Industry News

- Read more about Lipocine Completes Post Action Meeting With FDA for LPCN 1021 NDA
Lipocine Inc. announced the completion of a Post Action meeting with the U.S. Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The purpose of the meeting was to review the Complete Response Letter ("CRL") and to determine actions needed to achieve approval of LPCN 1021.
- Read more about Biotricity Receives a FDA 510(k) Clearance for a key component of its solution
Biotricity inc has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a key component of its solution. This clearance is another watershed moment in the company’s quest to market its remote cardiac monitoring solution comprised of the bioflux software and device. By developing medical remote monitoring solutions that help prevent and manage chronic diseases, biotricity seeks to revolutionize the health industry by bridging the gap in chronic care management.
- Read more about Addex begin phase IIa proof of concept study of dipraglurant in focal cervical dystonia
Addex Therapeutics announced that the company will conduct a phase IIa Proof of Concept Study of dipraglurant in focal cervical dystonia (CD). Addex expects to initiate the trial in the fourth quarter of 2016. The study was developed with support from the Dystonia Medical Research Foundation and in collaboration with investigators from the Dystonia Coalition, an international network of experts devoted to advancing research in dystonia. Buz Jinnah, Director of the Dystonia Coalition and Professor of Neurology at Emory University, will serve as the lead investigator.

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19 October 2016

Pfizer Announces The U.S. Availability Of Biosimilar INFLECTRA

INFLECTRA will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be available in the U.S. It is approved for the treatment of:
-adult patients and pediatric patients (ages six years and older) with moderate to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
-adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to conventional therapy; and
-moderate to severely active rheumatoid arthritis in combination with methotrexate; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis.
- Read more about FDA Approves Genentech’s Cancer Immunotherapy TECENTRIQ® (Atezolizumab)
Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) approved TECENTRIQ® (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. This approval is based on results from the randomized Phase III OAK and Phase II POPLAR studies. The largest study, OAK, showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.74, 95% CI: 0.63, 0.87). The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.
- Read more about Vedanta Biosciences Granted First European Patent Broadly Covering Pharmaceutical Compositions for Microbiome Therapeutics Based on Bacterial Consortia
Vedanta Biosciences, pioneering the development of a novel class of therapies for immune and infectious diseases based on rationally designed consortia of bacteria derived from the human microbiome, announced that the European Patent Office (EPO) has issued European Patent EP2575835. The patent broadly covers pharmaceutical compositions of Clostridium live bacterial strains and further expands Vedanta Biosciences’ patent portfolio after the issuances of three U.S. patents in the previous months and earlier issuances in Japan. The patents are exclusively licensed to Vedanta Biosciences under an agreement with the University of Tokyo and provide coverage through at least 2031.
- Read more about Medical Device Industry urges Ministry of Health & Family Welfare to expedite PMO's Decisions on regulatory reforms for the sector
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.
- Read more about US FDA accepts sNDA for Allergan's Avycaz
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.
- Read more about SkylineDx get Japanese patent for prognostic SKY92 gene signature
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.
- Read more about FDA Grants QIDP and Fast Track Designations to VT-1161
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.