Home Ghana Reports First Marburg Virus Outbreak; FDA Approves First-Ever Vitiligo Therapy

Ghana Reports First Marburg Virus Outbreak; FDA Approves First-Ever Vitiligo Therapy

Jul 20, 2022 10:34 CST Updated 16:04
Novartis

Drug Development and Manufacturing

IntroductionGhana detects deadly Marburg virus for the first time; FDA approves first vitiligo therapy; Gene-editing technology shows promise in preventing and treating heart disease… BioExploration keeps you updated on “pharma” news and explores the value of biotechnology with you!

01 Ghana Detects Deadly Marburg Virus for the First Time

According to a report by the Associated Press on July 18, after Ghana reported two cases of Marburg virus infection on the 17th, the WHO announced the first outbreak of the Marburg virus disease in Ghana. The WHO stated that this disease belongs to the same family as the Ebola virus and is a highly contagious hemorrhagic fever transmitted from fruit bats to humans and spreads among people through infected bodily fluids. The Marburg virus may be an extremely harmful and fatal virus, with previous fatality rates ranging from 24% to 88%. This is the second time the virus has been detected in West Africa. Previously, the Marburg virus had also appeared in Guinea, Angola, Congo, Kenya, South Africa, and other places.

02 FDA Approves First Vitiligo Therapy

On July 19, Incyte announced that the FDA had approved Ruxolitinib Cream 1.5% for the topical treatment of non-segmental vitiligo in adult and pediatric patients aged 12 years and older. This is the first FDA-approved therapy for vitiligo and the first and only approved topical JAK inhibitor. Vitiligo is a chronic autoimmune disease characterized by the loss of skin pigmentation. Overactivation of the JAK signaling pathway induces inflammatory responses during the pathological process of vitiligo. Ruxolitinib, a first-in-class JAK1/JAK2 inhibitor developed by Incyte, treats vitiligo by inhibiting the JAK signaling pathway.

03 Gene Editing Technology Shows Promise in Preventing and Treating Heart Disease

Xinhua News Agency, Beijing, July 18th: According to a recent report on the MIT Technology Review website in the United States, a patient with familial hypercholesterolemia underwent a gene-editing clinical trial in New Zealand in hopes of lowering blood cholesterol levels to prevent and treat heart disease. This clinical trial represents a new exploration in utilizing gene-editing technology for heart disease prevention and treatment. Previous animal studies have shown that this therapy can reduce low-density lipoprotein levels in monkeys by 60%, with effects lasting over a year and likely being permanent.

Patient Accepts Trial for Congenital High Cholesterol and Existing Heart Disease. Researchers from a U.S. biotech company replaced a single base in the PCSK9 gene of the patient’s liver cells, a gene that helps regulate low-density lipoprotein (LDL) cholesterol levels. The researchers anticipate this will permanently lower the volunteer's "bad" cholesterol levels. The study plans to provide gene-editing therapy to a total of 40 patients with familial hypercholesterolemia.

04 AstraZeneca/Daiichi Sankyo ADC New Indication Approved in the EU

On July 19, AstraZeneca and Daiichi Sankyo announced that their jointly developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has been approved for a new indication in the European Union, as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 based regimens. Clinical data showed that Enhertu reduced the risk of disease progression or death by 72% in these patients.

Enhertu is an ADC therapy targeting HER2. It is designed using Daiichi Sankyo's proprietary DXdADC technology platform and consists of a humanized monoclonal antibody targeting HER2 connected to a topoisomerase 1 inhibitor payload via a cleavable tetrapeptide linker. In May this year, the drug received FDA approval in the United States for second-line treatment of breast cancer.

05 Novartis Reports 2022 H1 Revenue of $25.3 Billion, Flat Compared to Last Year

On July 19, Novartis announced its 2022 H1 performance, being the first multinational pharmaceutical company to announce its 2022 half-year results. Novartis' net sales revenue in the first half of the year reached 25.312 billion US dollars, which was basically the same as the previous year. The net profit was 3.914 billion US dollars, a year-on-year decrease of 21%. Novartis focuses on the pharmaceutical field, mainly concentrating on five core therapeutic areas: hematology, solid tumors, immunology, neuroscience, and cardiovascular. Its current business is divided into two main lines: innovative drugs and generic drugs.

The net sales of brand innovative drugs amounted to $20.6 billion, primarily driven by the robust growth of products such as Entresto (Sacubitril/Valsartan), Kesimpta (Ofatumumab), Cosentyx (Secukinumab), Kisqali (Ribociclib), and Zolgensma. The net sales of generic drugs business handled by Sandoz in the first half of the year reached $4.7 billion (-1%).

Compiled by | Luna
Typesetting | Wen Jingze