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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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Sanofi Cuts 38 R&D Programs to Refocus on Cancer, Immunology, and Rare Diseases

Sanofi reportedly ended 38 R&D programs and is prioritizing oncology, immunology, rare disease and rare blood disorders.

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Novo Nordisk’s new diabetes drug, outlook lift shares

Novo Nordisk reported solid growth for the company’s new diabetes drug and will submit a tablet version – a key growth hope – for U.S. approval in first-quarter 2019, lifting the Danish drugmaker’s shares.

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Exclusive: Teva’s generic EpiPen launch stalls months after approval

Many of the largest U.S. pharmacies and drug distributors do not have Teva Pharmaceutical Industries Ltd.’s generic version of EpiPen five months after the life-saving allergy treatment was approved for sale in the United States, pharmacy chains and a group that tracks drug shortages told Reuters.

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FDA Approves Imbruvica for 10th Time

FDA approved Imbruvica combined with Gazyva for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma.

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FDA Places Cervical Cancer Study on Clinical Hold

The U.S. Food and Drug Administration placed Princeton, N.J.-based Advaxis’ Phase III clinical trial of axalimogene filolisbac (AXAL) in advanced cervical cancer on partial clinical hold.

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Yale Researchers Discover Immune System Protein That Can Help Suppress HIV

A new report released by researchers at Yale University could change the way some HIV patients are treated.

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J&J, U.S. states settle hip implant claims for $120 million

Johnson & Johnson and the company’s DePuy Orthopaedics unit have agreed to pay $120 million to resolve deceptive marketing claims by several U.S. states over the company’s metal-on-metal hip implants.

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Amid Government Shutdown, Companies Try New Approaches to IPOs

2018 was a record year for biotech initial public offerings (IPOs), but 2019 is off to a slow and rocky start because of the government shutdown.

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Imbruvica fails to meet pancreatic cancer study goal

AbbVie Inc.’s blockbuster cancer treatment Imbruvica in combination with chemotherapy agents failed to meet the main goal in a late-stage study of patients with a form of pancreatic cancer.

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