Welcome to The Pharma Flash, a weekly countdown of the top 5 news articles on American Pharmaceutical Review and Pharmaceutical Outsourcing's websites.
5. The FDA approved QULIPTA for the preventive treatment of migraine in adults. QULIPTA is an oral calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for migraine prevention. The approval is based on the results of two Phase 3 clinical trials in which QULIPTA demonstrated a significant reduction in the number of migraine days per month compared to placebo. The approval provides a new treatment option for the approximately 30 million Americans who suffer from migraines.
https://www.americanpharmaceuticalreview.com/1315-News/596244-FDA-Approves-QULIPTA-for-Adults-with-Chronic-Migraine/
4. Amgen won its patent appeal against Sanofi and other companies over its psoriasis drug Otezla The US Court of Appeals for the Federal Circuit upheld a previous ruling by the Patent Trial and Appeal Board that Amgen's patent on a method of using the drug was valid. The ruling allows Amgen to exclusively market Otezla in the US until 2028. Otezla was acquired by Amgen in 2019 as part of its acquisition of Celgene.
https://www.americanpharmaceuticalreview.com/1315-News/596294-Amgen-Wins-Otezla-Patent-Appeal/
3. Dr. Reddy's Labs launched Treprostinil Injection, a generic version of Remodulin Injection, in the US market. Treprostinil is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients to improve exercise capacity. The launch follows the approval of the abbreviated new drug application (ANDA) by the FDA. The product is available in single-dose vials containing 20 mg/mL of treprostinil.
https://www.americanpharmaceuticalreview.com/1315-News/596335-Dr-Reddy-s-Labs-Launches-Treprostinil-Injection-in-US/
2. Eli Lilly announced a $1.6 billion investment in its Indianapolis manufacturing facilities. The investment will be used to expand and modernize the facilities, adding capabilities for both small molecule and biologic API production. The expansion is expected to create approximately 2,300 jobs in Indiana. The investment is part of Lilly's efforts to increase capacity and prepare for the manufacturing of potential future medicines.
https://www.americanpharmaceuticalreview.com/1315-News/596246-Lilly-to-Invest-1-6B-in-Indiana-Manufacturing-Facilities/
1. The FDA has authorized changes to the instructions for administering bivalent mRNA COVID-19 vaccines. The changes include allowing the dilution of thawed Pfizer-BioNTech vaccine vials prior to use and enabling the transfer of thawed vaccine into syringes for administration. The FDA also authorized the use of undiluted thawed Pfizer-BioNTech vaccine stored in vials as a single dose. These changes aim to make it easier to administer the vaccines and reduce the risk of administration errors.
https://www.americanpharmaceuticalreview.com/1315-News/596247-FDA-Authorizes-Changes-to-Simplify-Use-of-Bivalent-mRNA-COVID-19-Vaccines/