Novo Nordisk to reduce US list prices of insulin products
Credit: Shutterstock/Emils Opics
Novo Nordisk announced plans to reduce the US wholesale acquisition cost (WAC), also known as the list price, of several pre-filled insulin pens and vials by up to 75% for people living with type 1 and type 2 diabetes.
Set to come into effect from 1 January 2024, these changes will be applicable for products including pre-filled pens and vials of basal (long-acting), bolus (short-acting) and pre-mix insulins, Levemir, Novolin, NovoLog and NovoLog Mix 70/30 in specific. The company will reduce the list price of four legacy insulin brands, including NovoLog and NovoLog Mix 70/30 by 75%, and Novolin and Levemir by 65% off the current list price.
Additionally, the list price of unbranded biologics (pre-filled pens and vials and pre-mix insulins) is being reduced to match the lowered price of each respective branded insulin (Insulin Aspart and Insulin Aspart Protamine/Insulin Aspart). Working with a diverse group of stakeholders, Novo Nordisk said it will understand the emerging needs of patients.
Merck reports rise in group net sales in fiscal 2022
Merck reported an increase in group net sales by 12.9% to €22.23bn in fiscal 2022 against €19.68bn in 2021. The growth in sales was driven by all regions and business sectors, particularly Life Science. Organically, the company generated an increase of 6.4% in group sales in fiscal 2022.
Favourable foreign exchange effects of 6.1% resulted primarily from the development of the US dollar and the Chinese renminbi. Additionally, due to the Exelead acquisition, a biopharmaceutical contract development and manufacturing company, sales increased by 0.4%.
For fiscal 2022, Merck’s EBITDA increased by 9.4% to €6.50bn compared to €5.94bn in the prior year. The company reported an organic sales increase of 8.2% to €10.38bn in its Life Science business during the year. The EBITDA pre of Life Science grew by 14.4% to €3.76bn, reflecting a 9.7% organic rise.
Merck presented strong data in Healthcare from its 2022 pipeline about Phase II trials for xevinapant (head and neck cancer) and evobrutinib (multiple sclerosis).
US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia
The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients.
SKYCLARYS is indicated to treat the ultra-rare, inherited neurodegenerative disorder in 16 years and above-aged adults and adolescents in the US. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease. There are three more drug candidates with major trial readouts that are expected in 2023. The FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations for the medication.
The European Medicines Agency (EMA) is also reviewing Reata’s marketing authorisation application (MAA) for SKYCLARYS in Europe. It also received Orphan Drug designation from the European Commission for treating the disorder.
The FDA approved SKYCLARYS based on the safety and efficacy data obtained from the MOXIe Part 2 randomised, double-blind, placebo-controlled trial and a post hoc Propensity-Matched Analysis of the open-label MOXIe Extension trial.
Sandoz plans new biologics production plant construction in Slovenia
Sandoz, a division of Novartis, has signed a Memorandum of Understanding (MoU) for constructing a new biologics production plant in Lendava, Slovenia, to support the growing demand for biosimilar medicines worldwide.
The company intends to invest at least $400m in the new plant, supporting its aim to drive the future growth of its worldwide biosimilars portfolio. It represents one of the largest-ever global private-sector investments in the country and strengthens the company’s Europe-wide production network.
Work on the new biologics production plant is expected to commence this year, and complete operations are scheduled to begin in late 2026. Recently, the company unveiled a $52.8m (€50m) additional investment for expanding its antibiotics production network in Europe. This brings Sandoz’s total new investment commitment made for the network to $264.1m (€250m).
Work on the new biologics production plant is expected to commence this year, and complete operations are scheduled to begin in late 2026.
Caris signs research partnership with Incyte for oncology pipeline
Molecular science and technology firm Caris Life Sciences and Incyte have entered a strategic research collaboration to advance the latter’s oncology pipeline.
Caris’s platform combines data obtained from protein analysis, whole exome sequencing, artificial intelligence (AI) models and signatures, and whole transcriptome sequencing for improving patient outcomes through personalised medicine advancement.
The collaboration will use data and analytics tools, clinical trial enrolment programme capabilities, and Caris’s comprehensive molecular tissue and liquid profiling services for two oncology therapeutic programmes.
Incyte will have the option to expand to a total of four programmes. Under the deal, Incyte will use the data insights and analytics capabilities of Caris for the discovery of new biomarkers and to optimise clinical positioning strategies for its programmes related to oncology.
The company will also use the biomarker-driven patient selection of Caris for clinical trials. Caris stated that the deal also includes options to collaborate on companion diagnostics development.