Industry News

Asterias Biotherapeutics, Inc., a biotechnology company pioneering the field of regenerative medicine, today announced that the first patient with incomplete AIS-B cervical spinal cord injury was successfully dosed with 10 million cells of AST-OPC1 in the SCiSTAR clinical trial at Shepherd Center in Atlanta. The company recently received FDA clearance to expand the study into this additional patient population based on the..."/>
Asterias Biotherapeutics Announces Dosing of First Patient in New SCiSTAR Clinical Trial Cohort Testing AST-OPC1 in an Expanded Cervical Spinal Cord Injury Patient Population
Hill-Rom Holdings, Inc.. The combination creates the most comprehensive perinatal safety platform available, and marks a new era in obstetric solutions. Users of both the PeriGen PeriCALM ® and WatchChild..."/>
PeriGen and WatchChild Combine Forces
AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced today the initiation of the Phase 3 IAP312 study of Zalviso ®, an investigational product candidate being developed for the management of moderate-to-severe acute pain in adult patients in a hospital setting."/>
AcelRx Initiates Phase 3 Study of Zalviso® in Patients with Moderate-to-Severe Acute Post-Operative Pain
ProNAi Therapeutics, Inc., a clinical-stage drug development company advancing targeted therapeutics for the treatment of patients with cancer, today announced that it has obtained an..."/>
ProNAi Licenses Oncology Drug Targeting DNA Damage Response Checkpoint Kinase 1 (Chk1) from CRT Pioneer Fund, UK
ProNAi Therapeutics, Inc., a clinical-stage drug development company advancing targeted therapeutics for the treatment of patients with cancer, today announced that it has obtained..."/>
ProNAi Licenses Oncology Drug Targeting DNA Damage Response Checkpoint Kinase 1 (Chk1) from CRT Pioneer Fund, UK
Accuray Incorporated announced today that data from a prospective, 21 center study showed 97 percent of low- and intermediate-risk prostate cancer patients had excellent cancer control five years after receiving stereotactic body radiation therapy administered with the CyberKnife ® System. The treatment was extremely well-tolerated; serious side effects were uncommon after more than five years of follow-up."/>
Prospective, Multi-Institutional Study Shows Five Treatments with the CyberKnife® System Provide Excellent Disease Control for Prostate Cancer Patients
Summit Therapeutics plc, the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection, today announces it has received Rare Pediatric Disease designation from the US Food and Drug Administration for ezutromid in the treatment of DMD. As a utrophin modulator, ezutromid has potential as a disease-modifying treatment for all patients with the fatal muscle wasting..."/>
Summit Receives Rare Pediatric Disease Designation From US FDA for Ezutromid in Treatment of Duchenne Muscular Dystrophy
pSivida Corp., a leader in the development of sustained release drug delivery products for treating eye diseases, today announced the appointment of Jay S. Duker, M.D, to the Company’ s Board of Directors. Duker is the Director of the New England Eye Center and Professor and Chairman of Ophthalmology at the Tufts Medical Center and the Tufts University School of Medicine.. Jay Duker is a recognized international expert in the treatment of diseases of the..."/>
PSivida Corp. Strengthens Board of Directors With Leading Ophthalmologist
EnteroMedics Inc., the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced the appointment of President and Chief Executive Officer Dan Gladney as Chairman of the Board of Directors, effective October 14, 2016. Mark Knudson, co-founder of EnteroMedics, who will be retiring from the Board. Knudson will be Special Advisor to the CEO on..."/>
EnteroMedics Announces Appointment of Dan Gladney as Chairman of the Board of Directors
Nektar Therapeutics today announced a new clinical collaboration to evaluate Bristol-Myers Squibb’ s Opdivo with Nektar’ s investigational medicine, NKTR-214, as a potential combination treatment regimen in five tumor types and seven potential..."/>
Bristol-Myers Squibb and Nektar Therapeutics Announce Oncology Clinical Collaboration to Evaluate the Combination of Opdivo (nivolumab) and NKTR-214
Boston Scientific and EndoChoice Holdings, Inc. today announced the companies have entered into a definitive agreement under which Boston Scientific has agreed to acquire EndoChoice. Upon completion of the transaction, EndoChoice will become part of the Boston Scientific endoscopy business. EndoChoice develops and commercializes innovative products and services for specialists treating a wide range of..."/>
Boston Scientific to Acquire EndoChoice
AbbVie revealed on Monday that it has filed its supplemental New Drug Application for ibrutinib for the treatment of patients with marginal zone lymphoma, a slow-growing form of non-Hodgkin's lymphoma. The company added that its sNDA submission with the US Food and Drug Administration is based on data from a multi-centre, open-label Phase II PCYC-1121-CA trial assessing ibrutinib as a single-agent treatment for MZL."/>
AbbVie submits sNDA for ibrutinib (IMBRUVICA) for treating marginal zone lymphoma
Exelixis Inc announced on Monday that Julie Anne Smith has been elected to the company's board of directors, effective 22 September 2016.. Currently, Smith serves as president and chief executive officer of Raptor Pharmaceuticals, a position she has held since 2013. She joined Raptor Pharmaceuticals in 2012, beginning her tenure as executive vice president and chief operating officer."/>
Exelixis names Julie Anne Smith to board
Mylan NV faced accusations Monday that Chief Executive Heather Bresch wasn't forthright when she told Congress the drugmaker makes $100 in profit on a two-pack of its EpiPen allergy device because she didn't make clear that tax expenses had been deducted from the figure. The company disclosed in a regulatory filing Monday that profit, which Bresch provided last week during a congressional hearing about the device's skyrocketing price, factored a 37.5 percent U.S...."/>
Mylan: Epipen profits higher than Bresch told Congress [The Pittsburgh Tribune-Review]
Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced that an editorial addressing approaches to Category 1 testing of abuse-deterrent formulations of opioids has been published in Pain Practice. The editorial titled, "Striving for Consensus on Approaches to Category 1 Testing of..."/>
Editorial Discussing Approaches to Category 1 Testing of Abuse-Deterrent Formulations of Opioids Published in Pain Practice
IsoRay, Inc., a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for the treatment of prostate, brain, lung, head and neck, and gynecological cancers, today announced that on September 23, 2016, it entered into a Stipulation of Settlement, pursuant to which IsoRay and IsoRay's former CEO have, subject to certain conditions and approvals, agreed to settle the previously-disclosed..."/>
IsoRay, Inc. Enters Into Agreement to Settle Class Action Shareholder Litigation
Cesca Therapeutics Inc., an autologous cell-based regenerative medicine company, today announced that Dalip Sethi, Ph.D., Director of Clinical Research, will be presenting at the 2016 International Society for Cellular Therapy North America Regional Meeting, to be held from September 30 to October 2, 2016 at the Peabody Hotel in Memphis, Tennessee. The company will also be exhibiting at the meeting in Booth 215.. “We are very pleased to present..."/>
Cesca Therapeutics to Present & Exhibit at the ISCT North America 2016 Regional Meeting
Provectus Biopharmaceuticals, Inc., a clinical-stage oncology and dermatology biopharmaceutical company, today announced that the Society for Immunotherapy of Cancer has accepted an abstract for a poster presentation related to the use of PV-10, an investigational ablative immunotherapy under..."/>
Provectus Biopharmaceuticals Announces Acceptance of Abstract for Poster Presentation at 31st SITC Annual Meeting
Intrexon Corporation announced on Monday the grant of options to purchase an aggregate of 2,000,000 shares of its common stock to Geno J. Germano in connection with his appointment as president pursuant to New York Stock Exchange Rule 303 A.08 and the 2013 Omnibus Incentive Plan. The company added that Germano received the options to purchase an aggregate of 2,000,000 shares of its common stock at an exercise price of USD29.94, the closing price per..."/>
Intrexon awards inducement stock options to new president Geno J. Germano
Amgen today announced top-line results of the Phase 3 CLARION trial, which evaluated an investigational regimen of KYPROLIS ®, melphalan and prednisone versus Velcade ®, melphalan and prednisone for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival."/>
Amgen Announces Top-Line Results From Phase 3 KYPROLIS® (Carfilzomib) CLARION Study In Newly Diagnosed Multiple Myeloma Patients

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