Pharmaceuticals & Biopharmaceuticals

Kos Backs Fathom Therapeutics in Oversubscribed $55M Series A

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Kos Backs Fathom Therapeutics in Oversubscribed $55M Series A

New York – November 06, 2026 -- Kos Biotechnology Partners has invested in Fathom Therapeutics' oversubscribed $55 million Series A, which was led by Sutter Hill Ventures, to back a drug discovery platform that combines quantum chemistry, physics-based simulation and artificial intelligence.

Kos commits capital through its inaugural life sciences fund

The investment came through Kos BioVentures, the firm's first life sciences fund. Kos, based in New York and Athens, manages $125 million in assets. It invests across all development stages in therapeutic breakthroughs, biodefense and tech-enabled pharma services.

CREATE Medicines Takes 4 In Vivo CAR Programs to Jefferies London

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CREATE Medicines Takes 4 In Vivo CAR Programs to Jefferies London

Cambridge, Mass. – November 06, 2026 -- CREATE Medicines, Inc. says it has treated more than 80 patients with in vivo CAR therapy, which it describes as the largest clinical dataset in the field. The company is now taking its four clinical-stage programs to investors and prospective partners at the Jefferies Global Healthcare Conference in London.

CREATE schedules one-on-one meetings at Jefferies London on Nov. 16-19, 2026

Management will hold one-on-one meetings at the Waldorf Hilton and ME London during the conference, which runs from Nov. 16 to 19, 2026. CEO and Co-Founder Daniel Getts, PhD, and Chief Medical Officer Matthew Maurer, MD, will represent the clinical-stage biotech.

Investors must request meetings through their Jefferies representative. Prospective partners can contact the company's business development team directly.

China Approves First Golimumab Biosimilar from Bio-Thera

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China Approves First Golimumab Biosimilar from Bio-Thera

Guangzhou – November 06, 2026 -- China's National Medical Products Administration (NMPA) has approved Bio-Thera Solutions' BAT2506, the first golimumab biosimilar cleared in the country, the Shanghai-listed company (688177.SH) said.

ASHULI is cleared for rheumatoid arthritis and ankylosing spondylitis

BAT2506 will be sold in China under the brand name ASHULI. The NMPA approved it for two indications: rheumatoid arthritis and ankylosing spondylitis.

Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α). Binding to TNF-α reduces the inflammatory markers CRP, IL-6, ICAM-1, MMP-3 and VEGF.

Bio-Thera adds its sixth approved biosimilar in China

CEO Shengfeng Li said ASHULI is the company's sixth biosimilar approved in China. He said biosimilars "have an important role in expanding patient access to important biologics."

Bausch Health Study: 62% 12-Month Survival in Severe Alcohol Hepatitis

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Bausch Health Study: 62% 12-Month Survival in Severe Alcohol Hepatitis

Laval – November 06, 2026 -- Only 62.0% of patients hospitalized with severe alcohol-associated hepatitis (AH) in the United States were estimated to survive 12 months, according to a real-world study from Bausch Health Companies Inc. and its gastroenterology unit, Salix Pharmaceuticals.

Study of 1,630 US adults tracks rehospitalization and transplant rates

The companies are presenting the poster, "Clinical Burden and Outcomes in a Large Real-World Cohort of Patients Hospitalized with Severe Alcohol-Associated Hepatitis," at the American Association for the Study of Liver Diseases' The Liver Meeting 2026. The meeting runs November 5-9 in Denver, Colorado. The cohort comprised 1,630 adults.

Rehospitalization climbs from 31.4% at 30 days to 69.1% at 12 months

Within 30 days of discharge, 31.4% of patients were rehospitalized. The estimated rate reached 69.1% by 12 months. The estimated liver transplantation rate at 12 months was 8.5%.

Servier to Present Nine Glioma Abstracts at SNO, Five Orals

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Servier to Present Nine Glioma Abstracts at SNO, Five Orals

Boston – November 06, 2026 -- Servier will present nine abstracts, including five oral presentations, at the 31st Society for Neuro-Oncology (SNO) Annual Meeting, held November 12-15 in Philadelphia. The package covers both of its glioma therapies: VORANIGO (vorasidenib) in IDH-mutant glioma and OJEMDA (tovorafenib) in BRAF-altered pediatric low-grade glioma (pLGG).

Four-year FIREFLY-1 data to cover retreatment after progression in pLGG

One oral presentation will deliver updated results from the four-year follow-up of the Phase 2 FIREFLY-1 study of OJEMDA in relapsed or refractory BRAF-altered pLGG. The analysis includes data on post-treatment observation and on retreatment with OJEMDA after disease progression.

iOnctura's Chemo-Free Lung Cancer Combo Halves Severe Side Effects

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iOnctura's Chemo-Free Lung Cancer Combo Halves Severe Side Effects

Geneva – November 06, 2026 -- iOnctura's chemo-free regimen of roginolisib plus dostarlimab produced grade 3 or higher treatment-emergent adverse events in 35% of patients with immunotherapy-resistant non-small cell lung cancer (NSCLC), against 75% in the chemotherapy-containing control arm, according to late-breaking Phase I/II PULMO-01 data presented at the SITC 2026 Annual Meeting.

The triplet arm, which added docetaxel to roginolisib and dostarlimab, recorded a 69% rate. No fatal adverse events were attributed to roginolisib.

Inimmune's INI-4001 Clears Phase 1 With No Dose-Limiting Toxicities

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Inimmune's INI-4001 Clears Phase 1 With No Dose-Limiting Toxicities

Missoula – November 06, 2026 -- Inimmune's TLR7/8 agonist INI-4001 produced no dose-limiting toxicities in a 10-patient Phase 1 study of heavily pretreated advanced solid tumor patients, and the company is weighing a Phase 2a start as early as 2027, subject to funding or partnership support.

INI-4001 tolerated up to 7.2 μg/kg across five dose levels

The trial (NCT06302426) tested the investigational small molecule for safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity. Patients received INI-4001 intravenously once weekly across five escalating dose levels. Adverse events were primarily transient, consistent with innate immune activation, and generally resolved within 24 hours. No concerning pharmacokinetic findings were reported.

FDA Grants Accelerated Approval to J&J's Subcutaneous RYBREVANT FASPRO in HNSCC

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FDA Grants Accelerated Approval to J&J's Subcutaneous RYBREVANT FASPRO in HNSCC

SAN DIEGO – November 06, 2026 -- The U.S. Food and Drug Administration granted Johnson & Johnson accelerated approval for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), a subcutaneous therapy co-formulated with Halozyme's ENHANZE technology, as a single agent for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), Halozyme Therapeutics (Nasdaq: HALO) announced.

FDA clears first dual-targeted therapy for post-chemotherapy, post-immunotherapy HNSCC

The indication covers adults whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. It excludes patients with HPV-associated oropharyngeal squamous cell carcinoma.

The approval is the first for a dual-targeted therapy in this setting. RYBREVANT FASPRO simultaneously targets epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET), extending the product's dual-targeted profile beyond lung cancer.

VS Pharmtech Wins FDA Phase 2 Nod for Cancer Enhancer VS-101

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VS Pharmtech Wins FDA Phase 2 Nod for Cancer Enhancer VS-101

SEOUL – November 06, 2026 -- VS Pharmtech reported complete remission in all seven patients in a Phase 1 trial of VS-101, a radiosensitizer for head and neck cancer, with no dose-limiting toxicities or serious adverse events. The U.S. Food and Drug Administration (FDA) has since approved the company's Phase 2 plans for head and neck cancer, breast cancer and glioblastoma.

VS-101 repurposes a 20-year-old drug at one-fifth of the original dose

VS-101 makes tumors more responsive to radiation. It weakens RAD51, a protein central to cancer cells' repair of radiation-induced DNA damage, which pushes the cells toward death. The drug has been in use for more than 20 years, and VS Pharmtech is developing it through drug repositioning. The company aims to give patients about 20% of the original dose. CEO Park Shin-young said the drug itself does not cause DNA damage or toxicity.

AusperBio's AHB-137 Holds Hepatitis B Cure 15 Months Off Treatment

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AusperBio's AHB-137 Holds Hepatitis B Cure 15 Months Off Treatment

SAN FRANCISCO – November 06, 2026 -- AusperBio's investigational antisense oligonucleotide AHB-137 maintained functional cure in 16 of 17 evaluable nucleos(t)ide analogue (NA)-treated chronic hepatitis B participants 12 months after they stopped all HBV treatment, according to long-term follow-up data from Study AB-10-8004. No participant required NA re-initiation during follow-up.

Nine of nine evaluable NA-treated participants stay cured at 15 months

In the NA-treated cohort, functional cure held in 9 of 9 evaluable participants at 15 months after NA discontinuation. The cohort enrolled 34 participants (21 complete responders, 13 partial responders) from the Phase 2 studies AB-10-8002 and AB-10-8003.