DABT

Innocan Pharma Announces Expert Team for LPT CBD Application to United States Food and Drug Administration

Retrieved on: 
Tuesday, December 12, 2023
Drug development, FSE, Emeritus, Research, DABT, Chronic pain, CSE, Entrepreneurship, Veterans Health Administration, CBD, Therapy, LPT, Toxicology, Book, Patient, Analgesic, FDA, Biology, Pharmacology, Caregiver, MD, Drug discovery, Abstract, University, Thermodynamics, The Co Founder, Doctor of Philosophy, Commendation, Publication, Partnership, Pharmaceutical industry, Pharmacy

The team is comprised of accomplished drug development and drug approval experts, with specific a experience in pharmacology, toxicology, clinical trials, and successful interaction with the FDA.

Key Points: 
  • The team is comprised of accomplished drug development and drug approval experts, with specific a experience in pharmacology, toxicology, clinical trials, and successful interaction with the FDA.
  • Dr. Robert B. Raffa, PhD, is Adjunct Professor at the University of Arizona College of Pharmacy and Professor Emeritus at Temple University School of Pharmacy.
  • Innocan CEO, Iris Bincovich, stated: "At Innocan, we continue to develop our liposomal CBD platform to play a role in effectively combating various diseases in the future.
  • We are excited to work with such leading experts to help Innocan Pharma achieve our gools and move the company forward with the FDA."

Ambrx to Host KOL Event Discussing ARX517 Data Presented at ESMO Congress 2023

Retrieved on: 
Tuesday, September 26, 2023
KOL, Mayo Clinic, ESMO, FACP, Oncology, DABT, Doctor of Philosophy, European Society for Medical Oncology, MS, Congress, UCLA Health, Patient, SAN, Weill Cornell Medicine, UCLA, Prostate cancer, Pharmaceutical industry, MD

SAN DIEGO, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., Ambrx (or the “Company”) (NASDAQ: AMAM), today announced that it will host an in-person key opinion leader (KOL) event during the European Society for Medical Oncology (ESMO) Congress 2023.

Key Points: 
  • SAN DIEGO, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., Ambrx (or the “Company”) (NASDAQ: AMAM), today announced that it will host an in-person key opinion leader (KOL) event during the European Society for Medical Oncology (ESMO) Congress 2023.
  • The event will take place on Sunday, October 22, 2023 from 8:00pm – 10:00pm CEST (2:00pm – 4:00pm ET) at the Santo Mauro Hotel in Madrid, Spain.
  • Discussions will feature preliminary safety, efficacy, and pharmacokinetic (PK) data from APEX-01 ( NCT04662580 ), a first-in-human study evaluating ARX517 in prostate cancer patients, which will be presented for the first time at ESMO 2023.
  • A replay of the event will be available on the Investor Relations section of the Ambrx website ( www.ambrx.com ) after the event.

ISPE Pharmaceutical Engineering® "Special Report: COVID-19" Honored with 2023 APEX Award

Retrieved on: 
Monday, August 21, 2023
Vaccine, NORTH, Therapy, ISPE, Operation Warp Speed, Consultant, Writing, COVID-19, Medication, CQA, Technical Service Council, Toxicology, Research, DABT, Doctor of Philosophy, The View from the Inside, Organization, Grand Award Records, International Society, Pharmaceutical industry

NORTH BETHESDA, Md., Aug. 21st, 2023 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) has been honored with a 2023 APEX Grand Award for Public Health Concerns for their "Special Report: COVID-19." This included two articles, "Pandemic Progress: Industry's Journey from 2020 to Today" and "Operation Warp Speed: A View From the Inside." Both articles were published in the May/June 2022 issue of Pharmaceutical Engineering®. This marks the fourth consecutive year that Pharmaceutical Engineering® has received an APEX Award.

Key Points: 
  • The International Society for Pharmaceutical Engineering (ISPE) has been honored with a 2023 APEX Grand Award for Public Health Concerns for their "Special Report: COVID-19."
  • This included two articles, "Pandemic Progress: Industry's Journey from 2020 to Today" and "Operation Warp Speed: A View From the Inside."
  • NORTH BETHESDA, Md., Aug. 21st, 2023 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) has been honored with a 2023 APEX Grand Award for Public Health Concerns for their "Special Report: COVID-19."
  • This marks the fourth consecutive year that Pharmaceutical Engineering® has received an APEX Award.

Aravive Announces Top-Line Results from Phase 3 AXLerate-OC Study of Batiraxcept in Platinum-Resistant Ovarian Cancer

Retrieved on: 
Wednesday, August 2, 2023
Pancreatic cancer, Bevacizumab, Therapy, Progression-free survival, Associate professor, Gynecologic Oncology (journal), DABT, PFS, Tectonic evolution of the Aravalli Mountains, Patient, Data, Safety, Renal cell carcinoma, Pharmaceutical industry

The trial did not show any difference between the two arms in the overall population (which included patients previously treated with bevacizumab).

Key Points: 
  • The trial did not show any difference between the two arms in the overall population (which included patients previously treated with bevacizumab).
  • The Company will continue to evaluate the complete dataset and determine next steps in the development of batiraxcept.
  • In the bevacizumab-naïve population (n=179), the median PFS in the batiraxcept plus paclitaxel arm was 5.4 months, compared to 5.4 months in the paclitaxel arm.
  • In the overall population, the median PFS in the batiraxcept plus paclitaxel arm was 5.1 months, compared to 5.5 months in the paclitaxel arm.

MCRA Expands Biocompatibility Division with Key Hire of Board-Certified Toxicologist

Retrieved on: 
Monday, July 24, 2023
Senior, Herbal cigarette, ISO, Biotechnology, Risk assessment, MCRA, OECD, Toxicity, DABT, Doctor of Philosophy, Associate, Chemistry, Clinical trial, Publication, Biocompatibility, Quality assurance, Knowledge, TRA, CMR, FDA, Reproduction, ENDS, Nanotechnology, US FDA, Safety, Medical device, EU, Toxicology, Computer security

Dr. More expands MCRA's biocompatibility services to include toxicological risk assessment (TRA) and other toxicology consulting services for medical devices and combination products.

Key Points: 
  • Dr. More expands MCRA's biocompatibility services to include toxicological risk assessment (TRA) and other toxicology consulting services for medical devices and combination products.
  • MCRA has hired Sharlee L. More, PhD, DABT, a board-certified toxicologist, as its Associate Director of Toxicology to support the company's growing biocompatibility service offerings for the medical device industry.
  • Dr. More will lead MCRA's new toxicology service line within the Biocompatibility Division.
  • The launch of toxicology consulting services at MCRA is an important achievement for the Biocompatibility Division.

Aravive to Participate in William Blair’s Innovator Series: Transitioning Biotech Breakthroughs to Commercial Success Being Held July 18, 2023

Retrieved on: 
Friday, July 14, 2023
Commercial, Therapy, Arav, DABT, Conference, Pharmaceutical industry, Property management

HOUSTON, July 14, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease today announced that Gail McIntyre, Ph.D., DABT, Chief Executive Officer will be participating in a fireside chat at the William Blair Innovator Series: Transitioning Biotech Breakthroughs to Commercial Success being held virtually on July 18, 2023.

Key Points: 
  • HOUSTON, July 14, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease today announced that Gail McIntyre, Ph.D., DABT, Chief Executive Officer will be participating in a fireside chat at the William Blair Innovator Series: Transitioning Biotech Breakthroughs to Commercial Success being held virtually on July 18, 2023.
  • Conference attendees can check the schedule for more details or reach out to their William Blair salesperson.

Aravive To Participate in the Jefferies Global Healthcare Conference

Retrieved on: 
Monday, June 5, 2023
Therapy, Arav, DABT, Conference, Hospital, Cryptocurrency, Pharmaceutical industry

HOUSTON, June 05, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease today announced that Gail McIntyre, Ph.D., DABT, Chief Executive Officer and Rudy Howard, Chief Financial Officer will be presenting a corporate overview and participating in 1x1 meetings at the Jefferies Global Healthcare Conference being held on June 7-9, 2023 in New York, NY.

Key Points: 
  • HOUSTON, June 05, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease today announced that Gail McIntyre, Ph.D., DABT, Chief Executive Officer and Rudy Howard, Chief Financial Officer will be presenting a corporate overview and participating in 1x1 meetings at the Jefferies Global Healthcare Conference being held on June 7-9, 2023 in New York, NY.
  • Jefferies Global Healthcare Conference – June 7-9, 2023

Aravive Announces Phase 3 Trial Design for Batiraxcept in Clear Cell Renal Cell Carcinoma

Retrieved on: 
Tuesday, May 16, 2023
Therapy, Progression-free survival, IO, DABT, PFS, Renal cell carcinoma, Tectonic evolution of the Aravalli Mountains, Patient, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ORR, Food, Pharmaceutical industry

HOUSTON, May 16, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced that the Company has received guidance from the U.S. Food and Drug Administration (FDA) on a registrational Phase 3 trial design for batiraxcept in clear cell renal cell carcinoma (ccRCC) at an End-of-Phase 2 (EOP2) meeting.

Key Points: 
  • HOUSTON, May 16, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced that the Company has received guidance from the U.S. Food and Drug Administration (FDA) on a registrational Phase 3 trial design for batiraxcept in clear cell renal cell carcinoma (ccRCC) at an End-of-Phase 2 (EOP2) meeting.
  • “We are very pleased to be advancing batiraxcept into Phase 3 development in ccRCC, having successfully completed our EOP2 meeting with the FDA,” said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive.
  • “We believe our trial design and planned endpoint analyses are consistent with the FDA’s guidance, and we look forward to initiating our registrational Phase 3 trial in the second half of 2023.
  • The global trial is planned to be conducted at approximately 100 sites in the U.S. and around the world.

Aravive Reports First Quarter 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, May 10, 2023
Pancreatic cancer, Operating cost, Biologics license application, KOL, Therapy, Cholangiocarcinoma, IO, ODD, CMC, Clinical trial, Platinum, Paclitaxel, DABT, PROC, ASCO, Tectonic evolution of the Aravalli Mountains, Cancer, AXL, Patient, Kidney, Poster, Metastasis, Research, FDA, Ovarian cancer, BLA, Nivolumab, Pharmaceutical industry, Satellite navigation device, Cryptocurrency

If successful, the Company plans to submit a BLA by year-end 2023.

Key Points: 
  • If successful, the Company plans to submit a BLA by year-end 2023.
  • In March 2023, preclinical results from a study of batiraxcept in bile duct cancer were published in the peer-reviewed journal Cancers.
  • As of March 31, 2023, cash and cash equivalents were $35.9 million, compared to $53.7 million as of December 31, 2022.
  • The Company anticipates that its current cash and cash equivalents will fund operating plans into the fourth quarter of 2023.

Aravive Appoints Carolina Petrini as Chief Commercial Officer

Retrieved on: 
Tuesday, April 11, 2023
Endocrinology, Employment, Central nervous system, Therapy, Senior, Marketing, Health care, Option, Health, DABT, Sale, PROC, Fast-moving consumer goods, Dermatology, Fortune 500, Patient, Everyday Health, Rare, George Washington University, Pharmaceutical industry

HOUSTON, April 11, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced the appointment of Carolina Petrini as the Company’s new Chief Commercial Officer effective April 10, 2023.

Key Points: 
  • HOUSTON, April 11, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced the appointment of Carolina Petrini as the Company’s new Chief Commercial Officer effective April 10, 2023.
  • Ms. Petrini brings over two decades of experience in developing pre-commercial, launch readiness and commercial strategies, building and leading high-performing commercial teams.
  • “We are delighted to welcome Carolina as our new Chief Commercial Officer,” said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive.
  • We look forward to leveraging her expertise as we prepare for the upcoming Phase 3 data readout in platinum-resistant ovarian cancer (PROC) in mid-2023.”
    Ms. Petrini commented, “I am thrilled to join the Aravive team and build the commercial organization.