NEWS

Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

Shots: Akeso has reported P-Ib/II study data assessing cadonilimab + anlotinib & docetaxel in pts with locally advanced or metastatic NSCLC who progressed after prior PD-(L)1 inhibitor-based therapy At mFU of 21.45mos., the trial showed 6mos. PFS rate of 55.7%, with an mPFS of 7mos. in the overall population, while in sq-NSCLC & PD-L1 TPS…

April 7, 2026

Organogenesis Reports Trial Results on PuraPly AM for Wound Healing in Diabetic Foot Ulcers

Shots: Organogenesis has reported the trial completion of PuraPly AM, assessing it in combination with SoC vs SOC alone for the management of non-healing diabetic foot ulcers (DFUs) The 170-patient trial achieved its 1EP, showing significant wound closure at 12wks., with the company planning to publish the study results soon in a journal PuraPly AM…

April 7, 2026

Apotex Receives Health Canada Approval for Denoza (Biosimilars, Prolia)

Shots: Health Canada has approved Denoza (denosumab injection), a biosimilar version of Prolia Denoza is approved for the treatment of osteoporosis in postmenopausal women and in men at high risk of fracture. It is also authorized for all other indications of the reference biologic, as detailed in the Product Monograph Denoza will be available in a prefilled syringe format Ref: Apotex | Image: Apotex | Press Release…

April 7, 2026

CuraTeQ Reports P-III Trial Data on BP11 (Biosimilar, Xolair) in Chronic Spontaneous Urticaria

Shots: CuraTeQ Biologics has reported topline P-III trial data assessing BP11, a biosimilar version of Xolair (omalizumab) vs Xolair in pts with chronic spontaneous urticaria Trial met its 1EPs in CSU at 300mg, evaluating ISS7 changes at Wk. 12 across 608 pts at ~80 sites, demonstrating equivalence between BP11 & Xolair within predefined margins Additionally,…

April 7, 2026

Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease

Shots: Amgen has reported topline P-III results assessing Tepezza (SC, Q2W × 12) vs PBO dosed via an on-body injector in pts with mod. to sev. active Thyroid Eye Disease (TED) The trial met its 1EP, showing a 76.7% vs 19.6% proptosis response rate, with 3.17 vs 0.80 mm mean proptosis reduction (key 2EP) at 24wks.…

April 7, 2026

Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications

Shots: Sanofi has reported P-IIb (AIRCULES), P-IIa (DUET) PoC & P-IIb (VELVET) data assessing lunsekimig (SC) in adults with mod. to sev. asthma, CRSwNP, & in mod. to sev. atopic dermatitis, respectively In AIRCULES, lunsekimig met 1 & 2EPs, reducing exacerbations & improving lung fuction as measured by pre-BD FEV1 vs PBO, while in DUET it met…

April 7, 2026

Neurocrine Biosciences to Acquire Soleno Therapeutics for $2.9B

Shots: Neurocrine Biosciences has entered into a definitive agreement to acquire Soleno, expanding its endocrinology & rare disease portfolio As per the deal, Neurocrine will acquire Soleno for $53/share in cash, representing a total transaction equity value of $2.9B Acquisition will add Vykat XR (diazoxide choline) to Neurocrine's portfolio for the treatment of hyperphagia with Prader-Willi…

April 6, 2026

The US FDA Accepts Ultragenyx’s Resubmitted BLA for UX111 in Sanfilippo Syndrome Type A

Shots: The US FDA has accepted the resubmitted BLA of UX111 (rebisufligene etisparvovec) for accelerated approval in Sanfilippo syndrome Type A (MPS IIIA), with a PDUFA action date of Sep 19, 2026 UX111 BLA is supported by up to 8yrs. of follow-up data showing durable clinical benefit & acceptable safety. Also, during prior late-cycle review,…

April 6, 2026

Adagene Reports P-Ib/II Trial Data on Muzastotug + Keytruda for Microsatellite Stable Colorectal Cancer (MSS CRC)

Shots: The P-Ib/II trial randomized 67 MSS CRC pts (65 evaluable) with no liver metastases to muzastotug (10mg/kg; Q3W or Q6W) or muzastotug (20mg/kg) followed by 10mg/kg (Q3W), or 20 mg/kg (Q6W), all in combination with Keytruda; P-II data expected in H1’27 As of Jan 24, 2026, pts in 10mg/kg cohorts (N=39) showed ORR of…

April 6, 2026

Denali Regains Full Rights to Frontotemporal Dementia Therapy as Takeda Exits DNL593 Pact

Shots: Takeda has terminated its collaboration with Denali for the co-development & commercialization of DNL593, citing strategic considerations unrelated to safety or efficacy Denali will regain full control of DNL593, a progranulin replacement therapy leveraging its Protein TransportVehicle platform to cross the blood-brain barrier for the treatment of frontotemporal dementia The ongoing P-I/II study has…

April 6, 2026

NEWS

Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

Organogenesis Reports Trial Results on PuraPly AM for Wound Healing in Diabetic Foot Ulcers

Apotex Receives Health Canada Approval for Denoza (Biosimilars, Prolia)

CuraTeQ Reports P-III Trial Data on BP11 (Biosimilar, Xolair) in Chronic Spontaneous Urticaria

Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease

Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications

Neurocrine Biosciences to Acquire Soleno Therapeutics for $2.9B

The US FDA Accepts Ultragenyx’s Resubmitted BLA for UX111 in Sanfilippo Syndrome Type A

Adagene Reports P-Ib/II Trial Data on Muzastotug + Keytruda for Microsatellite Stable Colorectal Cancer (MSS CRC)

Denali Regains Full Rights to Frontotemporal Dementia Therapy as Takeda Exits DNL593 Pact

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