Category Archives: Global News Feed


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Avadel Pharmaceuticals Announces Submission of New Drug Application for FT218 to the FDA

By Global News Feed

DUBLIN, Ireland, Dec. 16, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL) today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.

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Avadel Pharmaceuticals Announces Submission of New Drug Application for FT218 to the FDA

VYNE Therapeutics Added to Nasdaq Biotechnology Index

By Global News Feed

BRIDGEWATER, N.J., Dec. 16, 2020 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that it has been selected for inclusion in the NASDAQ Biotechnology Index (Nasdaq: NBI), based on the results of the annual reconstitution of the index announced by Nasdaq on December 11, 2020. The inclusion will become effective prior to the U.S. market open on Monday, December 21, 2020.

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VYNE Therapeutics Added to Nasdaq Biotechnology Index

Simplify Medical Announces First Implantation of its Cervical Artificial Disc in the U.S. Following 1-Level Approval from the FDA

By Global News Feed

SUNNYVALE, Calif., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Simplify Medical, Inc., a privately-held company focused on cervical spinal disc arthroplasty and developer of the Simplify® Cervical Artificial Disc, today announced its first surgery following the recent FDA approval for 1-level use. The Simplify Disc is designed for MRI compatibility*, physiologic motion, and anatomical height-matching, with the goals of improving patient outcomes and expanding treatment options for patients. The Simplify Disc achieved superiority to the fusion control on the trial’s composite primary endpoint (93.0% vs. 73.6%).

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Simplify Medical Announces First Implantation of its Cervical Artificial Disc in the U.S. Following 1-Level Approval from the FDA

Jounce Therapeutics Added to NASDAQ Biotechnology Index

By Global News Feed

CAMBRIDGE, Mass., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective prior to market open on Monday, December 21, 2020.

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Jounce Therapeutics Added to NASDAQ Biotechnology Index

XWPharma Names Michael M. Morrissey, PhD to Board of Directors

By Global News Feed

Appointment Adds Senior Biopharma Operational Expertise to Board Oversight as Company Advances its Pipeline of Novel CNS Therapeutics in Research and Clinical Development Appointment Adds Senior Biopharma Operational Expertise to Board Oversight as Company Advances its Pipeline of Novel CNS Therapeutics in Research and Clinical Development

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XWPharma Names Michael M. Morrissey, PhD to Board of Directors

Motus GI Announces Clinical Compendium of Pure-Vu System Patient Case Studies As Reported by Several Leading U.S. Hospitals

By Global News Feed

FORT LAUDERDALE, Fla., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus GI" or the "Company"), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, announced today that it has collected a series of case studies from several leading U.S. hospitals which highlight the advantages of utilizing its Pure-Vu System to successfully complete emergent or challenging colonoscopies for patients with inadequately prepared colons. The case studies are now available on the Motus GI website (click here).

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Motus GI Announces Clinical Compendium of Pure-Vu System Patient Case Studies As Reported by Several Leading U.S. Hospitals

Aquestive Therapeutics Announces Departure of Chief Financial Officer and Appointment of Interim Chief Financial Officer

By Global News Feed

WARREN, N.J., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that John Maxwell, Senior Vice President, Chief Financial Officer (CFO) of the Company, has provided his intent to resign his positions with the Company to pursue other interests. Current plans call for Mr. Maxwell to continue to serve as CFO of the Company until his departure, which currently is anticipated at year end. Mr. Ernie Toth, a seasoned financial executive most recently with EHE Health as Chief Financial Officer, will assume the role of CFO on an interim basis upon Mr. Maxwell’s departure.

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Aquestive Therapeutics Announces Departure of Chief Financial Officer and Appointment of Interim Chief Financial Officer

SARS-CoV-2 Viral Genome Sequencing Data Presented from Research Using Pacific Biosciences Technology

By Global News Feed

Presentation at the American Society for Microbiology NGS Conference highlights utility of PacBio’s highly accurate long-read sequencing platform in disease surveillance Presentation at the American Society for Microbiology NGS Conference highlights utility of PacBio’s highly accurate long-read sequencing platform in disease surveillance

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SARS-CoV-2 Viral Genome Sequencing Data Presented from Research Using Pacific Biosciences Technology

Novo Nordisk to enter phase 3 development in Alzheimer’s disease with oral semaglutide

By Global News Feed

Bagsværd, Denmark, 16 December 2020 – Novo Nordisk today announced the decision to enter phase 3 development in Alzheimer’s disease with 14 mg oral semaglutide, a once-daily oral formulation of the long-acting GLP-1 analogue semaglutide. The decision follows evaluation of GLP-1 data from preclinical models, real-world evidence studies, post-hoc analysis of data from large cardiovascular outcomes trials, as well as discussions with regulatory authorities.

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Novo Nordisk to enter phase 3 development in Alzheimer’s disease with oral semaglutide

Immutep Upscales Efti Manufacturing

By Global News Feed

Sydney, AUSTRALIA, Dec. 16, 2020 (GLOBE NEWSWIRE) --  Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, has prioritised the recommencement of the process of scaling up the manufacturing of its lead product candidate eftilagimod alpha (“efti” or “IMP321”).

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Immutep Upscales Efti Manufacturing

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