Approval for children aged 2 to 11 years with CSU who remain symptomatic despite H1 antihistamine treatment based primarily on data from the LIBERTY-CUPID clinical trial program
CSU is a chronic skin disease that causes itch and hives that can be debilitating for young children, especially for those whose disease remains uncontrolled
CSU marks the fifth disease driven in part by type 2 inflammation for which Dupixent is approved in children younger than 12 years of age
The FDA has hit New Life Pharma with a warning letter after the company refused inspectors access to sections of a GLP-1 manufacturing facility.
FDA inspectors visited the company’s New Jersey facility in February. The inspection revealed New Life manufactured GLP-1 drug products including sterile, multi-dose vials of semaglutide and tirzepatide, the active ingredients in Novo Nordisk’s Ozempic and Wegovy and in Eli Lilly’s Mounjaro and Zepbound, respectively.
During the inspection, New Life denied the FDA access to two areas of the production suite, the agency said. The off-limits sections were labeled “Area Not in Use.” New Life told the inspectors they did not have authority to enter the areas, according to the FDA, and confirmed it was refusing access to those parts of the site. The actions broke the rules against delaying, denying, limiting or refusing an FDA inspection.
The inspectors found current good manufacturing practice (CGMP) compliance failings in the parts of the facility that they could access. For example, New Life manufactured semaglutide and tirzepatide vials without appropriate procedures to prevent microbiological contamination, the FDA said. Citing multiple failures, the agency said the quality control unit did not fulfill its fundamental responsibility to ensure the facility complied with CGMP requirements and that the drug products met appropriate quality standards. Inspectors concluded the company lacked “the fundamental controls necessary to ensure the sterility of your drug products.”
The agency also noted that the semaglutide and tirzepatide multi-dose vials were “misbranded . . . because you did not properly register you firm or list your drugs with FDA.”
The company agreed to stop manufacturing drug products at the facility one week after the inspection concluded, the FDA said. Yet New Life later told the regulator it had only paused production until it completed appropriate media-fill validation studies, according to the warning letter. The FDA interpreted the update as meaning New Life intends to resume production after addressing violations associated with sterility.
“Considering all the drugs you manufactured are not approved by the agency and your systems for manufacturing sterile drugs are wholly lacking, you should not restart drug manufacturing at this facility,” the FDA said. “In response to this letter confirm that you will not manufacture drugs in the future.”
The letter, which the FDA sent on April 14, gives New Life 15 working days to respond in writing. The FDA found the company’s response to its Form 483 inadequate, triggering the warning letter. Problems with the Form 483 response included a lack of adequate evidence of corrective actions to bring operations into compliance with CGMP. New Life voluntarily recalled semaglutide and tirzepatide vials in February.
Fadahossein Maleki said the plan had been formally registered in parliament, while the Supreme National Security Council also wanted to examine it.
Maleki, a member of Iran parliament’s national security and foreign policy committee, also said various proposals had been discussed in the committee and in other parliamentary meetings on Hormuz.
F. Hoffmann-La Roche AG said its group sales reached CHF 14.7 billion in the first quarter of 2026, rising 6% at constant exchange rates (CER) but falling 5% in CHF.
Sales in the pharmaceuticals division came in at CHF 11.5 billion, rising 7% at CER but declining 4% in CHF, driven by demand for key medicines including Xolair, Phesgo, Hemlibra, Vabysmo and Ocrevus. Diagnostics sales stood at CHF 3.3 billion, increasing 3% at CER but falling 7% in CHF, as growth in core lab and pathology solutions offset pricing pressure in China.
"We delivered a strong start to the year, achieving 6% Group sales growth at constant exchange rates," Chief Executive Thomas Schinecker said. "Our pipeline continued to advance in areas where patients face significant unmet need, including multiple sclerosis, obesity and a severe autoimmune disease that can lead to kidney failure," he added, noting the company confirmed its full-year outlook.
https://breakingthenews.net/Article/Roche-Q1-sales-fall-5-to-CHF-14.7B/66130194
Sanofi SA revealed on Thursday that its net sales in the first quarter of the fiscal year 2026 saw an annual rise of 6.2% and 13.6% at the constant exchange rate (CER), to reach €10.5 billion.
The company's net income, calculated according to the International Financial Reporting Standards (IFRS), came in at €1.6 billion, and its IFRS earnings per share (EPS) at €1.34, down 11.8% on a yearly basis. Meanwhile, its business net income rose by 2.4%, or 11.1% at CER, to €2.3 billion, and its business EPS jumped by 5% and14% at CER, to €1.88. In the first quarter, Sanofi's gross profit rose 6.1% and 14.4% at CER, to €8.2 billion.
"We had a strong start to 2026 with double-digit sales and business EPS growth. Sales increased by 13.6%, supported by Pharma launches and recent acquisitions ... We obtained five regulatory approvals, all in immunology, achieved one positive phase 3 study readout for venglustat in rare diseases, and reported encouraging phase 2 data for lunsekimig in respiratory diseases," Interim CEO Olivier Charmeil said.
https://breakingthenews.net/Article/Sanofi's-Q1-net-sales-up-by-6.2-to-euro10.5-billion/66130413
Mobia Medical, which sells a nerve stimulation device for chronic ischemic stroke, filed on Friday with the SEC to raise up to $100 million in an initial public offering.
Mobia's Vivistim Paired Vagus Nerve Stimulation System is the first and only clinically-validated, FDA-approved solution for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. The system includes an implanted pulse generator and lead that deliver stimulation during functional movement in order to increase neuroplasticity and durably restore motor function. Management estimates that there are over four million chronic ischemic stroke survivors, of which one million have the health, cognition, and motivation to participate in post-stroke therapy, representing a $30 billion opportunity based on the system's price.
The Austin, TX-based company was founded in 2007 and booked $32 million in revenue for the 12 months ended December 31, 2025. It plans to list under the symbol MOBI. Mobia Medical filed confidentially on January 21, 2026. BofA Securities, J.P. Morgan, and Goldman Sachs are the joint bookrunners on the deal. No pricing terms were disclosed.
GMR Solutions, which is leading provider of emergency medical services and alternate-site care in the US, filed on Friday with the SEC to raise up to what we estimate could be $1.0 billion in an initial public offering.
Formed in 2018 through the merger of Air Medical Group Holdings and American Medical Response, GMR Solutions is a provider of emergency medical services and out-of-hospital care in the United States and internationally. The company delivers on-site clinical care through trained medical teams and coordinates patient transport via air and ground ambulance when higher levels of care are required, or directs non-emergent patients to lower-acuity settings. Its operations span a broad network of urban and rural communities, functioning as an entry point into the healthcare system and supporting care delivery across a range of emergency and non-emergency situations.
The Lewisville, TX-based company was founded in 2018 and booked $5.7 billion in revenue for the 12 months ended December 31, 2025. It plans to list on the NYSE under the symbol GMRS. GMR Solutions filed confidentially on October 28, 2025. J.P. Morgan, KKR, BofA Securities, Barclays, Goldman Sachs, Citi, Evercore ISI, Morgan Stanley, and UBS Investment Bank are the joint bookrunners on the deal.
