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The Pulse of the Pharmaceutical Industry

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U.S. FDA approves ViiV Healthcare’s Dovato

The FDA approved ViiV’s Dovato as a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for treating HIV-1 infection in adults with no antiretroviral treatment history and no known resistance to either DTG or 3TC.

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FDA Approves ADMA’s Asceniv for Immune Deficiency

The U.S. Food and Drug Administration approved ADMA Biologics’ Asceniv to treat primary humoral immunodeficiency disease (PIDD or PI) in adults and adolescents.

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Big Pharma accused of ‘endless talk, no action’ on antibiotic threat

The pharmaceutical industry should match its words with action on researching new antibiotics to address the threat posed by drug-resistant superbugs, a former UK government adviser said.

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Regeneron/Sanofi wins U.S. approval for expanded use of skin drug

The U.S. Food and Drug Administration approved expanded use of Regeneron Pharmaceuticals Inc. and Sanofi SA’s eczema drug Dupixent to include patients aged between 12 and 17 years.

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ViiV Healthcare Presents Positive, 48-Week Data from Two Pivotal Phase III Studies in Adults Living with HIV-1 Infection

ViiV Healthcare presented comprehensive 48-week data from the ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies of the novel, investigational, long-acting regimen of cabotegravir and rilpivirine.

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London HIV patient becomes world’s second AIDS cure hope

An HIV-positive man in Britain became the second known adult worldwide to be cleared of the AIDS virus after he received a bone marrow transplant from an HIV resistant donor, his doctors said.

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Bacteriophages to the Rescue: A Possible Approach to Antibiotic Resistance

A bacteriophage is a virus that infects bacteria. They are not typically used to treat bacterial infections, but in desperate cases, they have been used to treat particularly antibiotic-resistant infections.

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Rise of drug-resistant superbugs rings alarm bells in Europe

The spread of superbugs resistant to antimicrobial drugs shows no sign of slowing in Europe, health officials said, making food poisoning and other infections more difficult to treat.

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Motif Bio Receives Complete Response Letter from the FDA

Motif Bio plc announced today that the clinical-stage biopharmaceutical company received a complete response letter from the U.S. Food and Drug Administration regarding the new drug application for iclaprim for the treatment of acute bacterial skin and skin structure infections.

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Prior dengue infection may protect against Zika: study

Prior infection with dengue, a mosquito-borne disease that infects nearly 400 million people a year, could reduce the risk of contracting Zika nearly by half, U.S. and Brazilian researchers reported.

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