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AstraZeneca’s Imfinzi fails to meet main goals in head and neck cancer study

AstraZeneca’s immunotherapy treatment Imfinzi did not meet the main goals in a late-stage study for advanced head & neck cancer.

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Roche’s lung cancer combo treatment wins FDA approval

Roche Holding AG’s Tecentriq immunotherapy in combination with Avastin and chemotherapy won U.S. Food and Drug Administration approval as a first-line treatment for a type of lung cancer.

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AbbVie’s Rova-T Sees Another Failure

AbbVie halted a Phase III trial evaluating rovalpituzumab tesirine as a second-line therapy for advanced small-cell lung cancer after an Independent Data Monitoring Committee called for the stoppage due to shorter overall survival in the Rova-T arm.

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Roche’s Tecentriq wins speedy U.S. FDA review for small cell lung cancer

Swiss group Roche Holding AG said the company’s Tecentriq immunotherapy mixed with chemotherapy won priority review from the U.S. regulator for treating a type of lung cancer, a potential boost to the drug that has been trailing rivals’ revenues.

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BMS Teams with Two UK Research Groups to Create Lung Cancer Rule Book

Bristol-Myers Squibb is teaming up with Cancer Research UK and the Francis Crick Institute to create guidelines for immuno-oncology therapy development focused on lung cancer treatments.

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FDA approves Catalyst Pharma’s rare disease drug

The U.S. Food and Drug Administration approved Catalyst Pharmaceuticals Inc.’s drug Firdapse to treat a rare autoimmune disease.

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Key AstraZeneca lung cancer treatment misses study goal

AstraZeneca said the immunotherapy drug Imfinzi did not meet the main goal of improving survival rates for patients with the most advanced form of lung cancer, putting pressure on the company’s shares.

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FDA approves Pfizer’s Lorbrena treatment for certain lung cancer patients

The U.S. Food and Drug Administration approved Pfizer Inc.’s lung-cancer treatment Lorbrena for patients with a specific gene mutation who had been previously treated for an aggressive form of the disease.

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FDA Approves Another Indication for Merck’s Keytruda

Merck’s blockbuster anti-PD-1 therapy Keytruda won FDA approval in combination with chemotherapy as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.

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FDA Action Alert: Merck’s Keytruda in Lung Cancer, Trevena and AcelRx Drugs for Pain

Several PDUFA action dates for drug applications are up for review by the Food and Drug Administration.

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