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  • ANI Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) of the Abbreviated New Drug Application (ANDA) for nilutamide tablets which is first generic competitor to Nilandron®. Trailing twelve- month sales of Nilandron® were $23 million according to IMS Health.

  • Sun Pharma Advanced Research Company Ltd. And Sun Pharmaceutical Industries Ltd. and includes its subsidiaries or associate companies) announced a licensing arrangement for SPARC’s ELEPSIA XRTM (Levetiracetam Extended Release tablets). 

  • Celgene International Sàrl, announced that the European Commission (EC) has approved REVLIMID® (lenalidomide) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 

    MCL is a rare sub-type of aggressive non-Hodgkin's lymphoma (NHL), which starts in the lymph nodes but can move to other organs, causing tumours known as lymphomas. Between 3 and 6 percent of NHL patients have MCL. MCL has the poorest long-term survival of all B-cell lymphoma subtypes, with fewer than 50 percent of patients surviving at 5 years. In Europe there were 93,433 new cases of non-Hodgkin lymphoma, and 37,900 deaths in 2012. MCL has a median age of onset of 70 years and affects men more often than women. 

  • Celgene International Sàrl, announced that the European Commission (EC) has approved REVLIMID® (lenalidomide) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 

    MCL is a rare sub-type of aggressive non-Hodgkin's lymphoma (NHL), which starts in the lymph nodes but can move to other organs, causing tumours known as lymphomas. Between 3 and 6 percent of NHL patients have MCL. MCL has the poorest long-term survival of all B-cell lymphoma subtypes, with fewer than 50 percent of patients surviving at 5 years. In Europe there were 93,433 new cases of non-Hodgkin lymphoma, and 37,900 deaths in 2012. MCL has a median age of onset of 70 years and affects men more often than women. 

  • The United States Patent and Trademark Office (USPTO) has granted US patent for Cantargia AB’s (Cantargia) patent application concerning IL1RAP as a target molecule for antibody therapy of several solid tumor types. The granted patent follows the Notice of Allowance that was issued and communicated in June 2016. 

  • AstraZeneca announced that the Phase III AURA3 trial met its primary endpoint, demonstrating superior progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The AURA3 randomised trial assessed the efficacy and safety of Tagrisso as a 2nd-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed following 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso also demonstrated a safety profile consistent with previous trials.

  • 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.

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