Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu to Treat Solid Tumors

Shots: The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) to treat previously treated adults with HER2+ (IHC 3+) unresectable or metastatic solid tumors, who have unsatisfactory alternative treatment options MAA was supported by 3 P-II (DESTINY-PanTumor02, DESTINY-CRC02 & DESTINY-Lung01) trials, where DESTINY-PanTumor02 (n=267, incl. 111 HER2+ pts) assessed Enhertu (5.4mg/kg)…

ByRidhi RastogiSeptember 11, 2025

NEWS

Fapon Biopharma Reports First Patient Enrolment in P-I Trial of FP008 for Solid Tumors

Shots: Fapon Biopharma has enrolled the first patient in China for its P-I trial of FP008 for advanced solid tumors, conducted at Zhejiang Cancer Hospital. The patient completed the DLT observation with a favorable safety profile. The trial focuses on evaluating FP008's safety and tolerability FP008 demonstrated favorable safety and PK in monkey studies and…

ByDipanshu DixitAugust 7, 2025

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Next-Gen T Cell Engagers for Solid Tumors: Shaun Murphy in a Riveting Dialogue Exchange with PharmaShots

Shots: Unlike hematologic malignancies, where the elimination of most or all tumor cells results in immunosuppression, making headways in solid tumors requires a new holistic approach when using T Cell Engagers Abpro’s ABP-102/CT-P72, co-developed by Celltrion leverages a tetravalent format; bivalent for both HER2 and CD3 PharmaShots welcomes Shaun Murphy, Vice President, Nonclinical Research and…

BySaurabh ChaubeyJuly 21, 2025

NEWS

Tracer Biotechnologies Collaborates with QIAGEN to Co-Develop and Commercialize Tracer dPCR & Tracer WGS for Solid Tumors

Shots: Tracer has entered into a strategic collaboration with QIAGEN to co-develop & commercialize Tracer dPCR & Tracer WGS MRD assays for solid tumors on QIAGEN’s QIAcuity digital PCR platform Collaboration aims to provide highly sensitive, cost-effective, & decentralized MRD testing using QIAcuity’s PCR platform, allowing oncologists to monitor cancer recurrence & guide personalized treatment…

ByRidhi RastogiJune 6, 2025

NEWS

BMS Enters a ~$11.1B Deal with BioNTech to Jointly Develop and Commercialize BNT327

Shots: BMS & BioNTech will co-develop & co-commercialize BioNTech’s BNT327 alone & in combination to treat solid tumors; BMS to hold MA globally excl. the US, UK, China, Turkey, & EU, where BioNTech will be the holder As per the deal, BioNTech will receive $1.5B upfront, $2B in non-contingent annual payments through 2028 & ~$7.6B…

ByRidhi RastogiJune 3, 2025

NEWS

Astellas Enters a ~$1.54B Licensing Agreement with Evopoint Biosciences to Develop & Commercialize XNW27011

Shots: Evopoint Biosciences has granted Astellas exclusive license to develop & commercialize XNW27011 globally, excl. Mainland China, Hong Kong, Macao & Taiwan As per the deal, Evopoint will receive $130M upfront as well as ~$70M as near-term payments in addition to ~$1.34B in development, regulatory & commercial milestones, with net sales-based royalties XNW27011, an CLDN18.2-specific…

ByRidhi RastogiMay 30, 2025

NEWS

Minghui Pharmaceutical and Qilu Pharmaceutical Enter an Exclusive Licensing and Collaboration Agreement for MHB088C

Shots: Minghui has granted Qilu exclusive rights to develop, manufacture & market MHB088C in Greater China (incl. Mainland China, Hong Kong, Macau, & Taiwan) As per the deal, Minghui will receive ~$185.9M (CN¥ 1.345B) incl. $38.7M as upfront & near-term milestone payments & ~$147.2M in development, regulatory & sales milestones, plus double-digit net sales-based royalties;…

ByRidhi RastogiMay 9, 2025

NEWS

VERAXA Biotech Collaborates with OmniAb to Develop Novel Bispecific Antibody Drug Conjugate for Solid Tumors

Shots: VERAXA Biotech has entered into a co-discovery alliance with OmniAb to develop novel bispecific antibody drug conjugate (bsADC) targeting solid tumors using the former’s ADC linker tech & conjugation expertise & OmniAb’s suite of transgenic antibody discovery solutions As per the deal, VERAXA will initiate novel bsADC program targeting 2 cancer-related molecules, using OmniAb’s…

ByRidhi RastogiMay 5, 2025

NEWS

HighField Biopharmaceuticals Seeks NMPA’s IND Clearance for HF158K1 & HFK2 to Treat Solid Tumors

Shots: China’s NMPA has received 2 IND applications for HF158K1 (K1) & HFK2 (K2) to initiate P-I dose escalation trial in China to evaluate safety & PK of K1 alone & its preliminary efficacy with K2 to treat pts with solid tumors refractory to prior therapies Preclinical studies of K1, K2, & their combination showed…

ByRidhi RastogiApril 21, 2025

NEWS

Bayer’s Vitrakvi Receives the US FDA’s Full Approval for NTRK Fusion-Positive Solid Tumors

Shots: The US FDA has granted full approval to Vitrakvi for adults & pediatrics with NTRK fusion-positive metastatic or inoperable solid tumors, who had disease progression on prior therapy or lacked alternative therapy options Approval was based on 3 trials: LOXO-TRK-14001, SCOUT, & NAVIGATE, evaluating Vitrakvi in 339 adult & pediatric pts. Key EPs were…

ByRidhi RastogiApril 11, 2025

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu to Treat Solid Tumors

Fapon Biopharma Reports First Patient Enrolment in P-I Trial of FP008 for Solid Tumors

Next-Gen T Cell Engagers for Solid Tumors: Shaun Murphy in a Riveting Dialogue Exchange with PharmaShots

Tracer Biotechnologies Collaborates with QIAGEN to Co-Develop and Commercialize Tracer dPCR & Tracer WGS for Solid Tumors

BMS Enters a ~$11.1B Deal with BioNTech to Jointly Develop and Commercialize BNT327

Astellas Enters a ~$1.54B Licensing Agreement with Evopoint Biosciences to Develop & Commercialize XNW27011

Minghui Pharmaceutical and Qilu Pharmaceutical Enter an Exclusive Licensing and Collaboration Agreement for MHB088C

VERAXA Biotech Collaborates with OmniAb to Develop Novel Bispecific Antibody Drug Conjugate for Solid Tumors

HighField Biopharmaceuticals Seeks NMPA’s IND Clearance for HF158K1 & HFK2 to Treat Solid Tumors

Bayer’s Vitrakvi Receives the US FDA’s Full Approval for NTRK Fusion-Positive Solid Tumors

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