NEWS

Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Pulmonary Hypertension Early

Shots: The FDA has granted 510(k) clearance to an AI-enabled PH algorithm, a software-as-a-medical-device designed to detect early signs of PH, cleared for use with standard 12-lead ECGs The PH algorithm detects subtle early PH patterns in standard 12-lead ECGs & integrates with EHR & ECG management systems, plus it operates entirely within the health…

7 minutes ago

The CHMP Recommends Immedica’s Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) to Treat 1L ES-SCLC

Shots: The CHMP has recommended Zepzelca + Tecentriq as a 1L therapy for adults with ES-SCLC whose disease remains stable after initial treatment with Tecentriq, carboplatin, & etoposide Opinion was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced risk of progression or death by 46% & death risk by 27% vs Tecentriq…

1 hour ago

Takeda Presents P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis at AAD 2026

Shots: The 2 P-III (Latitude PsO 3001 & PsO 3002) trials assessed zasocitinib in 693 & 1108 adults with mod. to sev. PsO, with plans for NDA submission to FDA & other authorities starting Takeda’s FY’26 PsO 3001 showed 71.4% achieved sPGA 0/1 vs PBO (10.7%) & apremilast (32.1%), with 39.9% reaching sPGA…

2 hours ago

Pharming Reports the CHMP Positive Opinion on Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta (APDS) Syndrome

Shots: The CHMP has recommended Joenja for the treatment of pts (≥12yrs.) with APDS syndrome, with EC decision expected in Q2’26, which, if positive, would be valid across all 30 EEA member states Opinion was based on P-II/III trial of Joenja vs PBO in 31 APDS pts (≥12 years), showing significant improvement in immune dysregulation…

4 hours ago

Otsuka to Acquire Transcend Therapeutics for ~$1.225B

Shots: Otsuka, via its subsidiary Otsuka America, has entered into an agreement to fully acquire Transcend, with an aim to expand its portfolio in psychiatric & neurological indications As per the deal, Otsuka will acquire Transcend for $700M upfront, & ~$525M in sales milestones, representing the total deal value of ~$1.225B; closing is expected in…

5 hours ago

Insilico Medicine and Eli Lilly Sign ~$2.75B Multi-Program AI-Driven Drug Discovery Collaboration

Shots: Insilico has entered into a drug discovery collaboration with Eli Lilly to accelerate the discovery & development of novel therapeutics across multiple therapeutic areas using Insilico’s Pharma.AI As per the deal, Lilly will gain exclusive global rights to develop, manufacture & commercialize Insilico’s preclinical oral candidates for select indications. Also, both will collaborate on…

6 hours ago

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…

3 days 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 &…

3 days 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.…

3 days 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…

3 days ago

NEWS

Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Pulmonary Hypertension Early

The CHMP Recommends Immedica’s Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) to Treat 1L ES-SCLC

Takeda Presents P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis at AAD 2026

Pharming Reports the CHMP Positive Opinion on Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta (APDS) Syndrome

Otsuka to Acquire Transcend Therapeutics for ~$1.225B

Insilico Medicine and Eli Lilly Sign ~$2.75B Multi-Program AI-Driven Drug Discovery Collaboration

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

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