NEWS

Endo & Mallinckrodt Pharmaceuticals to Form a Combine Entity with $6.7B Cash-and-Stock

Shots: Mallinckrodt & Endo to combine their generic pharmaceuticals & Endo’s sterile injectables businesses, later separating the unit, with combined company headquartered in Dublin, Ireland & Endo operating as Mallinckrodt’s subsidiary As per the deal, Endo shareholders will receive $80M in cash & own 49.9% of the combined company, while Mallinckrodt shareholders will hold 50.1%,…

March 18, 2025

Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS)

Shots: The 2 P-III (STOP-HS1 & STOP-HS2) trials assessed povorcitinib (45 or 75mg, QD, PO) vs PBO in mod. to sev. HS pts (≥18yrs.; n=600 each) for 12wks., followed by 42wk. extension & 30-day follow-up STOP-HS1 met its 1EP, with povorcitinib (45 mg/75 mg) showing higher HiSCR50 rates at Wk. 12 (40.2%/40.6% vs 29.7%), while…

March 18, 2025

NANOBIOTIX and Janssen Amend Partnership to Develop and Commercialize JNJ-1900 (NBTXR3)

Shots: NANOBIOTIX & Janssen have amended their 2023 collaboration to develop & commercialize JNJ-1900 (NBTXR3), adjusting the deal value from $2.7B to $2.6B As per the revision, NANOBIOTIX will receive ~$1.77B in milestones related to cisplatin-ineligible HNSCC & inoperable stage 3 NSCLC, with ~$165M in milestones for China, South Korea, Singapore, & Thailand. J&J will cover…

March 18, 2025

AstraZeneca to acquire EsoBiotec for ~$1B

Shots: AstraZeneca to acquire EsoBiotec, which will operate as AstraZeneca’s subsidiary, while maintaining its operations in Belgium to advance cell therapy As per the deal, AstraZeneca will acquire all outstanding equity of EsoBiotec on a cash & debt-free basis for ~$1B, incl. $425M upfront at closing & ~$575M in development & regulatory milestones; closing…

March 18, 2025

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva)

Shots: The US FDA has accepted 351(k) BLA of AVT03, a biosimilar version of Prolia & Xgeva (denosumab), for all indications of reference product As per the 2024 license & supply agreement, Alvotech is responsible for the development & manufacturing of AVT03, while Dr. Reddy’s handles registration & marketing in licensed regions, incl. the U.S. …

March 18, 2025

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots: The EC has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Approval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by…

March 17, 2025

Perfuze Secures the US FDA’s 510(k) Clearance for its Zipline Access Catheters

Shots: The US FDA has granted 510(k) clearance to Zipline Access Catheters to treat acute ischemic strokes Zipline improves delivery of a large (070) & superbore (088) aspiration catheter to enhance trackability & simplify neuro-interventional procedures for faster as well as more efficient stroke treatment. Zipline also optimizes clot removal & improves success rates…

March 17, 2025

AstraZeneca and Alteogen Enter an Exclusive License Deal for ALT-B4 to Develop & Market Subcutaneous Formulations of Multiple Oncology Drugs

Shots: Alteogen has granted AstraZeneca global rights of ALT-B4 to develop & commercialize SC formulations of multiple oncology assets, while Alteogen will be responsible for clinical & commercial supply of ALT-B4 As per the deal, Alteogen will receive an upfront, along with development, regulatory, & sales milestones, plus royalties on sale of commercialized products…

March 17, 2025

Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

Shots: Amgen has reported P-III (MINT) trial data on Uplizna vs PBO in adults (N=238) with AChR+ gMG (n=190) or MuSK+ gMG (n=48), followed for 52 & 28wks., respectively; sBLA under FDA’s priority review for IgG4-RD (PDUFA: Apr 3, 2025), with regulatory filings expected to end by H1’25 Pts received an initial loading dose…

March 17, 2025

AbbVie Reports P-III (MIRASOL) Trial Data of Elahere for FRα-Positive Platinum-Resistant Ovarian Cancer (PROC)

Shots: AbbVie has reported final analysis data from P-III (MIRASOL) trial assessing Elahere vs CT in FRα+ PROC pts (n= 453) who had previously received 1-3L of therapy At 30.5mos. mFU, trial showed 37% improved PFS (mPFS: 5.59 vs 3.98mos.) & superior ORR (41.9% vs 15.9%), while mOS was 16.85 vs 13.34mos., with 32% reduced…

March 17, 2025

NEWS

Endo & Mallinckrodt Pharmaceuticals to Form a Combine Entity with $6.7B Cash-and-Stock

Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS)

NANOBIOTIX and Janssen Amend Partnership to Develop and Commercialize JNJ-1900 (NBTXR3)

AstraZeneca to acquire EsoBiotec for ~$1B

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva)

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Perfuze Secures the US FDA’s 510(k) Clearance for its Zipline Access Catheters

AstraZeneca and Alteogen Enter an Exclusive License Deal for ALT-B4 to Develop & Market Subcutaneous Formulations of Multiple Oncology Drugs

Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

AbbVie Reports P-III (MIRASOL) Trial Data of Elahere for FRα-Positive Platinum-Resistant Ovarian Cancer (PROC)

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