BioCapital

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  BioSpace Launches 2022 Hotbed Maps to Highlight Thriving Life Sciences Clusters

  1/18/2022

  As BioSpace proudly introduces our 2022 Hotbed Maps, let’s explore the industry’s most thriving territories, research leading employers and search for relevant jobs on BioSpace.

• The Foundation for the National Institutes of Health Announces the Appointment of Jay Bradner, M.D. and Jim Weiss to the Board of Directors

  5/22/2023

  The Foundation for the National Institutes of Health is proud to announce two new additions to the FNIH Board of Directors, Dr. Jay Bradner and Jim Weiss.

• FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose

  5/22/2023

  Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older.

• Indivior Announces U.S. Food and Drug Administration Approval of OPVEE® (nalmefene) Nasal Spray, An Opioid Overdose Rescue Medicine for Natural and Synthetic Opioids Like Fentanyl

  5/22/2023

  Indivior PLC (LSE: INDV) today announced that the U.S. Food and Drug Administration (FDA) approved OPVEE® (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.

• Avalo Announces Appointment of Michael Croft, Ph.D. and Jeff Edelson, M.D. to its Scientific Advisory Board

  5/22/2023

  Avalo Therapeutics, Inc. (Nasdaq: AVTX) announced the appointment of Dr. Michael Croft and Dr. Jeff Edelson to the company’s Scientific Advisory Board (SAB).

• IDEAYA Announces IND Clearance Enabling Phase 1/2 Clinical Trial for Combination of IDE397 and AMG 193 in MTAP-Deletion Solid Tumors

  5/22/2023

  IDEAYA Biosciences, Inc. announced that the U.S. Food and Drug Administration has completed its review of the Amgen-sponsored Investigational New Drug application and concluded that the proposed clinical study may proceed to evaluate IDE397 in combination with AMG 193 in solid tumors having MTAP deletion.

• Processa Pharmaceuticals to Participate in a Panel on Interaction with the FDA at the World Orphan Drug Congress

  5/22/2023

  Processa Pharmaceuticals, Inc. today announces CEO David Young, Pharm.D., Ph.D. will participate in a panel at the World Orphan Drug Congress to be held at the Gaylord National Resort & Convention Center in Washington, D.C. May 23-25, 2023.

• REGENXBIO Announces Presentation at the Barclays Gene Editing & Therapy Summit 2023

  5/22/2023

  REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present in a fireside chat and panel as well as host one-on-one investor meetings at the Barclays Gene Editing & Therapy Summit 2023 on Wednesday, May 24, 2023.

• Axalbion Presented Promising Phase 2 Clinical Data in Chronic Cough with AX-8, a Novel TRPM8 Agonist, in an Oral Presentation at the American Thoracic Society (ATS) 2023 International Conference

  5/22/2023

  Axalbion presented positive results from a Phase 2 proof-of-concept study with its transient receptor potential melastatin 8 (TRPM8) agonist, AX-8, in patients with refractory or unexplained chronic cough, in an oral session at the American Thoracic Society (ATS) 2023 International Conference, being held in Washington, DC, from May 19 - 24, 2023.

• NexImmune Announces Poster Presentation at the 2023 FOCIS Annual Meeting

  5/22/2023

  NexImmune, Inc. (Nasdaq: NEXI) today announced that it will be presenting a poster at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting, being held in Boston from June 20-23, 2023.

• Salubris Biotherapeutics Presents Positive Updates from Phase 1b Clinical Trial of JK07 in Late-Breaking Session at the European Society of Cardiology Heart Failure 2023 Congress

  5/20/2023

  Salubris Biotherapeutics, Inc., a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, announced positive updated results from the ongoing Phase 1b study of JK07 in heart failure with reduced ejection fraction.

• FDA Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery

  5/19/2023

  Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes.

• High School Scientists and Engineers Win Nearly $9 Million at the Regeneron International Science and Engineering Fair 2023

  5/19/2023

  Regeneron Pharmaceuticals, Inc. and Society for Science announced that Kaitlyn Wang, 17, of San José, CA, won the $75,000 top award in the 2023 Regeneron International Science and Engineering Fair, the world's largest global pre-college science and engineering competition, for a project that explored planets that orbit very close around their suns.

• FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa

  5/19/2023

  Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.  

• FDA Roundup: May 19, 2023

  5/19/2023

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

• HanAll Biopharma Announces Results from Phase III randomized, double-masked active treatment-controlled VELOS-3 Trial Evaluating Tanfanercept 0.25% for Treatment of Dry Eye Disease

  5/19/2023

  HanAll Biopharma Co., Ltd. announced results from the Phase III VELOS-3 trial evaluating the safety and efficacy of tanfanercept, a novel, topical anti-inflammatory treatment being studied for the treatment of dry eye disease (DED) in subjects diagnosed with moderate to severe DED.

• Aziyo Biologics Presents Positive Clinical Data on CanGaroo® Biologic Envelope

  5/19/2023

  Aziyo Biologics, Inc. today announced that positive data from the HEAL Study will be presented at Heart Rhythm Society (HRS 2023) on May 21, 2023, at 12:30 PM CT at the Morial Convention Center in New Orleans, LA.

• Prelude Therapeutics Announces Pricing of Public Offering

  5/18/2023

  Prelude Therapeutics Incorporated today announced the pricing of its underwritten public offering of 3,048,522 shares of its voting common stock and 1,448,222 shares of its non-voting common stock, each at a price to the public of $5.75 per share, and, in lieu of common stock to investors who so choose.

• SAIC Announces CEO Transition - May 18, 2023

  5/18/2023

  Science Applications International Corp. announced the appointment of 35-year global technology veteran Toni Townes-Whitley as the company’s Chief Executive Officer, effective October 2, 2023.

• HemoShear Attends Piper Sandler Conference

  5/18/2023

  HemoShear Therapeutics, Inc., a privately held clinical stage biotechnology company, participated in the Piper Sandler Spring Biopharma Symposium being held in Boston, MA, Wednesday, May 17 through Thursday, May 18, 2023.