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Johnson & Johnson
NEWS

Johnson & Johnson’s Darzalex (daratumumab) Receives the CHMP’s Positive Opinion for Multiple Myeloma

Shots: The CHMP has recommended Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat newly diagnosed multiple myeloma pts. Opinion was based on P-III (CEPHEUS) trial, which assessed efficacy & safety in transplant-ineligible or deferred NDMM pts (n=395) not planned for ASCT as initial therapy, in 13 countries across North America, South America and…
March 4, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study Evaluating Enhertu in HER2+ Metastatic Gastric Cancer Patients

Shots: The data from P-III (DESTINY-Gastric04) study showed statistically significant and clinically meaningful improvement in OS vs ramucirumab & paclitaxel in 2L HER2+ (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma pts. The safety profile observed in DESTINY-Gastric04 aligns with Enhertu's established safety record. The company expects to present data…
March 4, 2025

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AbbVie & Gubra
NEWS

AbbVie Enters into a Global License Agreement with Gubra to Develop & Commercialize GUB014295 to Treat Obesity

Shots: AbbVie and Gubra entered into a global license agreement to develop & commercialize GUB014295, a potential long-acting amylin analog for obesity treatment As per the deal, AbbVie will lead GUB014295's global development & commercialization, whereas Gubra will get $350M upfront, up to $1.875B development, commercial, sales milestones, with tiered royalties; transaction closure is…
March 4, 2025

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BBOT
NEWS

BridgeBio Oncology Therapeutics (BBOT) Enters into Business Combination Agreement with Helix Acquisition Corp. II to Develop RAS and PI3Kα-Targeting Drugs

Shots: BBOT will reverse merge with Helix in a SPAC transaction, where combined entity - "BBOT” will be listed on Nasdaq; closing expected in Q3’25 Upon closing, BBOT will have ~$550M cash (pre-transaction) incl. $100M in existing cash, $196M from Helix’s trust & $260M from PIPE financing. At $10.36/share, the combined entity's implied pro…
March 3, 2025

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GSK
NEWS

GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025

Shots: The P-III (ANCHOR-1: N=271, ANCHOR-2: N=257) trial assessed depemokimab + SoC vs PBO + SoC in CRSwNP pts that showed early benefits lasting over 52wks. ANCHOR data with SWIFT-1 & 2 trial data will support global filings for asthma with type 2 inflammation & CRSwNP Pooled analysis of 2EPs showed 0.7-point NPS decrease (-0.9 to…
March 3, 2025

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Krystal Biotech
NEWS

Krystal Biotech’s Vyjuvek (beremagene geperpavec) Receives the CHMP’s Positive Opinion for Dystrophic Epidermolysis Bullosa (DEB)

Shots: The CHMP has recommended Vyjuvek (B-VEC) for treating wounds in DEB pts with COL7A1 mutations from birth. The EC's decision is expected in Q2’25, with launch anticipated under the trade name Vyjuvek in 30 EEA states—Germany in mid-2025 & France in late 2025 Opinion was based on various clinical data, incl. P-I/II (GEM-1)…
March 3, 2025

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Magnet Biomedicine & Eli Lilly
NEWS

Magnet Biomedicine Partners with Eli Lilly to Advance Molecular Glue Therapeutics in Oncology

Shots: Magnet Biomedicine & Eli Lilly have entered into a collaboration & license agreement to identify, develop & commercialize molecular glue therapeutics in oncology using Magnet's TrueGlue discovery platform As per the deal, Magnet will get ~$40M in upfront, near-term payments & equity, plus more than $1.25B in milestones across development, regulatory, & commercial…
March 3, 2025

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