Merck & Co.

Long-Term Follow-up Data on Sustained Immunogenicity and Safety for GARDASIL®9 Published in Pediatrics

Retrieved on: 
Tuesday, September 5, 2023
Research, Teens, Infectious Diseases, Children, Clinical Trials, Biotechnology, Pharmaceutical, Consumer, Health, Science, MSD, Hypersensitivity, CIN, Male, Female, Pediatrics, Allergy, Life, Vaccination, CIN1, Human papillomavirus infection, Cancer, MRK, Vulvar cancer, Woman, Head, Month, AIS, Vulvectomy, Merck & Co., CDC, Incidence, Death, PIN, Anal cancer, Cervical cancer, Wart, Vain, Vaginal intraepithelial neoplasia, HPV, VIN, Cervical intraepithelial neoplasia, Anus, NYSE, Disease, Vaccine, Birth control, Recombinant, Merck

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.

Key Points: 
  • The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • As part of the primary objective of immunogenicity, data showed sustained HPV-antibody responses at 10 years after the third dose in boys and girls.
  • With the exception of cervical cancer, there is no routinely recommended screening for the detection of HPV-related cancers.

Merck to Participate in the Morgan Stanley 21st Annual Global Healthcare Conference

Retrieved on: 
Tuesday, September 5, 2023
Biotechnology, Health, Science, Pharmaceutical, Research, MSD, Merck & Co., Morgan, MRK, Conference, NYSE, EDT, Pharmaceutical industry, Merck

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Caroline Litchfield, executive vice president and chief financial officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Morgan Stanley 21st Annual Global Healthcare Conference on Monday, Sept. 11, 2023, at 2:15 p.m. EDT.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Caroline Litchfield, executive vice president and chief financial officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Morgan Stanley 21st Annual Global Healthcare Conference on Monday, Sept. 11, 2023, at 2:15 p.m. EDT.

Adagene Reports Six Month Financial Results for 2023 and Provides Corporate Update

Retrieved on: 
Thursday, August 31, 2023
Bevacizumab, Senior, ADCC, Neoplasm, Lead, Head, Bioinformatics, GAAP, Information technology, Doctor of Philosophy, Patient, HNSCC, ADCP, Research and development, R, HCC, SAB, CD47, PRS, Therapy, Merck & Co., Net, Cervical cancer, CPS, MSI, ADC, PD-1, PR, Safety, Exercise, AACR, Liver disease, MSS, Roche, Therapeutic index, GenScript Biotech, American Association for Cancer Research, CR, Pembrolizumab, ORR, Renal cell carcinoma, SCC, CRC, RCC, ADS, CMC, Yan Li, Clinical trial, Trae Waynes, Endometrial cancer, Financial toxicity, Poster, Tumor microenvironment, Pharmaceutical industry, Palladium, Medical imaging, Vaccine, Management, Cryptocurrency, Fine chemical, Bank, Legend, Immunoglobulin G, MD, Sanofi, Exelixis

Additionally, Fangyong (Felix) Du, Ph.D, Chief Technology Officer at Adagene since 2020, is stepping down from the board for personal reasons.

Key Points: 
  • Additionally, Fangyong (Felix) Du, Ph.D, Chief Technology Officer at Adagene since 2020, is stepping down from the board for personal reasons.
  • Cash and cash equivalents were US$128.8 million as of June 30, 2023, compared to US$143.8 million as of December 31, 2022.
  • The company uses non-GAAP net loss and non-GAAP net loss per ordinary shares for the period, which are non-GAAP financial measures, in evaluating its operating results and for financial and operational decision-making purposes.
  • The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

Slone Partners Places Christophe Arbet-Engels as Chief Medical Officer at X4 Pharmaceuticals

Retrieved on: 
Thursday, August 31, 2023
Christophe, Roche, Therapy, Biogen, Biotechnology, Slone, Research, CMO, Doctor of Philosophy, Merck & Co., X4, Boehringer Ingelheim, MD, Patient, Immune system, Management, Fine chemical, Ligand Pharmaceuticals

SOUTH RIDING, Va., Aug. 31, 2023 /PRNewswire-PRWeb/ -- Slone Partners, a nationwide executive search firm for life sciences, biotechnology, and healthcare companies, today announced the successful placement of Christophe Arbet-Engels, MD, PhD, as Chief Medical Officer (CMO) at X4 Pharmaceuticals, Inc., a biopharmaceutical company developing novel small molecule therapeutics to benefit patients with diseases of the immune system.

Key Points: 
  • SOUTH RIDING, Va., Aug. 31, 2023 /PRNewswire-PRWeb/ -- Slone Partners , a nationwide executive search firm for life sciences, biotechnology, and healthcare companies, today announced the successful placement of Christophe Arbet-Engels , MD, PhD, as Chief Medical Officer (CMO) at X4 Pharmaceuticals, Inc. , a biopharmaceutical company developing novel small molecule therapeutics to benefit patients with diseases of the immune system.
  • Dr. Arbet-Engels is a highly respected and experienced global pharmaceutical executive with keen business acumen honed over more than 20 years serving in complex organizational settings," said Leslie Loveless, Slone Partners CEO.
  • "Dr. Arbet-Engels is a highly respected and experienced global pharmaceutical executive with keen business acumen honed over more than 20 years serving in complex organizational settings," said Leslie Loveless , Slone Partners CEO.
  • "It was truly a pleasure collaborating with Slone Partners on the placement of Christophe as our new Chief Medical Officer," said Paula Ragan , Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals, "We very much value our relationship with the Slone team and consider them a valuable ongoing resource to X4 given their deep understanding of and high quality connections within the life science industry."

European Commission Approves KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy as First-Line Treatment for HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Expressing PD-L1 (CPS ≥1)

Retrieved on: 
Tuesday, August 29, 2023
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, MSD, Adenocarcinoma, Gastrointestinal cancer, Civil service commission, Progression-free survival, Marketing, HER2, Neoplasm, Trastuzumab, ESMO, European Directive on Traditional Herbal Medicinal Products, MRK, Immunotherapy, PFS, Merck & Co., Committee, Patient, GEJ, Committee for Medicinal Products for Human Use, European Society of Gynaecological Oncology, European Society for Medical Oncology, FDA, ITT, EC, PD-L1, NYSE, ORR, European Commission, Pharmaceutical industry, Medical imaging, EU, Merck

In the study, KEYTRUDA plus trastuzumab and chemotherapy significantly improved progression-free survival (PFS), and objective response rate (ORR), compared to trastuzumab and chemotherapy alone in this patient population.

Key Points: 
  • In the study, KEYTRUDA plus trastuzumab and chemotherapy significantly improved progression-free survival (PFS), and objective response rate (ORR), compared to trastuzumab and chemotherapy alone in this patient population.
  • Results from KEYNOTE-811 will be presented at the upcoming 2023 European Society for Medical Oncology (ESMO) Annual Meeting.
  • In May 2021, KEYTRUDA was approved in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in the U.S.
  • Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers and is continuing to study KEYTRUDA for multiple uses in gastric, hepatobiliary, esophageal and colorectal cancers.

APRINOIA Therapeutics Appoints Mark S. Shearman, Ph.D., as Chief Executive Officer

Retrieved on: 
Monday, August 28, 2023
Pharmacy, Medicinal chemistry, Drug development, Therapy, Doctor of Philosophy, Head, DSM-IV codes, Food, Merck Group, Brain, Merck & Co., Strategic planning, Editas Medicine, Tauopathy, Neuroscience, Dementia, Patient, Drug discovery, Preclinical development, INN, Growth, Diagnosis, Merck, Alzheimer's disease, AD, FDA, Applied Genetic Technologies Corporation, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Death, Synucleinopathy, PSP, Safety, Pharmaceutical industry, Management, IND

Dr. Shearman, who holds a Ph.D. in neuroscience, has extensive experience in pharmaceutical research, drug development and strategic partnerships.

Key Points: 
  • Dr. Shearman, who holds a Ph.D. in neuroscience, has extensive experience in pharmaceutical research, drug development and strategic partnerships.
  • Prior to APRINOIA, he held executive leadership positions at Editas Medicine, Applied Genetic Technologies Corporation, Merck KGaA and Merck & Co., and has served as Chair of APRINOIA’s Scientific Advisory Board since 2015.
  • “It is a great honor to assume the post of CEO of APRINOIA.
  • APRINOIA is focusing on tauopathies and synucleinopathies, that affect approximately 50 million and 10 million people worldwide, respectively.

Apogee Highlights Corporate Progress and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Monday, August 28, 2023
Slate, Exercise, COPD, PK, Jennifer Fox, IPO, Asthma, Research and development, Initial public offering, General counsel, Half-life, OX40L, I&I, Biotechnology, CMC, Skadden, Arps, Slate, Meagher & Flom, Pharmacokinetics, Atopic dermatitis, Negotiation, Inflammation, AstraZeneca, DSM-IV codes, Chronic obstructive pulmonary disease, Chemistry, Acquisition, Alexion Pharmaceuticals, Patient, Standard of care, Administration, SAN, Engineering, Immune system, Mab, Knowledge, Growth, Merck, R, Merck & Co., AD, Piper, Therapy, DLA Piper, Aulus Cornelius Cossus Arvina, Safety, Security (finance), Vaccine, Pharmaceutical industry, Management, Apsis, Paragon

SAN FRANCISCO and WALTHAM, Mass., Aug. 28, 2023 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD) and other inflammatory and immunology (I&I) indications, today provided a review of its pipeline of potentially best-in-class monoclonal antibody (mAb) therapies for I&I diseases, along with key anticipated milestones and recent business progress. In addition, Apogee reported second quarter 2023 financial results and provided guidance on its projected operating runway.

Key Points: 
  • In addition, Apogee reported second quarter 2023 financial results and provided guidance on its projected operating runway.
  • Research & Development (R&D) Expenses: R&D expenses for the second quarter of 2023 were $13.9 million, compared to $1.4 million for the second quarter of 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2023 were $4.9 million, compared to $0.4 million for the second quarter of 2022.
  • Net Loss: Net loss for the second quarter of 2023 was $18.9 million, compared to the net loss for the second quarter of 2022 which was $1.8 million.

Merck and Eisai Provide Update on Phase 3 LEAP-010 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Patients With Certain Types of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Retrieved on: 
Friday, August 25, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Senior, Hepatocellular carcinoma, Progression-free survival, RCC, Neoplasm, Lenvatinib, Pembrolizumab, Overalls, Survival, OS, MRK, Head, TKI, Multimedia, Research, Lung cancer, Immunotherapy, PFS, Merck & Co., LEAP, Cancer, Patient, Esophageal cancer, HNSCC, Data monitoring committee, Stomach, PD-L1, NYSE, ORR, DMC, Pharmaceutical industry, EU, Eisai, Merck

The primary endpoints of the study were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).

Key Points: 
  • The primary endpoints of the study were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).
  • View the full release here: https://www.businesswire.com/news/home/20230825671284/en/
    Two planned interim analyses were conducted by an independent Data Monitoring Committee (DMC) over an 11-month period.
  • In the first analysis, KEYTRUDA plus LENVIMA showed a statistically significant improvement in PFS and ORR versus KEYTRUDA plus placebo.
  • The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.

Merck Initiates Phase 3 Clinical Program for Oral PCSK9 Inhibitor Candidate MK-0616

Retrieved on: 
Friday, August 25, 2023
Science, Cardiology, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, MSD, Myocardial infarction, Amputation, Week, Cardiovascular disease, MRK, Lipid, Merck & Co., Harvard Medical School, Hypercholesterolemia, MD, Patient, Physician, Risk, LDL, PCSK9, Thrombolysis, Buerger's test, ASCVD, Moyamoya disease, Hospital, Death, NYSE, TIMI, Stroke, Pharmaceutical industry, Medicine, Brigham, Merck

This is the first Phase 3 clinical program for an oral PCSK9 inhibitor.

Key Points: 
  • This is the first Phase 3 clinical program for an oral PCSK9 inhibitor.
  • Merck also plans to initiate a Phase 3 cardiovascular outcomes study, CORALreef Outcomes by the end of 2023.
  • Merck is collaborating with the TIMI Study Group, a leading academic research organization for cardiovascular clinical trials, on the CORALreef Outcomes study.
  • Merck’s broad, global Phase 3 program for MK-0616 aims to enroll approximately 17,000 participants across the CORALreef Lipids, CORALreef HeFH and CORALreef Outcomes studies.

Agilent Receives European IVDR Certification for Companion Diagnostic Assay

Retrieved on: 
Thursday, August 24, 2023
Biotechnology, Consumer Electronics, Technology, Health, Oncology, Health Technology, Other Science, Medical Devices, Research, Software, Science, Carcinoma, Triple-negative breast cancer, TNBC, IVDR, Pathology, Cancer, Head, NSCLC, Lung cancer, Certification, Agilent Technologies, Patient, Laboratory, European, Esophageal cancer, Merck, Merck & Co., FDA, Pembrolizumab, CDX, Merck Sharp & Dohme Federal Credit Union, PD-L1, NYSE, Safety, Medical device, Medical imaging, Pharmaceutical industry, EU

Agilent Technologies Inc. (NYSE: A) today announced the issuing of a companion diagnostic (CDx) Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006.

Key Points: 
  • Agilent Technologies Inc. (NYSE: A) today announced the issuing of a companion diagnostic (CDx) Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006.
  • This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR).
  • IVDR compliance certification enhances the confidence of healthcare professionals and patients in the EU by showing that these medical devices can be safely relied upon in diagnostic workflows.
  • This IVDR certification allows healthcare professionals and patients to continue to benefit from the assay without disruption to critical diagnostic capabilities in established indications.