On January 2, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported the addition of Darlene Horton, M.D. as Chief Medical and Regulatory Affairs Officer (Press release, Coherus Biosciences, JAN 2, 2019, View Source [SID1234532391]). She assumed her role on January 1, 2019.

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"We are very pleased that Dr. Horton has joined the executive team at Coherus," said Denny Lanfear, Chairman, President and CEO of Coherus. "She is a foremost biotechnology leader and clinician with an exceptional track record of delivering value to patients and shareholders."

"I believe there is a significant opportunity to accelerate the development and commercialization of biosimilar products. Coherus is leading the way in expanding access to life-changing biologic medicines while also significantly reducing costs to our healthcare system," said Darlene Horton, M.D. "I am honored to be joining Denny and the team at this exciting time for the company."

Dr. Horton recently was Chief Executive Officer of TulangCo, Inc., and Chief Medical Officer at SMC Biotechnology. Previously, she was President and Chief Executive Officer of Nile Therapeutics, Inc., and Vice President and Co-Chair, Joint Steering Committee between Itero and Allergan, and Co-Founder and Chief Medical Officer of Itero Biopharmaceuticals. Prior to that, she was Chief Medical Officer, Clinical Research and Medical Affairs, Senior Vice President, Clinical Research and Member of Corporate Executive Team at Scios, Inc. (a Johnson & Johnson company), where she also was Head, CV Therapeutic Area Center of Excellence.

Darlene earned her B.S. with Honors in Microbiology, and Doctor of Medicine from University of Florida. She did her internship and residency in the Department of Pediatrics at UCSF, and her Pediatric Cardiology Fellowship at the CV Research Institute of UCSF. She worked as a UCSF Clinical Faculty member in Pediatric Cardiology for 20 years, as a Staff Pediatrician at St. Luke’s Hospital and in the Intensive Care Nursery at Kaiser Hospital in San Francisco, California.

On January 2, 2019 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported full enrollment of cohort 1 (N=87) for previously treated Non-Small Cell Lung Cancer (NSCLC) patients with EGFR exon 20 insertion mutations with sites across the U.S., Europe, and Canada (Press release, Spectrum Pharmaceuticals, JAN 2, 2019, View Source [SID1234532333]). The EGFR previously treated cohort is part of the ZENITH20 trial – an open-label, multi-center, global Phase 2 trial evaluating NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Results from this cohort are expected by the second half of 2019.

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"The rapid rate at which we enrolled our Phase 2 previously treated EGFR exon 20 insertion mutations cohort speaks to the critical unmet medical need and demonstrates that the poziotinib program is aggressively advancing," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We are pleased with the results seen in smaller poziotinib trials and look forward to data from this larger, multi-center trial in the second half of the year."

The EGFR previously treated cohort is the first to fully enroll in the ZENITH20 trial. This study consists of four cohorts, each of which is independently powered for a pre-specified statistical hypothesis. There are two cohorts in the previously-treated NSCLC setting and two in the first-line setting. The primary endpoint is objective response rate (ORR). Additional endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and safety.

"Full enrollment of the first cohort marks an important milestone as this cohort is intended to provide the data required for the NDA filing," said Francois Lebel, M.D., F.R.C.P.C, Chief Medical Officer of Spectrum Pharmaceuticals. "Our poziotinib development program is investigating the treatment of exon 20 mutations across tumor types as these mutations are among the most difficult-to-treat and currently have no targeted FDA-approved therapies, leaving patients and physicians with very limited options."

About Poziotinib

Poziotinib is a novel, oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The full poziotinib targeted therapy clinical program is focused on four development areas for EGFR and HER2 mutations, including previously treated NSCLC, first-line NSCLC, treatment of other solid tumors and combination therapy.

Spectrum received exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several trials in multiple solid tumors.

On January 2, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that Marc N. Casper, president and chief executive officer, will present at the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2019, at 4:00 p.m. (PST) at the Westin St. Francis, San Francisco, Calif (Press release, Thermo Fisher Scientific, JAN 2, 2019, View Source [SID1234532355]).

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You can access the live webcast of the presentation in the Investors section of our website, www.thermofisher.com.

On January 2, 2018 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 8, 2019 at 9:30 a.m. PT (12:30 p.m. ET/5:30 p.m. GMT) from the Westin St. Francis Hotel in San Francisco (Press release, Alkermes, JAN 2, 2019, View Source;p=RssLanding&cat=news&id=2381873 [SID1234532371]). The presentation will be followed by a question and answer session that will begin at 10:00 a.m. PT (1:00 p.m. ET/6:00 p.m. GMT). A webcast of both the presentation and question and answer session may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com

On January 2, 2019 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that Sujal Shah, President and Chief Executive Officer, will provide a corporate overview at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 9, 2019 at 4:30pm PT (Press release, CymaBay Therapeutics, JAN 2, 2019, View Source [SID1234532334]).

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A live audio webcast of the presentation can be accessed through the Investors section of the CymaBay Therapeutics corporate website at View Source The webcast will be archived on the corporate website for 90 days.