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The Pulse of the Pharmaceutical Industry

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Myovant’s Prostate Cancer Drug Ready for FDA Filing

Myovant announced that the company’s Phase III HERO trial relugolix met the study’s primary endpoint and six key secondary endpoints in advanced prostate cancer.

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Alkermes Buys Rodin Therapeutics

Dublin, Ireland-based Alkermes is acquiring Boston-based Rodin Therapeutics for $100 million up front and up to $850 million in milestone payments.

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Consistent Effects of Farxiga in Heart Failure Patients With Reduced Ejection Fraction Shown in New Analyses

AstraZeneca announced new data from five additional analyses of the landmark Phase III DAPA-HF trial, which showed that Farxiga (dapagliflozin) reduced the risk of the primary composite outcome of worsening heart failure or death from cardiovascular causes versus placebo, when added to standard of care.

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Roche to Acquire Fibrosis-Focused Promedior

A year after Bristol-Myers Squibb walked away from acquiring Promedior and the company’s fibrotic treatment portfolio, Roche stepped in to acquire the biotech firm for up to $1.4 billion.

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resTORbio Halts Respiratory Program for RTB101

Boston-based resTORbio announced topline data from the PROTECTOR 1 Phase III trial of RTB101 in clinically symptomatic respiratory illness (CSRI) in adults age 65 and older.

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FDA panel votes against Lilly-Boehringer Ingelheim’s diabetes drug

Independent experts on an FDA advisory panel voted against the use of an already approved drug from Eli Lilly and Boehringer Ingelheim as an add-on to insulin therapy for type 1 diabetes.

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Lilly’s Taltz Hits Mark in Phase III Inflammatory Study

Eli Lilly is planning to seek another regulatory approval for Taltz after the medication hit the primary and secondary endpoints in a Phase III study for non-radiographic axial spondyloarthritis.

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Amarin surges as fish-oil drug receives largely positive FDA review

Amarin Corp. Plc’s fish oil-derived drug and potential blockbuster Vascepa received a largely positive review from FDA staffers.

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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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AstraZeneca succeeds in treating lupus in late-stage study

AstraZeneca Plc’s experimental treatment anifrolumab significantly reduced disease activity in patients with the autoimmune disorder lupus in a late-stage study.

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