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The Pulse of the Pharmaceutical Industry

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FDA Approves Rare Blood Disease Treatment Reblozyl

The U.S. FDA approved Celgene and Acceleron Pharma’s Reblozyl for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

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Novartis gets U.S. nod for long-delayed Amgen copycat

Novartis won FDA approval for a long-delayed version of Amgen’s $4 billion seller Neulasta drug, helping the Swiss drugmaker in an uphill battle to sell copies of rivals’ blockbusters in the U.S.

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FDA approves RedHill’s bacterial infection treatment

RedHill Biopharma Ltd.’s three-drug combination therapy to treat Helicobacter pylori bacterial infections was approved by the U.S. Food and Drug Administration.

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FDA Approves Vumerity for Multiple Sclerosis

The U.S. Food and Drug Administration approved Vumerity (diroximel fumarate) – a novel oral fumarate with a distinct chemical structure – for the treatment of relapsing forms of multiple sclerosis.

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Allergan’s Botox approved by FDA for lower limb spasticity in pediatric patients

Allergan’s Botox was given the green light from the U.S. FDA to treat pediatric patients with lower limb spasticity.

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Vertex prices cystic fibrosis combo treatment at $311,503 per year

Vertex Pharmaceuticals Inc. priced the company’s FDA-approved Trikafta, a three-drug combination for cystic fibrosis, at $311,503 per year.

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FDA approves Janssen’s Stelara for ulcerative colitis

The U.S. Food and Drug Administration approved Janssen’s Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis.

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FDA approves Farxiga for treating heart failure risk

AstraZeneca’s blockbuster drug Farxiga won U.S. approval as a treatment to reduce the chances of hospitalization for heart failure in adults with type 2 diabetes and other cardiovascular risks.

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Alexion’s Ultomiris wins FDA clearance for aHUS

The U.S. Food and Drug Administration approved Alexion Pharmaceuticals Inc.’s Ultomiris for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy for adult and pediatric patients.

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Genentech’s Xofluza Approved for People at High Risk of Developing Flu-Related Complications

Genentech’s flu medication Xofluza won a new indication for the treatment of acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for less than 48 hours and are at high risk of flu-related complications.

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