality is that we’ve gone after…

A previously undisclosed U.S. intelligence report revealed that three scientists from China’s Wuhan Institute of Virology became sick enough in November 2019 to seek hospital care, according to the Wall Street Journal. The illnesses were consistent with both COVID-19 and common seasonal illnesses, but the report fuels speculation that the scientists at the Wuhan lab…

Pfizer’s (NSE:PFE) pneumococcal 13-valent conjugate vaccine Prevnar 13 brought in $5.85 billion last year, but Merck (NYSE:MRK) is hoping to increase its presence in the market with its investigational 15-valent pneumococcal conjugate vaccine. Although Merck has a pneumococcal vaccine on the market known as Pneumovax 23, its sales were $1.1 billion last year. While technically a…

Rybrevant, a novel fully-human bispecific antibody from the Janssen division of Johnson & Johnson, became the first treatment for people with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. In particular, the indication covers such cancer that has progressed on or after platinum-based chemotherapy. The agency also approved the…

After the authorization of COVID-19 vaccines, a growing number of sudden sensorineural hearing loss (SSNHL) reports have emerged from recently vaccinated people.  A recently published analysis in JAMA is among the first to consider whether COVID-19 vaccines play a role in SSNHL, which frequently occurs without a clear underlying cause.   Drawing from a pool of SSNHL patients…

While Big Pharma has yet to embrace psychedelics as potential treatments for depression and other psychiatric disorders, interest in psychedelic medicine is building.  Earlier this month, Nature Medicine published a Phase 3 study indicating that psychotherapy assisted with methyl​enedioxy​methamphetamine (MDMA) was a more effective treatment for post-traumatic stress disorder (PTSD) than therapy alone. The study authors concluded…

Bristol Myers Squibb (NYSE:BMY) has announced results from a Phase 2/3 study that found a fixed dose of relatlimab and Opdivo (nivolumab) led to significant progression-free survival (PFS) rates when used as first-line therapy for metastatic or unresectable melanoma. The RELATIVITY-047 trial found that the median progression-free survival rates were 10.12 months for those receiving…

In the U.S., more than 125 million people have been fully vaccinated against COVID-19. While most vaccine recipients tend to have relatively minor and fleeting adverse events from the shots, many people continue to worry about side effects. According to a recent survey from the physician social network Sermo found that 72% of physicians reported…

The pandemic has heightened interest in COVID-19 therapies, sometimes stealing attention from other pharmaceutical breakthroughs. But the pandemic has also served as a reminder that investment in new drugs can pay dividends while leading to a greater societal appreciation for the industry. A 2019 study published in International Health concluded that pharmaceuticals that have launched…

Drug sales in 2020 proved more resilient than many experts anticipated in the early days of the pandemic. Still, the impact on many injectable drugs was tangible in the first half of the year as hospitals initially dissuaded patients from seeking in-person treatment. But sales were generally strong for the full year. AbbVie’s injectable biologic…

The past year has been an unprecedented time for the pharmaceutical industry. On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society.  While the…

As CureVac (NSDQ:CVAC) awaits European authorization for its mRNA COVID-19 vaccine, it is conducting preclinical research on a second-generation vaccine candidate known as CV2CoV, which it is developing with GSK.  In a study involving rats, the new mRNA vaccine candidate yielded high levels of antigen and strong neutralizing antibody titers after the first vaccination.  Tübingen, Germany–based…

The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020. The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic…

Johnson & Johnson’s (NYSE:JNJ) pharmaceutical subsidiary Janssen has announced that its Tremfya (guselkumab) selective interleukin (IL)-23 inhibitor therapy led to durable, complete skin clearance in the majority of adults with moderate-to-severe plaque psoriasis (PsO) for up to five years. The drug also showed substantial efficacy in treating active psoriatic arthritis (PsA) for up to one…

A Phase 2a-b trial found that the Novavax (NASDAQ: NVAX) NVX-CoV2373 vaccine was 51% effective against the B.1.351 variant in HIV-negative participants without evidence of prior SARS-CoV-2 infection. The overall vaccine efficacy against SARS-CoV-2 was 49% and 60% for HIV-negative participants, according to the study published in NEJM. The study authors note that the efficacy figures are…

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…