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Merck KGaA, Pfizer’s cancer drug Bavencio gets EU nod

European regulators granted market approval for Merck KGaA and Pfizer’s immuno-oncology drug Bavencio to treat a rare and aggressive type of skin cancer called Merkel cell carcinoma.

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CDC issues guidance on storm recovery

The Centers for Disease Control and Prevention has been using multiple channels to get the word out about post-storm safety to residents of areas still reeling from the effects of recent hurricanes.

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Bay Area Startup Arcus Biosciences Lands $307 Million+ Deal With Taiho Pharma

Arcus Biosciences announced it has inked an option and license deal with Taiho Pharmaceutical Co. to develop and commercialize product candidates in Arcus’s portfolio in Japan and specific Asian territories excluding China.

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Eli Lilly Heads to Finish Line with Breast Cancer Treatment Abemaciclib

Indianapolis-based Eli Lilly continues to make the case for cyclin-dependent kinases inhibitors, particularly CDK4 and CDK6, as an effective treatment of cancers.

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Alnylam Genetic Disease Drug Meets Study Goals

Positive Phase III data were reported for Alnylam’s RNA interference treatment for hereditary ATTR amyloidosis with polyneuropathy.

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Shire, Shionogi’s ADHD drug for adults clears late-stage trial in Japan

Shire Plc and Shionogi & Co. Ltd. said a drug to treat ADHD in adults had met its main goal in a late-stage trial in Japan, bringing it one step closer to approval in the world’s third-biggest market for ADHD treatments.

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Novartis drug wins EU approval for rare diseases

Swiss drugmaker Novartis won European Union approval for Rydapt to be used against a mutated form of acute myeloid leukemia (AML) and other rare diseases.

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UK backs Opdivo for lung cancer after Bristol-Myers cuts price

Bristol-Myers Squibb’s immunotherapy drug Opdivo was recommended for some patients with lung cancer by Britain’s healthcare cost watchdog NICE after the drugmaker agreed a discounted price.

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Pfizer Announces Outcome of FDA Advisory Committee Meeting for Sutent sNDA

An FDA advisory committee voted 6 in favor and 6 against the benefit-risk profile for Pfizer’s Sutent as adjuvant treatment of adults at high risk of recurrent RCC after nephrectomy.

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Ipsen Receives Approval from European Commission for Xermelo for the Treatment of Carcinoid Syndrome Diarrhea in Patients Inadequately Controlled by Somatostatin Analogue Therapy

Ipsen today announced that the European Commission approved Xermelo (telotristat ethyl) 250 mg three times a day for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.

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

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