Wednesday, August 2, 2023
Octapharma announced that Balfaxar® received FDA approval for the urgent reversal of acquired coagulation factor deficiency induced by a vitamin K antagonist such as warfarin therapy in adult patients with need for urgent surgery or invasive procedures. Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy. More than 2.4 million US patients are prescribed warfarin to prevent blood clots from forming following a heart attack, heart valve surgery, stroke, deep vein thrombosis/pulmonary embolism, or for certain types of irregular heartbeat (atrial fibrillation). The main side effect of warfarin is an increased risk of bleeding particularly for patients undergoing urgent surgery or invasive procedures.
The FDA approved Ycanth for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. Ycanth is the first FDA-approved treatment for molluscum. Ycanth is administered to patients only by health care providers. Providers apply a single application of Ycanth on the areas of patients’ skin with molluscum bumps every 3 weeks as needed.
Molluscum contagiosum is a viral skin infection that can cause white, pink, or flesh-colored bumps that may itch or become irritated. Molluscum is transmitted by skin-to-skin contact and can affect anyone at any age, though it’s most common among children under 10.
Amneal Pharmaceuticals submitted Abbreviated New Drug Applications to the FDA for three key complex generic products, including: an Injectable propofol emulsion, the generic version of Diprivan®, which is an IV general anesthetic and sedation drug. Bimatoprost ophthalmic solution, is the generic version of Lumigan®, and is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Albuterol sulfate inhalation is the generic version of Proair® HFA, and is indicated for the treatment or prevention of bronchospasm related to exercise-induced or reversible obstructive airway disease.
EVERSANA announced a partnership with Amazon Web Services (AWS) to accelerate generative artificial intelligence (AI) use cases across the life sciences industry. Together, the organizations will seek to harness the power of generative AI to help pharmaceutical and life science manufacturers drive efficiencies and business value while improving patient outcomes. To meet the industry’s unique needs, EVERSANA and AWS will identify, develop and deploy high-impact solutions across the pharmaceutical commercialization value chain. EVERSANA will leverage its digital and AI innovation capabilities coupled with Amazon Bedrock — AWS’s fully managed service for building and scaling generative AI applications that make a selection of industry-leading foundation models (FMs) accessible via a simple API — to apply best-of-breed FMs as the companies work to solve customer challenges.
Curia made an agreement to provide the company and its clients a means of access to Touchlight’s doggybone DNA (dbDNA). The arrangement expands Curia’s mRNA manufacturing offerings with an additional differentiated source of DNA raw material that is immediately available to be accessed by Curia customers. Under the arrangement, Touchlight will directly manufacture dbDNA on behalf of Curia’s customers. Touchlight’s dbDNA is a linear, double-stranded, covalently-closed DNA vector. Touchlight’s enzymatic DNA is produced with a cell-free enzymatic process that offers benefits in speed, quality and capacity when compared to traditional plasmid DNA production.