Johnson & Johnson has reached a voluntary agreement with the U.S. government to improve access to medicines and lower costs for Americans, including discounts and tariff exemptions, while also investing $55 billion in U.S. manufacturing and research, with new facilities announced in North Carolina and Pennsylvania.
The Committee for Medicinal Products for Human Use (CHMP) recommended three new medicines for approval, including Exblifep for urinary tract infections, Ryzneuta for neutropenia, and Niapelf for schizophrenia, while refusing marketing authorizations for Nezglyal and Syfovre. The committee also recommended extensions of therapeutic indication for four medicines and confirmed its original recommendation to not renew the conditional marketing authorization for Translarna. Additionally, the CHMP endorsed measures to minimize risks for medicines containing pseudoephedrine and will re-examine its opinion on generic medicines following a request.
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of seven new medicines, including Casgevy, the first medicine using CRISPR/Cas9 gene-editing technology, for the treatment of transfusion dependent beta-thalassemia and severe sickle cell disease. Other recommended medicines include Skyclarys for Friedreich's ataxia, Velsipity for ulcerative colitis, and four generic medicines. The CHMP also confirmed the non-renewal of a conditional marketing authorization for Blenrep. Additionally, extensions of therapeutic indications were recommended for four medicines, and positive opinions were adopted for two medicines intended for use outside the EU. The CHMP has also recommended the suspension of marketing authorizations for certain generic medicines tested by Synapse Labs Pvt. Ltd due to irregularities in study data.
Researchers are developing inhalable therapies to target a wider range of diseases, including cancer and diabetes, by delivering medicines directly to the lungs, which can make drugs more efficient and effective than oral or injectable drugs. The lungs are a first line of defense against infection and provide a direct pathway to the circulatory system, making them an ideal target for inhalable therapies.