NEWS

GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B

Shots: The EMA has accepted MAA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB) MAA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml across 29 countries Both trials met…

23 hours ago

Novartis to Acquire Excellergy for ~$2B

Shots: Novartis has entered into an agreement to acquire Excellergy, incl. its asset Exl-111, strengthening Novartis immunology strategy in food allergy & other IgE-driven diseases As per the deal, Novartis will acquire Excellergy for ~$2B, incl. upfront & milestone payments, with closing expected in H2’26 EXL-111 is engineered to dissociate receptor-bound IgE, enabling faster &…

24 hours ago

AstraZeneca Reports the P-III (OBERON & TITANIA) Trial Data on Tozorakimab for Chronic Obstructive Pulmonary Disease (COPD)

Shots: AstraZeneca reported data from replicate P-III (OBERON & TITANIA) trials assessing tozorakimab (300mg, Q4W) vs PBO over 52wks. on top of inhaled therapy in 2,306 adults with symptomatic COPD & prior exacerbations The trial met its 1EP, reducing annualised rates of mod. to sev. COPD exacerbations in former smokers & the overall population, incl.…

1 day ago

Insilico Medicine Expands AI-Driven CNS Collaboration with Tenacia in a ~$94.75M Deal

Shots: Insilico Medicine and Tenacia Biotechnology have expanded their AI-driven R&D collaboration to develop an additional CNS candidate with defined properties, advancing it to the preclinical candidate stage for neurological disorders The initial collaboration, launched in Mar 2025, combined Insilico’s Pharma.AI platform with Tenacia’s CNS expertise to develop BBB-permeable small-molecule inhibitors, with the program progressing…

1 day ago

Abcuro Presents the P-II/III (MUSCLE) Study Data on Ulviprubart for Inclusion Body Myositis at GCOM 2026

Shots: Abcuro has reported the P-II/III (MUSCLE) trial data assessing ulviprubart (ABC008; Q8W) in 272 IBM pts randomized to either 0.5mg/kg (n=94, Low Dose), 2mg/kg (n=92, High Dose), or PBO (n=86) Across all pts, the 1EP showed a trend toward slower IBMFRS decline at Wk. 76, with a 1.7-point decrease in the low-dose group vs…

1 day ago

Novo Nordisk’s Awiqli Receives the US FDA Approval for Type 2 Diabetes

Shots: The US FDA approved Awiqli (insulin icodec-abae; 700 units/mL) to improve glycaemic control in adults with type 2 diabetes as an adjunct to diet & exercise, with Novo planning a US launch in the FlexTouch device in H2’26 Approval was based on the P-IIIa (ONWARDS) program assessing Awiqli (QW) vs basal insulin (QD) in…

1 day ago

Novocure Reports Topline P-II (PANOVA-4) Trial Data on TTFields Therapy for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Shots: Novocure reported P-II (PANOVA-4) trial data evaluating Tumor Treating Fields (TTFields) with Tecentriq & gemcitabine/nab-paclitaxel as a 1L treatment for mPDAC, with a median TTFields duration of 25.6wks. & median systemic therapy duration of 6 cycles Trial met its 1EP, showing a DCR of 74.4% in TTFields group (N=78) vs 48% with gem/nab-pac alone…

2 days ago

Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

Shots: Otsuka Pharmaceutical has reported P-III (VISIONARY) trial data evaluating Voyxact (sibeprenlimab-szsi; 400mg, SC, Q4W) vs PBO in IgAN pts at risk for disease progression Trial showed 82.5% vs 52.6% pts achieved negative microscopic hematuria (0–5/HPF; exploratory EP) at 48wks., with a median time to achieve 0–5/HPF was 9 vs 24wks.; data were presented at…

2 days ago

Kallisio’s Stentra Receives CE Mark for Precision Oral Immobilization System in Head & Neck Radiation Therapy

Shots: Kallisio has received CE certification under the EU MDR 2017/745 for its Stentra intraoral positioning system, with initial deployment planned through selected clinical pilot sites in Germany Stentra is a patient-specific intraoral device designed to support precise positioning & stabilization during head & neck radiation therapy, integrating seamlessly into existing workflows without requiring changes…

2 days ago

Biogen and Alteogen Partner for ALT-B4 to Advance Subcutaneous Formulations of Biologics

Shots: Alteogen has granted Biogen exclusive rights to ALT-B4 (berahyaluronidase alfa) to develop & commercialize SC formulations of two biologics, with an option for Biogen to develop a third product As per the deal, Alteogen will receive $20M upfront, $10M upon initiation of second product development, along with ~$549M in development, regulatory, & sales milestones…

2 days ago

NEWS

GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B

Novartis to Acquire Excellergy for ~$2B

AstraZeneca Reports the P-III (OBERON & TITANIA) Trial Data on Tozorakimab for Chronic Obstructive Pulmonary Disease (COPD)

Insilico Medicine Expands AI-Driven CNS Collaboration with Tenacia in a ~$94.75M Deal

Abcuro Presents the P-II/III (MUSCLE) Study Data on Ulviprubart for Inclusion Body Myositis at GCOM 2026

Novo Nordisk’s Awiqli Receives the US FDA Approval for Type 2 Diabetes

Novocure Reports Topline P-II (PANOVA-4) Trial Data on TTFields Therapy for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

Kallisio’s Stentra Receives CE Mark for Precision Oral Immobilization System in Head & Neck Radiation Therapy

Biogen and Alteogen Partner for ALT-B4 to Advance Subcutaneous Formulations of Biologics

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