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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
NEWS

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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NEWS

Henlius Reports First Patient Dosing in P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro) in the US 

    Shots:  Henlius has dosed the first U.S. patient in the global P-I HLX15-SC (HLX15-SC-NDMM-001) trial, a biosimilar version of Darzalex Faspro, as a 1L treatment for newly diagnosed multiple myeloma (NDMM)  The study will compare HLX15-SC vs. US-licensed Darzalex Faspro in transplant-ineligible NDMM patients, evaluating PK similarity, safety, tolerability, immunogenicity, and efficacy in combination with lenalidomide & dexamethasone (Rd)  HLX15 is an anti-CD38 daratumumab biosimilar candidate for…
July 13, 2026

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INSIGHTS+ TOP 20

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2006-2025) 

Shots:  PharmaShots' latest report chronicles the transformation of the global biopharma industry from 2006–2025, highlighting how innovation, strategic M&A, AI adoption, and evolving commercialization strategies have reshaped the competitive landscape while companies navigated patent cliffs, pricing pressures, and shifting market dynamics.   The report tracks the rise and fall of leading biopharma companies over two decades driven by…
July 10, 2026

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NEWS

Nanjing Leads Biolabs Receives NMPA Priority Review for Opamtistomig to Treat EP-NEC

Shots: The Chinese NMPA has accepted the BLA & granted priority review to Opamtistomig (LBL-024) as a monotx. for the treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) BLA was supported by the registrational trial data, designed to assess the efficacy & safety of Opamtistomig in pts with advanced EP-NEC whose disease had progressed following ≥2…
July 10, 2026

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