AMGN

GLP-1: Beyond Diabetes, a Blockbuster Horizon Beckons

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Wednesday, January 10, 2024

NEW YORK, Jan. 10, 2024 /PRNewswire/ -- On Sept. 20, 2019, history was made when the U.S. Food and Drug Administration approved Rybelsus as the first oral glucagon-like peptide-1 (GLP-1) agonist for type 2 diabetes (T2D). However, it wasn't just a milestone for T2D management. It was a turning point in medicine, opening the floodgates to a universe of potential therapeutic applications for this remarkable molecule. While undeniably transformative for diabetes and weight loss, GLP-1's reach now extends far beyond, likely surpassing even the wildest dreams of its creators. From Alzheimer's and Parkinson's to drug addiction, clinical trials are painting a stunning picture of GLP-1's versatility. And it doesn't stop there. Strong evidence points to opportunities in heart disease, chronic kidney disease and a plethora of other conditions. The newfound applications of this super-drug re-enforce the significant potential for Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile), with its powerful DehydraTECH(TM) drug-delivery formulation and processing technology that improves both delivery and efficacy of GLP-1 for diabetes and potentially a host of other maladies. Lexaria joins other companies, including Amgen Inc. (NASDAQ: AMGN), Eli Lilly and Company (NYSE: LLY), Roche (OTCQX: RHHBY) and WW International Inc. (NASDAQ: WW), that are committed to providing powerhouse solutions in the fields of diabetes, weight loss and more.

Key Points: 
  • GLP-1 agonists are among the hottest drugs in healthcare, with uses targeting multibillion-dollar diabetes and obesity markets and much more.
  • Lexaria Bioscience has developed DehydraTECH drug-delivery platform, which is being shown to improve pharmacokinetics of orally administered drugs.
  • Lexaria issued final data from the pilot study and is planning for multiple human and animal studies early in 2024.
  • Uncontrolled blood sugar dramatically increases the risk of devastating comorbidities, including kidney disease, vision loss, amputations, heart attacks, strokes and early death.

Generate:Biomedicines Fortifies Leadership in Generative AI with Advancing Clinical Pipeline and Expanded Amgen Collaboration, Overviewed at the 42nd Annual J.P. Morgan Healthcare Conference

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Thursday, January 4, 2024

Mike Nally, Chief Executive Officer, will overview these updates, as well as share more about the company’s strategy to further strengthen its leadership in generative biology, at the 42nd Annual J.P. Morgan Healthcare Conference, which will be occurring from January 8-11 in San Francisco.

Key Points: 
  • Mike Nally, Chief Executive Officer, will overview these updates, as well as share more about the company’s strategy to further strengthen its leadership in generative biology, at the 42nd Annual J.P. Morgan Healthcare Conference, which will be occurring from January 8-11 in San Francisco.
  • The presentation will take place on January 10 from 10:00-10:25am PST at the Golden Gate (32nd Floor) of The Westin St. Francis.
  • Deploying structure in the learning loop utilizing CryoEM to generate data for iterative learning which has shown faster, improved outcomes.
  • “We look forward to working even more closely together in order to deliver best-in-class therapies that address significant unmet patient needs.”

AMGEN TO PRESENT AT THE 42ND ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

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Wednesday, January 3, 2024

THOUSAND OAKS, Calif., Jan. 3, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 2024 J.P. Morgan Healthcare Conference at 9:00 a.m. PT on Monday, January 8, 2024.

Key Points: 
  • THOUSAND OAKS, Calif., Jan. 3, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 2024 J.P. Morgan Healthcare Conference at 9:00 a.m. PT on Monday, January 8, 2024.
  • Robert A. Bradway, chairman and chief executive officer at Amgen will present at the conference.
  • The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
  • Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar.

AMGEN ANNOUNCES EXECUTIVE APPOINTMENTS TO ACCELERATE INNOVATION

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Thursday, December 14, 2023

THOUSAND OAKS, Calif., Dec. 14, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced two changes to its senior leadership team in the areas of research and development (R&D) and technology, underscoring the advancement of the company's robust pipeline and its commitment to ongoing scientific and technological innovation. James Bradner, M.D., has joined Amgen as executive vice president of Research and Development, and chief scientific officer. Bradner is succeeding David M. Reese, M.D., who has been appointed executive vice president and chief technology officer. Both Bradner and Reese will report to Robert A. Bradway, chairman and chief executive officer at Amgen.

Key Points: 
  • James Bradner, M.D., has joined Amgen as executive vice president of Research and Development, and chief scientific officer.
  • Both Bradner and Reese will report to Robert A. Bradway, chairman and chief executive officer at Amgen.
  • "For more than 40 years, Amgen's focus on innovation has enabled us to deliver life-changing medicines to patients suffering from serious diseases around the world," said Robert A. Bradway, chairman and chief executive officer at Amgen.
  • At Amgen we have been preparing for this moment for over a decade," said David M. Reese, executive vice president and chief technology officer at Amgen.

FDA Grants Priority Review to Amgen's Tarlatamab Application for Advanced Small Cell Lung Cancer

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Wednesday, December 13, 2023

THOUSAND OAKS, Calif., Dec. 13, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab.

Key Points: 
  • Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy for the treatment of adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
  • The FDA grants Priority Review to applications for medicines that offer, if approved, significant improvements over available options or may provide a treatment option where no adequate therapy currently exists.
  • Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for tarlatamab is June 12, 2024.
  • The application is being reviewed by the FDA under the Project Orbis framework and Real Time Oncology Review (RTOR).

AMGEN HIGHLIGHTS HEMATOLOGY PORTFOLIO AT ASH 2023

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Friday, December 8, 2023

THOUSAND OAKS, Calif., Dec. 8, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data from its blood cancer portfolio and pipeline at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place from Dec. 9-12 in San Diego.

Key Points: 
  • THOUSAND OAKS, Calif., Dec. 8, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data from its blood cancer portfolio and pipeline at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place from Dec. 9-12 in San Diego.
  • "Data at this year's ASH meeting illustrate the expanding potential of our innovative hematology medicines, BLINCYTO and KYPROLIS, as well as our commitment to providing additional treatment options with our biosimilar eculizumab," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
  • "As the pioneer of T-cell engager technology and building on nearly a decade of real-world experience, we continue to advance our first-in-class BiTE® molecule, BLINCYTO, into earlier lines of treatment where we have seen encouraging data in patients living with acute lymphoblastic leukemia."
  • Preliminary Results of the Gimema ALLL2820 Trial
    Abstract # 4249 , Session #614, Monday, December 11 from 6:00 - 8:00 p.m. PT
    *E1910 is sponsored by National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by the NCI Funded National Clinical Trial Network.

AMGEN TO PRESENT AT THE EVERCORE ISI HEALTHCONX CONFERENCE

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Wednesday, November 22, 2023

THOUSAND OAKS, Calif., Nov. 22, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Evercore ISI HealthCONx Conference at 9:10 a.m. EST on Wednesday, Nov. 29, 2023.

Key Points: 
  • THOUSAND OAKS, Calif., Nov. 22, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Evercore ISI HealthCONx Conference at 9:10 a.m. EST on Wednesday, Nov. 29, 2023.
  • Peter H. Griffith, executive vice president and chief financial officer at Amgen, and Paul Burton, senior vice president and chief medical officer at Amgen will present at the conference.
  • The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
  • Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar.

1 in 25 carries a genotype that is associated with a shortened lifespan

Retrieved on: 
Wednesday, November 15, 2023

REYKJAVIK, Iceland, Nov. 15, 2023 /PRNewswire/ -- The study, published today in the New England Journal of Medicine, focuses on genotypes that increase the risk of a disease for which preventive or therapeutic measures have been established. These genotypes are termed actionable genotypes. The scientists used a population-based data set, consisting of 58,000 whole-genome sequenced Icelanders, to assess the fraction of individuals carrying actionable genotypes.

Key Points: 
  • The scientists used a population-based data set, consisting of 58,000 whole-genome sequenced Icelanders, to assess the fraction of individuals carrying actionable genotypes.
  • The study assessed the relationship between actionable genotypes and the lifespan of their carriers.
  • A pathogenic variant in BRCA2, predisposing to breast, ovarian and pancreatic cancer, shortened lifespan by seven years and a variant in LDLR, which causes high levels of cholesterol and cardiovascular disease, shortened lifespan by six years.
  • The researchers determined that 1 in 25 individuals carried an actionable genotype and have, on average, a shortened lifespan.

1 in 25 carries a genotype that is associated with a shortened lifespan

Retrieved on: 
Wednesday, November 15, 2023

REYKJAVIK, Iceland, Nov. 8, 2023 /PRNewswire/ -- The study, published today in the New England Journal of Medicine, focuses on genotypes that increase the risk of a disease for which preventive or therapeutic measures have been established. These genotypes are termed actionable genotypes. The scientists used a population-based data set, consisting of 58,000 whole-genome sequenced Icelanders, to assess the fraction of individuals carrying actionable genotypes.

Key Points: 
  • The scientists used a population-based data set, consisting of 58,000 whole-genome sequenced Icelanders, to assess the fraction of individuals carrying actionable genotypes.
  • The study assessed the relationship between actionable genotypes and the lifespan of their carriers.
  • A pathogenic variant in BRCA2, predisposing to breast, ovarian and pancreatic cancer, shortened lifespan by seven years and a variant in LDLR, which causes high levels of cholesterol and cardiovascular disease, shortened lifespan by six years.
  • The researchers determined that 1 in 25 individuals carried an actionable genotype and have, on average, a shortened lifespan.

AMGEN PRESENTS NEW CARDIOVASCULAR RESEARCH AT AHA 2023

Retrieved on: 
Friday, November 10, 2023

THOUSAND OAKS, Calif., Nov. 10, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data reinforcing the safety and efficacy of Repatha® (evolocumab) from the FOURIER Open Label Extension (OLE) [FOURIER-OLE] trial at the American Heart Association (AHA) Scientific Sessions 2023 in Philadelphia. These presentations will focus on the reduction of a known cardiovascular disease (CVD) risk factor, LDL "bad" cholesterol (LDL-C). Amgen will also present new research from the Phase 2 OCEAN(a)-DOSE study of its investigational small interfering RNA (siRNA) olpasiran that will focus on a primarily genetically determined and presumed independent CVD risk factor, lipoprotein(a) [Lp(a)].1,2,3,4,5

Key Points: 
  • These presentations will focus on the reduction of a known cardiovascular disease (CVD) risk factor, LDL "bad" cholesterol (LDL-C).
  • Amgen also shared new research from the OCEAN(a)-DOSE study on Lp(a) involving its investigational olpasiran.
  • Additional research presented at AHA will include Mass General Brigham Lp(a) registry data on whether the association between Lp(a) and major adverse cardiovascular events (MACE) differs based on baseline ASCVD status.
  • Amgen will reconvene the LDL-C Action Summit and the newly formed LDL Awareness to Action Implementation Consortium ahead of AHA.