Novartis

Biotech's Role in Addressing the Pancreatic Cancer Emergency

Retrieved on: 
Thursday, March 14, 2024
Ovarian cancer, Immunotherapy, Patient, History, Lutetium (177Lu) oxodotreotide, IND, Cancer, NVS, NUVB, NCI, Novartis, Science, Colorectal cancer, Risk, American Cancer Society, FOLFIRINOX, PDAC, Pancreatic Cancer Action Network, Safety, Immune system, Interim, University, Translational research, Survival rate, Disease, Clinical professor, Associate, Tumor microenvironment, Death, TSX, Pancreatic cancer, Sunnybrook Health Sciences Centre, ACRS, FDA, DCP, Diagnosis, Entrepreneurship, Environment, Physician, Triple-negative breast cancer, Mortality, News, PROC, DDC, Hereditary nonpolyposis colorectal cancer, Optimism, ONC, Pharmaceutical industry

VANCOUVER, BC, March 14, 2024 /PRNewswire/ -- USA News Group - Known as one of the most deadly forms of cancer, pancreatic cancer still has the highest mortality rate of all major cancers today. However, researchers and the biotech sector are working diligently to improve the chances of those who receive this dire diagnosis. Recently, in late 2023, researchers at the Mayo Clinic made a discovery that advances knowledge of how pancreatic cancer spreads and identified a new potential therapeutic target along the way. With the American Cancer Society projecting a record year for new cancer cases in 2024, and Europe facing a pancreatic cancer emergency, it's important to focus on the advances being made in the biotech sector that are giving hope to patients and their families. Among the developers making gains include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), ImmunityBio, Inc. (NASDAQ: IBRX), Aclaris Therapeutics, Inc. (NASDAQ: ACRS), and Nuvation Bio Inc. (NYSE: NUVB). 

Key Points: 
  • There is a point of optimism to build upon, as the Pancreatic Cancer Action Network (PanCAN) has stated the five-year survival rate for pancreatic cancer has increased to 13% .
  • "Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients."
  • It will focus on patients with pancreatic cancer, HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), and platinum-resistant ovarian cancer (PROC).
  • Nuvation is already undergoing dosing in the Phase 1 monotherapy study of NUV-868 in solid tumors in patients with pancreatic cancer, ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer and other solid tumors.

Biotech's Role in Addressing the Pancreatic Cancer Emergency

Retrieved on: 
Thursday, March 14, 2024
Ovarian cancer, Immunotherapy, Patient, History, Lutetium (177Lu) oxodotreotide, IND, Cancer, NVS, NUVB, NCI, Novartis, Science, Colorectal cancer, Risk, American Cancer Society, FOLFIRINOX, PDAC, Pancreatic Cancer Action Network, Safety, Immune system, Interim, University, Translational research, Survival rate, Disease, Clinical professor, Associate, Tumor microenvironment, Death, TSX, Pancreatic cancer, Sunnybrook Health Sciences Centre, ACRS, FDA, DCP, Diagnosis, Entrepreneurship, Environment, Physician, Triple-negative breast cancer, Mortality, News, PROC, DDC, Hereditary nonpolyposis colorectal cancer, Optimism, ONC, Pharmaceutical industry

VANCOUVER, BC, March 14, 2024 /PRNewswire/ -- USA News Group - Known as one of the most deadly forms of cancer, pancreatic cancer still has the highest mortality rate of all major cancers today. However, researchers and the biotech sector are working diligently to improve the chances of those who receive this dire diagnosis. Recently, in late 2023, researchers at the Mayo Clinic made a discovery that advances knowledge of how pancreatic cancer spreads and identified a new potential therapeutic target along the way. With the American Cancer Society projecting a record year for new cancer cases in 2024, and Europe facing a pancreatic cancer emergency, it's important to focus on the advances being made in the biotech sector that are giving hope to patients and their families. Among the developers making gains include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), ImmunityBio, Inc. (NASDAQ: IBRX), Aclaris Therapeutics, Inc. (NASDAQ: ACRS), and Nuvation Bio Inc. (NYSE: NUVB). 

Key Points: 
  • There is a point of optimism to build upon, as the Pancreatic Cancer Action Network (PanCAN) has stated the five-year survival rate for pancreatic cancer has increased to 13% .
  • "Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients."
  • It will focus on patients with pancreatic cancer, HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), and platinum-resistant ovarian cancer (PROC).
  • Nuvation is already undergoing dosing in the Phase 1 monotherapy study of NUV-868 in solid tumors in patients with pancreatic cancer, ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer and other solid tumors.

Rigel Pharmaceuticals Announces Appointment of Lisa Rojkjaer, M.D. as Chief Medical Officer

Retrieved on: 
Tuesday, March 12, 2024
CONNECT, Internal medicine, University, Growth, Biotechnology, Novo Nordisk, Hematology, Science, AML, Monroe Dunaway Anderson, Executive, Patient, SAN, Novartis, FLT3, Head, Drug, Therapy, Drug development, Sangamo Therapeutics, Molecular Partners, MorphoSys, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 12, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the appointment of Lisa Rojkjaer, M.D.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 12, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the appointment of Lisa Rojkjaer, M.D.
  • as Executive Vice President and Chief Medical Officer.
  • Dr. Rojkjaer is an industry veteran with over 20 years of clinical development, regulatory, and medical affairs experience with a focus on hematology and oncology.
  • Prior to joining Rigel, Dr. Rojkjaer held several leadership positions in clinical development and medical affairs at biotechnology and global pharmaceutical companies, having most recently served as Chief Medical Officer of Sangamo Therapeutics.

APPIS 2024: Healthcare Stakeholders Come Together to Prioritize Action for Better Patient Outcomes in Asia Pacific, Middle East, and Africa

Retrieved on: 
Monday, March 11, 2024
Engagement, Success, Health literacy, AME Publishing Company, Congress, Organization, Face, Health, Health equity, Real, Partnership, Novartis, Patient, Health care, Communication, Cancer, Human, HTR, Summit, GMT, Glomus tumor, Physician, Medical device

The APPIS Innovator Program and APPISx are also key components of APPIS that will bring healthcare stakeholders together throughout the year to drive positive impact for patients.

Key Points: 
  • The APPIS Innovator Program and APPISx are also key components of APPIS that will bring healthcare stakeholders together throughout the year to drive positive impact for patients.
  • The Summit aims to facilitate meaningful partnerships to address barriers to access for patients across Asia Pacific, Middle East, and Africa.
  • This year, the APPIS Summit will feature over 40 speakers, including healthcare experts, patient leaders, policymakers, and health journalists.
  • APPISx promotes country-level engagements by bringing together patient organizations and healthcare stakeholders to catalyze action-oriented solutions that address barriers to healthcare.

Olema Oncology Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, March 11, 2024
Breast cancer, SAN, Cancer, Investigational New Drug, Woman, ESMO, Biomedical Research, FDA, Everolimus, Corporation, Ribociclib, GAAP, SVB, Patient, Clinical trial, Novartis, Congress, Silicon Valley Bank, Oncology, Initiate, IND, Trial of the century, Research, Pharmaceutical industry

“In 2023 we demonstrated the unique opportunity ahead for palazestrant to make a meaningful impact on improving treatment options for women with ER+/HER2- breast cancer.

Key Points: 
  • “In 2023 we demonstrated the unique opportunity ahead for palazestrant to make a meaningful impact on improving treatment options for women with ER+/HER2- breast cancer.
  • Presented palazestrant monotherapy Phase 2 clinical results at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, as an oral presentation demonstrating compelling activity in both wild-type and ESR1-mutant tumor types.
  • Non-GAAP G&A expenses were $3.1 million and $13.3 million for the quarter and year ended December 31, 2023, respectively, excluding $1.4 million and $5.5 million non-cash stock-based compensation expense respectively.
  • A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

Hyku Biosciences, a Covalent Precision Medicine Company, Announces CEO Transition for its Next Phase of Growth

Retrieved on: 
Monday, March 11, 2024
Gilead Sciences, Chemistry, Mantra, Sale, IPO, Doctor of Philosophy, University, Therapy, Business, Organization, Novartis, Bachelor of Science, Science, Biogen, Management

LEXINGTON, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Hyku Biosciences, Inc. (Hyku), a covalent precision medicine company, today announced the appointment of Kleem Chaudhary, Ph.D. as President and Chief Executive Officer, succeeding co-founder and acting CEO Milind Deshpande, Ph.D. who will now serve as an advisor to the company. Dr Chaudhary will also serve as a member of the Board of Directors of Hyku.

Key Points: 
  • Dr Chaudhary will also serve as a member of the Board of Directors of Hyku.
  • Most recently, he was Chief Operating and Business Officer at Redona Therapeutics.
  • Dr. Chaudhary holds a Ph.D. in chemistry from the University of North Carolina at Chapel Hill and a B.Sc.
  • “We are excited to have Kleem join Hyku and I look forward to working with him to advance the exciting science at Hyku.”

Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Saturday, March 9, 2024
EMA, Week, Psoriasis, Committee, SB5, Political moderate, Ustekinumab, Organon, FDA, Food, Samsung, BLA, Trial of the century, AAD, Safety, CHMP, Pharmacokinetics, Abstract, Biologics license application, American Academy, Novartis, Interchangeability

“We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.

Key Points: 
  • “We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.
  • The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022.
  • The study showed that efficacy, safety, and immunogenicity between the three arms were comparable up to Week 52.
  • Details of the Samsung Bioepis’ abstracts are as follows:
    Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis: Randomized, Double-blind, Phase III, 52-Week Results

Sandoz receives FDA approval for first and only denosumab biosimilars

Retrieved on: 
Tuesday, March 5, 2024
Bone fracture, Fracture, Woman, Hypocalcemia, Osteoporosis, Bone disease, Hypercalcaemia, FDA, Quality of life, Food, Cancer, Denosumab, Metastasis, Risk, Breast, Safety, Mitigation, Novartis, REMS, Benign tumor, Disease, Patent, Patient, Medicine, Multiple myeloma, Ageing, Dietary supplement

Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.

Key Points: 
  • Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.
  • I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most."
  • Wyost® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.
  • Given ongoing patent litigation around these products, Sandoz will not comment on anticipated launch timing or other launch details at this time.

Osmol Therapeutics Appoints Ron Weitzman, M.D., as Interim Chief Medical Officer

Retrieved on: 
Monday, March 4, 2024
Montreal Cognitive Assessment, CIPN, Prostate cancer, Chemotherapy-induced peripheral neuropathy, MBA, Therapy, Internal medicine, Drug, Novartis, Pharmacotherapy, Oncology, IND, CICI, Pharmaceutical industry

NEW HAVEN, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- Osmol Therapeutics, a privately held clinical-stage biopharmaceutical company focused on developing preventative treatments for chemotherapy-induced peripheral neuropathy (CIPN) and chemotherapy-induced cognitive impairment (CICI), today announced that it has appointed Ron Weitzman, M.D., as interim Chief Medical Officer, replacing Arthur DeCillis, M.D., who is joining Osmol’s Scientific Advisory Board.

Key Points: 
  • NEW HAVEN, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- Osmol Therapeutics, a privately held clinical-stage biopharmaceutical company focused on developing preventative treatments for chemotherapy-induced peripheral neuropathy (CIPN) and chemotherapy-induced cognitive impairment (CICI), today announced that it has appointed Ron Weitzman, M.D., as interim Chief Medical Officer, replacing Arthur DeCillis, M.D., who is joining Osmol’s Scientific Advisory Board.
  • “We are pleased to welcome Ron, with his significant oncology drug development expertise, to the Osmol team,” said Bob Linke, MBA, President and CEO of Osmol Therapeutics.
  • Ron Weitzman, M.D., has held leadership roles at various global biopharmaceutical companies, including Tango Therapeutics, Exelixis, Genentech and Novartis.
  • Most recently he served as Chief Medical Officer at Tango Therapeutics, where he oversaw development of multiple oncology drugs, including three Investigational New Drug (IND) applications, while leading the clinical and clinical operations teams.

Verona Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 29, 2024
Conference call, AstraZeneca, Research, New Drug Application, FDA, Quality of life, Marketing, EST, Growth, PDUFA, Travel, Conference, Chronic obstructive pulmonary disease, GMT, Hub, Safety, Information technology, Patient, Pharming, Clinical trial, Novartis, Disease, VRNA, IND, NDA, Head, Bromide, COPD, Pharmaceutical industry

LONDON and RALEIGH, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma" or the "Company"), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces its financial results for the fourth quarter and full year ended December 31, 2023, and provides a corporate update.

Key Points: 
  • The debt facility provides non-dilutive capital and further financial flexibility to support Verona Pharma’s continued growth, including the commercialization of ensifentrine.
  • Net loss: Net loss was $14.1 million for the fourth quarter ended December 31, 2023 (Q4 2022: net loss $10.5 million).
  • Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EST / 2:00 p.m. GMT on Thursday, February 29, 2024, to discuss the fourth quarter and full year 2023 financial results and the corporate update.
  • An electronic copy of the fourth quarter and full year 2023 results press release will also be made available today on the Company’s website.