Issue 32 | 2018
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Nov 2018

Enable Injections Enters into Strategic Partnerships with UCB and Apellis Pharmaceuticals

Enable Injections Inc a patientcentric drug delivery combination product company developing advanced wearable devices for subcutaneous delivery of highvolume therapeutics today announced it has entered into development agreements with Apellis Pharmaceuticals and most recently UCB Enable Injections currently has partnerships with five companies to deliver…


Nov 2018

Ferring Pharmaceuticals Enters Exclusive Agreement with INVO Bioscience

Ferring Pharmaceuticals announced today that it has signed an agreement to acquire from INVO Bioscience Inc the exclusive US commercialization rights for the INVOcell intravaginal culture IVC system which comprises the INVOcell IVC device retention device and holding block The INVOcell IVC device uses a…


Nov 2018

Ziopharm Oncology Announces Immuno-oncology Clinical Supply Agreement with Regeneron

Ziopharm Oncology Inctoday announced a clinical supply agreement with Regeneron Pharmaceuticals Inc to evaluate Ziopharms AdRTShIL plus veledimex in combination with Regenerons PD antibody Libtayo cemiplimabrwlc to treat patients with recurrent glioblastoma rGBM AdRTShIL plus veledimex is an investigational gene therapy designed to induce and…


Nov 2018

BridgeBio Pharma LLC Signs Joint Collaboration Agreement with Cincinnati Children's to Accelerate Development of Genetic Disease Therapeutics

BridgeBio Pharma LLC and Cincinnati Childrens Hospital Medical Center today announced they are entering into a research collaboration to identify and develop genetic disease therapies This partnership will combine BridgeBios strengths in therapeutic development for diseases of high unmet need with Cincinnati Childrens worldclass researchers…


Nov 2018

Strides enters into strategic partnership with SUDA Pharmaceuticals for the US market

Strides Pharma Science Limited Strides has announced that its stepdown wholly owned subsidiary Strides Pharma Global Pte Limited Singapore has entered into an exclusive product development licensing and supply agreement with SUDA Pharmaceuticals Ltd for its novel drug SUDH an oral spray of sumatriptan to…

press releases


Nov 2018

Ardelyx Announces FDA Acceptance of the Filing of its New Drug Application for Tenapanor for the Treatment of Patients with IBS-C

Ardelyx Inc today announced that the US Food and Drug Administration FDA has accepted for review the New Drug Application NDA for tenapanor for the treatment of patients with irritable…


Nov 2018

NeuroRx Receives FDA Breakthrough Therapy Designation for NRX-101, First Oral Drug Targeting Suicidal Bipolar Depression

NeuroRx a clinical stage biopharma company focused on the development of Rapid Acting Antidepressants RAADs that target the brains NMDA receptor has been granted Breakthrough Therapy Designation by the US…


Nov 2018

NMPA Accepts Biosimilar New Drug Application for IBI303, a Biosimilar Candidate to Humira(R) (adalimumab)

Innovent Biologics Inc Innovent a worldclass Chinabased biopharmaceutical company that develops and commercializes high quality drugs announced today that National Medical Products Administration NMPA successor to CFDA has accepted its…


Nov 2018

Theravance Biopharma Highlights Expanded COPD Indication for Trelegy Ellipta in Europe

Theravance Biopharma Inc Theravance Biopharma today highlighted that the European Commission authorized an expanded label for oncedaily Trelegy Ellipta fluticasone furoateumeclidiniumvilanterol FFUMECVI recognizing the products effect on exacerbations and making…


Nov 2018

Generon Receives Investigative New Drug (IND) Approval from China SFDA for A-319 to Treat Patients with B Cell Malignancies

Generon Corporation a leading biopharmaceutical company in China today announced it received approval for the Companys Investigational New Drug IND application from the State Food and Drug Administration SFDA of…

Events


Nov 2018

World ADC San Diego 2018

Hanson Wade Ltd
Marriott Marquis San Diego


Nov 2018

Microbiome Human Nutrition

Hanson Wade
Sheraton Boston Hotel


Nov 2018

Computational Drug Development for Biologics Summit

Hanson Wade Ltd
The Westin Boston Waterfront


Nov 2018

Cell & Gene Therapy Manufacturing 2018

DoubleTree by Hilton Hotel London


  • 3

    Are you Ready for EU FMD?

    With the deadline looming for enactment of EU FMD and US DSCSA Vikash Pushpraj Senior Vice President rfxcel explains how achieving compliance is about much more..
  • 5

    Cancer Stem Cell (CSC) Inhibitors

    Cancer as a group of heterogeneous diseases very well known Unimaginable amounts of money and manhours have been spent in finding cure for this deadly disease H..

Knowledge Bank

  • Interviews


    Staff Engineer, Manufacturing Science and Technology, South East Asia
    Karen Chan is a process engineer at Merck Pte Ltd Chan has six years of experience in the biopharmaceutical industry and two years of experience in research development She provides technical support in areas such as process development troubleshoot..

  • Articles

    Identification of MicroRNAs and Their Targets in Cancer

    Although our cells are well equipped with regulatory checkpoints transformation of normal cells to malignant cancerous cells often occurs as a genetic disease While awareness on the various cancercausing factors has been raised worldwide the incidence of cancer continues to increase each year To further complicate matters existing cancer treatments can be rendered ineffective…

  • Techno Trends

    Alnylam’s ONPATTRO to Treat Patients with Hereditary ATTR Amyloidosis in Adults

    Alnylams ONPATTRO patisiran lipid complex injection is a firstofitskind RNA interference RNAi therapeutic used to treat the polyneuropathy of hereditary transthyretinmediated hATTR Amyloidosis in adults RNAi is a completely new approach to the treatment of these diseases targeting the faulty protein that is causing the disease rather than treating the symptoms RNAi therapeutic is an entirely new class of medicines…

Editorial Section

  • Strategy

    Statin Drug Interactions and Related Adverse Reactions

    Statins are generally well tolerated with a low frequency of adverse events but since statins are prescribed on a longterm basis many patients will typically receive pharmacological therapy for concomitant conditions during the course of statin treatment and potentially interacting…

  • Research development

    Stem Cell and Gene Delivery

    These days gene and stem cell therapies have the potential to make the substantial impact on the treatment of several diseases However there are pros and cons of each strategy but the optimal selection of gene delivery vector or stem…

  • Clinical Trials

    Managing Clinical Trial Agreements

    Clinical Trial Agreements set out how a clinical trial will be run at the site and are an essential GCP document There are a number of key factors that determine whether a Clinical Trial Agreement is successful in achieving that…

  • Information Technology


    Faster decision making and better trial oversight at all levels requires truly next generation data integration and analytics Source and format agnostic data aggregation aided by modern data lake architecture and advanced analytics deliver interactive…