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The race is on as several drugmakers get closer to the finish line in developing the first Bruton tyrosine kinase (BTK) inhibitor to treat multiple sclerosis (MS). BTK is a [...]

For the drug industry, 2023 turned out to be a banner year for FDA drug approvals with a total of 55. The FDA has approved 18 new drugs so far […]

These days, glucagon-like peptide 1 (GLP-1) receptor agonists need no introduction; they are the hot topic in professional meetings and conferences, in Hollywood and on TikTok Part of abroader class [...]

The antibody-drug conjugate (ADC) class has seen substantial growth since the first FDA approval of an ADC, Pfizer's Mylotarg (gemtuzumab ozogamicin), in 2000. Mylotarg, which was used to treat patients [...]

Janus kinases (JAKs) are a group of inflammatory proteins associated with the pathogenesis of several inflammatory and autoimmune disorders, including skin conditions such as atopic dermatitis, vitiligo, alopecia areata and [...]

After going dormant for decades because of government restrictions, research focusing on the use of psychedelics for the treatment of psychiatric conditions has sprung to life. Research conducted in this [...]

Triple-negative breast cancer accounts for about 15% of breast cancers and is considered the most aggressive type, with a five-year survival rate of approximately 30%. The four-year survival rate for [...]

Before December 2020, when the FDA authorized the use of two COVID-19 messenger RNA (mRNA) vaccines developed by Pfizer and Moderna, the science behind mRNA vaccines had been researched for [...]

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer in the United States, accounting for about 85% of all lung carcinomas. It is the leading cause [...]

The emergence of the SARS-CoV-2 virus in late 2019 prompted drug manufacturers, biotechnology companies and laboratories to swing into action to develop agents that would neutralize the virus and prevent [...]

In the United States, breast cancer is second only to skin cancer as the malignancy most commonly diagnosed among women. Nearly 300,000 women will be diagnosed with invasive breast cancer [...]

First discovered approximately 60 years ago, lipoprotein(a) is a variant of low-density lipoprotein. Elevated lipoprotein(a), which experts often refer to as 'L-P-little-a,' has been associated with an increased risk of [...]

Duchenne muscular dystrophy (DMD) is a progressive, X-linked genetic disorder primarily affecting boys. It is the most common form of childhood muscular dystrophy, affecting about 1 in 3,500 male births [...]

Respiratory syncytial (pronounced sin-SISH -shul) virus (RSV) is a highly contagious virus that can affect the lower respiratory tract and is a leading cause of pneumonia and other respiratory tract [...]

The current landscape in hemophilia treatment looks quite different than it did decades ago when plasma-derived clotting factor replacement therapy was the standard of care. Recent advances have introduced extended [...]

TUMOR NECROSIS FACTOR-ALPHA (TNF-ALPHA) blockers are biologics typically prescribed to treat various inflammatory autoimmune conditions, including ulcerative colitis. Specifically, Remicade (infliximab and biosimilars) and Humira (adalimumab and biosimilars) are FDA-approved [...]

Multiple sclerosis (MS) is about three times more prevalent in women than men, and hormonal differences are believed to be the culprit. Research suggests, for example, that MS symptoms may [...]

Alzheimer's disease is the most common type of dementia, affecting more than 6 million people in the United States. According to the Alzheimer's Association projection, by 2050 Alzheimer's disease is [...]

Ulcerative colitis and Crohn's disease are the two most common inflammatory bowel diseases. Ulcerative colitis is characterized by chronic inflammation and ulceration of the colon mucus membrane, resulting in symptoms [...]

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a neurodegenerative, fatal disease affecting motor neurons that control voluntary muscle movement. Initial symptoms can include muscle cramping, twitching, [...]

Nonalcoholic steatohepatitis (NASH) is a progressive form of nonalcoholic fatty liver disease (NAFLD). It is considered the second phase of NAFLD and is characterized by hepatic inflammation and ballooning due [...]

Post-traumatic stress disorder (PTSD) is a chronic psychiatric condition that occurs in some people after experiencing or witnessing traumatic events, such as military combat trauma, childhood trauma and physical or [...]

Hemophilia is a rare, X-linked, hereditary bleeding disorder characterized by blood clotting factor deficiencies that affects mainly males. It results in excessive bleeding, particularly in the joints, soft tissues and [...]

Asthma is a chronic respiratory disease that causes narrowing and inflammation of the airways that compromises breathing and, in some cases, can be fatal. Symptoms include coughing, wheezing, shortness of [...]

Antibody-drug conjugates (ADCs) are oncology drugs that have been compared to guided missiles because they home in on certain cell-surface targets and then unleash toxic chemotherapy drugs to battle cancer [...]

Atopic dermatitis (AD), also known as eczema, is a chronic inflammatory skin condition affecting up to 10% of adults and 20% of children in the United States. It is characterized [...]

Multiple sclerosis (MS) is a progressive autoimmune disease that affects nearly 1 million people in the United States. The debilitating disorder is characterized by lesion formation throughout the central nervous [...]

Macrophages, which are cells that engulf or 'eat' other cells, are key players in the body's immune response. But they need some guidance. Checkpoints built into human cells keep macrophages [...]

People with plaque psoriasis have a number of treatment options: topical agents, phototherapy, oral treatments and biologies. And now drugmakers are vying to create even more. In front of the [...]

The article focuses on a study that found no significant increased risk of infection in older adults with inflammatory bowel disease (IBD) taking immunosuppressants. Topics include the evaluation of infection risk associated with advanced therapies like immunomodulators & biologics; methodology of using Medicare data to compare patients on advanced therapies versus nonimmunosuppressive drugs; and there was a slight increase in infection risk, it was not statistically significant.

The article reports on a phase 2 trial demonstrating that tulisokibart, an investigational monoclonal antibody targeting tumor necrosis-like cytokine 1A (TL1A). Topics include the trial's significant findings showing that 26% of patients on tulisokibart achieved clinical remission at week 12 compared to just 1% on placebo, the development of a genetic diagnostic test to identify likely responders to the treatment, and the conclusion that tulisokibart is safer and more effective than placebo.

The article reports on a study that found treatment with Entyvio (vedolizumab) followed by Humira (adalimumab) results in the lowest risk of adverse events for patients with ulcerative colitis (UC). Topics include the comparative analysis of biologic treatment sequences for inflammatory bowel disease (IBD); the evaluation of various first- and second-line biologics; and the study's implications for clinical decision-making in treating patients with moderate to severe IBD.

The article focuses on the mismatch between the visual representation of inflammatory bowel disease (IBD) in media and the actual demographics of the patient population. Topics include the influence of these depictions on public and professional perceptions, the stigma associated with IBD, and the methods used in a recent study to analyze the portrayal of IBD in online images and television commercials.

The article discusses the rising out-of-pocket costs for disease-modifying therapies (DMTs) used to treat multiple sclerosis (MS). A study led by Amanda V. Gusovsky and colleagues compared costs for MS drugs with those for other neurologic conditions, revealing a 217% increase in out-of-pocket costs for MS DMTs from 2012 to 2021. Additionally, the article highlights the issue of upcoding in healthcare, with a RAND study showing a 41% increase in discharges with the highest severity level, potentially leading to increased payments to hospitals. [Extracted from the article]

The article focuses on the expansion of mRNA vaccine technology beyond COVID-19, with companies like Pfizer and Moderna investigating its potential for seasonal influenza, cytomegalovirus (CMV), Zika virus, genital herpes, and HIV, highlighting ongoing clinical trials and the development progress of various mRNA vaccine candidates targeting these infectious diseases.

The article informs the FDA granted approvals to 22 new drugs, including notable newcomers such as Inpefa for heart failure, Miebo for dry eye disease, and Veozah for hot flashes associated with menopause. Additionally, a maternal vaccine for RSV infections in children has shown promising results, and Eli Lilly's Mounjaro, has demonstrated significant weight loss effects in clinical trials and is expected to compete against other weight loss drugs in the market.

The article reports that the drug manufacturer GlaxoSmithKline announced that it had stopped enrollment in three phase clinical trials evaluating the company respiratory syncytial virus maternal vaccine candidate in pregnant women. Topics include considered that Syncytial is pronounced sin-SISH-uhl as the news comes after a February 18, 2022 pause in these trials following a recommendation from the independent data monitoring committee.

The article informs that the U.S. Food & Drug Administration has approved mitapivat (Pyrukynd, Agios Pharmaceuticals) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, which is a lifelong and rare hemolytic anemia.

The article reports on the Fast-Track designation received by Bayer from the U.S. Food and Drug Administration (FDA) for its investigational anticoagulant asundexian (BAY243334). Topics discussed include information on asundexian, how to receive Fast Track designation, and clinical trials that are evaluating proper dosing and safety of asundexian.

The article presents the discussion on FDA approving baclofen oral suspension for the treatment of individuals with spasticity from multiple sclerosis (MS) or individuals with other spinal cord diseases or injuries. Topics include Fleqsuvy allowing for the lowest volume prescribed for patients showing the important consideration for suffering from dysphagi; and Fleqsuvy not indicating in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The article reports that Pfizer and BioNTech plans to extend their rolling submission to the U.S. Food and Drug Administration (FDA) seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age. It mentions in light of the increase in reported COVID-19 cases and hospitalization in children younger during the surge of theomicron variant the FDA has requested for the same.

The article discusses approval of Quviviq tablets by Food & Drug Administration to treat adults with insomnia. Quviviq is a dual orexin receptor antagonist (DORA) that blocks neuropeptides orexin A and orexin B from binding to receptor sites. Insomnia is the most common sleep disorder in adults and approval of Quviviq is based on results of phase three trials.

The article discusses about the newer treatments under development, including chimeric antigen receptor T-cell (CAR-T) therapy and bispecific antibodies for multiple myeloma, a form of cancer. It mentions about the involvement of using the patient's own T cells to attack cancer cells in CAR-T therapy. It further reports on Pfizer's elranatamab as a B-cell maturation antigens (BCMAs) bispecific antibody under investigation for the potential treatment of multiple myeloma.