Drug development, clinical trials and industry dynamics. What changes timelines, risk and competitive positioning.
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Sep 12, 2026The contract covers manufacturing services from Samsung Biologics’ site in Songdo, South Korea, but the company did not identify the customer or product because of client confidentiality. Strategically, the announcement matters less for the missing identity than for what it says about demand absorption as Samsung continues to add large-scale capacity.
Sep 11, 2026Novartis reported a positive multiple sclerosis result for remibrutinib, then disclosed that pelacarsen showed no significant cardiovascular benefit and del-desiran failed a myotonic dystrophy type 1 study. The sequence has intensified investor scrutiny of acquisitions including Avidity Biosciences and MorphoSys as Novartis prepares for patent expirations affecting some of its largest products from 2029 to 2031.
Sep 10, 2026Plump will continue to lead R&D until a successor is named and will remain on Takeda’s board until June 2027. His departure comes as Takeda tries to convert a rebuilt late-stage pipeline into new growth drivers while managing revenue pressure and the loss of exclusivity on key products.
Sep 10, 2026According to STAT, mosliciguat produced strong efficacy in a Phase 2 study of pulmonary hypertension associated with interstitial lung disease, or PH-ILD. The publication framed the result as another example of Roivant turning business development into pipeline value, with potential implications for the company’s balance sheet if the program continues to work.
Sep 9, 2026The company reported that Quintessential met its primary endpoint on overall response rate and its key secondary endpoint on complete response rate, but it has not yet disclosed the underlying data. The update matters because Bristol Myers is trying to establish a position in a post-BCMA setting where physicians need alternatives to repeated BCMA retargeting and where Johnson & Johnson already has Talvey on the market.
Sep 7, 2026Novo told investigators it was winding up the Hermes and Athena trials early, citing a low likelihood of a different outcome from Zeus. For a program once modeled by BMO at around $3 billion in peak sales, the decision sharply reduces the routes left to justify a broader cardiovascular expansion beyond obesity and diabetes.
Sep 4, 2026The Menarini Group has agreed to collaborate with Gan & Lee Pharmaceuticals on bofanglutide, a once-every-two-weeks GLP-1 candidate. Beyond the €62 million upfront payment, Gan & Lee could receive up to €664 million in milestones plus double-digit royalties on sales.
Invivyd said Elia, a board member since 2022 and current chairman, will now hold both chairman and CEO roles. The leadership change comes as the company prepares for top-line data from a phase 3 study of VYD2311 in adults and adolescents.
Sep 4, 2026Zanvastro, formerly zilganersen, is an antisense oligonucleotide that lowers production of GFAP, the protein that accumulates in Alexander disease. For Ionis, the approval adds a commercial foothold in neurology as it prepares other RNA-based programs, including its Phase 3 effort in Angelman syndrome.
Sep 3, 2026Medicus will pay $12 million upfront and another $15 million on Sept. 2, 2027, according to an SEC filing, while Pfizer also contributed $2 million to support the program. The transaction shows how large acquirers can keep economic exposure to discontinued assets without carrying full development costs.
Sep 3, 2026GSK has licensed worldwide rights to HMPL-A830 outside mainland China, Hong Kong, Macau and Taiwan, where Hutchmed retains control. Initial development will focus on colorectal, pancreatic and lung cancers, with Hutchmed running Phase 1 before GSK takes over later-stage development and commercialization.
Sep 3, 2026Fortrea said the acquisition will bring Worldwide’s clinical pharmacology unit and bioanalytical laboratory operations into its clinical pharmacology services business unit. The transaction is aimed at adding early-phase capacity and reducing handoffs between clinical and bioanalytical functions, while Worldwide plans to use the proceeds to support its late-stage focus areas.
Machine learning, predictive models and computational biology: how AI is changing discovery workflows and probability of success.
Gene therapy, CRISPR, synthetic biology and emerging platforms. Separating what is real from what is hype, and what actually translates.
Where capital is flowing and why the tape moves, across funding rounds, M&A, IPOs and market analysis.
Digital health, diagnostics and medical devices, and the signals that matter for adoption, reimbursement and outcomes.
FDA actions, approvals, policy shifts and compliance: how the rules change timelines and probability.