Issue 26
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29

May 2017

BioPharma Services, Inc. Successfully Completes 3 FDA Inspections with ZERO Form 483’s

BioPharma Services Inc is proud to announce that it has successfully completed inspections this month by the US FDA with concurrent audits at both research centers in Toronto Canada and Columbia Missouri Over the course of weeks the backtoback inspections focused on a total of…

29

May 2017

Glenmark Pharma gets ANDA approval for nebivolol tablets

Glenmark Pharmaceuticals Ltd Says receives ANDA approval for nebivolol tablets mg mg mg and mg Co may be eligible for days of generic drug exclusivity for nebivolol tablets mg mg mg and mg

27

May 2017

Novartis receives FDA approval for expanded use of Zykadia®

Novartis today announced the US Food and Drug Administration FDA approved the expanded use of Zykadia ceritinib to include the firstline treatment of patients with metastatic nonsmall cell lung cancer NSCLC whose tumors are anaplastic lymphoma kinase ALKpositive as detected by an FDAapproved test Zykadia…

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27

May 2017

Lupin Pharmaceuticals Inc. Announces a Nationwide Recall of MibelasTM 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1mg/0.02mg Chewable Tablets and Ferrous Fumarate 75mg) Tablets

Lupin Pharmaceuticals Inc announced today that it has voluntarily recalled lot L Exp of Mibelas Fe Norethindrone Acetate and Ethinyl Estradiol mg mg chewable and ferrous fumarate mg Tablets at…

27

May 2017

NLS Pharma Announces New Information In Support Of The Mechanism Of Action Of Its Lead Compound NLS-1 mazindol CR

NLS Pharma Group a Swiss biotech group focusing on the development of novel treatments for attention deficit hyperactivity disorder ADHD sleep disorders and cognitive impairments announced today that studies investigating…

26

May 2017

Neurana Pharmaceuticals Receives Notice of Allowance of Patents For Tolperisone, a Novel Skeletal Muscle Relaxant

Neurana Pharmaceuticals Inc a specialty pharmaceutical company focused on the development and commercialization of products that address unmet therapeutic needs of the central nervous system today announced receipt of a…

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29-31

May 2017

30-01

May 2017

Market Access for Precision Medicine

Hanson Wade
Hyatt Regency Dulles

TOP ARTICLES

  • 3

    Parenteral Preparations

    INTRODUCTION Parenteral preparations are defined as solutions suspensionsemulsions for injection or infusion powders for injection or infusion gels for injecti..

Knowledge Bank

  • Interviews

    Datwyler Pharma Packaging

    Senior Manager Global Scientific Affairs
    Renaud Janssen PhD is the Senior Manager of Global Scientific Affairs at Datwyler Pharma Packaging He frequently presents on international conferences on subjects related to elastomeric and aluminiumplastic closures for pharmaceutical applications Re..

  • Articles

    The European Lead Factory

    In drug discovery the search for new chemical equity to be developed into valuable preclinical and clinical candidates is very time and costintensive This is a particular difficulty for academics or small and medium enterprises SMEs who are likely to have limited resources Additionally small companies are often created around a single compound or…

  • Techno Trends

    Evotec and Eternygen to Develop Novel Metabolic Disease Therapy

    Evotec and Eternygen announced a drug discovery collaboration to develop novel metabolic disease therapy The two companies will develop novel small molecule inhibitors against an Eternygen target to treat metabolic disease using Evotecs technology platform and broad expertise in drug discovery and preclinical development Eternygen is working on the sodium coupled citrate transporter NaCT a novel target which is a…

Editorial Section

  • Strategy

    Generics in Switzerland

    The article talks about the Swiss Generics market the penetration rate of generics in Switzerland why generics are a safe and smarter choice manufactured to modern standards with affordable prices and the threat of government forcing generic companies to benchmark…

  • Research development

    Biologics and Biosimilars

    With the early generation of biologics starting to lose patent protection the field of biosimilars too has been gaining attention Biosimilars are the generic version of a biologic drug developed for launch post the patent expiry of the original drug…

  • Clinical Trails

    Patient Recruitment

    To address the challenges faced in patient recruitment and retention in clinical trials innovative technologies are being utilised in AsiaPacific as well as other regions to optimise the processes involved From patient matching to improving the consent process technology has…

  • Expert Talk

    Biologics’ Drug Delivery Systems

    In this interview Peter Soelkner of Vetter discusses drug delivery trends for biologics and in particular prefilled syringes He offers insight into the advantages and challenges of this system for biologics important issues to consider…

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