Week

Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24

Retrieved on: 
Wednesday, March 6, 2024
Biotechnology, Hospitals, Health, Pharmaceutical, Clinical Trials, MSD, MRK, Week, Doctor of Philosophy, Gilead Sciences, Fungal infection, CROI, Islatravir, MD, AIDS, Science, Boxed warning, Female, Nausea, Conference, European, Safety, Stigma, Lenacapavir, Tablet, HIV, Viral load, Xerostomia, Merck & Co., Pharmaceutical industry

These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections ( CROI ).

Key Points: 
  • These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections ( CROI ).
  • At 24 weeks, the novel investigational combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA
  • The potent antiviral activities, along with pharmacokinetic profiles of islatravir and lenacapavir, support their development as an investigational once-weekly oral combination regimen.
  • No participants in the Biktarvy group had a viral load of more than 50 copies/mL at Week 24.

MaaT Pharma indicates completion of Patient Recruitment for the Phase 2a Investigator-Sponsored Randomized Clinical Trial Evaluating MaaT013 in Combination with Immune Checkpoint Inhibitors in Metastatic Melanoma

Retrieved on: 
Tuesday, March 5, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, PICASSO, Week, Directorate, Neoplasm, Institut Gustave Roussy, PHRC, Ipilimumab, Nivolumab, ICI, National Cancer Institute, INRAE, Safety, MET, Patient, Survival, Cancer, Pharmaceutical industry

A total of 70 patients have been enrolled in 5 different centers in France in the randomized controlled Phase 2a PICASSO trial, which started in April 2022.

Key Points: 
  • A total of 70 patients have been enrolled in 5 different centers in France in the randomized controlled Phase 2a PICASSO trial, which started in April 2022.
  • The Company provided MaaT013 drug candidate and placebo and will contribute to the microbiome profiling of patients using its proprietary gutPrint® research engine.
  • The unblinding will be done at Week 27 (W27) to assess the primary endpoint which is safety.
  • Having reached this key recruitment milestone, the first publication will be submitted at the end of 2024 or in the first quarter of 2025.

Gilead’s Innovative HIV Treatment Research Pipeline Aims to Address Unmet Needs and Advance Public Health

Retrieved on: 
Tuesday, March 5, 2024
Biotechnology, Pharmaceutical, AIDS, General Health, Health, Infectious Diseases, Hospitals, Clinical Trials, Bictegravir, ARV, CD4, Week, Doctor of Philosophy, Aes, Gilead Sciences, Fungal infection, Research, CROI, MDR, MD, Diarrhea, Science, Food, Female, Hook effect, ZAB, Conference, Constipation, European, Safety, Group 2, Black, Lancet, COVID-19, RNA, Public, Patient, Lenacapavir, Plasma, TAB, Observational study, HIV, Viral load

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data highlighting the breadth of its innovative HIV treatment research pipeline.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data highlighting the breadth of its innovative HIV treatment research pipeline.
  • “The latest findings across our HIV pipeline showcase the potential of multiple candidates to help transform HIV management,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences.
  • It is estimated that up to 10% of people with HIV take a complex treatment regimen, defined as 2 or more pills each day.
  • Results showed that all three treatment groups had robust virologic suppression at six months, with consistently low viral loads throughout the study.

Dermavant to Present New ADORING Data Including Treatment of Patients with Skin of Color from Phase 3 Trials of VTAMA® (tapinarof) Cream, 1% in Adults and Children 2 Years of Age and Older with Atopic Dermatitis at the 2024 AAD Annual Meeting

Retrieved on: 
Friday, March 1, 2024
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Cream, LTS, Pros, Therapy, Incidence, Week, Psoriasis, Dermatology, Headache, Political moderate, Atopic dermatitis, Pain, Validation, Swelling, Itch, DLQI, Skin, Irritation, Folliculitis, Accepted, Common, QD, Stinger, Safety, Abstract, Patient, Rash, San Diego Convention Center, Nose, American Academy, Vaccine

VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of atopic dermatitis (AD).

Key Points: 
  • VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of atopic dermatitis (AD).
  • VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. and is the same strength and formulation being studied in the ADORING Phase 3 development program for AD.
  • The following posters will be viewable onsite at the San Diego Convention Center.
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

MindMed Reports 2023 Financial Results and Business Updates

Retrieved on: 
Wednesday, February 28, 2024
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Senior, Week, ODT, MindMed, FDA, University Hospital of Basel, DSM-IV codes, Standard of care, GAD, Patient, Anxiety, Medicine, Pharmaceutical industry

Mind Medicine (MindMed) Inc. (NASDAQ:MNMD), (Cboe Canada:MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the year ended December 31, 2023 and provided a business update.

Key Points: 
  • Mind Medicine (MindMed) Inc. (NASDAQ:MNMD), (Cboe Canada:MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the year ended December 31, 2023 and provided a business update.
  • “2023 was a highly productive year for MindMed, which concluded with positive Phase 2b results for MM120 in the treatment of adult patients with GAD,” said Rob Barrow, Chief Executive Officer and Director of the Company.
  • As of December 31, 2023, MindMed had cash and cash equivalents totaling $99.7 million compared to $142.1 million as of December 31, 2022.
  • MindMed management will host a conference call at 8:00 AM EST today to provide a corporate update and review the Company’s 2023 financial results.

Seek Labs Welcomes Cindy Dunkle, Accomplished HR Leader with Extensive Life Sciences Experience, to Board of Directors

Retrieved on: 
Tuesday, February 27, 2024
Health, Infectious Diseases, Other Science, Research, Science, Pharmaceutical, Biotechnology, Therapy, Acquisition, Week, CRISPR, Poverty, Seek, Metropolitan, Management, IPO, Metropolitan State University, Safety, Genentech, Environmental health, Patient, Adverum Biotechnologies, Woman

Dunkle brings decades of life sciences leadership experience and connections that will enhance Seek Labs’ strategic direction and employee-centered approach.

Key Points: 
  • Dunkle brings decades of life sciences leadership experience and connections that will enhance Seek Labs’ strategic direction and employee-centered approach.
  • Dunkle is widely recognized for her profound understanding of human capital management in the life sciences sector.
  • Jared Bauer, CEO, expressed his enthusiasm to have Dunkle join Seek Labs’ Board: “We are thrilled to have Cindy Dunkle join our Board of Directors.
  • "I am honored to join Seek Labs’ Board of Directors at a pivotal moment as the company continues to grow and expand its footprint in the life sciences and biotechnology industry,” said Cindy Dunkle.

U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy® to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance

Retrieved on: 
Monday, February 26, 2024
AIDS, FDA, Health, Hospitals, Pharmaceutical, Biotechnology, Infection, Division, Week, Doctor of Philosophy, Gilead Sciences, HIV-1, Drug resistance, MD, PWH, Science, Food, DHHS, Boxed warning, Hospital, Life, Risk, Safety, NRTI, RNA, History, Public, Guideline, DTG, Harvard Medical School, Mutation, Tablet, HIV, Vaccine

HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH.

Key Points: 
  • HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH.
  • The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes.
  • “Clinical data have established Biktarvy as a long-term HIV treatment option for a broad range of PWH.
  • There were also zero cases of treatment-emergent resistance to Biktarvy, regardless of known or suspected pre-existing M184V/I resistance, in the final resistance analysis population.

Everest Medicines and Kezar Life Sciences Receive IND Approval from China NMPA for PALIZADE Trial in Lupus Nephritis

Retrieved on: 
Monday, February 26, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Week, UPCR, HKEX, CRR, Safety, Patient, Lupus nephritis, Clinical trial, CDE, IND, KZR, NMPA, Kidney failure, Pharmaceutical industry

Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. (Nasdaq: KZR) announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Kezar’s investigational new drug (IND) application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis (LN).

Key Points: 
  • Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. (Nasdaq: KZR) announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Kezar’s investigational new drug (IND) application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis (LN).
  • Everest will join Kezar and enroll patients in China as part of the ongoing PALIZADE trial, a global, placebo-controlled Phase 2b clinical trial evaluating the efficacy and safety of two dose levels of zetomipzomib or placebo in patients with active LN.
  • In September 2023, Everest obtained exclusive rights to develop and commercialize zetomipzomib in Greater China, South Korea and Southeast Asia.
  • “With the approval of the zetomipzomib IND in China, Everest now has three medicines in the renal space either commercialized or in clinical development.

Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 22, 2024
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, Week, Regulation, Research, Investment, University, Regulation Fair Disclosure, Webcast, CRP, Intellectual property, Progressive supranuclear palsy, Medication, Plasma, ALS, Marketing, Disclosure, AMX0035, Neurosurgery, Publication, Psychiatry, C-reactive protein, Safety, Biomarker, Amylyx Pharmaceuticals, Clinical trial, Survival, Journal of Neurology, Mutation, IND, Wolfram syndrome, PSP, Otsuka Pharmaceutical, Brain cell, Pharmaceutical industry

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2023.
  • Net product revenue for the three months ended December 31, 2023 was $108.4 million, compared to net product revenue of $102.7 million for the three months ended September 30, 2023.
  • Amylyx announced the first patient dosed in the Global Phase 3 ORION Study of AMX0035 in Progressive Supranuclear Palsy (PSP).
  • The first participant was dosed in December 2023, and topline results are anticipated in 2025 or 2026.

Celltrion presents new two-year data for subcutaneous infliximab (CT-P13 SC) in inflammatory bowel disease (IBD) at the 19th ECCO Congress

Retrieved on: 
Friday, February 23, 2024
Health, Pharmaceutical, Celltrion, Ulcerative colitis, Week, Crohn's disease, European, Safety, UC, Abstract, Patient, IBD, Congress, ECCO

These data were presented as poster presentations at the 19th European Crohn’s and Colitis Organisation (ECCO) annual congress in Stockholm, Sweden.

Key Points: 
  • These data were presented as poster presentations at the 19th European Crohn’s and Colitis Organisation (ECCO) annual congress in Stockholm, Sweden.
  • The LIBERTY-CD and LIBERTY-UC studies were continued up to 102 weeks as extension phase treatments, building on the initial LIBERTY trials.
  • The two-year studies assessed the long-term efficacy and safety of CT-P13 SC in patients with Crohn's disease (CD) and ulcerative colitis (UC), respectively.
  • “The early observation of mucosal healing at Week 22 showcases the potential of subcutaneous infliximab treatment in improving patient care,” said Nam Lee, Medical Director at Celltrion.