Novartis

Akari Targets Mid-2027 Phase 1 Start for Splicing-Payload ADC

TAMPA – October 27, 2026 -- Akari Therapeutics (Nasdaq: AKTX) plans to begin Phase 1 clinical development of its lead antibody drug conjugate, AKTX-101, in mid-2027, with the compound now moving through IND-enabling toxicology and safety studies and large-scale GMP manufacturing.

CEO Abizer Gaslightwala laid out the strategy in a new CEO Corner segment. He argues that payload differentiation will matter more as ADCs move into front-line therapy and patients develop resistance to current payload classes, leaving few follow-on options.

Vanda's VQW-765 Fails Phase III Social Anxiety Trial; Program on Hold

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Vanda's VQW-765 Fails Phase III Social Anxiety Trial; Program on Hold

Washington – October 15, 2026 -- Vanda Pharmaceuticals (Nasdaq: VNDA) has put its VQW-765 program on hold after the Phase III Study 3201 in adults with social anxiety disorder missed its primary endpoint, and the company said the data did not confirm earlier Phase II findings.

Phase III trial misses primary and key secondary endpoints

Study 3201 (NCT07221578) tested VQW-765 as an on-demand treatment for acute anxiety. Female participants who received the drug showed no statistically significant difference in distress from those who received placebo during the performance phase of the Trier Social Stress Test (TSST). The primary endpoint was measured on the Subjective Units of Distress Scale (SUDS), a 0-to-100 self-rating of nervousness.

The study also missed its key secondary endpoint, SUDS during the TSST performance phase in the full male and female population.

Novartis, Thermo Fisher Back New Digital CMC Consortium

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Novartis, Thermo Fisher Back New Digital CMC Consortium

Dover, Delaware – October 06, 2026 -- The Digital CMC Consortium has launched as a new industry collaboration aimed at the end-to-end digitalization of Chemistry, Manufacturing, and Controls (CMC) processes in drug development. Founding participants include Novartis, Thermo Fisher Scientific, Takeda, Rockwell Automation, Flagship's Pioneering Medicines, Stellix, ZS Associates, and QbDVision.

Consortium targets legacy PDF-based workflows that bottleneck drug development

The CMC phase of pharmaceutical development remains tethered to manual, document-based processes that treat PDF tables as the source of truth, despite rapid advances in drug discovery and clinical trial digitization elsewhere in the industry. The Consortium aims to convert static CMC knowledge into reusable, interoperable digital assets to improve speed, quality, and regulatory confidence.

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.

CD&R Names Ex-BMS CEO Giovanni Caforio Operating Advisor

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CD&R Names Ex-BMS CEO Giovanni Caforio Operating Advisor

London – September 13, 2026 -- CD&R has appointed Giovanni Caforio, current Chair of Novartis and former CEO of Bristol Myers Squibb (BMS), as an Operating Advisor to its funds, tasking him with sourcing and evaluating healthcare investment opportunities globally.

Caforio brings 35 years of biopharmaceutical leadership to CD&R's healthcare strategy

Dr. Caforio has led Novartis' board since 2025 and previously spent over two decades at BMS after 12 years at Abbott Laboratories. He will support CD&R funds in identifying new healthcare deals and work directly with the firm's portfolio companies worldwide.

Alteogen Signs Up to $3.2B Novartis Deal for Hybrozyme SC Platform

Daejeon – – September 08, 2026 -- Alteogen Inc. (KOSDAQ: 196170) has signed an option and license agreement with Novartis worth up to US$3,223 million, granting the Swiss drugmaker rights to develop subcutaneous formulations for multiple Novartis products using Alteogen's ALT-B4 hyaluronidase.

Novartis secures multi-product option rights to ALT-B4 technology

Under the agreement, Novartis will hold multiple options to obtain exclusive rights to develop and commercialize subcutaneous formulations for several of its products using ALT-B4 (berahyaluronidase alfa). The enzyme, built on Alteogen's proprietary Hybrozyme platform, converts biologics normally delivered via intravenous infusion into faster, more convenient subcutaneous injections by temporarily depolymerizing hyaluronan in the extracellular matrix.