ABL Bio Secures Upfront Payment and Equity Investment from Lilly to Accelerate Grabody Programs

Shots: ABL Bio has secured a total of $55M, incl. $40M upfront & $15M in equity investment, from Eli Lilly under their ~$2.602B license, research & collaboration agreement Under the deal, ABL Bio & Eli Lilly are jointly advancing multiple therapeutic candidates across diverse modalities, leveraging ABL Bio’s Grabody platform for collaborative research & development…

ByRidhi RastogiDecember 29, 2025

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Bruno Vision Care Reports the US FDA Clearance of Deseyne for Presbyopia

Shots: FDA has cleared Deseyne, a daily disposable soft contact lens for presbyopia that uses patented Extended Depth of Focus technology Deseyne provides continuous near, intermediate, & distance vision through Cataltheia’s patented hyper-refractive central zone, showing a clinical advantage over multifocal lenses with minimal patient adaptation, strong comfort, & no adverse events reported in studies Made…

ByRidhi RastogiDecember 26, 2025

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Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

Shots: The US FDA has granted IND clearance to initiate a P-IIa trial of 9MW1911 for the treatment of patients with mod. to sev. chronic obstructive pulmonary disease (COPD) In the China P-IIa trial (n=80) vs PBO, 9MW1911 showed dose-proportional exposure & dose-dependent efficacy, with the RP2D (n=30) reducing mod. to sev. COPD exacerbations by…

ByRidhi RastogiDecember 26, 2025

NEWS

Sanofi and Regeneron’s Dupixent (Dupilumab) Receives MHLW Approval for Children with Bronchial Asthma

Shots: The MHLW has approved Sanofi and Regeneron’s Dupixent for the treatment of bronchial asthma in children (6-11yrs.) with severe or refractory disease whose symptoms are inadequately controlled with existing therapy Approval was based on the P-III (VOYAGE) trial data in the overall population & those with a type 2 inflammation phenotype, which showed reduced…

ByRidhi RastogiDecember 26, 2025

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Italfarmaco and JCR Pharmaceuticals Partner to Commercialize Givinostat in Japan

Shots: Italfarmaco has entered into an exclusive licensing agreement with JCR Pharmaceuticals for the development and commercialisation of givinostat in Japan As per the deal, JCR will secure exclusive rights to commercialize givinostat, marketed as Duvyzat in US, EU & UK, for Duchenne muscular dystrophy (DMD) in Japan & will lead local execution of clinical…

ByRidhi RastogiDecember 26, 2025

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Omeros Receives the FDA Approval for Yartemlea (Narsoplimab-wuug) to Treat TA-TMA

Shots: The US FDA has approved Yartemlea for the treatment of HSCT-Associated Thrombotic Microangiopathy, with US launch planned for Jan 2026. MAA is under the EMA’s review, with a decision expected in mid-2026 Approval was based on the TA-TMA Study (n=28) plus EAP (N=221 adults & pediatric pts), where 19 pts (13 adult & 6…

ByRidhi RastogiDecember 26, 2025

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Innovent’s Tabosun (Ipilimumab N01) Receives the NMPA approval for MSI-H/dMMR Resectable Colon Cancer

Shots: The NMPA has approved Innovent's Tabosun (ipilimumab N01 injection or IBI310) + sintilimab for the neoadj. treatment of stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer Approval was based on the P-III (NeoShot) trial assessing ipilimumab N01 + sintilimab as neoadj. therapy in pts with MSI-H/dMMR colon cancer Trial met…

ByRidhi RastogiDecember 26, 2025

NEWS

Sanofi’s Wayrilz (Rilzabrutinib) Receives the EC Approval for Immune Thrombocytopenia

Shots: The EC has approved Sanofi's Wayrilz for adults with Immune Thrombocytopenia (ITP) who are refractory to other treatments Approval was based on P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO in adults (n=202) with ITP over 12wks., after which 64% vs 32% achieved a durable platelet count continued for 24wks., followed…

ByRidhi RastogiDecember 24, 2025

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Rectify Pharmaceuticals and Boehringer Ingelheim Partner to Develop Small Molecules for Chronic Kidney Disease (CKD)

Shots: Rectify has entered into a strategic research & licensing agreement with BI to accelerate the development of small molecule therapies for CKD & other conditions Collaboration will leverage Rectify’s positive functional modulators (PFM) platform to develop oral small molecules that restore or enhance ABCC6 function, targeting pathologic calcification to slow disease progression in CKD, Pseudoxanthoma elasticum,…

ByRidhi RastogiDecember 24, 2025

NEWS

Ipsen Signs ~$1.06B Deal with Simcere Zaiming for SIM0613

Shots: Ipsen has entered into an exclusive licensing agreement with Simcere Zaiming for SIM0613 to treat solid tumors with the highest unmet needs Ipsen will secure global rights to SIM0613 outside Greater China, gain manufacturing rights after technology transfer, & assume responsibility for all development activities beyond Greater China, incl. P-I preparation & IND/CTA submissions As…

ByRidhi RastogiDecember 24, 2025

Ridhi Rastogi

ABL Bio Secures Upfront Payment and Equity Investment from Lilly to Accelerate Grabody Programs

Bruno Vision Care Reports the US FDA Clearance of Deseyne for Presbyopia

Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

Sanofi and Regeneron’s Dupixent (Dupilumab) Receives MHLW Approval for Children with Bronchial Asthma

Italfarmaco and JCR Pharmaceuticals Partner to Commercialize Givinostat in Japan

Omeros Receives the FDA Approval for Yartemlea (Narsoplimab-wuug) to Treat TA-TMA

Innovent’s Tabosun (Ipilimumab N01) Receives the NMPA approval for MSI-H/dMMR Resectable Colon Cancer

Sanofi’s Wayrilz (Rilzabrutinib) Receives the EC Approval for Immune Thrombocytopenia

Rectify Pharmaceuticals and Boehringer Ingelheim Partner to Develop Small Molecules for Chronic Kidney Disease (CKD)

Ipsen Signs ~$1.06B Deal with Simcere Zaiming for SIM0613

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