Novartis AG

RemeGen on Wednesday said its dual-target fusion protein telitacicept crossed the finish line in a late-stage study in primary Sjögren's syndrome, with the company aiming to submit a regulatory filing "promptly" with China’s National Medical Products Administration (NMPA).The Phase III trial randomised 381 Chinese patients with active primary Sjögren’s syndrome to receive weekly subcutaneous telitacicept at doses of 80 mg or 160 mg, or placebo, for 48 weeks. The primary endpoint measured the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at 24 weeks.Top-line results showed that telitacicept met the study’s main goal, demonstrating significant and sustained symptom improvement compared with placebo, alongside a favourable safety profile. Detailed findings will be presented at forthcoming medical conferences.Telitacicept — designed to selectively inhibit the two cytokines BlyS (also known as BAFF) and APRIL — holds approvals in China under the brand name Tai'ai to treat systemic lupus erythematosus (SLE), rheumatoid arthritis and generalised myasthenia gravis (gMG). In a late-stage gMG study in China reported earlier this year, telitacicept achieved a 4.8-point improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale over placebo at 24 weeks, meeting the trial’s primary endpoint. Additionally, it is being explored in IgA nephropathy.In June, cash-strapped Vor Bio secured ex-China rights to telitacicept in a deal potentially worth over $4 billion. A global late-stage trial of the drug in a broader gMG population is also under way, with preliminary results anticipated in the first half of 2027.Meanwhile, this week also saw yet another favourable Sjögren's readout, with Novartis' monoclonal antibody ianalumab (VAY736) succeeding in two pivotal studies.

AbbVie employs more than 6,000 people across its U.S. manufacturing operation. The company's latest investment project in Illinois will grow its U.S. production footprint. As pharma companies big and small play up their U.S. investment plans during the second Trump administration, the particulars of one project at AbbVie are coming into focus.Tuesday, the Illinois pharma giant revealed plans to spend $195 million to expand its manufacturing presence in North Chicago. Specifically, the company plans to begin construction on a facility to produce active pharmaceutical ingredients in the fall and have the site be fully operational in 2027.The plant, which is part of the company's $10 billion plan to invest in the U.S., will help the drugmaker produce current and next-gen therapies in neuroscience, immunology and oncology, AbbVie said in an Aug. 12 release.AbbVie already employs more than 6,000 people at 11 manufacturing sites in the U.S., and the new expansion is expected to add to that total by an undisclosed amount. In Illinois, the company employs more than 11,000 people across all job functions.Several months ago, AbbVie executives laid out their plan to spend $10 billion on U.S. capital investments by 2035. While AbbVie didn't lay out all of the specifics at the time, the company did reveal its intention to build four new U.S. production sites as part of the investment campaign."Over the next decade, AbbVie will expand production of API, drug product, peptides and medical devices in the U.S. to support future medical breakthroughs," AbbVie CEO Robert Michael said in a statement Tuesday. "This is an important step to maintain U.S. leadership in pharmaceutical innovation and deliver next-generation medicines that make a remarkable impact on patients' lives." AbbVie's project comes as drugmakers of all sizes race to shore up their domestic production operations. Besides AbbVie's $10 billion commitment, other large pharmas such as Johnson & Johnson, Eli Lilly, Novartis, Roche and AstraZeneca have each pledged to spend tens of billions to grow their U.S. footprints in the coming years.The pledges have rolled in as President Donald Trump and members of his administration have repeatedly threatened to impose tariffs on pharmaceuticals imported into the U.S. Most recently, Trump said in early August that pharma tariffs would be announced "within a week or so," with the rates starting small but eventually reaching 250%.

AbbVie is expanding its US manufacturing footprint with a new active pharmaceutical ingredient plant in the works. The company said Tuesday that the $195 million project will expand its North Chicago manufacturing outpost and is part of the more than $10 billion in planned US investments it committed to over the next decade. Construction on the API facility will begin later this year, with the site expected to be fully operational by 2027. The facility will be an added boost for drug manufacturing in Illinois, where AbbVie is headquartered and has more than 11,000 employees. AbbVie CEO Rob Michael described the decision as “an important step to maintain U.S. leadership in pharmaceutical innovation.” AbbVie first announced its broader $10 billion investment plans in late April, to help stave off the impact of potential tariffs on the industry and to satisfy the Trump administration’s push for more US investments. Michael was included in an event at the White House at the end of that month, celebrating those investments across industries. Chief executives from Genentech, Johnson & Johnson, Eli Lilly, Merck and Novartis were also in attendance. President Donald Trump has since increased pressure on drugmakers to move their manufacturing to the US, and industry-specific tariffs are expected to be unveiled soon. He’s floated a potential grace period but said that drugmakers could be eventually hit with tariffs as high as 250%. But for drugs and ingredients coming from Europe, the tariff rate won’t eclipse 15%, according to a trade agreement between the US and EU announced last month. The sector-specific tariff rate on pharma imports, which will follow the conclusion of the Commerce Department’s Section 232 investigation, won’t stack on the 15% EU tariff rate under that deal.