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FDA approves Novartis biosimilar to Amgen’s Enbrel

The U.S. Food and Drug Administration approved Novartis AG’s biosimilar version of Amgen Inc.’s arthritis drug Enbrel.

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2016 Annual Report: Top 200 Medicines

AbbVie’s biologic therapy Humira for autoimmune diseases was the worldwide prescription-drug sales leader in 2015 for the fourth consecutive calendar term.

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FDA panel backs Valeant psoriasis drug with risk program

Valeant Pharmaceuticals International Inc.’s experimental drug to treat the skin disorder psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide.

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Eli Lilly Projects 20 New Product Launches in 10 Years

Indianapolis-based Eli Lilly and Company is on a roll, announcing that between 2014 and 2023, it may launch 20 new products.

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Bay Area’s XenoPort Snags Psoriasis and MS Deal Worth $490 Million+

Hyberabad, India-based Dr. Reddy’s Laboratories announced today that it had inked a licensing deal with Santa Clara, Calif.-based XenoPort worth more than $490 million.

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2016 Annual Report: Top 10 Pipelines

The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.

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Investors Grin Over Biogen’s $3.4 Billion Cash Pile and Earnings Report

January 28, 2016 By Mark Terry, BioSpace.com Breaking News Staff   Cambridge, Mass.-based Biogen Inc. (BIIB) announced its 2015 financial and fourth-quarter reporting yesterday, citing $10.8 billion in annual revenues, an increase of 11 percent over 2014. Biogen exceeded analysts expectations, who were predicting a revenue increase of about 9 percent. Net income was $3.6 […]

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FDA declines to expand approval of Pfizer arthritis drug

U.S. health regulators declined to approve Pfizer Inc’s oral rheumatoid arthritis drug Xeljanz to treat moderate to severe cases of the scaly skin condition plaque psoriasis, the drugmaker said on Wednesday. Pfizer said it received a so-called complete response letter from the Food and Drug Administration. Such letters typically outline concerns and conditions that must […]

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Novartis biosimilar copycat takes aim at Amgen’s drug Enbrel

The U.S. Food and Drug Administration has accepted Novartis (NOVN.VX) unit Sandoz’s regulatory submission for approval of a biosimilar copy of Amgen’s (AMGN.O) blockbuster Enbrel drug, the Swiss drugmaker said on Friday.   Biosimilars aim to copy biologic products, which are made inside living cells, but they can never be exact duplicates, so biosimilar manufacturers […]

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Xenoport to seek partner to develop drug; CEO steps down

Xenoport Inc said it would stop developing on its own a drug that showed high rates of side effects in a study and instead focus on its treatment for restless leg syndrome. The company also said on Thursday that Ronald Barrett, its chief executive since 2001, has stepped down and will be succeeded by Chief […]

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