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Epitopea & Merck have entered into license & research collaboration agreement to discover Cryptigen tumor-specific antigens (TSAs) in an undisclosed solid tumor
As per the deal, Epitopea will receive an undisclosed upfront & ~$300M in milestones per product in exchange for Merck receiving exclusive development & commercialization rights to the TSA products identified…
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The EC has approved Welireg for VHL-related localized RCC, CNS hemangioblastomas, or pNET unsuitable for localized procedures and advanced ccRCC post-PD-1/PD-L1 inhibitors or VEGF therapies progression across EU member states, as well as Iceland, Liechtenstein & Norway
Approval for VHL-related tumors was based on P-II (LITESPARK-004) study (n=61), showing ORR of 49% (all…
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The EMA’s CHMP has granted positive opinions to 5 Biologics in January 2025, leading to treatments for patients and advances in the healthcare industry
The major highlighted drugs were Merck’s Capvaxive to treat Pneumococcal Disease
PharmaShots has compiled a list of 4 drugs that have been granted positive opinions and approvals by the EMA’s…
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Merck initiated P-III (waveLINE-010) trial to assess zilovertamab vedotin (ROR1- ADC) + R-CHP (Rituximab, cyclophosphamide, doxorubicin & prednisone) vs R-CHOP (R-CHP + vincristine) to treat pts with previously untreated DLBCL; global enrolment is ongoing
Trial will enrol ~1,046 pts to assess PFS as the 1EP, with 2EPs incl. OS, event-free survival, duration of…
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The CHMP has recommended Capvaxive for active immunization against invasive disease & pneumonia caused by Streptococcus pneumoniae in adults (≥18yrs.), with the EC’s decision expected in Q2’25 for EU, Iceland, Liechtenstein and Norway. Ongoing regulatory review in Japan, plus multiple filings are underway
Opinion was backed by P-III (STRIDE-3) data, assessing Capvaxive vs PCV20…
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The 43rd Annual J.P. Morgan Conference took place from 13th to 16th January in San Francisco, USA. J.P. Morgan Healthcare Conference serves as a pioneering hub that features presentations and dialogues on the advances of the healthcare industry by bringing healthcare professionals, researchers, manufacturers, and other healthcare stakeholders to one platform.
Innovation remained the…
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P-III (LEAP-015) trial assessed Keytruda + Lenvima + CT (CAPOX or mFOLFOX6 regimen) as a 1L therapy for LA/M inoperable HER2- GE adenocarcinoma pts in 2 parts (P1: safety run-in & P2: main trial). LEAP program is also assessing it in hepatocellular carcinoma & esophageal cancer
P2 pts (n=880) received Keytruda (400mg, IV…
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The CHMP has recommended conditional approval of Welireg for VHL-related localized RCC, CNS hemangioblastomas or pNET unsuitable for localized procedures and advanced ccRCC post PD-1/PD-L1 inhibitors or VEGF therapies progression. EC’s decision is anticipated in Q1’25
Opinion for VHL-related tumors was based on LITESPARK-004 study (n=61), showing ORR of 49% (all PRs), with 56%…
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The third quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Eli Lilly's acquisition of Morphic Holdings for ~$3.2B
This quarter also showcased multiple clinical trial results including Roche's P-I Study Data of CT-996 to treat Obesity
Our…
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With more than 50 percent of ongoing clinical trials, Oncology remains one of the most explored therapy areas in healthcare
In 2023, the global oncology market was valued at $222.36B and is envisioned to grow to $521.6B by 2033, registering a CAGR of 8.9% from 2024 to 2033. With $27.6B registered oncology revenue, Merck…

