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Genentech’s gantenerumab Fails in Phase III Trial; CHMP Recommends’ Dupixent; FDA Clears Imfinzi and Imjudo with chemotherapy; NICE Recommends Ipsen’s Cabometyx (cabozantinib); NICE Backs KEYTRUDA; NRG Announces £16 Million Series A Funding; FDA Backs AstraZeneca’s PT027

Genentech’s gantenerumab Fails in Phase III Trial for Alzheimer’s Disease In yet another setback for an amyloid-targeting drug, Roche's Genentech division has reported disappointing top-line results from its highly anticipated phase III trial of gantenerumab in early Alzheimer's disease. The failure is entirely ...

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checkpoint-inhibitors-for-refractory-cancer-treatment
Checkpoint Inhibitors: A Potential Approach in the Fight Against Refractory Cancer

Immune checkpoint inhibitors are drugs that inhibit immune checkpoints. These drugs allow immune cells to respond more strongly to cancer by blocking them. This blocks the “off” signal, allowing T-cells to kill cancer cells. Checkpoint inhibitors can be used to treat a variety of cancers, including lung cancer (...

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Pharma News Merck, AstraZeneca, and GSK
Merck’s Sotatercept Trial Result; PARP Rivals Closing in on AstraZeneca and Merck’s Lynparza; FDA Clears GSK’s Boostrix for Pertussis; Fast Track Designation to Nanoscope Therapeutics’s MCO-010; FDA Awards Fast Track Designation to Eftilagimod Alpha Plus Pembrolizumab; Solid Biosciences to Acquire AavantiBio

Merck’s Sotatercept Clears Phase III Trial Merck’s USD 11.5 billion acquisition of Acceleron last year was based on the promise of pulmonary arterial hypertension (PAH) candidate sotatercept, which has recently met the mark in a much-anticipated phase III trial. The STELLAR trial found that adding the activin re...

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Pharma News for Amgen BioNTech and Gilead
Amgen Announced the Result of its CodeBreak-200 Trial; FDA Clears Bristol-Myers Squibb’s Deucravacitinib; BioNTech’s Amplified CAR-T Therapy; TIL Therapy Improves on Yervoy in Melanoma; GSK’s Daprodustat will have to face FDA Advisory Committee; Breakthrough Therapy Status to Pfizer’s Group B Strep Vaccine; EU Approves Gilead’ Tecartus; Gilead’ Trodelvy Results in TROPiCs-02 Trial

Amgen Reveals the Top-line Result of its CodeBreak-200 trial of Lumakras in Lung Cancer The top-line result of Amgen's CodeBreak-200 trial of Lumakras in lung cancer was presented in abstract form at ESMO two weeks ago, showing a 34% improvement in progression-free survival (PFS) compared to chemotherapy. The fu...

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Pharma News for Azurity, Sobi, and Sanofi
AstraZeneca’s Imfinzi for Biliary Tract Cancer; FDA Clears Boehringer’s Spesolimab; Novo Nordisk to Acquire Forma Therapeutics; Sanofi’s Xenpozyme Approved for ASMD; Another FDA Approval to Azurity’s Konvomep; Amgen’s Lumakras Trial Results; FDA Grants Priority Review to Sanofi & Sobi’s efanesoctocog alfa; Neurocrine Bio to Takeover UK Biotech Diurnal

FDA Approves AstraZeneca’s Imfinzi for Biliary Tract Cancer Imfinzi, a checkpoint inhibitor developed by AstraZeneca, has been approved by the FDA as the first immunotherapy for biliary tract cancer (BTC), a rare and aggressive form of cancer with few treatment options. Imfinzi (durvalumab) has been approved by ...

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Latest MedTech News for CereVasc and Nanopath
CereVasc’s eShunt System Study; FDA Approves NGS-Based CDx for Trastuzumab Deruxtecan; Nanopath Secures $10 Million Funding; BD, Accelerate Diagnostics Announce Collaboration; Avails Medical’s Clinical Trials for eQUANT; Movano Ring Exceeds Accuracy Targets for SpO2 & Heart Rate Monitoring

CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System On August 09, 2022, CereVasc, Inc., a privately held, clinical-stage medical device company developing novel, minimally invasive treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved ...

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Pharma News for Novartis and Gilead
Novartis’ Canakinumab for NSCLC; Novartis’s Zolgensma Updates; Trodelvy Prospects in New Breast Cancer Use; Novartis Secures European Approval For Pluvicto; Bristol-Myers Squibb’s Abecma Phase III Trials; Trastuzumab Approved for Deruxtecan for HER2-Mutant NSCLC

Novartis’ Canakinumab Fails in Phase III Trials for NSCLC Canakinumab's prospects as an anticancer therapy were already dwindling when a third phase III trial in non-small cell lung cancer (NSCLC) failed to reach its objectives. The most recent setback came from the CANOPY-A study, which included patients with N...

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Pharma News for Sanofi, Bayer, Spero
AstraZeneca’s Imfinzi Shows Positive Results; Novartis Announces Results of Tislelizumab; FDA Grants Orphan Drug Designation to Evorpacept; EU Approves Sanofi’s Xenpozyme; Bayer’s Kerendia Approves in China; FDA Breakthrough Therapy Designation to Talquetamab; FDA Puts Clinical Hold on Sanofi’s Tolebrutinib; FDA Rejects Spero’s Tebipenem

FDA Grants Orphan Drug Designation to Evorpacept for AML ALX Oncology Holdings announced that the U.S. Food and Drug Administration had granted orphan drug designation to Evorpacept, a next-generation CD47 blocker, for treating patients with acute myeloid leukemia (AML). Acute Myeloid Leukemia (AML) is an agg...

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Pharma News and Updates for GSK, Roche, and Owkin
GSK’s RSV Vaccine Clears Phase III Test in Adults; Roche’s Tecentriq for Adjuvant NSCLC; Owkin Bags $ 180 million from BMS; EU Approves Roche’s Mosunetuzumab; Dostarlimab Elicits Clinical Complete Response in dMMR Rectal Cancer; FDA Backs Bluebird’s CALD Gene Therapy; Takeda’s Dengue Fever Vaccine TAK-003; FDA Approves Dupilumab

GSK Starts Preparations for Regulatory Filings as RSV Vaccine Clears Phase III Test in Adults GSK plans to initiate preparation for regulatory submissions for its respiratory syncytial virus (RSV) vaccine after the vaccine performed well in the much-anticipated AReSVi 006 trial in individuals aged 60 and above.&...

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Pharma News and Updates for BMS, Mirati, Roche, Dermavant, Merck
Bristol-Myers Squibb’s Opdivo Approval; Mirati’s KRAS-inhibitor Adagrasib; J&J and Legend Biotech’s CAR-T Carvykti Approval; Roche’s Glofitamab; Arena Pharma’s Etrasimod Phase 3 Trials; FDA Approves Dermavant’s Vtama; FDA Approves Novartis’ Cell Therapy; NICE Approves Merck’s Keytruda

Bristol-Myers Squibb’s Opdivo Gets FDA Approval for Esophageal Cancer The FDA has approved two combination drug regimens based on Bristol-Myers Squibb’s PD-1 inhibitor Opdivo for previously untreated advanced Esophageal Cancer, encroaching on the territory belonging to Merck & Co’s rival Keytruda. The latest...

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