Tag: information

Responder rate of 57% at one year in open-label extension (OLE) comparable to 63% at 12 weeks in Phase 2 Avail™ trial

FREMONT, Calif., June 12, 2026 (GLOBE NEWSWIRE) -- Dmitry Shubov Consulting, an advisory firm helping Southeast Asian startups scale into the U.S., is telling founders to watch out for what it calls the 2026 U.S. “pilot trap.” The warning stems from a recent LegalBooks article, “How to Structure Enterprise Pilots That Show Traction,” which highlighted why clear success metrics and a direct path to full adoption are so vital. Looking at this issue through a cross-border lens, Dmitry Shubov Consulting notes that many Southeast Asian startups can misread early U.S. pilot projects, software trials, or enterprise testing as a sign of market readiness. The trouble is, they are rarely prepared for the complex pricing, contracting, procurement, and rollout demands needed to turn that initial interest into a lasting commercial deal.

For many founders, getting a U.S. company to test a product feels like a major breakthrough. And in some ways, it is. But Dmitry Shubov Consulting says a pilot only matters if the company knows how to carry that momentum forward once the trial period ends.

“Too many founders see a pilot in the U.S. as proof that they’ve already gained real traction, when often it only shows that a company is willing to test something new,” said Dmitry Shubov, founder of Dmitry Shubov Consulting. “If there’s no clear plan for pricing, internal ownership, decision-makers, and what happens after the pilot ends, that momentum can fade very quickly.”

The firm says this is where many promising expansion efforts begin to lose steam. Startups may focus heavily on product performance during a pilot but spend too little time thinking through what comes next — who owns the budget, how success will be measured, what legal review may be required, and what would need to happen for the customer to move from a short-term test to a paid relationship.

Rather than treating a pilot as a simple sign that the product works, Dmitry Shubov Consulting says founders should look at it as the beginning of a much bigger business process. That means being clear on what success looks like, who inside the customer’s organization is actually making the decision, what issues might come up during legal or procurement review, and what needs to happen for the relationship to continue after the pilot wraps up. With funding still tight in 2026, the firm says startups cannot rely on early interest alone — they need to show they can follow through.

By raising this pressing issue now, Dmitry Shubov Consulting hopes to encourage founders to look at pilot activity more carefully and more strategically. Early U.S. interest can be valuable, but only if a startup is prepared to turn that opening into something lasting. Reach out to Dmitry Shubov Consulting for more information.

FORM 8.5 (EPT/RI)

AMSTERDAM, June 12, 2026 (GLOBE NEWSWIRE) -- For more than a century, HEINZ and Heineken^® have played a role in bringing people together… around tables, in front of screens, at events, and beyond. Now the two iconic brands have officially come together to celebrate a connection of their own — giving everyone the match we’ve all been waiting for.

Basel, June 12, 2026 – Novartis today presented data from the RemIND trial at the European Academy of Allergy and Clinical Immunology (EAACI) Congress showing that Rhapsido^®  (remibrutinib) met its primary endpoints across the three most common chronic inducible urticaria (CIndU) subtypes, becoming the first-ever treatment to demonstrate efficacy in a global Phase III CIndU clinical trial⁷. In the RemIND trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. These results demonstrate that Rhapsido may provide sustained relief for patients whose disease remains inadequately controlled after treatment with second-generation H1-antihistamines⁷.

“Chronic inducible urticaria (CIndU) is a form of chronic hives in which everyday triggers—such as pressure, heat, cold, or sunlight—can lead to itchy wheals, and there are currently no approved targeted treatment options,” said Prof. Dr. med. Martin Metz, Deputy Director, Institute of Allergology, Charité–Universitätsmedizin Berlin, Germany. “The RemIND results across the three most common CIndU subtypes highlight the potential of Rhapsido as an important new treatment option for patients with significant unmet need.”

The three most prevalent CIndU subtypes are symptomatic dermographism (SD), cold urticaria, and cholinergic urticaria, with SD being the most common⁸. Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Rhapsido for the treatment of SD subtype and will continue additional filings to health authorities globally throughout 2026. Rhapsido is approved for use in the U.S., European Union, China and several other countries for the treatment of chronic spontaneous urticaria (CSU), in adult patients with inadequate response to H1-antihistamines.

“Rhapsido significantly improves symptom control for patients living with the three most common subtypes of chronic inducible urticaria, and it has the potential to become the first approved targeted therapy. This is a major step forward for CIndU patients who have limited options,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “The CIndU data presented today are consistent with Rhapsido’s proven efficacy and favorable safety profile in chronic spontaneous urticaria and demonstrate Novartis’ commitment to developing truly meaningful innovation for patients with complex immune-mediated diseases.”

Primary endpoint results at Week 12 in the RemIND trial¹