AiMeD, the apex body of Indian medical device manufacturers, has urged the Ministry of Health and Family Welfare for speedy implementation of the decision taken three months ago by the Prime Minister’s Office to initiate wide ranging regulatory reforms for medical device sector in order to boost domestic manufacturing and investment in the sector as well as to ensure enhanced healthcare security for common Indian citizens.
The US Food and Drug Administration (FDA) has accepted for filing Allergan's supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam), seeking the addition of new phase 3 clinical trial data evaluating Avycaz in patients with complicated urinary tract infections (cUTI), including pyelonephritis, due to designated susceptible pathogens to the current product label.
SkylineDx,a commercial-stage biotech company, has received a notice of allowance for a Japanese patent related to its prognostic SKY92 gene signature for multiple myeloma. The announcement comes as SkylineDx prepares to attend the 78th Annual Meeting of the Japanese Society of Hematology (JSH2016) in Pacifico Yokohama, October 13 -15, 2016.
Viamet Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to VT-1161, a novel oral agent for the treatment of recurrent vulvovaginal candidiasis (RVVC), or recurrent vaginal yeast infection, a common and difficult to treat condition in women. There are no approved therapies in the United States for RVVC.
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the first patient has been enrolled in the global phase 3 QuANTUM-First study evaluating the oral FLT3-ITD inhibitor quizartinib in patients with newly-diagnosed FLT3-ITD-positive (+) acute myeloid leukemia (AML).
Researchers have prevented the development of Alzheimer’s disease in mice by using a virus to deliver a specific gene into the brain. The early-stage findings, by scientists from Imperial College London, open avenues for potential new treatments for the disease.
Clever Culture Systems AG (CCS), the Swiss based joint venture between Australian medical technology company LBT Innovations Limited (ASX: LBT) and Hettich AG (Switzerland) has received clearance of its 510(k) de novo submission to the US Food and Drug Administration (FDA) for APAS® as a Class II medical device.
Novartis announced data from the phase III COMBI-v study demonstrating an overall survival (OS) and a progression-free survival benefit for patients with BRAF V600 mutation-positive advanced melanoma when treated first-line with the combination of Tafinlar (dabrafenib) + Mekinist (trametinib) compared to vemurafenib monotherapy. The results of this study, which was conducted in 704 patients, are being presented at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen.
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Novartis announced updated results from a Phase II study (ASCEND-3), which demonstrated that anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients taking Zykadia® (ceritinib) as their first ALK inhibitor (post-chemotherapy) had a median progression-free survival (PFS) of 18.4 months [95% CI: 10.9-26.3; median follow-up time of 25.9 months, as measured by blinded independent review committee (BIRC).Results were presented during an oral session at the Annual European Society for Medical Oncology Congress (ESMO) in Copenhagen.
Nicox S.A. announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis.
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