Pfizer Reveals Data from P-III (BREAKWATER) trial of Braftovi Regimen in Patients with Metastatic Colorectal Cancer

Shots: Pfizer reported topline data of P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in untreated BRAF V600E-mutant mCRC pts, randomized to Braftovi + Erbitux (n=158), Braftovi + Erbitux + mFOLFOX6 (n=236), or CT (mFOLFOX6/ FOLFOXIRI/ CAPOX) ± Avastin (n=243) Study showed improved PFS (1EP) & OS (2EP) along with previously reported improved cORR…

ByRidhi RastogiFebruary 4, 2025

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Algiax Pharmaceuticals Reports Topline Data from P-IIa Trial of AP-325 for Neuropathic Pain

Shots: Algiax reported topline data from the P-IIa PoC trial assessing AP-325 (GABA-A modulator) vs PBO in 99 pts with peripheral post-surgical neuropathic pain in Germany, Spain, the Czech Republic, Belgium, & France Data showed rapid PI-NRS reduction in <2wks., sustained effects, plus significantly higher ≥50% & ≥70% responder rates with ~25% vs. 11% pts…

ByRidhi RastogiFebruary 4, 2025

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Datar Cancer Genetics Launches Exacta AI to Offer Personalized Treatment Options for Cancer Patients

Shots: Datar Cancer Genetics has introduced Exacta AI (multi-analyte platform) to provide ~10 evidence-based drug combinations as a treatment for cancer patients who have exhausted SoC options Exacta AI integrates 360° tumor work-up with AI-driven analysis of complex tumor interactome data to assess drug interactions, toxicity, & side effects for ADCs, CPIs, targeted therapies,…

ByRidhi RastogiFebruary 4, 2025

NEWS

Roche Reveals Data from P-III (EMBARK) Study of Elevidys in Ambulatory Boys with Duchenne Muscular Dystrophy

Shots: The P-III (EMBARK: N=126) study was carried out in 2 parts, with P1 involving ambulatory DMD boys (n=63; 4-7yrs.) to receive Elevidys (1.33x10^14 vg/kg) vs PBO while P2 involved crossing over of the patients (5-9yrs.); 59 crossed over to Elevidys post 52wks. Parts 1 (post 2yrs.) & 2 (post 1yr.) depicted improved NSAA…

ByRidhi RastogiJanuary 28, 2025

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ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Shots: The US FDA has granted 510(k) clearance to ClearPoint Navigation Software 3.0 that will introduce intraoperative CT workflow, expanding its use from MRI. The company is planning to initiate limited market release in Q1’25 & full release in H2’25 Navigation Software 3.0 is compatible with intraoperative CT & Conebeam CT imaging, enabling precision neurosurgery in facilities…

ByRidhi RastogiJanuary 28, 2025

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Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Shots: The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25 Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr…

ByRidhi RastogiJanuary 28, 2025

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Neurocrine Biosciences and Takeda Amend Partnership to Develop and Commercialize Osavampator in Japan

Shots: Neurocrine & Takeda have revised their 2020 collaboration to develop & commercialize osavampator (NBI-1065845/TAK-653), which originally granted Neurocrine exclusive license to osavampator, NBI-1070770, & the GPR139 antagonist program As per the amendment, Neurocrine will get exclusive rights to develop & market osavampator to treat major depressive disorder (MDD) globally, while Takeda will reacquire…

ByRidhi RastogiJanuary 28, 2025

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Novo Nordisk Completes P-Ib/IIa Study of Subcutaneous Amycretin in Overweight or Obese People

Shots: The P-Ib/IIa trial assessed amycretin (Q1W) vs PBO in overweight or obese patients (n=125) in 5 parts Part A (single ascending dose) assessed PK & determined the initial dose for Part B (multiple dose arm), which evaluated safety/tolerability over 36wks. Parts C, D, & E (PoC) evaluated weight loss with 3 doses (1.25mg,…

ByRidhi RastogiJanuary 27, 2025

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Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma

Shots: 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…

ByRidhi RastogiJanuary 27, 2025

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China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

Shots: China’s NMPA has accepted an NDA for gumokimab (AK111) to treat mod. to sev. plaque psoriasis based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks. Data showed short-term efficacy, with a PASI 75 response rate approaching 96% & an sPGA 0/1 response nearing 90%. PASI 90 hit ~80%, &…

ByRidhi RastogiJanuary 27, 2025

Ridhi Rastogi

Pfizer Reveals Data from P-III (BREAKWATER) trial of Braftovi Regimen in Patients with Metastatic Colorectal Cancer

Algiax Pharmaceuticals Reports Topline Data from P-IIa Trial of AP-325 for Neuropathic Pain

Datar Cancer Genetics Launches Exacta AI to Offer Personalized Treatment Options for Cancer Patients

Roche Reveals Data from P-III (EMBARK) Study of Elevidys in Ambulatory Boys with Duchenne Muscular Dystrophy

ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Neurocrine Biosciences and Takeda Amend Partnership to Develop and Commercialize Osavampator in Japan

Novo Nordisk Completes P-Ib/IIa Study of Subcutaneous Amycretin in Overweight or Obese People

Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma

China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

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