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  • Agile Therapeutics, Inc., a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, announced that preparations are underway for an initial Phase 2 clinical trial of a novel contraceptive regimen, which will begin the development of its pipeline beyond its current lead product candidate, Twirla®, a once weekly contraceptive patch currently in phase 3 development. The planned Phase 2 clinical trial will examine the use of Twirla in an innovative regimen designed to allow women to experience shorter, lighter periods.

  • A new type of HIV drug currently being tested works in an unusual way, scientists in the Molecular Medicine Partnership Unit, a collaboration between EMBL and Heidelberg University Hospital, have found. They also discovered that when the virus became resistant to early versions of these drugs, it did not do so by blocking or preventing their effects, but rather by circumventing them. The study, published online today in Science, presents the most detailed view yet of part of the immature form of HIV.

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  • The U.S. Food and Drug Administration approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances. The Tecnis Symfony Extended Range of Vision IOL is manufactured by Abbott Medical Optics, Inc. of Santa Ana, California.

  • In red the part that binds to the virus, in grey the “tail” of the antibody (named Fc) that binds the receptors of the antibodies present on the different types of cells, and in yellow the LALA mutation that blocks the binding of the antibody to such receptors.

    A team of researchers from the Institute for Research in Biomedicine (IRB, USI Università della Svizzera italiana) and the Swiss biotech company Humabs BioMed SA has identified novel therapeutic monoclonal antibody candidates isolated from Zika-infected patients and new strategies for Zika virus diagnostics. An article published today in the renowned scientific journal Science describes for the first time an in-depth analysis of the human antibody and T cell immune response to the Zika virus infection with important implications for differential diagnostics and for the development of vaccines and new treatments.

  • Loxo Oncology, Inc, a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), “for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.”

  • Amgen announced that the company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the US Food and Drug Administration's (FDA) Arthritis Advisory Committee. ABP 501 is a biosimilar candidate to Humira (adalimumab), an anti-tumour necrosis factor-alpha (TNF-a) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.

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