Weekly international regulatory approvals, licensing collaborations, mergers & acquisitions, clinical developments, and financial performance of top global pharmaceutical companies — September 28 to October 4, 2026

• Eli Lilly: On October 2, Eli Lilly announced that the U.S. FDA has approved Jaypirca (pirtobrutinib, 100 mg and 50 mg tablets), a non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, for an expanded indication to treat adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without known 17p deletion. This approval enables Jaypirca to be used as a first-line therapy for eligible patients. The Jaypirca label includes warnings and precautions regarding infections, bleeding, cytopenias, cardiac arrhythmias, second primary malignancies, hepatotoxicity (including drug-induced liver injury), and embryo-fetal toxicity. The approval was based on preliminary results from the BRUIN CLL-313 clinical trial, presented at the American Society of Hematology Annual Meeting and Exposition and published in the Journal of Clinical Oncology. With a median follow-up of 28 months, progression-free survival (PFS)—the primary endpoint—was significantly superior in the trial group (n=141) versus the bendamustine plus rituximab control group (n=141) (hazard ratio = 0.20); median PFS was not reached in the trial group, compared with 33.5 months in the control group. Overall response rate (ORR) was 94% in the trial group (13% complete response [CR], 81% partial response [PR]) versus 81% in the control group (21% CR, 60% PR). Serious adverse reactions occurring in ≥3% of patients included pneumonia (5%). • Novo Nordisk: On October 3, Novo Nordisk announced that the U.S. FDA informed the company that the Biologics License Application (BLA) for denecimig—intended for adults and children with hemophilia A (with or without inhibitors)—remains under review. Novo Nordisk submitted the BLA to the U.S. FDA in September 2025, with an original anticipated approval decision in Q3 2026. Following submission, the FDA conducted a pre-approval inspection of the manufacturing site and issued feedback. The FDA notified Novo Nordisk that ongoing remediation efforts at the manufacturing site are the reason for the extended review timeline. Novo Nordisk is actively implementing corrective actions per FDA feedback and closely collaborating with regulators to resolve remaining items. Denecimig is an FVIIIa-mimetic bispecific antibody designed to provide prophylactic treatment for bleeding episodes in patients with hemophilia A (with or without inhibitors), administered subcutaneously once monthly, once every two weeks, or weekly. It functions by bridging factor IXa and factor X, thereby mimicking activated coagulation factor VIII (FVIIIa) and restoring thrombin generation to support blood clotting. • Abbott: On September 30, Abbott announced the U.S. commercial launch of its SimpleScreen CRC test for colorectal cancer (CRC) screening. Approved by the U.S. FDA, this blood-based CRC screening tool is indicated for adults aged 45 years and older at average risk for the disease.

A $7.3-billion bet! Is GSK making a comeback?

On July 28, 2026, GSK released its second-quarter financial results—exceeding expectations: global sales totaled £8.4 billion, up 5% year-on-year; core operating profit rose 7%. Immediately following the announcement, GSK’s pre-market share price surged 3.35%. Yet what truly ‘moved’ investors may not have been this backward-looking report—but rather the three-year ‘Accelerate Growth’ plan unveiled alongside it. According to the plan, GSK will save £1.9 billion annually over the next three years, with the majority of these savings redirected into its R&D pipeline. As a result, GSK has doubled the number of Phase III trials slated to begin in 2026—from the originally planned 10 to over 20. While aggressively cutting costs on one front, GSK is simultaneously reinvesting heavily in R&D. Facing the looming dolutegravir patent cliff, GSK is preparing for a ‘do-or-die’ effort to seize the final window of opportunity and sustain its upward financial trajectory. 01 Oncology business makes a strong comeback—strategic reallocation of R&D assets amid the patent cliff. Per GSK’s Q2 2026 financial report, global sales reached £8.4 billion, up 5% year-on-year; core operating profit increased 7%. Breaking down the 5% overall growth: Specialty Medicines sales amounted to £3.8 billion (+14%); Vaccines sales were £2.3 billion (+8%); and General Medicines sales stood at £2.3 billion (−9%). Overall, legacy products and traditional businesses continue to decline, while Specialty Medicines are emerging as the true engine of growth. Within Specialty Medicines, oncology delivered 17% growth—maintaining double-digit momentum after a remarkable 43% surge across all of 2025. By contrast, the flagship HIV business generated £2.1 billion in Q2 sales, yet both full-year 2025 and Q2 2026 showed flat 10% growth—indicating the HIV franchise has entered a plateau phase. Meanwhile, the oncology business—strategically deprioritized a decade ago—is now staging a robust resurgence. Although both oncology and the Respiratory, Immunology & Inflammation (RI&I) portfolios performed well, they remain insufficient to offset the precipitous revenue loss expected upon dolutegravir’s patent expiration between 2028 and 2030. The ‘moment of truth’ is approaching—and GSK lacks a globally blockbuster successor to dolutegravir. With the time window narrowing, GSK has opted for a comprehensive internal asset reallocation via its ‘Accelerate Growth’ plan. Under the plan, GSK will cut £1.9 billion in annual costs over three years—primarily by streamlining support services and procurement, reducing resource allocation to mature generic medicines, and simplifying its supply chain—while investing £400 million to build a new R&D center at the Cambridge Biomedical Campus. Most of these cost savings will accelerate late-stage pipeline development, covering 7 core assets, 18 indications, and 25 Phase III studies. Consequently, GSK has raised its guidance for Phase III trials launching in 2026—from 10 to over 20.

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