Pharmaceuticals & Biopharmaceuticals

Paramus, N.J. – October 01, 2026 -- NS Pharma, Inc. reported 5-year efficacy and safety data showing its investigational therapy brogidirsen maintained or improved motor function in Duchenne muscular dystrophy (DMD) patients amenable to exon 44 skipping, with zero treatment discontinuations across the study period.

Six-participant trial records no serious adverse events over five years

The data, presented by Japan's National Center of Neurology and Psychiatry (NCNP) at the 31st annual International Congress of the World Muscle Society in Hiroshima, Japan, covered an open-label extension of an investigator-initiated clinical trial. All six participants received weekly intravenous dosing of brogidirsen (NS-089/NCNP-02), an antisense oligonucleotide co-discovered by Nippon Shinyaku and NCNP. After five years of administration, no serious or severe adverse events, anaphylaxis, or discontinuations tied to long-term dosing were recorded.

Dallas – October 01, 2026 -- Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has accepted and granted priority review to Nanoscope Therapeutics' New Drug Application for MOGENRY (sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy for inherited retinal dystrophies (IRDs). If approved by the Ministry of Health, Labour and Welfare, MOGENRY would become the first disease-agnostic treatment available to IRD patients in Japan, a condition caused by mutations across more than 250 genes that leads to progressive photoreceptor loss and blindness.

Dublin – – October 01, 2026 -- Ensera, a global CDMO specializing in commercialization support for injectable drug programs, has launched the Ensera Alliance Network, uniting device platform and fill-finish specialists to streamline the commercialization of drug-device combination products.

Five specialist firms join the new coordination network

The network currently comprises injector platform providers SHL Medical, Stevanato Group and Ypsomed, alongside fill-finish specialists Argonaut Manufacturing Services and American Injectables. Ensera said it plans to expand the network over time by adding organizations whose capabilities and standards complement existing members.

Valby, Denmark – October 01, 2026 -- H. Lundbeck A/S reported that 60% of participants in its Phase IV THRIVE trial achieved 'much improved' or 'very much improved' status on a standardized patient scale after switching to eptinezumab, marketed as VYEPTI, following an inadequate response to a prior CGRP-targeting preventive migraine therapy.

Trial enrolled 164 adults who had failed one prior CGRP preventive treatment

The 24-week, open-label, multicenter trial (NCT06701526) was conducted in the United States and enrolled 164 adults with at least eight monthly migraine days who had previously used either a subcutaneous anti-CGRP monoclonal antibody or a preventive gepant, but had not received eptinezumab. Participants started on 100 mg of eptinezumab, escalating to 300 mg at week 12, with 147 receiving both infusions; 84% (138/164) completed the trial.

Madrid – October 01, 2026 -- Fresenius SE & Co. KGaA has completed the acquisition of the remaining 45% stake in mAbxience from Insud Pharma, giving the German healthcare group full ownership of the Spanish biosimilars manufacturer.

Fresenius consolidates control after four-year partnership

Fresenius first acquired a 55% majority stake in mAbxience in August 2022 and has consolidated the business since then. The deal closes out that ownership structure, placing mAbxience's biosimilars platform entirely within Fresenius Kabi's Biopharma division, which spans development, manufacturing and commercialization.

Singapore – October 01, 2026 -- Emerald Clinical Trials has appointed Michael Stibilj as Chief Executive Officer, effective October 01, 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 – – October 01, 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 – October 01, 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.