Medical Tidbits,ASTRAZENECA’S COMBINATION OF DURVALUMAB WITH TREMELIMUMAB SHOWS CLINICAL ACTIVITY IN NON-SMALL CELL LUNG CANCER IRRESPECTIVE OF PD-L1 STATUS

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LONDON–(BUSINESS WIRE)–AstraZeneca and MedImmune, its global biologics research and development arm, today announced publication in The Lancet Oncology of a Phase Ib study (study 006), showing antitumour activity of combination treatment with durvalumab and tremelimumab, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), irrespective of PD-L1 status  read more

Volpi Group Partners With QIAGEN To Manufacture the Imaging Module for the GeneReader[TM] NGS Platform

The Volpi Group, a 60-year-old optical electronics firm based in Schlieren, Switzerland, today announced that it is collaborating with QIAGEN Instruments AG on the manufacture of the automated fluorescence imaging module used in QIAGEN’s GeneReader[TM] next-generation sequencing (NGS) instrument. The benchtop GeneReader combines with other QIAGEN NGS products to provide the first seamless, fully automated Sample to Insight workflow.  For more information http://www.volpi.chhttp://www.volpiusa.com

Ferring announces the start of the PRONOUNCE Trial for patients with advanced prostate cancer and cardiovascular disease receiving degarelix or leuprolide

SAINT PREX, Switzerland–(BUSINESS WIRE)–Ferring Pharmaceuticals announced today the commencement of the Phase 3b PRONOUNCE Trial. The trial will compare the occurrence of major adverse cardiovascular events (MACEs) in patients with prostate cancer and cardiovascular disease (CVD), receiving the GnRH receptor antagonist, degarelix, to patients receiving a GnRH receptor agonist, leuprolide. read more

Quintiles Wins 2016 Leadership Excellence Award

RESEARCH TRIANGLE PARK, N.C.–(EON: Enhanced Online News)–Quintiles, the world’s largest biopharmaceutical services company, has been awarded the HR.com 2016 Leadership Excellence Award for Innovation in Deployment of Leadership Programs. read more

Ideal Cures Pvt. Ltd.: Ideal Cures Expands its Global Reach with a Presence in America

MUMBAI, India–(BUSINESS WIRE)–Ideal Cures Pvt. Ltd, an India based global company, manufacturer, global supplier and provider of technical support for pharmaceutical coatings and excipients, announces the opening of their representative office in the United States of America, and the appointment of Dr. Kamlesh Oza, Ph. D. as President – Global Business Development. This new office in the US will augment its global reach from a well-developed network in Asia and Europe to the Americas.  Ideal Cures presently has three EXCiPACT™ certified cGMP manufacturing plants in India and offices in India, Italy, Spain, Turkey and Israel.

KPI also targets lupus, chronic pain

SEATTLE–(BUSINESS WIRE)–KPI Therapeutics, a clinical-stage biotechnology company, today announced it initiated two new research programs to treat such diseases as Atopic Dermatitis, Dry Eye Syndrome, and Uveitis at the BIO CEO & Investment Conference in New York. Using novel peptides from the same family as its lead autoimmune drug dalazatide, KPI will develop topical biologic Kv1.3 inhibitors that target the immune cells which cause these autoimmune diseases. KPI is also currently conducting research in lupus and chronic pain. Dalazatide, another peptide from the ShK platform, is being developed for lupus and other autoimmune diseases.

STENTYS initiates the Commercialization of the first Self-Expanding Drug-Eluting stent for the Below-The-Knee Indication

STENTYS (FR0010949404 — STNT) (Paris:STNT), a medical technology company commercializing the world’s first and only Self-Apposing® coronary stent, today announces the first distribution agreements for its drug-eluting stent for treating BTK (Below-The Knee) arteries in Germany and Belgium, making it the first self-expanding drug-eluting stent commercialized for this indication in Europe. read more

Promius Pharma™ Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, 0.05%

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s announced today that its US subsidiary, Promius PharmaTM, LLC, U.S. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), has received approval for Sernivo™ (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA). Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the coming quarter. read more

Vizient, Inc. Endorses the FDA’s Biosimilars Approval Pathway

Letter of support sent to the FDA’s Arthritis Advisory Committee Reviewing Biosimilar Infliximab

IRVING, Texas–(BUSINESS WIRE)–Citing the escalating costs for certain commonly used biologics and the associated expenses for its members of over $6 billion, Vizient, Inc. has sent a letter to the Food and Drug Administration’s (FDA) Arthritis Advisory Committee endorsing the continued implementation of the U.S. biosimilar pathway. On February 9, 2016, the committee is scheduled to hold an advisory hearing on an application for a biosimilar version of infliximab, currently only available as the branded biologic Remicade® (Janssen Biotech). read more

Egalet Signs Agreement with Septodont, Inc. to Promote SPRIX® (ketorolac tromethamine) Nasal Spray to Dentists in United States

–Data published in Postgraduate Medicine supports use of SPRIX Nasal Spray as effective non-opioid option post dental procedures–

Egalet Corporation (Nasdaq: EGLT) (“Egalet”), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced a collaboration agreement with Septodont, Inc., a company dedicated to providing innovative pharmaceutical products to the dental profession. Under this agreement Septodont will promote SPRIX (ketorolac tromethamine) Nasal Spray exclusively to dentists in the United States using its focused specialty sales force. Under the terms of the agreement, Egalet will receive an upfront licensing fee, earn sales-based milestones and share in profits from net sales of SPRIX to dentists in the U.S. read more

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