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Shares of MiMedx are down more than 31 percent this morning following the abrupt resignation of Board Chairman and Chief Executive Officer Parker H. "Pete" Petit. Additionally, William C. “Bill” Taylor resigned as president and chief operating officer.
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Shares of Alkermes plc are climbing in premarket trading after the company announced the U.S. Food and Drug Administration approved Aristada Initio (aripiprazole lauroxil) as part of a combination treatment for schizophrenia.
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Roche announced that its Phase III IMpassion130 clinical trial met its co-primary endpoint of progression-free survival (PFS) in triple-negative breast cancer (TNBC).
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RedHill Biopharma Announces Allowance of Two New RHB-104 Patents Ahead of Top-Line Phase III Results for Crohn’s Disease
7/2/2018
RedHill Biopharma Ltd., a specialty biopharmaceutical company, has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) and an Intention to Grant from the European Patent Office (EPO) for two new patents covering RHB-104, expected to be valid until at least February 5, 2029, once granted.
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Compugen Announces FDA Clearance of IND Application for COM701, a First-in-class Immuno-Oncology Therapeutic Antibody
7/2/2018
A Phase 1 trial in patients with advanced solid tumors is to be conducted at multiple centers in the United States
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TTP Plc and Cubed Laboratories Announce Successful Completion of Product Development Project
7/2/2018
NESDEP portable laboratory for pathogen detection is now being transferred for manufacture
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Phase III IMpassion130 Study Showed Genentech’s TECENTRIQ Plus Abraxane Significantly Reduced the Risk of Disease Worsening or Death in People With Metastatic or Locally Advanced Triple Negative Breast Cancer
7/2/2018
First Phase III immunotherapy study to demonstrate a statistically significant progression-free survival (PFS) improvement in intention-to-treat (ITT) and PD-L1 positive first-line metastatic triple negative breast cancer (TNBC) populations
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New Analysis of Rekovelle® Data Further Supports Use of AMH to Personalise Fertility Treatment
7/2/2018
Rekovelle’s unique dosing algorithm, which is based on a woman’s anti-Müllerian hormone (AMH) level and body weight, is designed for predictable ovarian response
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ReCor Medical Announces FDA Approval Of IDE For Pivotal Study Of Paradise® Ultrasound Denervation System For Treatment Of Hypertension
7/2/2018
ReCor expects to initiate enrollment in RADIANCE-II in October of this year.
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Toyoda Gosei and EBM Corporation Develop a Prototype "Super BEAT" Medical Simulator Using e-Rubber
7/2/2018
Surgical training simulator can reproduce the beating of the heart with extreme accuracy.
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Onco360 Selected for BRAFTOVI ™ (encorafenib) and MEKTOVI® (binimetinib) Limited Distribution Pharmacy Network
7/2/2018
BRAFTOVI and MEKTOVI provide another important therapeutic option for patients with unresectable or metastatic melanoma with BRAF B600E or BRAFV600K mutations
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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy as First-Line Treatment for Metastatic Squamous Non-Small Cell Lung Cancer
7/2/2018
Application Based on Data from Pivotal Phase 3 KEYNOTE-407 Trial
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LYNPARZA® (olaparib) Approved in Japan for BRCA-Mutated Metastatic Breast Cancer
7/2/2018
LYNPARZA is the First and Only PARP Inhibitor Approved for Use Beyond Ovarian Cancer
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Cellerant Therapeutics, Inc. Announces FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation for Romyelocel-L to Prevent Infections During Neutropenia
7/2/2018
RMAT designation confers similar advantages as breakthrough therapy designation.
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Soligenix Announces Closing of $8,000,000 At The Market Public Offering
7/2/2018
Soligenix, Inc. (Nasdaq: SNGX), announced today the closing of its previously announced underwritten public offering of 7,766,990 shares.
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Veracyte Chairman and CEO to Speak at MedCity CONVERGE
7/2/2018
Veracyte, Inc. today announced that Bonnie Anderson, chairman and chief executive officer, will speak at the 2018 MedCity CONVERGE conference in a session entitled, “Early Diagnosis Through Predictive Biomarkers, Noninvasive Testing.”
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DiaCarta Inc. Appoints Arrow Diagnostics as Exclusive Distributor for ColoScape™ in Italy
7/2/2018
DiaCarta Inc. today announced that it has signed a distribution agreement with Arrow Diagnostics.
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NewLink Genetics Announces Positive Updated Phase 1 Data with Indoximod Plus Radio-Immunotherapy for Pediatric Patients with DIPG Presented at ISPNO 2018
7/2/2018
NewLink Genetics Corporation reported that updated Phase 1 data evaluating indoximod plus front-line radiation and maintenance chemotherapy were presented Sunday, July 1, at the ISPNO 2018 Annual Meeting.
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Celgene Corporation to Announce Second Quarter 2018 Results on July 26, 2018
7/2/2018
Celgene Corporation will host a conference call and live audio webcast on Thursday, July 26, 2018 at 9 a.m. ET to discuss second quarter 2018 financial and operational results.
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Novocure to Report Second Quarter 2018 Financial Results
7/2/2018
Novocure announced today that it will report financial results for the second quarter 2018 on Thursday, July 26, 2018, before the U.S. financial markets open.