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

NEWS

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

NEWS

Sanofi to Acquire Dynavax for ~$2.2B

Shots: Sanofi has entered into an agreement to acquire Dynavax, incl. Heplisav-B (adult hepatitis B vaccine), Z-1018 (differentiated shingles vaccine candidate) & additional vaccine pipeline projects As per the deal, Sanofi will acquire Dynavax for $15.50/share in cash, representing the total equity value of ~$2.2B, after which a Sanofi subsidiary will merge with & into Dynavax…

ByRidhi RastogiDecember 24, 2025

NEWS

Novo Nordisk Reports the US FDA Approval of Oral Wegovy for Weight Management

Shots: FDA has approved Wegovy (25mg, QD, PO) for weight loss, chronic weight management & major adverse CV events risk reduction in adults with obesity/overweight; US availability expected in early Jan 2026. Regulatory filing is made to the EMA & other authorities in H2’25 Approval was based on the P-IIIb (OASIS 4) trial assessing oral…

ByRidhi RastogiDecember 24, 2025

NEWS

Windward Bio Secures Exclusive Rights to WIN027 from Qyuns Therapeutics in a ~$700M Deal

Shots: Windward Bio via its affiliate, LE2025 Therapeutics, has entered into a licensing agreement with Qyuns to develop & commercialize WIN027 (QX027N; anti-TSLPxIL-13 bsAb) As per the deal, Windward will obtain exclusive rights to develop, manufacture, & commercialize WIN027 outside of China, with Qyuns receiving an upfront payment, equity, & development, regulatory, & commercial milestones,…

ByRidhi RastogiDecember 24, 2025

INSIGHTS+

New Drug Designations – November 2025

Shots: PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA  The November 2025 report covers designations granted to 22 drugs and 1 medical device, spanning 8 small molecules, 8 biologics, 2 cell and gene therapies & 1 medical…

ByRidhi RastogiDecember 23, 2025

NEWS

Shionogi to Acquire Tanabe Pharma’s Radicava Franchise in $2.5B Rare Disease Deal

Shots: Shionogi to acquire a newly established company that will be created by Tanabe Pharma to hold the rights to Radicava ORS (edaravone) & IV Radicava As per the deal, Tanabe Pharma will establish a new entity, & Shionogi will acquire 100% of its shares, with Tanabe’s US Radicava business company becoming a wholly owned…

ByRidhi RastogiDecember 23, 2025

NEWS

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R Follicular Lymphoma (FL)

Shots: The MHLW has approved Incyte’s Minjuvi + rituximab & lenalidomide for the treatment of adults with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Approval was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL or r/r nodal, splenic or extranodal MZL…

ByRidhi RastogiDecember 23, 2025

Ridhi Rastogi

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

Sanofi to Acquire Dynavax for ~$2.2B

Novo Nordisk Reports the US FDA Approval of Oral Wegovy for Weight Management

Windward Bio Secures Exclusive Rights to WIN027 from Qyuns Therapeutics in a ~$700M Deal

New Drug Designations – November 2025

Shionogi to Acquire Tanabe Pharma’s Radicava Franchise in $2.5B Rare Disease Deal

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R Follicular Lymphoma (FL)

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