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NEWS

Pathos AI Inks ~2.2B Licensing Deal with Alphamab Oncology for JSKN016

Shots: Pathos AI has entered into a licensing agreement with Jiangsu Alphamab Biopharmaceuticals for JSKN016, a TROP2/HER3 bispecific ADC independently developed by Alphamab As per the deal, Pathos AI will receive exclusive rights to research, develop, manufacture & commercialize JSKN016 outside Greater China, funding all related costs, while Alphamab retains exclusive rights in mainland China,…
August 4, 2026

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NEWS

Corbus Pharmaceuticals Reports FDA Clearance to Initiate TEMPO-1 Trial of CRB-701 in OPSCC

Shots: The US FDA has granted clearance to initiate a registrational study (TEMPO-1) of CRB-701, a Nectin-4-targeted ADC, in 2L oropharyngeal squamous cell carcinoma (OPSCC), with enrolment beginning in Sep 2026 Trial (n=250) will evaluate the efficacy & safety of CRB-701 vs investigator’s choice of capecitabine, cetuximab or docetaxel, assessing ORR as the 1EP to…
July 29, 2026

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NEWS

CORE Biomedicine Licenses Preclinical Oncology Portfolio from Eisai

Shots: CORE Biomedicine has entered into a licensing agreement with Eisai, securing exclusive global rights to develop & commercialize multiple preclinical oncology programs As per the deal, CORE will obtain exclusive, global rights to certain preclinical oncology programs spanning distinct targets & biological pathways, providing CORE with a broad pipeline to develop next-generation precision medicines…
July 29, 2026

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Astrazeneca and Daiichi-Sankyo New
NEWS

Daiichi Sankyo and AstraZeneca Report CHMP Positive Opinion for Enhertu + Perjeta to Treat HER2-Positive Metastatic Breast Cancer

Shots: The CHMP has recommended Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with HER2+ unresectable or metastatic breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157) Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior CT or HER2-targeted therapy,…
July 27, 2026

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Pfizer New
NEWS

Pfizer Receives the US FDA Priority Review for Talzenna + Xtandi to Treat HRR-Gene Mutated mCSPC

Shots: The US FDA has accepted sNDA & granted priority review to Talzenna (talazoparib) + Xtandi (enzalutamide) to treat men with HRR gene-altered mCSPC, with PDUFA action date in Q4’26. Regulatory review is ongoing in the EU sNDA was supported by the P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi…
July 24, 2026

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NEWS

IMUNON Reports P-II MRD Trial Data on IMNN-001 for Newly Diagnosed Advanced Ovarian Cancer

Shots: IMUNON has reported preliminary data from its ongoing P-II MRD trial assessing IMNN-001 (intraperitoneally) in combination with SoC neoadj. & adj. CT (N/ACT) + Avastin, in women with newly diagnosed advanced ovarian cancer Data from nine pts per arm reaching second-look laparoscopy showed IMNN-001 achieved deeper antitumor responses than control, with lower MRD positivity…
July 22, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in June 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon.  European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…
July 21, 2026

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Personalis
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Tempus AI to Acquire Personalis for ~$1.5B

Shots: Tempus AI has entered into a definitive agreement to acquire Personalis, expanding Tempus' capabilities in minimal residual disease (MRD) As per the deal, Personalis shareholders will receive $16.25 per share, valuing the company at an enterprise value of $1.5B, net of Tempus AI’s existing ownership interest; closing expected in late 2026 or early 2027…
July 21, 2026

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NEWS

Henlius Reports First Patient Dosing in P-I Trial of HLX18 (Biosimilar, Opdivo) in China 

Shots:  Henlius has dosed the first patient in China in the P-I (HLX18-MRST001) trial assessing its nivolumab biosimilar, HLX18, in patients with resected solid tumors  The study will compare HLX18 vs. Opdivo in patients with resected solid tumors, evaluating PK similarity, efficacy, safety, and immunogenicity following monotherapy  HLX18 is Henlius' nivolumab biosimilar candidate, developed under global biosimilar guidelines. Reference nivolumab is approved worldwide for multiple cancers, including melanoma, NSCLC, RCC, HCC, urothelial, gastric, esophageal, colorectal, and head & neck cancers  Ref: Henlius  |  Image: Henlius   | Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more…
July 16, 2026

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Kelun Biotech
NEWS

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung06) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs CT + Keytruda as the 1L treatment for PD-L1-negative locally advanced or metastatic non-squamous NSCLC (TPS <1%) IDMC has concluded that the trial met its 1EP of improved PFS at interim analysis vs Keytruda + pemetrexed & Pt-based CT, plus…
July 15, 2026

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