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Oct 15Thu
  1. doi.org48

    Open-label extension study of leniolisib in activated PI3Kδ syndrome: Long-term efficacy and safety

    Long-term leniolisib was generally well tolerated in 37 patients with activated phosphoinositide 3-kinase delta syndrome treated for a median of 4.3 years. Annual infection rates (P = 0.0005), respiratory infection rates (P = 0.0017) and immunoglobulin replacement therapy use (P = 0.0095) all declined per year of treatment, with clinically meaningful gains in 36-Item Short Form Survey general health scores. This extends the efficacy and safety evidence for leniolisib in APDS well beyond the pivotal trials.

Oct 9Fri
  1. biospace.com80

    How Abogen went from COVID hype to a $7.8B Novartis deal

    Novartis has taken an exclusive worldwide license to ABO2203, Abogen Biosciences' mRNA-encoded CD19xCD3 T cell engager for B-cell malignancies and autoimmune diseases, paying $575 million upfront with up to roughly $7.2 billion in potential option, milestone and royalty payments. Early data in relapsed or refractory B-cell non-Hodgkin lymphoma showed overall response rates of 33%, 67% and 100% across dose cohorts, with no CRS or ICANS reported. The deal, which also gives Novartis options on further Abogen RNA platform programs, marks Abogen's shift beyond its faded COVID vaccine business.

    Why it matters: Large upfront payment signals big-pharma validation of in vivo mRNA T cell engagers and Abogen's post-COVID pivot.

Oct 8Thu
  1. biospace.com66

    Big Pharma–backed Matchpoint scores $150M series B, advancing autoimmune asset

    Preclinical Matchpoint Therapeutics has raised a $150 million series B co-led by Nextech Invest and Norwest, with participation from Sanofi Ventures, Atlas Venture, Access Biotechnology and the T1D Fund. The money will advance MPT-062, an oral T cell modulator for autoimmune and inflammatory conditions, into human trials starting next year. Matchpoint also has a July 2025 deal with Novartis, which paid $60 million upfront for its ACE platform and could owe up to $1 billion in milestones plus royalties.

    Why it matters: A large series B funds a first-in-class oral autoimmune program before it reaches human trials, against a market trend favouring later-stage assets.

  2. biospace.com40

    Q3 layoffs down YOY, with 90% fewer biopharma employees affected

    BioSpace tallies show biopharma layoffs fell sharply year over year in Q3, with a 56% drop in companies making or projecting cuts and a 90% plunge in affected employees; the 27 companies and 2,568 people affected are the lowest quarterly figures since tracking began in 2024. Eight Big Pharma companies accounted for cuts of 1,845 employees in the quarter, including Bristol Myers Squibb letting go of 265 people in Princeton, New Jersey, GSK closing a German vaccine site with about 650 job losses, and Novartis, whose 2026 disclosures total at least 922 people. Novo CEO Mike Maziar Doustdar said overall headcount has dropped by 13,000 over the past year, including 9,000 layoffs under a restructuring announced in September 2025 targeting around $1.25 billion in annualized savings.

  3. biopharmadive.com40

    Halozyme prevails in patent fight with Merck; Enliven readies anticipated leukemia trial

    A Netherlands court blocked sales of Merck's subcutaneous Keytruda Qlex in eight European countries, siding with Halozyme in a patent dispute over its under-the-skin drug delivery technology. Separately, Enliven Therapeutics reached agreement with the FDA on a late-stage trial of relcobitinib in chronic myeloid leukemia, enrolling 450 people to test superiority at spurring a major molecular response. Halozyme is also challenging Merck in a U.S. court after a win in Germany.

    Why it matters: Patent ruling blocks subcutaneous Keytruda across Europe and FDA-aligned CML trial design sharpens competition for Novartis and Merck.

Oct 7Wed
  1. biospace.com40

    Genmab and AbbVie’s Epkinly win, a rush of deals, Sarepta’s turnaround hopes, more

    Genmab and AbbVie's bispecific antibody Epkinly, approved in May 2023 for diffuse large B cell lymphoma after at least two prior systemic lines, cut risk of disease progression or death by 51% in a Phase 3 trial when combined with R-CHOP in the frontline setting. In deals, Shionogi bought IntraBio for $2 billion, Novartis committed up to $7.8 billion to Abogen Biosciences, Eli Lilly added up to $870 million with Gate Bioscience, and Sanofi and Regeneron renewed their collaboration with a $1 billion upfront. Sarepta shared Elevidys data in older Duchenne patients at the World Muscle Society meeting, with Jefferies citing upcoming readouts and an FDA decision on Amondys 45 and Vyondys 53.

Oct 6Tue
  1. biospace.com46

    Compliance concerns hinder rollout of AI in drug manufacturing: Survey

    Fewer than 10% of drugmakers are scaling AI in clinical or commercial manufacturing, according to a CRB survey of more than 400 R&D and manufacturing professionals for its 2026 Horizons report. Use is concentrated in nonregulated areas such as administrative workflows (56%) and drug discovery (45%), with accuracy and quality concerns and insufficient validation standards cited as the main barriers. CRB found that 31% of respondents plan to use AI in regulated manufacturing within three years, and another 31% are considering it without a formal plan.

    Why it matters: Shows regulatory and validation concerns are blocking AI adoption in drug manufacturing, with an FDA warning letter already issued.

Oct 3Sat
  1. biocentury.com67

    Novartis turns to mRNA-encoded engagers for B cell depletion

    Novartis is paying Suzhou Abogen Biosciences $575 million up front for exclusive worldwide rights to ABO2203, an mRNA-encoded CD19 x CD3 T cell engager for autoimmune indications, plus options on undisclosed next-generation assets from Abogen's RNA platform. Abogen could receive up to $7.2 billion in milestones if all options are exercised. Early clinical data support the mRNA-encoded T cell engager approach, which adds a new modality to B cell-depleting therapies for autoimmune diseases.

Oct 2Fri
  1. biopharmadive.com65

    Novartis wagers almost $8B on a Chinese biotech’s RNA drugs

    Novartis will pay Abogen Biosciences $575 million up front in a deal worth as much as $7.8 billion, gaining access to the Chinese biotech's mRNA-encoded drugmaking technology and an option to license ABO2203, a T cell engager targeting CD3 and CD19 being studied in relapsed or refractory B-cell non-Hodgkin lymphoma. Abogen is eligible for up to $7.2 billion in milestone payments, and Novartis could license additional programs. The deal follows a series of Novartis trial failures in September, including three deaths in a paused autoimmune CAR-T trial.

    Why it matters: Large-pharma licensing of Chinese RNA-encoded T cell engager technology at near-record deal value signals a pipeline rebuild after trial failures.

  2. biospace.com64

    Novartis bets up to $7.8B for an mRNA-encoded T cell engager from China’s Abogen

    Novartis will pay Suzhou-based Abogen Biosciences $575 million upfront, with up to around $7.2 billion in milestones plus royalties, to develop ABO2203, an mRNA-encoded CD3xCD19 T cell engager designed to deplete disease-causing B cells in vivo. First-in-human data in nine relapsed or refractory B cell non-Hodgkin lymphoma patients showed no CRS, dose-limiting toxicities or neurological complications, with 100% objective response at the highest dose. Novartis also gains options to license therapies from Abogen's AI-driven RNA platform; target indications were not disclosed.

  3. biorxiv.org52

    KRASG12C Inhibition Remodels the Non-Small Cell Lung Cancer Surfaceome to Uncover Targetable Vulnerabilities

    KRAS G12C inhibitors remodel the cell surface proteome of KRAS G12C-mutant lung adenocarcinoma, and folate receptor alpha (FOLR1) emerges as a therapeutically actionable target that is significantly upregulated during treatment, part of an acute cellular state transition toward epithelial identity. Quantitative temporal proteomic profiling across cell lines, tumor models, and treatment durations identified this adaptation. Combining KRASi with mirvetuximab soravtansine-gynx, a clinically approved FOLR1-targeting antibody drug conjugate, enhanced tumor cell cytotoxicity and deepened response and tumor control in cellular and in vivo models.

Sep 30Wed
  2. biopharmadive.com41

    Novo to pay Hengrui up to $2.6B for a once-weekly obesity pill

    Novo Nordisk is paying Hengrui Pharma $300 million up front and up to $2.6 billion in milestones for rights to HRS-1596, a once-weekly oral obesity drug that acts on GLP-1 and GIP. Novo gains rights outside China, Taiwan and nearby territories, aiming to challenge Eli Lilly's Zepbound. Described as Phase 1 ready, the drug has not been tested in humans and could be years from regulatory clearance.

Sep 29Tue
  1. statnews.com43

    STAT+: AstraZeneca invests $2 billion in Summit Therapeutics

    AstraZeneca has invested $2 billion in Summit Therapeutics, according to the headline of a STAT+ report. Separately, Novo Nordisk licensed a once-weekly oral GLP-1/GIP receptor agonist for obesity from Hengrui Pharma, paying $300 million upfront for global rights outside China, with total deal value of $2.6 billion if milestones are met; the drug is ready for Phase 1 development.

    Why it matters: AstraZeneca's $2 billion Summit stake and Novo's $2.6 billion obesity drug deal both move competitive pharma positioning.

Sep 21Mon
  1. STAT News65

    STAT+: Radiopharma companies merge after one receives surprise FDA rejection

    Telix Pharmaceuticals will acquire all shares of ITM Isotope Technologies Munich SE in a merger worth at least $1.65 billion, with up to $700 million more payable to ITM shareholders if ITM's lead drug meets regulatory and sales goals. The deal combines two radiopharmaceutical companies and creates a well-resourced player in a field dominated by Novartis, which launched two radioactive isotope cancer treatments in 2018 and 2022.

    Why it matters: A $1.65 billion radiopharmaceutical merger consolidates the cancer isotope delivery field shortly after an FDA rejection.

Sep 15Tue
  1. fiercepharma.com61

    FDA approves first radioligand equivalent, Curium’s copycat of Novartis’ Lutathera

    The FDA has approved Bexlutry, Curium's lutetium Lu 177 dotatate injection, as the industry's first radioligand equivalent. The approval for the Boston company follows a court ruling that cleared Curium of all patent claims brought by Novartis, whose reference product is Lutathera.

    Why it matters: First FDA-approved radioligand equivalent, a copycat of Novartis' Lutathera, after Novartis lost its patent case.

Sep 4Fri
  1. Lancet74

    [177Lu]Lu-PSMA-617 in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (PSMAddition): a phase 3 randomised, controlled trial.

    Adding 177Lu-PSMA-617 to androgen deprivation therapy plus an androgen receptor pathway inhibitor reduced the relative risk of radiographic progression or death by 28% in PSMA-positive metastatic APMN/S prostate cancer, meeting the primary endpoint of prolonged radiographic progression-free survival. In the phase 3 PSMAddition trial, 572 patients per arm were randomised; radiographic progression or death occurred in 24% of the 177Lu-PSMA-617 arm versus 30% of the control arm. Grade 3 or worse adverse events occurred in 51% versus 43%, with dry mouth the most common event in the 177Lu-PSMA-617 arm.

    Why it matters: It tests PSMA-directed radioligand therapy in first-line metastatic hormone-sensitive disease, earlier than current approved use.

Aug 29Sat
  1. biocentury.com48

    Mid-sized biotechs pressured to accept MFN deals crafted for big pharma

    A new round of most-favored nation drug pricing deals, expected to be announced as soon as Monday, reveals pressure from the Trump administration on mid-sized biopharmas. About 10 companies have accepted deals while others have resisted. The White House offers exemptions from mandatory Medicare MFN drug-pricing models and tariff relief in exchange for deep cuts to Medicaid reimbursement, with decisions hinging on payer mix and tariff exposure.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org