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The Pulse of the Pharmaceutical Industry

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Takeda’s dengue vaccine effective overall in study but with major limitation

Takeda Pharmaceutical Co.’s experimental dengue vaccine was highly effective at preventing the mosquito-borne disease in a late stage study, but TAK-003 failed to protect against one type of the virus in people with no prior exposure to dengue.

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Novartis gets U.S. nod for long-delayed Amgen copycat

Novartis won FDA approval for a long-delayed version of Amgen’s $4 billion seller Neulasta drug, helping the Swiss drugmaker in an uphill battle to sell copies of rivals’ blockbusters in the U.S.

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FDA approves RedHill’s bacterial infection treatment

RedHill Biopharma Ltd.’s three-drug combination therapy to treat Helicobacter pylori bacterial infections was approved by the U.S. Food and Drug Administration.

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GlaxoSmithKline starts late-stage trial for experimental antibiotic

GlaxoSmithKline Plc started a late-stage study testing the company’s experimental antibiotic gepotidacin in patients with urinary tract infections and gonorrhoea.

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U.S. FDA Advisory Committee Recommends Approval of Cefiderocol for Treatment of Complicated Urinary Tract Infections

The U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee voted to recommend approval of Shionogi & Co. Ltd.’s investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options.

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FDA green lights AstraZeneca’s asthma drug Fasenra for self-administration

The U.S. Food and Drug Administration approved self-administration of AstraZeneca’s asthma treatment Fasenra which uses a pre-filled, single-use auto-injector pen.

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U.S. FDA approves Gilead’s Descovy for HIV prevention

The U.S. Food and Drug Administration approved Gilead Sciences Inc.’s Descovy to reduce the risk of sexually acquired HIV infection in men and transgender women who have sex with men.

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Verrica Submits New Drug Application to U.S. FDA

Verrica Pharmaceuticals Inc. submitted a New Drug Application to the U.S. Food and Drug Administration for VP-102 (cantharidin 0.7% topical solution) for the treatment of molluscum contagiosum.

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New Campaign Focuses on Fighting Superbugs

Leading scientists, public policy experts and biotech industry leaders joined forces to launch “Working to Fight AMR,” a coalition working to raise public awareness of the growing threat posed by antimicrobial resistance.

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First Antibiotic With New Mechanism of Action Approved in Almost 20 Years

The U.S. FDA gave Nabriva Therapeutics a thumbs-up for the company’s oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.

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