Orion Pharma Partners with Shilpa Medicare to Commercialize Nivolumab Biosimilar in the EU

Shots: Orion Pharma has entered into an agreement with Shilpa Biologicals to commercialize IV nivolumab biosimilar that is currently under development, across Europe As per the deal, Orion will gain exclusive right to distribute, market & sell the biosimilar in the EU, while Shilpa will supply the product & receive certain development & regulatory milestone…

ByRidhi RastogiJune 30, 2026

NEWS

The EC Approves Daiichi Sankyo and AstraZeneca’s Enhertu for Previously Treated HER2+ Metastatic Solid Tumors

Shots: Enhertu approval for previously treated adults with unresectable or metastatic HER2+ (IHC 3+) solid tumors & no satisfactory treatment option, was based on subgroup data from P-II trials, incl. DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. In DESTINY-PanTumor02, Enhertu achieved a cORR of 52.3% & mDOR of 21.1mos. in previously treated HER2+ solid tumors (n=111), while DESTINY-Lung01 reported a cORR of…

ByRidhi RastogiJune 29, 2026

NEWS

Zymeworks to Acquire Theravance for ~$929M

Shots: Zymeworks has entered into a definitive agreement to acquire Theravance Biopharma, adding Yupelri, the only once-daily nebulized LAMA for COPD, to its partnered portfolio to strengthen long-term commercial cash flows As per the deal, Zymeworks will acquire Theravance for ~$929M, with Theravance’s shareholders receiving $17 per share in cash; closing is expected in H2’26…

ByRidhi RastogiJune 29, 2026

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Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Shots: The US FDA has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED), with immediate launch planned across the US. Also, SC elegrobart BLA filing for TED on track for Q1’27 Approval was granted under FDA Priority Review & supported by the P-III THRIVE (active TED) & THRIVE-2 (chronic TED) trials, which…

ByRidhi RastogiJune 29, 2026

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Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)

Shots: Samsung Bioepis has reported the P-I & P-III trial results on SB27, a proposed biosimilar to Keytruda (pembrolizumab), which met their 1EP, with trial completion expected within 2026 The P-I trial (n=163) evaluated PK, efficacy, safety, & immunogenicity of SB27 vs EU & US-sourced Keytruda in resected stage II/IIIA NSCLC pts after adjuvant Pt-based CT,…

ByRidhi RastogiJune 29, 2026

NEWS

Ipsen to Acquire Kartos Therapeutics for ~$1.75B

Shots: Ipsen has entered into a definitive merger agreement to acquire Kartos Therapeutics, incl. its asset, navtemadlin, expanding its hemato-oncology late-stage pipeline As per the deal, Ipsen will acquire Kartos Therapeutics through a fully-owned subsidiary for $450M upfront & ~$1.3B in milestones, incl. a significant regulatory approval milestone & sales-based milestones; closing is expected by…

ByRidhi RastogiJune 29, 2026

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Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the CHMP Positive Opinion for Rett Syndrome

Shots: The CHMP has recommended Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.); If approved, authorization would be valid in all 30 EEA states Opinion was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I…

ByRidhi RastogiJune 29, 2026

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Daiichi Sankyo and AstraZeneca Report the CHMP Positive Opinion for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The CHMP has recommended Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy; regulatory review is ongoing in China & Japan, as well as Australia, Canada, Singapore & Switzerland as part of Project Orbis Opinion was backed by the global P-III (TROPION-Breast02)…

ByRidhi RastogiJune 26, 2026

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Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

Shots: The NMPA has accepted BLA of Everest's Lerochol (lerodalcibep; SC, QM) as an adjunct to diet & exercise to reduce LDL-C in adults with hypercholesterolemia, incl. heterozygous familial hypercholesterolemia; regulatory review is ongoing in the EU The BLA was supported by multiple global trials & a P-III China study, where in global trials, Lerochol…

ByRidhi RastogiJune 26, 2026

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LENZ Therapeutics Partners with Arrotex Pharmaceuticals to Commercialize Vizz in Australia and New Zealand

Shots: LENZ has entered into an exclusive license & commercialization agreement with Arrotex to register & commercialize Vizz (aceclidine ophthalmic solution) 1.44% for the treatment of presbyopia in Australia & New Zealand As per the deal, Arrotex will obtain exclusive commercialization rights for Vizz for the treatment of presbyopia in Australia & New Zealand. In return,…

ByRidhi RastogiJune 26, 2026

Ridhi Rastogi

Orion Pharma Partners with Shilpa Medicare to Commercialize Nivolumab Biosimilar in the EU

The EC Approves Daiichi Sankyo and AstraZeneca’s Enhertu for Previously Treated HER2+ Metastatic Solid Tumors

Zymeworks to Acquire Theravance for ~$929M

Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)

Ipsen to Acquire Kartos Therapeutics for ~$1.75B

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the CHMP Positive Opinion for Rett Syndrome

Daiichi Sankyo and AstraZeneca Report the CHMP Positive Opinion for Datroway to Treat Metastatic Triple Negative Breast Cancer

Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

LENZ Therapeutics Partners with Arrotex Pharmaceuticals to Commercialize Vizz in Australia and New Zealand

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