On May 14, 2018 Coherus BioSciences, Inc. (NASDAQ:CHRS), reported that the U.S. Food and Drug Administration (FDA) has accepted and acknowledged for review the re-submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate (Press release, Coherus Biosciences, MAY 14, 2018, View Source;p=RssLanding&cat=news&id=2348926 [SID1234526578]). In the communication, FDA indicated that they consider the resubmission a complete response to their June 9, 2017 action letter. FDA provided a biosimilar user fee act (BSUFA) action date of November 3, 2018. The letter did not indicate the need to prepare for an advisory committee meeting.

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"We appreciate FDA’s prompt action on our file and look forward to working with them on the review," said Denny Lanfear, President and CEO of Coherus BioSciences. "We believe that CHS-1701 is well-positioned to deliver greater access to oncology patients and savings to the healthcare system. We are continuing to make good progress in building inventory of CHS-1701 and in preparing for commercial launch in the U.S."

BioXcel Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, BioXcel Therapeutics, 2018, MAY 14, 2018, View Source [SID1234527534]).

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Mersana Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Mersana Therapeutics, 2018, MAY 14, 2018, View Source [SID1234527574]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On May 14, 2018 Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the Company’s PHP Therapy was featured in a Video Learning Session presented at the Annual Meeting of the European Conference of Interventional Oncology (ECIO). Dr. M.C. Burgmans of Leiden University Medical Center (LUMC) in the Netherlands presented the training in the main auditorium session dedicated to advances in liver cancer therapies (Press release, Delcath Systems, MAY 14, 2018, View Source;p=RssLanding&cat=news&id=2348840 [SID1234526580]). Dr. Burgmans presented an overview of the Percutaneous Hepatic Perfusion (PHP) procedure, discussed the therapy’s developmental history, demonstrating how to perform the procedure, as well as outlining its potential in ocular melanoma liver metastases and intrahepatic cholangiocarcinoma, and highlighting ongoing clinical research.

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"In his presentation, Dr. Burgmans stated his belief that PHP Therapy should be considered as first line therapy in ocular melanoma liver metastases, an opinion informed by both our commercial experience in Europe and our prior research into this tumor type," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems. "LUMC is one of the our most experienced treatment centers, and with CHEMOSAT recently added to the Dutch National Treatment Guidelines for use in ocular melanoma, we believe Dr. Burgmans comments reflect growing confidence in this therapy’s role in treating this disease. We continue to work tirelessly to advance our current clinical trial in this disease in order to further validate this role for our therapy and to deliver on its full potential to patients in need."

The ECIO was held in Vienna, Austria, April 22-25, 2018.

On May 14, 2018 Augmenix, Inc. reported that they will be exhibiting at this year’s American Urological Association meeting in San Francisco, California (Press release, Augmenix, MAY 14, 2018, View Source [SID1234526598]). Located at Booth 6251 Hall D, the company will be featuring their leading product, SpaceOAR hydrogel, which is used in patients receiving radiation therapy for prostate cancer. Attendees of the AUA meeting are invited to visit the exhibit to learn about the latest developments that make SpaceOAR hydrogel the #1 rectal spacer for prostate cancer radiotherapy worldwide.

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Highlights Include:

In booth presentations from Urology experts including Dr. Katsuto Shinohara, from University of California, San Francisco who will speak about the clinical benefits and procedural overview of SpaceOAR hydrogel. Dr. Evan Goldfischer from the Premier Medical Group and Clinical Assistant Professor of Urology at the New York Medical College will speak about integrating SpaceOAR hydrogel into office-based Urology practices. Mark Painter, CEO of PRS, LLC will present the recent positive developments in national reimbursement for the SpaceOAR hydrogel procedure.

Augmenix will also unveil its new customized hands-on simulators at the exhibit, designed to provide Urologists with the ability to perform the SpaceOAR procedure before using it with patients.

The company will also formally launch the Augmenix Spacing Academy, designed to provide the information, tools and on-site support to enable Urologists to experience consistent and optimal patient outcomes.

About SpaceOAR Hydrogel

In April 2015, the Food and Drug Administration (FDA) cleared SpaceOAR hydrogel. In a prospective, randomized, multi-center clinical trial in the United States, patients treated with SpaceOAR hydrogel prior to prostate cancer radiation treatment demonstrated bowel, urinary, and sexual benefits through three years median of follow-up. The study found that the patients who did not receive SpaceOAR hydrogel experienced a clinically significant decline in bowel, urinary, and sexual quality of life eight times more often than patients who received SpaceOAR hydrogel. (1,2)

Most recently, Augmenix announced that a Category 1 CPT code (55874) was issued for SpaceOAR hydrogel, which became effective on January 1, 2018. SpaceOAR hydrogel is covered by six out of seven Medicare Administrative Contractors (MACs), Geisinger Health Plan, Aetna, Inc., and military payer TRICARE.