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Scientists zoom in on bug behind Strep throat and scarlet fever

Scientists studying a bacterium that causes scarlet fever, severe sore throat and a form of heart disease are developing a vaccine that could prevent hundred of thousands of infections a year.

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Merck’s Pneumococcal Vaccine for Babies Looks Good in Trial

Merck & Co.’s investigational 15-valent pneumococcal conjugate vaccine was “noninferior” to a currently available 13-valent pneumococcal conjugate vaccine in healthy babies 6 to 12 weeks of age.

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Pfizer posts earnings beat, raises 2019 profit forecast

Pfizer beat Wall Street estimates for Q1 profit and slightly raised the company’s 2019 earnings forecast as the largest U.S. drugmaker reined in costs and recorded higher Ibrance and Prevnar sales.

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GSK’s HIV drug wins European panel thumbs-up

GlaxoSmithKline’s two-drug treatment for HIV infections won marketing approval from a European Medicines Agency panel. The British drugmaker received U.S. FDA approval in April 2019.

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

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