Drug development

CARBOGEN AMCIS announces successful ANVISA audit of its facility in China

Retrieved on: 
Tuesday, March 19, 2024
Quality control, Certification, Active ingredient, Calibration, Good manufacturing practice, History, ANVISA, GMP, Drug development, API, Fine chemical

BUBENDORF, Switzerland, March 19, 2024 (GLOBE NEWSWIRE) -- Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announces the successful completion of its first Brazilian Regulatory Authority Agency (ANVISA) routine inspection of its facility in Shanghai.

Key Points: 
  • BUBENDORF, Switzerland, March 19, 2024 (GLOBE NEWSWIRE) -- Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announces the successful completion of its first Brazilian Regulatory Authority Agency (ANVISA) routine inspection of its facility in Shanghai.
  • Pascal Villemagne, CEO of CARBOGEN AMCIS, said: “I want to congratulate the Shanghai team on their first successful independent regulatory inspection, and for being commended by the inspectors for their transparent and open approach.
  • The ANVISA audit was focused on areas including utilities, maintenance and calibration, production, quality control and assurance.
  • CARBOGEN AMCIS is a wholly owned subsidiary of Dishman Carbogen Amcis Limited, Ahmedabad, India.

CHARM Therapeutics Announces Foundation of Scientific Advisory Board (SAB)

Retrieved on: 
Tuesday, March 19, 2024
College, PI3, Data science, Machine, Deep learning, Therapy, Harvard University, Audit trail, Membrane protein, School, Statistics, Biotechnology, ICR, Electrical engineering, Princeton University, 3D, Dartmouth College, Breast cancer, SAB, Applied science, Drug resistance, Royal, Machine learning, Computer science, Drug discovery, Associate, Royal Society, Intelligence, Research, AKT, Cancer, University, Cancer research, DARPA, Howard Hughes Medical Institute, Drug development, Principal, AstraZeneca, Entrepreneurship, The Institute, Biomarker, Columbia University, Faculty, Saint John's College, Stanford University, Chemical engineering, Medicine, Management

LONDON – 19 March 2024 -- CHARM Therapeutics (“CHARM”, “The Company”), a 3D deep-learning research company discovering and developing transformational medicines, today announces the foundation of its Scientific Advisory Board (SAB) to provide expert insight and guidance to the Company on the optimal application of 3D deep learning, protein design and prediction in real world medicine.

Key Points: 
  • LONDON – 19 March 2024 -- CHARM Therapeutics (“CHARM”, “The Company”), a 3D deep-learning research company discovering and developing transformational medicines, today announces the foundation of its Scientific Advisory Board (SAB) to provide expert insight and guidance to the Company on the optimal application of 3D deep learning, protein design and prediction in real world medicine.
  • This pioneering technology enables CHARM to target and develop treatments for previously hard-to-drug targets in cancer and other therapeutic areas.
  • Laksh Aithani, Co-Founder, Chief Executive Officer and Board Member of CHARM Therapeutics, said: “As CHARM advances its 3D deep learning platform in discovery it’s critical to maintain aligned oversight of our priorities and keep abreast of this emerging field.
  • Founding members of CHARM’s SAB:
    David Baker, Ph.D. is a Scientific Co-Founder at CHARM and Chair of the SAB.

Nykode Therapeutics Announces Advances in the Inverse Vaccine Platform With the Potential to Treat Autoimmune Diseases

Retrieved on: 
Tuesday, March 19, 2024
Motivation, Mouse, Multiple sclerosis, Capital market, ASA, Immune system, Summit, Poster, Drug development, Vaccine

Nykode employs its unique technology platform to pioneer the field of inverse vaccines, with the potential to develop high-precision treatments for autoimmune diseases.

Key Points: 
  • Nykode employs its unique technology platform to pioneer the field of inverse vaccines, with the potential to develop high-precision treatments for autoimmune diseases.
  • At the conference, Nykode demonstrated for the first time a significant effect in a therapeutic setting in a preclinical model for Multiple Sclerosis (MS) with its inverse vaccine platform.
  • The data also illustrate the strong contribution of the specific targeting unit and confirm that the disease protection is antigen-specific, underscoring the potential of Nykode’s technology in the field of autoimmune diseases.
  • In addition to an oral presentation, Nykode presented a poster at the Summit to elaborate on these findings.

Adverum Biotechnologies Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Pipeline Highlights and Corporate Updates

Retrieved on: 
Monday, March 18, 2024
Research, Adverum Biotechnologies, Vasculitis, Three Months, Macula, Chorioretinitis, Inflammation, Patient, Episcleritis, American Academy, Anti-VEGF, LUNA, Intraocular pressure, Investment, Clinical trial, Injection, Safety, Drug development, Paratriathlon, AMD, AAO, OPTIC, Retinitis, CST, Vascular occlusion, Annual general meeting, VEGF, Pharmaceutical industry

REDWOOD CITY, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today reported financial results for the fourth quarter and full year 2023. The company also provided recent pipeline highlights and corporate updates.

Key Points: 
  • The company also provided recent pipeline highlights and corporate updates.
  • 85% and 68% of patients at the 2E11 and 6E10 doses, respectively, received no supplemental injections through 26 weeks.
  • Stock-based compensation expense included in research and development expenses was $1.0 million for the fourth quarter of 2023.
  • Stock-based compensation expense included in general and administrative expenses was $3.1 million for the fourth quarter of 2023.

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.

Clearside Biomedical Appoints Victor Chong, M.D., MBA as Chief Medical Officer

Retrieved on: 
Monday, March 18, 2024
DAS, Retina, University, Moorfields Eye Hospital, Pathology, Oligonucleotide, Ranibizumab, Data analysis, Partnership, Business, Boehringer Ingelheim, DME, Patient, Pharming, Research, Royal College of Ophthalmologists, Cell biology, Diabetic retinopathy, C3, University College London, MBA, Eye, Johnson & Johnson, Janssen, Drug development, John Radcliffe Hospital, AMD, CLS, University of Oxford, Royal college, Geographic atrophy, Stargardt disease, DMI, Pharmaceutical industry

ALPHARETTA, Ga., March 18, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that Victor Chong, M.D., MBA was appointed Chief Medical Officer on March 14, 2024.

Key Points: 
  • ALPHARETTA, Ga., March 18, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that Victor Chong, M.D., MBA was appointed Chief Medical Officer on March 14, 2024.
  • George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer of Clearside, commented, “Victor is a well-known and well-respected retinal clinician and scientist, who is a strategically focused and visionary leader.
  • We are delighted to have him join the Clearside team.
  • “With the upcoming ODYSSEY data and extensive partnership portfolio, this is an exciting time to join Clearside.

Parexel Announces CEO Succession Plan

Retrieved on: 
Monday, March 18, 2024
ChromeOS, Goldman Sachs, Ohio State University, Growth, AmerisourceBergen, Health care, Acquisition, Commercial, University, Luminary, EQT, Chairperson, Drug development, HBA, Health, Family, Tandem Diabetes Care, MHA, Pharmaceutical industry

Ms. Howell, who joined Parexel in 2018 as Chief Commercial and Strategy Officer, will be appointed to the company’s Board of Directors May 15.

Key Points: 
  • Ms. Howell, who joined Parexel in 2018 as Chief Commercial and Strategy Officer, will be appointed to the company’s Board of Directors May 15.
  • Mr. Macdonald will continue on the Board through Dec. 31, 2024, and will remain an industry advisor to EQT and the largest individual investor in Parexel.
  • Together, she and Jamie have worked to ensure Parexel is well positioned for the future.”
    “It’s been a privilege to lead Parexel during this critical period in the company’s strategic transformation,” said CEO Jamie Macdonald.
  • I’m truly grateful for my time with this amazing organization and to have been part of such an incredible team.”
    “I’m honored to serve as the next CEO of Parexel,” said Peyton Howell.

Fulcrum Therapeutics Appoints Patrick Horn M.D., Ph.D., as Chief Medical Officer

Retrieved on: 
Monday, March 18, 2024
Sickle cell disease, University, Medicine, Doctor of Philosophy, Albireo, New Drug Application, Patient, SVP, Research, Losmapimod, Senior, Homocystinuria, Facioscapulohumeral muscular dystrophy, Therapy, DRS, Hereditary angioedema, Drug development, Interim, Boston, Fulcrum, PFIC, DSM-IV codes, Pharmaceutical industry

CAMBRIDGE, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced the appointment of Patrick Horn, M.D., Ph.D., as chief medical officer, effective immediately. Dr. Horn is a seasoned executive with over 20 years of end-to-end drug development experience spanning multiple therapeutic areas, with an emphasis on rare diseases, across both large pharmaceutical and biotech companies. Interim chief medical officer, Iain Fraser, MBChB, DPhil, will continue to serve on Fulcrum’s executive leadership team as SVP of early development. Together, Drs. Horn and Fraser will be responsible for leading clinical development and overseeing regulatory strategy and execution.

Key Points: 
  • Interim chief medical officer, Iain Fraser, MBChB, DPhil, will continue to serve on Fulcrum’s executive leadership team as SVP of early development.
  • Horn and Fraser will be responsible for leading clinical development and overseeing regulatory strategy and execution.
  • His most recent role was as the Chief Medical Officer at HemoShear Therapeutics, specializing in rare metabolic diseases.
  • Prior to transitioning to industry, Dr. Horn was a practicing pediatrician at major academic institutions in Chicago.

FDA’s Approval of Breakthrough NASH Treatment Opens Door for a Long-Neglected Patient Population

Retrieved on: 
Thursday, March 14, 2024
Organization, Obesity, Cirrhosis, Exercise, Cardiology, Partnership, F2, Risk, Patient, Fatty liver disease, Hope, Diet, NASH, Language, Liver disease, Liver cancer, Hypertension, FDA, Drug development, JD, Food, GLI

Developed by Madrigal Pharmaceuticals, Rezdiffra™ (resmetirom) was approved for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis, in conjunction with diet and exercise.

Key Points: 
  • Developed by Madrigal Pharmaceuticals, Rezdiffra™ (resmetirom) was approved for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis, in conjunction with diet and exercise.
  • This breakthrough follows years of NASH patient-led, multi-stakeholder advocacy and partnership with researchers in both drug and diagnostic development.
  • “Today’s announcement represents the culmination of the work of the united NASH community.
  • It is particularly satisfying that we can mark Women’s History Month with a breakthrough from a female-founded company.

Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis

Retrieved on: 
Thursday, March 14, 2024
Diagnosis, Fatty liver disease, Cirrhosis, Exercise, Entrepreneurship, Liver disease, Physician, F2, Patient, Research, Diet, Fibrosis, Drug development, NASH, Therapy, NAFLD, FDA, THR, Food, Pharmaceutical industry

Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
  • Bill Sibold, Chief Executive Officer of Madrigal, stated, “NASH with moderate to advanced liver fibrosis is a serious and progressive liver disease that, until now, has not had an FDA-approved therapy.
  • Fibrosis improvement and NASH resolution were consistent regardless of age, gender, type 2 diabetes status, or fibrosis stage.
  • Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program.