Biopharmaceuticals

Singapore – September 30, 2026 -- Emerald Clinical Trials has appointed Michael Stibilj as Chief Executive Officer, effective October 1, 2026, tasking the 30-year CRO veteran with leading the next phase of growth for a platform that now spans more than 1,000 professionals across 40-plus countries and 70-plus locations.

Stibilj joins from six years as Chief Operating Officer at Novotech

Before Novotech, Stibilj served three years as CEO of PPC Group and spent 22 years at IQVIA in regional and global leadership roles, with operational experience across China, Singapore and Australia.

Appointment follows the acquisition of Hongyi Clinical Development Services

The deal combined Emerald with Hongyi to create a clinical development platform supporting sponsors from first-in-human trials through post-marketing across China, Asia-Pacific, Europe and the Americas.

Indianapolis – – September 30, 2026 -- Eli Lilly and Company (NYSE: LLY) reported that its oral GLP-1 therapy Foundayo (orforglipron) reduced cardiovascular death risk by 53% and all-cause death risk by 57% compared with insulin glargine in the Phase 3 ACHIEVE-4 trial, the largest and longest study of the medicine in type 2 diabetes to date.

Foundayo meets non-inferiority bar on major cardiovascular events

Among 2,749 participants randomized across 16 countries including the U.S., Germany, India, Brazil and South Korea, Foundayo showed a 16% lower risk of MACE-4 (cardiovascular death, heart attack, stroke or hospitalization for unstable angina) versus insulin glargine, with a hazard ratio of 0.84 (95.0% CI: 0.59 to 1.20), meeting the prespecified non-inferiority threshold. The risk of MACE-3 (cardiovascular death, heart attack or stroke) was 23% lower (hazard ratio: 0.77; 95.0% CI: 0.52 to 1.13).

San Diego – September 30, 2026 -- Halozyme Therapeutics (Nasdaq: HALO) has appointed James "Jim" Daly to its Board of Directors, returning a veteran biopharmaceutical commercial executive to help steer the company's drug-delivery technology expansion.

Daly rejoins board after prior tenure, bringing three decades of launch experience

Daly previously served on Halozyme's board and has held senior commercial leadership roles at Incyte Corporation, Amgen and Glaxo Wellcome/GlaxoSmithKline. He was Executive Vice President and Chief Commercial Officer of Incyte from 2012 to 2015, following a decade at Amgen where he most recently served as Senior Vice President, North America Commercial Operations, Global Marketing and Commercial Development. Earlier, he spent more than 16 years at Glaxo Wellcome/GlaxoSmithKline, including as Senior Vice President and General Manager of the U.S. respiratory business.

Maple Grove, Minn. – September 30, 2026 -- Upsher-Smith Laboratories, LLC has launched Fluvoxamine Maleate Extended-Release Capsules in 100 mg and 150 mg strengths, entering a U.S. market valued at approximately $44.6 million according to IQVIA data covering August 2025 through July 2026.

Upsher-Smith secures AB-rated status against branded Luvox CR

The product carries a Therapeutic Equivalence (TE) code of AB, with Luvox CR designated as the Reference Listed Drug. The AB rating allows the generic to be considered therapeutically equivalent and substitutable for the brand-name extended-release formulation in U.S. pharmacy channels.

Cambridge, Mass. – September 30, 2026 -- Biopharma companies are losing time and money to a recurring pattern of disconnected experiments and manual data reconciliation that Zifo calls the 'DMTA doom loop,' according to a new position paper from the scientific informatics firm.

Zifo identifies a structural flaw in the Design-Make-Test-Analyse process

The paper, titled 'The Billion-Dollar Bottleneck: Why CMC Is Strangling the Biopharma Pipeline,' argues that the DMTA cycle used in chemistry, manufacturing and controls (CMC) work is forced into a rigid, linear execution model rather than adapting to what the science actually requires. Zifo says evidence in many CMC environments is scattered across scientific applications, instruments, spreadsheets, PDFs, batch records and individual expertise, forcing scientists to reconstruct experimental histories and decision reasoning before they can even begin new work.

Conshohocken, Pa. – – September 30, 2026 -- Suvoda has released a unified clinical trial technology platform that merges its RTSM systems with Greenphire's financial management tools, cutting kickoff-to-UAT timelines by up to 80% through new agentic AI capabilities.

Agentic AI Slashes Setup Times Across RTSM and eCOA

Suvoda's new AI layer, starting with randomization and trial supply management (RTSM) and electronic clinical outcome assessment (eCOA), is delivering the 80% reduction in kickoff-to-UAT timelines. A conversational assistant called Sofia allows sponsors and sites to query data and execute permissioned actions across multiple languages, with every action logged for audit purposes while humans retain final sign-off authority.

Secaucus, N.J. – September 30, 2026 -- Pierre Fabre Pharmaceuticals Inc. (PFP) has resubmitted a Biologics License Application to the U.S. Food and Drug Administration for tabelecleucel, seeking approval as a monotherapy for adult and pediatric patients aged 2 and older with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed at least one prior therapy.

Resubmission follows April 2026 FDA alignment meeting

PFP filed the updated application after reaching agreement with the FDA during an April 2026 Type A meeting. The package includes an expanded dataset with additional patients and longer follow-up from the pivotal Phase 3 ALLELE study, which evaluates tabelecleucel in patients with EBV+ PTLD following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).

Indianapolis – September 30, 2026 -- Eli Lilly and Company (NYSE: LLY) said its EBGLYSS (lebrikizumab-lbkz) monotherapy met the primary and secondary endpoints of the Phase 3b ADtouch study at Week 16, with more than half of treated patients achieving clear or almost clear skin on hands and feet (HF-IGA 0/1), the company disclosed ahead of the European Academy of Dermatology and Venereology Congress in Vienna, running Sept. 30-Oct. 3.

Trial enrolled 221 patients with moderate-to-severe hand and foot atopic dermatitis

The randomized, double-blind, placebo-controlled ADtouch trial (NCT06921759) assigned 221 adults and adolescents 1:1 to EBGLYSS 250 mg or placebo every two weeks over 16 weeks, following an initial loading dose. Participants had an inadequate response to topical therapies and applied moisturizer throughout the study.

Barcelona – September 30, 2026 -- Servier is standardizing customer reference data across more than 80 countries using Veeva OpenData, part of a global push to build an AI-ready data foundation for its commercial and medical teams.

Servier scales AI infrastructure after prior success with Veeva Link Key People

The French pharmaceutical company, governed by a Foundation, is harmonizing customer reference data globally to create a unified semantic layer that connects with Veeva Link. Liam Hanrahan, director of world operations excellence at Servier, said the move goes beyond process improvement, calling it the construction of a global data foundation designed to redefine how the company operates and scale AI across its affiliates.

Plainsboro, New Jersey – – September 30, 2026 -- Adults with overweight or obesity who switched from injectable GLP-1 therapies to the oral Wegovy pill lost an average of 4.0 kg (8.8 lb) over three months, according to new real-world data from Novo Nordisk's OCTANE study presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes in Milan on September 30, 2026.

Patients switching to the oral formulation saw rapid weight-loss gains after three months

The retrospective analysis of 194 patients on the Ro telehealth platform found that 40.7% achieved weight loss of 5% or more within three months of switching from injectable semaglutide or tirzepatide to once-daily oral semaglutide (p0.001). The proportion of participants classified with a BMI of 30 kg/m2 or higher fell by 21.6 percentage points, dropping from 87.1% at baseline to 65.5% at the three-month mark.