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Bayer, Bristol-Myers, Ono Partner for Colorectal Cancer Study

Bayer, Bristol-Myers Squibb and Ono Pharmaceutical teamed up to study the most common type of metastatic colorectal cancer.

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U.S. overdose deaths post annual drop for first time in two decades

U.S. overdose deaths dropped during 2018 for the first time in nearly two decades, the CDC said, in a sign that a nationwide epidemic of drug-related deaths is abating.

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Novartis, Amgen and Banner End Alzheimer’s Program

Novartis, Amgen and the Banner Alzheimer’s Institute announced they are halting two pivotal Phase II/III clinical trials in the Alzheimer’s Prevention Initiative Generation Program.

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Array BioPharma’s Triple-Drug Combo Could be Gamechanger for Colorectal Cancer

Array BioPharma announced positive results from the Phase III BEACON CRC trial evaluating a triple combination of the BRAF inhibitor Braftovi (encorafenib), the MEK inhibitor Mektovia (binimetinib), and the anti-EGFR antibody Erbitux (cetuximab) in patients with advanced BRAFV600E-mutant metastatic colorectal cancer after one or two lines of therapy.

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After Rocky Road, Karyopharm Wins FDA Approval for Multiple Myeloma Drug

Shares of Karyopharm Therapeutics skyrocketed more than 36 percent after the U.S. Food and Drug Administration approved the Newton, Mass.-based company’s Xpovio for treating multiple myeloma.

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Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. FDA in 2019

Gilead Sciences announced that a path forward was established to submit a New Drug Application in 2019 for the investigational oral, selective JAK1 inhibitor filgotinib as a rheumatoid arthritis treatment.

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Libtayo Approved in the European Union

The European Commission granted conditional marketing authorization for Libtayo (cemiplimab) for treating adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

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FDA approves expanded label for Regeneron/Sanofi’s Dupixent

The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.

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Aldeyra’s Reproxalap Falls Short in Anterior Uveitis Trial

Lexington, Mass.-based Aldeyra Therapeutics reported that the company’s reproxalap failed to meet primary or secondary endpoints in noninfectious anterior uveitis.

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Bristol-Myers plans to divest Celgene’s psoriasis drug

Bristol-Myers Squibb Co. offered to divest Celgene Corp.’s psoriasis treatment Otezla to allay concerns raised by the U.S. competition regulator, and pushed back the closing of their $74 billion deal.

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Extensive pharmaceutical business and marketing intelligence. For back issues, please contact MDAD@kmpsgroup.com.

June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!

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