Drug Discovery and Development Archives - Page 131 of 158

Adamis Pharmaceuticals’ Tempol shows promise against SARS-CoV-2 in preclinical research

The investigational drug Tempol from Adamis Pharmaceuticals Corp. (NSDQ:ADMP) could be a potent oral antiviral treatment for COVID-19 based on cell culture research, according to scientists at the National Institutes of Health (NIH).

The positive research news caused Adamis Pharmaceuticals’ stock to jump 61% from $0.69 to $1.13 today. The quick jump in its stock valuation triggered a trading halt.

Tempol belongs to a growing class of anti-COVID-19 drugs that aim to stop viral replication.

Pfizer (NYSE:PFE) is also developing a similar potential COVID-19 treatment known as PF-07321332 that is a protease inhibitor. That investigational drug binds to a viral enzyme known as protease to stop viral replication.

Remdesivir, the subcutaneous injectable drug from Gilead Sciences (NSDQ:GILD) that won FDA approval on October 22, 2020, binds to the RNA polymerase and protease of SARS-CoV-2.

Tempol relies on a different mode of action. The drug in…

Why Lilly’s tirzepatide has blockbuster potential

Tirzepatide from Eli Lilly (NYSE:LLY) continues to show promise for diabetes, outperforming popular diabetes drugs in head-to-head clinical trials, according to GlobalData.

In the recent SURPASS-4 study, tirzepatide supported the reduction of hemoglobin A1C (HbA1c) in people with type 2 diabetes while also supporting weight loss. The study pitted tirzepatide against insulin glargine.

Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist (RA).

The experimental drug also bested the injectable anti-diabetes drug semaglutide in the SURPASS-2 trial. Semaglutide from Novo Nordisk (NYSE:NVO) is currently FDA indicated as a treatment for type 2 diabetes. Semaglutide also supported substantial weight loss in a recent clinical trial, potentially supporting its use as an obesity treatment. Semaglutide is also a GLP-1 receptor agonist.

Almost one-quarter of Americans remain vaccine-hesitant

[Photo by Maksim Goncharenok from Pexels]

A study from Informa Pharma Intelligence and YouGov concluded that vaccine hesitancy remains a significant hurdle in the U.S. A separate study published in JAMA indicates vaccine hesitancy is falling. Specifically, the number of people who were suspicious about COVID-19 vaccines fell from 46% in October 2020 to 35% in March 2021.

Conversely, the Informa-YouGov survey from April 21 and 22 concluded that 23% of Americans were vaccine-hesitant. The study had 1,327 adult participants.

While approximately half of the U.S. public has received at least one vaccine dose, vaccinating the remainder of the eligible population could be a hurdle.

But the recent data from the Informa-YouGov survey indicate that achieving President Biden’s goal of providing at least one vaccine dose to 70% of the American adults by July 4 is at least feasible.

Another factor tha…

AbbVie faces Senate questions related to tax practices

Senate Finance Committee Chair Ron Wyden (D-Ore.) has announced an investigation of AbbVie’s (NYSE: ABBV) tax practices.

In a statement, the senator argued that the company’s tax rate from 2018 to 2020 was 9.5% — less than half of the 20% rate it paid in 2016.

Wyden has sent a letter to AbbVie CEO Richard Gonzalez seeking information about the company’s tax practices.

In the letter, Wyden questioned why the company reported a U.S. pretax loss of $4.5 billion while an offshore pretax profit of $7.9 billion in 2020. “Despite the United States market being the source of most of AbbVie’s revenues and richest price premiums, it appears that the company has consistently reported net losses in the United States while reporting substantial foreign profits,” he wrote.

AbbVie did not immediately respond to a request for comment regarding Wyden’s investigation.

AbbVie is also the subject of a May report from the House Committee on Oversight and Reform…

Anifrolumab data promising for systemic lupus erythematosus

AstraZeneca (LON:AZN) has announced that a new posthoc analysis of data from the TULIP Phase 3 clinical trials of anifrolumab showed promise in patients with systemic lupus erythematosus (SLE), the most common type of lupus. Anifrolumab is a monoclonal antibody that blocks the activity of interferons such as interferon-α and interferon-β. If approved, anifrolumab would be a first-in-class type I interferon inhibitor.

The most recent clinical trial data demonstrated that anifrolumab led to consistent skin rash and arthritis improvements in patients with moderate to severe SLE compared to placebo.

“Arthritis and rash are the most common and persistent problems in lupus and often have a significant impact on a person’s life,” said Joan Merrill, Oklahoma Medical Research Foundation, Arthritis & Clinical Immunology Research Program, U.S., in a statement. The data from the recent analysis indicate that anifrolumab was “consistently effective using three different…

Corbus Pharmaceuticals adds two mAbs to its pipeline

Corbus Pharmaceuticals (NSDQ:CRBP) is expanding its pipeline in immuno-oncology and fibrotic disease with licensing deals for two monoclonal antibodies (mAbs), which it has named CRB-601 and CRB-602.

Both mAbs target integrins that inhibit activation of transforming growth factor-beta (TGF-β), a cytokine linked to inflammation, fibrosis and cancer. “TGF beta needs to be activated from its latent form to exert its biologic activities,” explained Dr. Barbara White, Corbus’s chief medical officer and director of research.

CRB-601 is a high potency anti-alpha V beta 8 (anti-avb8 mAb) antibody that the company acquired from the University of California, San Francisco. “We believe that CRB-601 could offer advantages over competitor approaches and expect to initiate Phase 1 clinical studies next year,” said Corbus CEO Yuval Cohen.

The CRB-602 antibody inhibits both alpha V beta 6 and alpha V beta 8. Corbus acquired that antibody from Panorama Research Inc. (Sun…

Lilly’s Taltz leads to durable improvement in axial spondyloarthritis in Phase 3 study

Eli Lilly and Company (NYSE:LLY) has announced that recent Phase 3 data suggest Taltz (ixekizumab) was effective in the long-term management of axial spondyloarthritis (axSpA). Taltz, an interleukin-17A antagonist, is currently indicated for plaque psoriasis, psoriatic arthritis and active ankylosing spondylitis.

In the COAST-Y study, Taltz demonstrated long-term improvements in patients’ symptoms with the two subtypes of axSpA. The first, known as radiographic axSpA (r-axSpA), involves defined structural damage of the sacroiliac joints evident on x-ray films. The second type, known as non-radiographic axSpA (nr-axSpA), lacks such structural damage.

The former can lead to substantial reductions in quality of life. “If left uncontrolled, individuals living with active radiographic axSpA can experience severe, chronic pain and structural damage in the spine that can lead to fusion of the spine and loss of mobility,” explained Dr. Walter P. Maksymowych, professor …

J&J’s Tremfya shows promise in psoriatic arthritis patients who are TNFi non-responders

The Janssen division of Johnson & Johnson (NYSE:JNJ) has announced that its selective IL-23 inhibitor Tremfya (guselkumab) led to joint symptom improvement and skin clearance in the majority of patients with an inadequate response to tumor necrosis factor inhibitors (TNFi’s).

After 24 weeks of treatment, 44.4% of patients who received Tremfya had at least a 20% improvement in joint symptoms using the American College of Rheumatology’s ACR20 scale, which requires at least a 20% improvement in several arthritis measures. Some 19.9% of placebo recipients had the same degree of improvement.

At one year, 57.7% achieved more than 20% improvement in joint symptoms using the American College of Rheumatology’s ACR20 scale, which requires at least a 20% improvement in several arthritis measures. Some 53.4% of the psoriatic arthritis patients had complete skin clearance.

“We’re basically continuing to develop the body of evidence to help physicians make d…

FDA to review Akebia’s and Otsuka’s vadadustat for anemia resulting from chronic kidney disease

FDA has accepted a new drug application (NDA) for the oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor vadadustat from Akebia Therapeutics (NSDQ:AKBA) and its partner Otsuka Pharmaceutical Co. (TYO:4578).

The two companies are pursuing the use of the drug to treat anemia resulting from chronic kidney disease.

The oral drug would offer patients more flexibility than anemia treatments known as Erythropoiesis-stimulating agents, which are injectable drugs that stimulate the bone marrow to produce red blood cells.

FDA has assigned the application a standard review and has set a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022.

The agency is not intending on holding an Advisory Committee meeting for the application.

In a statement, Akebia CEO John P. Butler said the company looks “forward to working with the FDA” as it reviews the application. …

Moderna seeks full FDA approval for its COVID-19 vaccine

Vials containing the Moderna COVID-19 vaccine. [Image from Wikipedia]

Moderna (Nasdaq:MRNA) announced today that it submitted for full FDA approval of its mRNA COVID-19 vaccine for individuals 18 years of age and older.

Cambridge, Mass.-based Moderna initiated the rolling submission process with the FDA for a Biologics License Application (BLA) to license its mRNA COVID-19 vaccine, according to a news release. The move mirrors Pfizer and BioNTech, who last month initiated the process for a BLA for their COVID-19 vaccine.

The company said it will continue to submit data to the FDA in support of the BLA on a rolling basis with a request for priority review. Once the submission is complete, the FDA will notify Moderna when it is formally accepted for review.

Moderna’s two-dose COVID-19 vaccine is currently available under the FDA’s emergency use authorization (EUA), which …

Pharmasol debuts new psiXchange capabilities to facilitate delivery of clinical trial safety documentation

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 2.4 also supports the real-time dissemination of information to global stakeholders involved in drug safety management. Clinical research associates, for instance, using the software now have access to more robust status information. This feature supports compliance with the requirements of the FDA and European regulatory authorities.

The software can also immediately send safety documents such as suspected serious adverse reactions (SUSARs), line listings and development safety update reports to recipients such as e…

CureVac’s COVID-19 vaccine candidate inches forward to Phase 2b/3 efficacy readout

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 COVID-19 vaccines in the world.

The data and safety monitoring board also concluded that there were no safety concerns linked to the CVnCoV in the HERALD study.

The company’s second-generation vaccine is known as CV2CoV, which it is developing in collaboration with GSK.