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J&J Reports Positive Phase III Data for Two-Drug HIV Combo

The Janssen Pharmaceutical Companies of Johnson & Johnson confirmed top-line data from the Phase III Antiretroviral Therapy as Long-Acting Suppression (ATLAS) trial of the first investigational long-acting injectable two-drug regimen for the treatment of HIV-1.

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PhRMA Releases Annual Survey, Shows Highest R&D Spending Ever

Among the industry group PhRMA’s findings was that overall R&D spending was at an all-time high in 2017, hitting $71.4 billion, up from $65.5 billion in 2016 and from $29.8 billion in 2001.

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Acorda Therapeutics CTO Leaves To Helm Unnamed Biotech Company

Chief Technology Officer Rick Batycky is leaving Acorda Therapeutics to take over the helm of an unnamed biotechnology company.

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Novartis Nabs Siemens Veteran As New Head Of Ethics

As Novartis wrangles with the fallout from the Swiss drugmaker’s association with Michael Cohen and the fees it paid his consulting company for access to the administration of President Donald Trump, the Swiss pharma giant brought on a new chief ethics officer.

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Realm Phase II Trial Fails to Reach Endpoints

Shares of Realm Therapeutics plunged more than 50 percent after the company’s Phase II atopic dermatitis drug failed to distinguish itself from the control arm in the study.

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Bayer teams up with Evotec, Haplogen

Collaboration partners Evotec AG and Haplogen GmbH announced that Haplogen will enter into a multi-year drug discovery and development deal with Bayer AG to focus on pulmonary diseases.

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Magnolia Neurosciences Launches with $31 Million

Magnolia Neurosciences, co-founded by Accelerator Life Science Partners and The University of Texas MD Anderson Cancer Center, launched with a $31 million Series A financing.

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FDA Issues CRL for New Dosing Label for Eylea

The U.S. FDA rejected Regeneron Pharmaceuticals’ attempt to secure a supplemental approval for the Tarrytown, N.Y.-based company’s blockbuster drug Eylea as a once-per 12-week treatment for wet age-related macular degeneration.

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Japan’s Astellas Acquires U.K.-Based Quethera

Astellas Pharma Inc. plunked down nearly $109 million to snap up privately held Quethera Ltd. and the gene therapy company’s novel treatments for glaucoma and other ocular disorders.

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Artios Snags $84 Million to Advance DNA Damage Response Cancer Treatments

Artios Pharma received a financial boost from Pfizer, AbbVie and Novartis through an $84 million (£65 million) Series B funding.

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Gemphire Plunges After Investigational Drug Worsens Liver Fat Levels in Pediatric NAFLD Trial Patients

Shares of Gemphire Therapeutics crashed 73 percent in premarket trading after the company revealed its mid-stage non-alcoholic fatty liver disease treatment for pediatric patients actually worsened the disease in some patients.

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Bexion Pharmaceuticals Early-Stage Cancer Drug Being Hailed as Game Changer

Bexion Pharmaceuticals and the drugmaker’s investigational cancer treatment BXQ-350 is receiving lots of mainstream media coverage as a potential game changer.

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FDA Advisory Panel Supports Paratek’s Investigational Antibiotic, PDUFA Set for October

Shares of Paratek Pharmaceuticals climbed in pre-market trading after the company announced a U.S. Food and Drug Administration advisory committee voted overwhelmingly in favor of intravenous and oral treatments for acute bacterial skin and skin structure infections (ABSSSI).

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GW Pharmaceuticals Slaps Price Tag on Cannabis-Based Epilepsy Drug

GW Pharmaceuticals revealed a $32,500 price for the company’s cannabis-based epilepsy drug Epidiolex.

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FDA Approves New Generic Drug Under Novel Pathway Aimed at Increasing Competition

The U.S. Food and Drug Administration approved a new generic potassium chloride oral solution under a novel term called the Competitive Generic Therapy designation.

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Boston Scientific Continues M&A Spree

Boston Scientific Corp. forked over up to $160 million to acquire California stent maker Veniti Inc. The deal marks the third acquisition for Boston Scientific in two months.

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Bellerophon Late-Stage PAH Study Fails

Bellerophon Therapeutics’ Phase III pulmonary arterial hypertension drug INOpulse failed to meet endpoints following a pre-specified interim analysis from a Data Monitoring Committee.

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Spark’s Hemophilia A Gene Therapy Significantly Reduced Bleeding in Clinical Trial

An investigational gene therapy treatment for hemophilia A saw a 97 percent response rate after one treatment.

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From “Jeans to Genes”: Dyadic CEO Discusses How To Revolutionize Biopharma Manufacturing

Mark Emalfarb – founder, chairman and chief executive officer of Jupiter, Florida-based Dyadic International – believes he knows how to revolutionize biopharma manufacturing.

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FDA Issues New Draft Guidance to Promote Development of Medications to Treat Opioid Use Disorder

The U.S. Food and Drug Administration issued a new draft guidance for the development of novel medicines aimed at the treatment of opioid use disorder.

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