FDA

Melinta’s Baxdela FDA approved

Wednesday, June 21, 2017

Melinta Therapeutics, a privately held company focused on discovering, developing, and commercializing novel antibiotics to treat serious bacterial infections, has announced that the U.S. Food and Drug Administration (FDA) has approved Baxdela™ (delafloxacin), indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Baxdela is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including MRSA (methicillin-resistant Staphylococcus aureus), and is available in both intravenous (IV) and oral formulations.

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Bridging Clinical Research and Clinical Health Care Collaborative to launch

Wednesday, June 14, 2017

In 2018, the Bridging Clinical Research and Clinical Health Care Collaborative will bring together industry leaders from pharma, biotech, CROs, healthcare organizations, advocacy groups and the FDA to advance the participation of patients and physicians in the conduct of clinical trials. The conference will be April 4–5, 2018, at the Gaylord National Resort and Conference Center in National Harbor, Maryland.

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Pfizer and Lilly receive FDA Fast Track designation for Tanezumab

Tuesday, June 13, 2017

Pfizer and Eli Lilly announced that the FDA has granted Fast Track designation for tanezumab for the treatment of chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP). Tanezumab is an investigational humanized monoclonal antibody that selectively targets, binds to and inhibits nerve growth factor (NGF). It is the first NGF inhibitor to receive Fast Track designation, a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.

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FDA requests removal of Opana ER for risks related to abuse

Monday, June 12, 2017

The FDA requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

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FDA approves Alkermes ARISTADA treatment for schizophrenia

Wednesday, June 7, 2017

Alkermes announced that the FDA has approved two-month ARISTADA (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ARISTADA is now FDA-approved in four doses and three dosing duration options (441mg, 662mg or 882mg once monthly, 882mg once every six weeks and 1064mg once every two months) and can be initiated at any dose or interval, offering an unprecedented range of flexibility to patients and healthcare providers. The new two-month dose is expected to be available in mid-June.

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Alternative solutions to complement monitoring strategies

Monday, June 5, 2017

The Pulse on Site Success by Christophe Berthoux

Research sites are likely most familiar with traditional on-site monitoring, which requires monitors to conduct visits to check a high percentage of data, and ensure that everything is reported correctly. As clinical trials increase in complexity, on-site monitoring can become an inefficient and expensive process. In order to minimize cost and increase efficiency, Sponsors and CROs are considering several alternative solutions to complement monitoring strategies.

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FDA approves new hemophilia treatment

Thursday, June 1, 2017

Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B.

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Merck receives FDA approval of new HIV-1 treatment

Tuesday, May 30, 2017

Merck has announced that the U.S. Food and Drug Administration (FDA) has approved ISENTRESS® HD, a new 1200 mg once-daily dose of the company’s integrase inhibitor, ISENTRESS® (raltegravir), to be administered orally as two 600 mg film-coated tablets with or without food, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults, and pediatric patients weighing at least 40 kg, who are treatment-naïve or whose virus has been suppressed on an initial regimen of ISENTRESS 400 mg given twice daily.

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