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Alder Submits BLA to U.S. FDA for Eptinezumab

Alder BioPharmaceuticals Inc. announced the submission of a Biologics License Application (BLA) to the U.S. FDA for eptinezumab for migraine prevention targeting the calcitonin gene-related peptide (CGRP).

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Morphic and Janssen Strike Potential $750 Million Deal

Morphic Therapeutic and J&J division Janssen Biotech entered into a collaborative deal to develop novel integrin therapeutics for conditions not adequately addressed by current therapies.

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Menopause and Estrogen Decline Could Show a Link to Alzheimer’s Disease

As pharma companies struggle with developing a treatment for Alzheimer’s disease, researchers continue to find evidence that links the dreaded form of dementia to other medical and health issues. The latest news suggests a potential link between Alzheimer’s and menopause.

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Top 10 Pipelines To Watch: 2019 Annual Report

The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

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FDA Approves Split-Dosing Regimen for Darzalex

The U.S. Food and Drug Administration gave Janssen Biotech and the Johnson & Johnson company’s research partner Genmab an approval for their Darzalex split-dosing regimen.

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AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma

AbbVie Inc., along with Teneobio Inc. and that company’s affiliate TeneoOne Inc., announced that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma.

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FDA approves Sanofi’s Cablivi for aTTP

The U.S. FDA approved Cablivi in combination with plasma exchange and immunosuppression for treating acquired thrombotic thrombocytopenic purpura (aTTP) in adults.

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With New CEO MIA, Gilead Reports Tough Q4 and 2018

Gilead Sciences reported earnings per share profits for the 2018 fourth quarter of $1.44 per share, below analysts’ expectations of $1.70. Revenue for the quarter was $5.8 billion, better than Wall Street’s $5.5 billion expectations, but down from $5.949 billion in the same quarter during 2017.

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Roche adapts newer breast cancer drug in face of Herceptin imitations

Roche aims to broaden the use of the Swiss drugmaker’s Kadcyla breast cancer treatment as rivals crowd into the market with biosimilar copies of the company’s older mainstay product Herceptin.

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A Link Between Gum Disease and Alzheimer’s?

Researchers with Cortexyme published research in the journal Science Advances describing the role of Porphyromonas gingivalis, a bacteria that causes gingivitis, to Alzheimer’s disease.

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