Standard of care

RenovoRx Announces $11.1 Million at Market Private Placement

Retrieved on: 
Monday, April 8, 2024
Biotechnology, Pharmaceutical, Health, Oncology, LAPC, Venture round, TAMP, Pancreatic cancer, Sale, Standard of care, Security (finance)

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced the execution of definitive subscription agreements with accredited investors for a private placement which is expected to result in gross proceeds of approximately $11.1 million to RenovoRx, before deducting offering expenses.

Key Points: 
  • RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced the execution of definitive subscription agreements with accredited investors for a private placement which is expected to result in gross proceeds of approximately $11.1 million to RenovoRx, before deducting offering expenses.
  • The proceeds from this financing, in addition to RenovoRx’s previously announced private placement on January 29, 2024 for gross proceeds of approximately $6.1 million, extend the Company’s cash runway into 2026.
  • The financing allows RenovoRx to advance its lead program, the pivotal Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer (LAPC), through the second interim readout and towards completion of the trial.
  • Investors will pay a purchase price of $1.4075 for each share and associated Series A Warrant and Series B Warrant, with such price being at the market for purposes of Nasdaq Stock Market rules.

BioCity Announces FDA Clearance of the Investigational New Drug Application for its First-In-Class Antibody Drug Conjugate Targeting Glypican 3

Retrieved on: 
Tuesday, April 9, 2024
HCC, Malignancy, Disease, Lung, Patient, Bystander effect, Standard of care, Death, Spacecraft, IND, Investigational New Drug, Cancer, Drug resistance, Liver cancer, Therapy, ADC, Hepatocellular carcinoma, FDA, GPC3, Food, CDH3

SHANGHAI, April 9, 2024 /PRNewswire/ -- BioCity Biopharma today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Phase 1 study of BC2027.

Key Points: 
  • SHANGHAI, April 9, 2024 /PRNewswire/ -- BioCity Biopharma today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Phase 1 study of BC2027.
  • BC2027, which is BioCity's second first-in-class antibody drug conjugate (ADC) approved for clinical development, targets Glypican 3 (GPC3), a proteoglycan found in the outer membrane of cancer cells.
  • BC2027 binds with very high affinity to GPC3 and efficiently internalizes into cancer cells where it releases its cancer killing payload.
  • Dr. Yong Jiang Hei, CEO of BioCity, noted that "Drug resistance has increasingly become a challenge in cancer treatment.

HealthTrackRx Appoints Leading Healthcare Expert Dr. Steven Goldberg as Chief Medical Officer

Retrieved on: 
Tuesday, April 9, 2024
Diagnosis, PCR, Medicine, Infection, Coventry Health Care, Thomas Jefferson University, Partnership, Georgetown University, Greater Louisville Inc., Humana, Standard of care, MD, MBA, Quality, WellCare, Express Scripts, Approximation error, Region, Kaiser Permanente, CMO, Binghamton University, Quest Diagnostics

DENTON, Texas, April 9, 2024 /PRNewswire/ -- HealthTrackRx, the nation's premier molecular diagnostic testing laboratory, today announced the appointment of Steven Goldberg, MD, MBA, as its Chief Medical Officer (CMO).

Key Points: 
  • DENTON, Texas, April 9, 2024 /PRNewswire/ -- HealthTrackRx, the nation's premier molecular diagnostic testing laboratory, today announced the appointment of Steven Goldberg, MD, MBA, as its Chief Medical Officer (CMO).
  • In the newly created role, Dr. Goldberg will lead the Company's partnership with payors, clinicians, and industry to enhance access to faster, better diagnostics.
  • A distinguished physician and respected healthcare innovator, Dr. Goldberg previously served as Chief Health Officer and Vice President of Medical Affairs at Quest Diagnostics and, preceding that, more than a decade in leading roles of several major health plans, including Chief Medical Officer at WellCare Health Plans, Senior Medical Director at Coventry Health Care, Chief of Medical Affairs at Express Scripts, Corporate Medical Director, Clinical Policy and Quality at Humana, Regional Chief Medical Officer at Excellus BCBS, Network Medical Director at Aetna Health Plans, and Medical Director at Kaiser Permanente NE.
  • "HealthTrackRx is transforming antibiotic stewardship protocols and helping payors and health plans manage spending by eliminating unnecessary tests, misdiagnosis, and ineffective antibiotic treatment.

Pharmazz Inc. and Dr. Reddy's Laboratories have entered into a licensing agreement to market Centhaquine (Lyfaquin) as a resuscitative agent for hypovolemic shock in India

Retrieved on: 
Friday, March 22, 2024
Cardiac output, U.S. FDA, Internal bleeding, Partnership, System, Patient, Research, Trauma, Diarrhea, Hypovolemic shock, Mortality, Gastrointestinal bleeding, Manuscript, Laboratory, Blood volume, Standard of care, DRUGS, Clinical trial, Resuscitation, Safety, DCGI, Phase, Vomiting, Blood, FDA, Food, Shock (mechanics), Emerging market, Generic drug

Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI).

Key Points: 
  • Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI).
  • As per the agreement, Dr. Reddy's has received exclusive rights to market and distribute Centhaquine in India.
  • For patients with hypovolemic shock, I believe Dr. Reddy's is the best partner for Pharmazz to market Centhaquine, an innovative, first-in-class novel resuscitative agent, in India."
  • U.S. FDA clearance of our Phase III IND is an important milestone for Pharmazz and the potential future treatment of hypovolemic shock patients.

ACELYRIN, INC. Announces Positive Phase 1/2 Proof-of-Concept Data for Lonigutamab, First Subcutaneous Anti-IGF-1R to Demonstrate Clinical Responses in Thyroid Eye Disease

Retrieved on: 
Wednesday, March 20, 2024
Oculoplastics, Patient, Private practice, Webcast, TED, Cohort, Standard of care, NEJM, MD, Graves' ophthalmopathy, Hyperglycemia, Safety, Huber loss, Orbital, Medical device

LOS ANGELES, March 20, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced positive proof-of-concept data from an ongoing Phase 1/2 trial of lonigutamab in thyroid eye disease (TED). Lonigutamab is a subcutaneously (SC) delivered humanized IgG1 monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), a validated mechanism of action for the treatment for TED.

Key Points: 
  • There have been no reports of hyperglycemia or hearing impairment and no serious adverse events.
  • “It is very encouraging to see the results of subcutaneous administration of an anti-IGF-1R therapy.
  • The data shown suggest that there is a clinically meaningful response in patients as early as 3 weeks after a single subcutaneous dose of lonigutamab.
  • “It is important to note that this is preliminary data in a small group, however the positive results are highly promising.

NuCana Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 20, 2024
Lung cancer, Apoptosis, Docetaxel, FOLFIRI, Irinotecan, Immunotherapy, Progression-free survival, Patient, Lung, Dicarboxylic acid, Standard of care, Cancer, Bevacizumab, Melanoma, NCNA, Therapy, PFS, Pharmaceutical industry

EDINBURGH, United Kingdom, March 20, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the fourth quarter and year ended December 31, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics.

Key Points: 
  • EDINBURGH, United Kingdom, March 20, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the fourth quarter and year ended December 31, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics.
  • As of December 31, 2023, NuCana had cash and cash equivalents of £17.2 million compared to £17.8 million as of September 30, 2023 and £41.9 million as of December 31, 2022.
  • NuCana continues to advance its various clinical programs and reported a net loss of £7.7 million for the quarter ended December 31, 2023, as compared to a net loss of £15.2 million for the quarter ended December 31, 2022.
  • Net loss for the year ended December 31, 2023 was £27.6 million, compared to a net loss of £32.0 million for the year ended December 31, 2022.

Aspira Women’s Health Expands Senior Leadership Team with the Addition of Sandra Milligan, M.D., J.D. as President

Retrieved on: 
Monday, March 18, 2024
Georgetown University Law Center, Ovarian cancer, Development, Acceleration, California State University, Luminex Corporation, Information technology, Standard of care, Senior, Respiratory disease, University, Gynaecology, Woman, Doctor of Philosophy, Research and development, Endometriosis, Drug development, Dana–Farber Cancer Institute, Therapy, Amgen, DIA, Human resources, Medical device

AUSTIN, Texas, March 18, 2024 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or the “Company”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today announced that it has expanded its senior management team with the addition of Sandra Milligan, M.D., J.D. as President effective April 1, 2024. Dr. Milligan will report to Nicole Sandford, who will remain CEO. The Company has also promoted Dr. Todd Pappas, Vice President of Research & Development, to lead the Company’s product development team reporting directly to Dr. Milligan, following the departure of Dr. Jody Berry.

Key Points: 
  • The Company has also promoted Dr. Todd Pappas, Vice President of Research & Development, to lead the Company’s product development team reporting directly to Dr. Milligan, following the departure of Dr. Jody Berry.
  • She has demonstrated success in supporting pipeline and product development in both oncology and non-oncology disease areas, with recent emphasis in women’s health.
  • Dr. Milligan is a known and respected leader in women’s health who drives cross-functional strategies to achieve corporate success.
  • As President, Dr. Milligan will be a key member of the executive leadership team with direct responsibility for the Research and Development, Operations, Information Technology, and Human Resources functions.

XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps

Retrieved on: 
Friday, March 15, 2024
Nosebleed, Research, Polyp (medicine), Vanderbilt University, Sciatica, Fluticasone, Education, Drainage, Disease, Incidence, Headache, Inflammation, Patient, Conditional sentence, Chronic obstructive pulmonary disease, Sinusitis, CRS, Standard of care, Quality of life, Migraine, Nasal cavity, Ear, ENT, Service, MPH, Nose, OPTN, FDA, Frustration, Food, Pharmaceutical industry

YARDLEY, Pa., March 15, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the U.S. Food and Drug Administration (FDA) has approved XHANCE® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older.

Key Points: 
  • Chronic sinusitis (also called “chronic rhinosinusitis” or “CRS”) is one of the most common chronic diseases, affecting approximately 30 million adults in the United States.
  • Research shows that the disease impairs quality of life to a similar degree as other serious chronic conditions, such as chronic obstructive pulmonary disease, sciatica, or migraine.
  • Chronic sinusitis is also one of the most common diagnoses in adult outpatient medicine.
  • Chronic sinusitis is diagnosed in approximately 10 million outpatient visits, of which approximately 70% result in antibiotic prescriptions, and leads to more than 600,000 surgeries annually.

Faron to Host Webcast to Discuss latest data from Phase 1 part of the BEXMAB Study of Bexmarilimab

Retrieved on: 
Thursday, March 14, 2024
Nasdaq First North, AML, Fårö, Associate, Webcast, Patient, Myeloid leukemia, Standard of care, Acute myeloid leukemia, University, Doctor of Philosophy, MD, Myelodysplastic syndrome, Faron Pharmaceuticals, Myelocyte, MDS, AIM

This interactive event will also include an introduction to myeloid leukemia, insights into bexmarilimab’s unique mode of action and the Company’s latest understanding of the early and long-term efficacy of bexmarilimab treatment.

Key Points: 
  • This interactive event will also include an introduction to myeloid leukemia, insights into bexmarilimab’s unique mode of action and the Company’s latest understanding of the early and long-term efficacy of bexmarilimab treatment.
  • Faron will also provide an update on bexmarilimab’s future development pathway and business opportunity.
  • There will be an opportunity to ask questions during the webcast.
  • To register for the event visit: https://faron.videosync.fi/bexmab-study-update/ or contact the IR team for more information at [email protected] .

TVM Capital Life Science to Participate in LSI USA ’24 Emerging Medtech Summit 2024

Retrieved on: 
Wednesday, March 13, 2024
Radiation, Thrombosis, Partner (business rank), Infection, Intelligence, TVM, Risk, General partnership, Patient, Eye injury, Standard of care, AI, Workflow, Investment, Medtech, LSI, Phlebitis, Eli Lilly and Company, Vector, Therapy, FDA, Physician, Health, PFC, Medical imaging

MUNICH, Germany and MONTREAL, March 13, 2024 (GLOBE NEWSWIRE) -- TVM Capital Life Science (“TVM”), a leading international venture capital firm focused on investments in life sciences innovation, today announced that the Company will participate in the sixth annual LSI USA ’24 Emerging Medtech Summit 2024, which brings together leading innovators, active investors and committed strategics from the medtech industry to partner and build next-generation healthcare technologies.

Key Points: 
  • MUNICH, Germany and MONTREAL, March 13, 2024 (GLOBE NEWSWIRE) -- TVM Capital Life Science (“TVM”), a leading international venture capital firm focused on investments in life sciences innovation, today announced that the Company will participate in the sixth annual LSI USA ’24 Emerging Medtech Summit 2024, which brings together leading innovators, active investors and committed strategics from the medtech industry to partner and build next-generation healthcare technologies.
  • The conference will take place March 18-22, 2024, in Dana Point, California, USA.
  • “Medtech innovation continues to be at the forefront of healthcare advancement, driving transformative changes in patient care, operational efficiency and cost reduction.
  • As part of our commercial-stage medical technologies investment strategy, TVM seeks breakthrough solutions that align with emerging trends and could redefine the standard of care.