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Myovant to Seek FDA Approval for Uterine Fibroid Treatment Following Successful Trial

Myovant is preparing to seek regulatory approval for the company’s once-daily relugolix combination therapy for the treatment of uterine fibroids following positive Phase III results that showed a 71.2 percent response rate in patients.

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ViiV’s Investigational HIV Drug Finds Success in Hard-to-Treat Patient Population

GlaxoSmithKline, Pfizer and Shinogi’s joint venture ViiV Healthcare said the Phase III BRIGHTE study hit 96-week endpoints in heavily treatment-experienced adults with HIV-1 infection.

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Durect and Gilead Collaborate on HIV Therapy

A collaboration and license deal was inked with Gilead Sciences Inc. to develop and market a long-acting injectable HIV therapy using Durect Corp.’s SABER technology.

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Intec Pharma Crashes as Phase III Parkinson’s Treatment Fails in Comparison Trial

Shares of Israel-based Intec Pharma Ltd. were down nearly 82 percent after the company announced that a Phase III Parkinson’s disease therapy failed to demonstrate statistical superiority to treatment with Sinemet, a combination of carbidopa and levodopa.

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InvaGen Receives FDA Approval for Generic of Pfizer’s Lyrica

The U.S. FDA approved InvaGen Pharmaceuticals’ generic version of Pfizer’s Lyrica (pregabalin) for eight different dosages.

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Martin Shkreli Loses Criminal Conviction Appeal

Martin Shkreli will continue to reside in federal prison after the notorious “Pharma Bro” failed to win an appeal to his 2017 criminal conviction for securities fraud and conspiracy to commit fraud.

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Roche and Novo Nordisk Top Clinical Trial Transparency Survey

In the third installment of the Good Pharma Scorecard, Roche and Novo Nordisk scored perfect marks in overall trial transparency.

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Gilead Snaps up Antiviral Programs From Novartis

Gilead Sciences struck a deal with Swiss pharma giant Novartis for three preclinical antiviral programs aimed at the treatment of human rhinovirus, influenza and herpes viruses.

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Bayer, Bristol-Myers, Ono Partner for Colorectal Cancer Study

Bayer, Bristol-Myers Squibb and Ono Pharmaceutical teamed up to study the most common type of metastatic colorectal cancer.

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Genmab Raises $506 Million in IPO

Copenhagen, Denmark-based Genmab A/S raised $506 million with an initial public offering (IPO), with the company trading on the Nasdaq under the ticker symbol GMAB.

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!

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