GSK

Spero Therapeutics Announces Fourth Quarter and Full Year 2023 Operating Results and Provides a Business Update

Retrieved on: 
Wednesday, March 13, 2024
Gram-negative bacteria, Department of Defence, Urinary tract infection, GSK, Patient, Human services, Quality of life, IND, Tebipenem, Clinical trial, Therapy, Infection, Research, Policy, Treasurer, Carbapenem-resistant enterobacteriaceae, Safety, Pharmacokinetics, Federal, Food, AP, Drug discovery, Disease, Kidney, SPA, Acinetobacter baumannii, MDR, Pyelonephritis, Annual report, FDA, Army, HBR, Government, Unitary state, NTM, Assistant, Fungal infection, Pseudomonas aeruginosa, Hope, National Institutes of Health, ID, Mycobacterium avium complex, Bangladesh Technical Education Board, Administration, Pharmaceutical industry

“2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.

Key Points: 
  • “2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.
  • Top-line data from the Phase 2a proof-of-concept clinical trial in treatment-naive and treatment-experienced non-refractory NTM-PD patients is expected in 2H 2024.
  • Spero commenced enrollment in PIVOT-PO, a global, randomized, double-blind, Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including AP in December 2023.
  • Total revenue for the fourth quarter of 2023 was $73.5 million, compared with total revenue of $47.4 million for the fourth quarter of 2022.

Pharmaceutical Industry Medical Affairs and Market Access Veteran John Byrd, PhD, MBA to Join AESARA as VP, Management Consulting

Retrieved on: 
Wednesday, April 3, 2024
Health Technology, Health Insurance, Other Health, Marketing, Pharmaceutical, Practice Management, Communications, Managed Care, Mental Health, General Health, Hospitals, Biotechnology, Alternative Medicine, AIDS, Health, GSK, Boehringer Ingelheim, Market access, Novartis, Management consulting, Communication

We are pleased to announce the appointment of John Byrd as VP, Management Consulting at AESARA, a digital-forward Value & Evidence agency that develops innovative and trusted solutions to power transformative market access.

Key Points: 
  • We are pleased to announce the appointment of John Byrd as VP, Management Consulting at AESARA, a digital-forward Value & Evidence agency that develops innovative and trusted solutions to power transformative market access.
  • Ruslan Horblyuk, Chief Strategic Consulting Officer at AESARA, said, "John brings an unmatched breadth and depth of Medical Affairs and Market Access expertise at a time when we are focused on expanding our Management Consulting portfolio and capabilities at AESARA.
  • In his prior roles, John set the vision and strategic direction to ensure effective communication and implementation of value evidence, population health management and quality improvement programs.
  • I look forward to helping the company expand the capabilities within management consulting while continuing to deliver bold, innovative, and transformative solutions to our clients,” said John Byrd.

DIA 2024 Global Annual Meeting Welcomes Life Sciences Leaders to Confront Emerging Challenges in Healthcare

Retrieved on: 
Tuesday, April 2, 2024
Medical Devices, FDA, Health, Health Technology, General Health, Pharmaceutical, Eli Lilly, Combination, DCT, Microsoft Research, Artificiality, Trust (social science), GSK, Novartis, Patient, Food and Drug Administration, Artificial intelligence, USS Midway, AI, EMA, Merck & Co., Medicine, European Medicines Agency, Johnson & Johnson, Ecosystem, Drug development, Pharmacovigilance, Food, DIA, Student, Diamond, DEI, Medical device

The ethical use of artificial intelligence (AI) in healthcare, the development of advanced therapies, and other emerging regulatory and scientific challenges demand in-depth discussion as DIA , a global organization of life sciences professionals, accepts registrations for the DIA 2024 Global Annual Meeting , to be held June 16-20 in San Diego.

Key Points: 
  • The ethical use of artificial intelligence (AI) in healthcare, the development of advanced therapies, and other emerging regulatory and scientific challenges demand in-depth discussion as DIA , a global organization of life sciences professionals, accepts registrations for the DIA 2024 Global Annual Meeting , to be held June 16-20 in San Diego.
  • Thousands of industry representatives, regulators, government officials, academics, innovators, and patients will convene for the world's preeminent neutral life sciences forum — and the only thing missing is you.
  • "This year marks the 60th anniversary of DIA and the Global Annual Meeting, and we're celebrating by continuing to forge a bold future marked by innovation and impact," said Marwan Fathallah, DIA's President and Global Chief Executive.
  • — An interactive forum featuring U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) representatives discussing today's regulatory, scientific, and communication challenges.

Oncoinvent Announces Changes to its Board of Directors and Formation of Scientific and Clinical Advisory Board

Retrieved on: 
Tuesday, April 2, 2024
Oncology, Health, Clinical Trials, Radiology, Pharmaceutical, Biotechnology, MSD, Ovarian cancer, Mirati Therapeutics, London Business School, University of Coimbra, GSK, BMS, Doctor of Philosophy, Therapy, Algeta, Colorectal cancer, International, Pharmacy, Radiopharmaceutical, Radium-223, Agios Pharmaceuticals, Amgen, Cubist Pharmaceuticals, Takeda Pharmaceutical Company, Bristol Myers Squibb, University, Private sector, The central science, Drug development, Sanofi, Psychiatry, BASF, Master of Science, M.B.A, Science, GE HealthCare, Pharmaceutical industry

“We are excited to welcome an internationally renowned group of industry leaders as new members of our Board of Directors.

Key Points: 
  • “We are excited to welcome an internationally renowned group of industry leaders as new members of our Board of Directors.
  • “We are also pleased to announce the formation of a Scientific and Clinical Advisory Board, consisting of our highly distinguished founders who are uniquely positioned to support Oncoinvent in our clinical programs.
  • Dr. O’Bryan-Tear has been an adviser to several US and European biotech companies and has held board positions at Fusion Pharmaceuticals and Clarity Pharmaceuticals.
  • In addition, Oncoinvent founding scientists Roy Larsen, Ph.D., and Øyvind Bruland, M.D., Ph.D., previously board members, will lead a newly established Scientific and Clinical Advisory Board.

Elegen Launches ENFINIA™ DNA Enhancement for Rapid Synthesis of Highly Complex DNA

Retrieved on: 
Wednesday, March 20, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Genetics, SV40, Associate, GSK, NGS, RNA, DNA, EAP, Messenger, Cauliflower mosaic virus, Doctor of Philosophy, Lentivirus, Therapy, IRES, Access, Orbital, IVT, Vaccine

This upgrade to ENFINIA DNA sets a new standard for DNA manufacturing, providing an industry-leading combination of speed, length, NGS-verified accuracy and complexity.

Key Points: 
  • This upgrade to ENFINIA DNA sets a new standard for DNA manufacturing, providing an industry-leading combination of speed, length, NGS-verified accuracy and complexity.
  • EAP partners received long and very complex DNA sequences that were either rejected by other suppliers or would have taken months to synthesize.
  • Elegen commercially launched ENFINIA DNA in Q1 2023 , delivering NGS-verified, linear DNA up to 7kb in 6 to 8 business days.
  • This latest enhancement of ENFINIA DNA to produce high-complexity DNA marks another step in the company’s mission to develop innovative solutions for DNA manufacturing, including even longer DNA, plasmid DNA and clinical-grade DNA production.

OmniAb Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Wednesday, March 20, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Research, Multiple myeloma, Lung cancer, Partner, NMPA, Growth, NSCLC, CIDP, Partnership, Telephone, GSK, Patient, TED, NASDAQ Biotechnology Index, Epitope, Artificial intelligence, Sale, Myasthenia gravis, Neonatal Fc receptor, Fluorouracil, Graves' ophthalmopathy, Investment, Teclistamab, NBI, National Medical Products Administration, Johnson & Johnson, Drug development, Safety, Chicken, Machine learning, Gastrointestinal cancer, Immunoglobulin G, BLA, Chronic inflammatory demyelinating polyneuropathy, Pharmaceutical industry

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.
  • OmniAb launched two new technologies during 2023 including OmniDeep™ and, during the fourth quarter, OmnidAb™.
  • Fourth quarter 2023 and recent partner highlights include the following:
    Immunovant reported positive initial results for batoclimab in Graves’ disease (GD).
  • OmniAb was added to the Nasdaq Biotechnology Index (NBI) in the fourth quarter.

Positive RUBY phase III data show potential for Jemperli (dostarlimab-gxly) combinations in more patients with primary advanced or recurrent endometrial cancer

Retrieved on: 
Saturday, March 16, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, OS, Food and Drug Administration, Endometrial cancer, Progression-free survival, Risk, GSK, Patient, Aes, Death, MD, Nature, Clinical trial, Copenhagen University Hospital, Gynecologic Oncology (journal), Division, PFS, Food, Pharmaceutical industry

2 Exploratory analyses of OS in dMMR/MSI-H and OS in MMRp/MSS populations were pre-specified with no planned hypothesis testing.

Key Points: 
  • 2 Exploratory analyses of OS in dMMR/MSI-H and OS in MMRp/MSS populations were pre-specified with no planned hypothesis testing.
  • RUBY Part 2: addition of niraparib to dostarlimab-gxly in maintenance setting significantly improved PFS in first-line primary advanced or recurrent endometrial cancer compared to chemotherapy alone, meeting the primary endpoint of the trial.
  • Discontinuation of dostarlimab-gxly or placebo due to a TEAE occurred in 24.1% of patients in the treatment arm and 5.2% of patients in the control arm.
  • Discontinuation of niraparib or placebo due to a treatment-emergent AE occurred in 15.7% of patients in the treatment arm and 4.2% of patients in the control arm.

AHF Urges Trinidad and Tobago to Sidestep Greedy GSK

Retrieved on: 
Friday, March 15, 2024
AIDS, Public Policy, Government, Health, Infectious Diseases, Advocacy Group Opinion, Pharmaceutical, ARV, GSK, HIV, COVID-19, AHF, Caribbean region of Colombia, Letter, AIDS Healthcare Foundation, Face, Biosimilar, Pharmaceutical industry

AIDS Healthcare Foundation (AHF) is calling on the government of Trinidad and Tobago to consider issuing a compulsory license for Tivicay (dolutegravir), a GSK antiretroviral (ARV) drug that treats HIV, which currently costs 25 times more than available biosimilar generics in neighboring Caribbean countries.

Key Points: 
  • AIDS Healthcare Foundation (AHF) is calling on the government of Trinidad and Tobago to consider issuing a compulsory license for Tivicay (dolutegravir), a GSK antiretroviral (ARV) drug that treats HIV, which currently costs 25 times more than available biosimilar generics in neighboring Caribbean countries.
  • In February, AHF and the Medical Research Foundation of Trinidad & Tobago sent a letter to GSK CEO Dame Emma Walmsley, which in part stated, “We urge you to address the lack of access to the antiretroviral drug Tivicay in Trinidad due to its high cost by lowering its price in line with biosimilar generics available in the Caribbean Region – or by committing not to threaten legal action against the purchase of a generic version of Tivicay.”
    To date, GSK has yet to respond to the letter.
  • Currently, Tivicay is under patent protection in Trinidad and Tobago, and GSK has threatened legal action if the country decides to import affordable generic ARVs.
  • “As a small island nation, Trinidad and Tobago is still recovering from the economic and social consequences of COVID-19 – paying 25 times more to provide lifelong HIV treatment for its people is untenable,” said AHF President Michael Weinstein.

Nimbus Therapeutics Appoints Katharine Knobil, M.D., to Board of Directors

Retrieved on: 
Tuesday, March 12, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Metabolism, GSK plc, Pharmacy, GSK, Cornell University, Patient, Acquisition, Marker, University, Biology, MBA, Agilent Technologies, Research and development, Therapy, Takeda, Patient safety, TYK2, Vaccine, Human, Pharmaceutical industry

Nimbus Therapeutics , LLC (“Nimbus Therapeutics” or “Nimbus”), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, today announced that Katharine Knobil, M.D., has been appointed to the Company’s Board of Directors.

Key Points: 
  • Nimbus Therapeutics , LLC (“Nimbus Therapeutics” or “Nimbus”), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, today announced that Katharine Knobil, M.D., has been appointed to the Company’s Board of Directors.
  • “We are honored to welcome Dr. Knobil to our Board of Directors as we embark on the next exciting chapter at Nimbus with plans to accelerate and expand our development programs in multiple therapeutic areas including oncology, immunology, and metabolism.
  • Dr. Knobil is currently a member of the Board of Directors at Marker Therapeutics (NASDAQ: MRKR) and Pliant Therapeutics (NASDAQ: PLRX).
  • “Nimbus has built a robust R&D organization that has demonstrated continued success in advancing promising discovery-stage science to product development.

Trevi Therapeutics Adds Clinical Development Expertise in Chronic Cough to Leadership Team

Retrieved on: 
Tuesday, April 2, 2024
Science, Teva Pharmaceuticals, GSK, Executive, Inflammation, Patient, Knowledge, MD, Cough, Drug, Trevi, IPF, Idiopathic pulmonary fibrosis, Medical school, RCC, Therapy, Chronic cough, Pharmaceutical industry

NEW HAVEN, Conn., April 2, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced the appointment of Margaret Garin, MD, MSCR, as Vice President of Clinical Development. Dr. Garin will be responsible for progressing the clinical development of Haduvio in chronic cough and brings unique and relevant experience from her previous lead role in clinical development at Bellus Health.

Key Points: 
  • Dr. Garin will be responsible for progressing the clinical development of Haduvio in chronic cough and brings unique and relevant experience from her previous lead role in clinical development at Bellus Health.
  • Her background spans various stages of the clinical development process including both strategic and executional roles, as well as the science of cough.
  • "I am happy to welcome Meg to our team," said David Clark, Chief Medical Officer of Trevi Therapeutics.
  • I am thrilled to have the ability to continue my work in chronic cough by joining the Trevi team to further the development of Haduvio for these patients."