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Biopharmaceuticals

Marengo's Invikafusp Alfa-TRODELVY Combo to Debut Data at SITC 2026

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Marengo's Invikafusp Alfa-TRODELVY Combo to Debut Data at SITC 2026

Cambridge, Mass. – October 02, 2026 -- Marengo Therapeutics will present interim results from its STARt-002 trial combining invikafusp alfa with Gilead's TRODELVY (sacituzumab govitecan-hziy) at the Society for Immunotherapy of Cancer's 41st Annual Meeting in Phoenix, Arizona, November 4-8, 2026.

STARt-002 pairs a T-cell agonist with an antibody-drug conjugate for the first time in clinical testing

The Phase 1b/2 study tests invikafusp alfa, a Vβ6-selective dual T-cell agonist, alongside TRODELVY's TROP2-directed cytotoxic payload delivery. Marengo's Chief Medical Officer Kevin Chin said the ADC is designed to release tumor antigens and inflame the tumor microenvironment, priming less immunogenic tumors for T-cell-mediated responses that invikafusp alfa can then amplify.

Quotient Sciences, Acesion Pharma Partner on AI Drug Formulation

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Quotient Sciences, Acesion Pharma Partner on AI Drug Formulation

Nottingham, England – October 02, 2026 -- Quotient Sciences and Copenhagen-based Acesion Pharma have launched a collaboration to apply AI-enhanced formulation development to Acesion's early-stage pipeline of small molecules targeting atrial fibrillation, a condition affecting an estimated 50-60 million people globally.

AI tool uses Bayesian optimization to screen drug formulations for clinical success

The collaboration deploys Quotient Sciences' new AI-enhanced formulation development solution within its Translational Pharmaceutics platform, applying active machine learning with Bayesian optimization to identify and prioritize drug products most likely to succeed in clinical testing. The approach is designed to compress early clinical decision-making timelines for sponsors developing new treatments.

Ascletis' ASC36_35FDC Shows Stronger Weight Loss Than Rival Combos in Preclinical Data

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Ascletis' ASC36_35FDC Shows Stronger Weight Loss Than Rival Combos in Preclinical Data

Hong Kong – – October 02, 2026 -- Ascletis Pharma Inc. (HKEX: 1672) presented preclinical data showing its ASC36_35FDC injectable combination drove a 24.8% body-weight reduction in a diet-induced obesity rat model on Day 14, outperforming two competitor co-formulations tested under identical dosing conditions.

The data were unveiled in a short oral discussion at the 62nd European Association for the Study of Diabetes (EASD) Annual Meeting, held September 28–October 2, 2026, in Milan, Italy.

Lundbeck to Present Phase III MSA Data, Parkinson's Pipeline at MDS 2026

Valby – October 02, 2026 -- H. Lundbeck A/S will present late-breaking Phase III data on its multiple system atrophy (MSA) drug candidate amlenetug alongside new Parkinson's disease pipeline results at the International Congress of Parkinson's Disease and Movement Disorders (MDS) 2026 in Seoul, South Korea, running October 4-8.

MASCOT trial enrolled 401 participants across a global Phase III program

The late-breaking oral presentation will detail baseline characteristics of participants in MASCOT (NCT06706622), Lundbeck's ongoing Phase III trial of amlenetug in MSA. The trial enrolled 401 participants with clinically probable or established MSA, covering both MSA-C and MSA-P subtypes, across sites in North America, Europe, Asia and Australia. The double-blind treatment period runs 72 weeks, comparing high- and low-dose amlenetug against placebo, with results expected in Q3 2027.

Samfara Acquires Danish Controlled-Substance API Maker Chr. Olesen Synthesis

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Samfara Acquires Danish Controlled-Substance API Maker Chr. Olesen Synthesis

London – October 02, 2026 -- Samfara has completed the acquisition of Chr. Olesen Synthesis, a Danish manufacturer of controlled-substance active pharmaceutical ingredients, marking the London-based life sciences investment firm's first deal. The transaction sees Samfara buy the business from Chr. Olesen and funds managed by Signet Healthcare Partners, with Chief Executive Thomas Moestrup co-investing alongside the new owner. Financial terms were not disclosed.

Chr. Olesen Synthesis supplies opioid-disorder and ADHD treatment ingredients globally

Based near Copenhagen, Chr. Olesen Synthesis develops and manufactures APIs and advanced intermediates specialising in controlled substances, including buprenorphine for opioid use disorder and lisdexamfetamine for ADHD. Its cGMP-certified plant in Hvidovre has been in commercial production since 2015, supplying pharmaceutical companies across Europe, North America and the Middle East.

Novartis Pays Abogen $575M Upfront for mRNA T-Cell Engager Rights

Suzhou – October 02, 2026 -- Novartis has agreed to pay Abogen Biosciences an upfront fee of USD 575 million to secure worldwide rights to ABO2203, an mRNA-encoded CD19xCD3 T-cell engager for autoimmune diseases, with total deal value reaching up to approximately USD 7.2 billion if all milestones and options are exercised.

Novartis secures exclusive worldwide license to Abogen's lead autoimmune asset ABO2203

The licensing and option agreement grants Novartis an exclusive global license to ABO2203, which Abogen describes as the first mRNA-encoded T-cell engager to enter clinical evaluation for autoimmune diseases. The molecule uses mRNA to direct endogenous production of T-cell engagers in vivo, targeting B-cell depletion through a mechanism the companies say differs from traditional recombinant T-cell engagers.

Hansoh's Olatorepatide Shows 19.3% Weight Loss at Week 48 in Phase III Trial

Milan – October 02, 2026 -- Hansoh Pharma's dual-biased GLP-1/GIP receptor agonist Olatorepatide (HS-20094) achieved a mean weight loss of 19.3% at Week 48 in the 15 mg dose group of a Phase III Chinese trial, with no plateau observed in the weight-loss curve.

The data, presented as a Late-breaking Abstract oral presentation at the European Association for the Study of Diabetes (EASD) Annual Meeting running September 28 to October 2, 2026 in Milan, come from the LIGHTEN study, a multicenter, randomized, double-blind, placebo-controlled trial enrolling 604 Chinese adults with overweight or obesity.

Trial enrolled 604 participants across four dose arms over 48 weeks

Participants with a BMI of 28 kg/m2 or above, or 24-28 kg/m2 with a weight-related comorbidity, were randomized 1:1:1:1 to once-weekly subcutaneous Olatorepatide at 5mg, 10mg or 15mg, or placebo. A total of 90.1% completed the full 48-week treatment period.

GMP Labeling Flags Supply Chain Risk in Pharma Compliance Labels

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GMP Labeling Flags Supply Chain Risk in Pharma Compliance Labels

Granite Bay, Calif. – October 01, 2026 -- GMP Labeling Inc. is marking Manufacturing Day 2026 by positioning its nearly 40-year domestic production history as a hedge against global supply chain disruption for pharmaceutical and biotechnology manufacturers. The California-based company, founded in 1987, manufactures quality control labels, sample identification tags, and equipment status markers used across regulated production lines.

Label failures can halt regulated production lines

Material inconsistencies or shipping delays in compliance labeling can interrupt manufacturing workflows, complicate federal audits, and compromise quality records, according to the company. Robin Kalsbeek, General Manager of GMP Labeling, said a label functions as a critical element of traceability and compliance rather than a minor supply item in biotechnology and medical manufacturing settings.

Curaleaf's QMID Becomes First TGA-Registered Cannabis Inhaler in Australia

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Curaleaf's QMID Becomes First TGA-Registered Cannabis Inhaler in Australia

London – October 01, 2026 -- Curaleaf International's Que Medical Inhalation Device (QMID) has become the first cannabis inhalation device to secure registration from Australia's Therapeutic Goods Administration, clearing the way for clinicians to prescribe a standardized-dosing device in a market that has treated more than one million patients since 2016.

TGA Grants Class IIb Status to QMID on September 15, 2026

The device, developed with Jupiter Research LLC, was listed in the Australian Register of Therapeutic Goods as a Class IIb Medical Device, marking the first regulatory approval in Australia for a device delivering Cannabis Sativa L. extracts via patient inhalation. The approval follows a multi-year regulatory process and arrives one year after QMID received EU Medical Device Registration.

SAS, NC State Launch AI Research Partnership for Drug Discovery

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SAS, NC State Launch AI Research Partnership for Drug Discovery

Cary, N.C. – October 01, 2026 -- SAS and North Carolina State University have launched the SAS Think & Do Tank, a two-year pilot research partnership applying data and AI to human health, nutrition and environmental resilience challenges, 50 years after SAS originated from an NC State agricultural research project.

Partnership targets faster drug discovery through translational predictive biology

One of the initiative's first research efforts focuses on translational predictive biology, combining studies in living systems with advanced lab models such as organoids and organ-on-chip technologies that mimic human organ function. NC State researchers aim to build predictive models that help identify promising treatments earlier, explain why interventions succeed or fail, and cut the time and cost of moving new therapies toward clinical use.