Skip to content Skip to footer

Protillion Biosciences and Merck Enter ~$510M Drug Discovery Collaboration

Shots: Protillion has entered into a multi-target discovery collaboration & license agreement with Merck, integrating Protillion’s Prot-MaP technology with Merck’s global expertise in the discovery of novel therapeutic candidates As per the deal, Protillion will receive an undisclosed upfront payment & ~$510M in research, development, & commercial milestone payments for the successful development of multiple…

Read more

Merck new

Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

Shots: The US FDA has approved MSD's Welireg + Keytruda/Keytruda QLEX as adj. therapy in clear cell renal cell carcinoma (ccRCC) pts at intermediate-high or high risk of recurrencepost-nephrectomy or post-nephrectomy & resection of metastatic lesions Approval was backed by the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO)…

Read more

Merck

Merck Secures the US FDA Breakthrough Therapy Designation for Calderasib to Treat Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC

Shots: The US FDA has granted BTD to Merck's calderasib (MK-1084) + Keytrudafor the 1L treatment of pts with advanced or metastatic NSCLC with KRAS G12C-mutation & expressing PD-L1 (TPS ≥1%) Designation was supported by P-I (KANDLELIT-001) trial data showing calderasib monotx. (n=21) achieved a 38% ORR, calderasib + Keytruda (n=69) delivered an ORR of 77%, while…

Read more

Merck

Merck Reports the P-III (TroFuse-005) Trial Data on Sacituzumab Tirumotecan for Advanced or Recurrent Endometrial Cancer

Shots: Merck has reported global P-III (TroFuse-005) trial data assessing sac-TMT (4 mg/kg, Q2W) vs doxorubicin/paclitaxel in 776 pts with endometrial carcinoma & carcinosarcoma who have received prior Pt-based CT & anti-PD-1/anti-PD-L1 immunotherapy either together or separately Trial met its 1EP of improved OS & PFS in the above pts, plus it also reached its key…

Read more

EMA Marketing Authorization of New Drugs in April 2026    

Shots:  The European Medicines Agency advanced multiple approvals and late-stage recommendations in April 2026 across infectious diseases, neurology, immunology, endocrinology, and rare disorders, involving companies including Merck, Moderna, Novartis, Sanofi, and Mitsubishi Tanabe Pharma  CHMP positive opinions included Redemplo for familial chylomicronemia syndrome, Itvisma for spinal muscular atrophy, and Cenrifki for non-relapsing SPMS  The EC also approved therapies including Enflonsia for RSV prevention in infants, mCOMBRIAX for influenza/COVID-19 prevention, Palsonify for acromegaly, Rhapsido for…

Read more

The US FDA New Drug Approvals in April 2026 

Shots:  Approval activity continued strongly into April 2026, with the US FDA authorizing two significant therapies across metabolic disease and infectious disease, reinforcing the agency’s focus on chronic disease management, long-term treatment innovation, and broader patient access.  Two notable therapies achieved regulatory clearance: Eli Lilly’s Foundayo for weight loss in obese or overweight adults with weight-related conditions,…

Read more

Merck Partners with Google Cloud in ~$1B Deal to Build AI-Enabled Enterprise Platform

Shots: Merck partnered with Google Cloud in a multi-year deal worth up to $1B to deploy an AI-driven agentic platform across R&D, manufacturing, commercial, and corporate functions The collaboration will integrate advanced AI tools, incl. Gemini Enterprise, to enhance productivity, digitize data, & support Merck’s global workforce of ~75,000 employees The partnership aims to accelerate…

Read more

Merck new

Merck Report the EC Approval of Enflonsia for RSV Prevention in Infants 

Shots:  The EC has approved Enflonsia (clesrovimab) to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk infants  The Phase 2b/3 CLEVER trial (N=3,614) evaluated in infants entering their first RSV season. Enflonsia reduced RSV-associated medically attended LRIs…

Read more