Steve Duffy

Brightly colored versions of the synthetic opioid fentanyl are appearing across the US, according to the Drug Enforcement Administration.

Ligelizumab is a high-affinity monoclonal anti-immunoglobulin E antibody.

Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.

Rilzabrutinib is an oral Bruton tyrosine kinase inhibitor currently in development for a number of immune-mediated diseases.

To get a better understanding of the situation and how the future months could unfold, MPR sat down with Joshua Barocas, MD, an Assistant Professor of Medicine at the Boston University School of Medicine and Infectious Diseases physician at Boston Medical Center.

Foscarnet sodium injection is indicated to treat cytomegalovirus retinitis in patients with AIDS and acyclovir-resistant mucocutaneous HSV in immunocompromised patients.

The FDA has approved Actemra® (tocilizumab; Genentech) subcutaneous injection for slowing the rate of decline in pulmonary function in SSc-ILD.

The eXciteOSA device is used while the individual is awake and provides electrical muscle stimulation through a mouthpiece that sits around the tongue.

This action was in response to an executive order issued on August 6, 2020 aimed at protecting the public against outbreaks of emerging diseases and chemical, biological, radiological, and nuclear threats.

So far, the therapies scheduled to be part of the trial are risankizumab, an interleukin-23 antagonist, and lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.

The US Department of Health and Human Services and the Department of Defense have agreed to receive 100 million doses of BNT162, a vaccine for SARS-CoV-2, once the manufacturers obtains approval or emergency use authorization (EUA) from the Food and Drug Administration.

Haymarket Medical Network, a part of business media company Haymarket Media, Inc., is proud to join the Ad Council’s first ever Private Marketplace (PMP) along with other partners Cadreon, The Trade Desk and Acxiom.

The FDA has approved the supplemental Biologics License Application (sBLA) for Taltz (ixekizumab: Lilly) injection for the treatment of pediatric patients aged ≥6 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The FDA has approved Advil Dual Action with Acetaminophen, the first OTC fixed-dose combination therapy containing ibuprofen and acetaminophen for the temporary relief of minor aches and pains.

Among systemic treatments for plaque psoriasis, brodalumab, guselkumab, ixekizumab, and risankizumab-rzaa were found to be associated with the highest Psoriasis Area and Severity Index (PASI) response rates.

If a second course of therapy is needed, it is not recommended before a 2-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy.

Desmoglein 3 chimeric autoantibody receptor T cell therapy, is designed to selectively target the cause of mucosal pemphigus vulgaris.

23andMe, a consumer genetics company, has licensed its first drug compound to Almirall, a global pharmaceutical company.

Caroline O. Pardo, Ph.D., General Manager for Haymarket Medical Education, is pleased to announce that HME, based in Paramus, NJ, has been accredited as a provider of interprofessional continuing education by the Accreditation Council for Continuing Medical Education, the Accreditation Council for Pharmacy Education, and the American Nursing Credentialing Center.

The New Drug Application for berotralstat for the prevention of hereditary angioedema attacks has been submitted to the Food and Drug Administration.

Bimekizumab (UCB), an investigational treatment for moderate-to-severe plaque psoriasis, met its two primary end points in a second phase 3 trial.

Aclaris Therapeutics announced positive results from a phase 3 trial investigating a proprietary formulation of hydrogen peroxide (A-101) for the topical treatment of common warts.

Clascoterone is a topical androgen receptor inhibitor.

According to results from the ECLIPSE trial, treatment with guselkumab was found to be superior to secukinumab in adult patients with moderate-to-severe plaque psoriasis based on 90% or better improvement in patients’ Psoriasis Area and Severity Index score compared to baseline (PASI 90 response).

FMX103 is a topical foam formulation of the antibiotic minocycline.

In addition to being manufactured outside of the controls required by current Good Manufacturing Practices, these products are also being marketed for diseases without FDA approval.

Epizyme has submitted a New Drug Application (NDA) for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

Vitamins and supplements sold at CVS Pharmacy will now go through third party testing to verify the accuracy of the dietary ingredients listed on the packaging and to confirm that the product is free of certain additives.

The Food and Drug Administration (FDA) has approved the intravenous (IV) formulation of Benlysta (belimumab; GlaxoSmithKline) for the treatment of pediatric patients ≥5 years old with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.

The FDA has approved Skyrizi (risankizumab-rzaa; AbbVie) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.