LLY

U.S. Food and Drug Administration Issues Complete Response Letter for Accelerated Approval of Donanemab

Retrieved on: 
Thursday, January 19, 2023
LLY, The New England Journal of Medicine, NEJM, Plaque, Medicine, Donanemab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Eli Lilly and Company, FDA, Alzheimer's disease, Physician, Peter Mintun, Patient, Food, Lilly, Pharmaceutical industry

INDIANAPOLIS, Jan. 19, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. No other deficiencies in the application were noted.

Key Points: 
  • Complete response letter based on limited number of patients with 12-month drug exposure data in the accelerated approval submission; no other deficiencies were identified
    INDIANAPOLIS, Jan. 19, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission.
  • Lilly will continue to work with the FDA to evaluate the fastest pathway to make this potential treatment option widely available to patients.
  • In the complete response letter to the accelerated approval application, the FDA specifically requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab.
  • The safety profile of donanemab has remained consistent since our accelerated approval submission.

Lilly Confirms Date and Conference Call for Fourth-Quarter 2022 Financial Results Announcement

Retrieved on: 
Thursday, January 19, 2023
NYSE, Lilly, Eli Lilly and Company, LLY, Pharmaceutical industry

INDIANAPOLIS, Jan. 19, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will announce its fourth-quarter 2022 financial results on Thursday, Feb. 2, 2023.

Key Points: 
  • INDIANAPOLIS, Jan. 19, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will announce its fourth-quarter 2022 financial results on Thursday, Feb. 2, 2023.
  • Lilly will also conduct a conference call that day with the investment community and media to further detail the company's financial performance.
  • Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly's website at https://investor.lilly.com/webcasts-and-presentations .
  • A replay will also be available on the website following the conference call.

Lilly and ProQR to Expand RNA Editing Collaboration

Retrieved on: 
Thursday, December 22, 2022
Eli Lilly and Company, Partnership, Peripheral nervous system, Central nervous system, Nervous system, LLY, Research, Genetic distance, Axiom Space, Patient, NYSE, Collaboration, Therapy, ADAR, RNA, Lilly, Liver, Pharmaceutical industry, ProQR

The collaboration, originally announced in September 2021, applied ProQR’s proprietary Axiomer® RNA editing platform to target disorders of the liver and nervous system.

Key Points: 
  • The collaboration, originally announced in September 2021, applied ProQR’s proprietary Axiomer® RNA editing platform to target disorders of the liver and nervous system.
  • Through this expanded collaboration, Lilly and ProQR will explore further applications of the Axiomer platform to unlock new innovative treatments for people living with diseases with high unmet medical need.
  • “Lilly is a leader in RNA therapeutics, and our expanded partnership is another validation of our leadership in ADAR-mediated RNA editing, our robust IP estate, and the potential of our broadly applicable Axiomer platform technology.
  • Lilly will have the ability to exercise an option to further expand the partnership for a consideration of $50 million.

Eagle Pharmaceuticals Receives FDA Approval for Additional Indication for PEMFEXY® in Combination with Pembrolizumab and Platinum Chemotherapy

Retrieved on: 
Monday, December 19, 2022
Eli Lilly and Company, Pembrolizumab, Food, LLY, Regulation of tobacco by the U.S. Food and Drug Administration, Pemetrexed, Eagle, Platinum, ALK, Patient, NYSE, FDA, Large-cell lung carcinoma, Patent, Mesothelioma, New Drug Application, Pharmaceutical industry

WOODCLIFF LAKE, N.J., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (“FDA”) has approved an additional indication for PEMFEXY® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (“NSCLC”) with no EGFR or ALK genomic tumor aberrations. Eagle’s approved PEMFEXY (pemetrexed injection) is a ready-to-dilute (“RTD”) novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug (“LD”), ALIMTA®.

Key Points: 
  • Eagle’s approved PEMFEXY (pemetrexed injection) is a ready-to-dilute (“RTD”) novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug (“LD”), ALIMTA®.
  • “With this fifth indication, PEMFEXY is now approved for all of the same indications as ALIMTA, and we believe it allows for key advantages such as eliminating the need for reconstitution.
  • At the same time, we also believe that Eagle is well positioned to capture the commercial opportunity that PEMFEXY represents,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
  • In February 2020, Eagle received approval from the FDA of its New Drug Application for PEMFEXY, following the settlement agreement of patent litigation with Eli Lilly and Company (NYSE: LLY) in December 2019.

Nucleate announces Eli Lilly and Company as a new Platinum Sponsor of the 2023 Activator program

Retrieved on: 
Thursday, January 5, 2023
Treasurer, Eli Lilly and Company, EVP, Eli Lilly, LLY, Activator, Regenerative medicine, Nucleation, Patient, NYSE, Entrepreneurship, Lilly, Pharmaceutical industry, Culture

BOSTON, Jan. 5, 2023 /PRNewswire-PRWeb/ -- Nucleate, a nonprofit organization led by academic trainees and dedicated to empowering future biotech leaders, today announced that Eli Lilly and Company (NYSE: LLY) will become a Platinum Level Sponsor of the 2023 Activator Program. Nucleate's equity-free Activator program has supported more than 100 venture teams in their earliest stages of development, including Glyphic, NextRNA, and Manifold Bio. Lilly will be providing $300,000 in grants to promising technologies as part of the inaugural Eli Lilly and Company Genetic Medicine Grand Challenge.

Key Points: 
  • Nonprofit organization dedicated to empowering future biotech leaders, announced that Eli Lilly and Company (NYSE: LLY) will be a Platinum Sponsor of the 2023 Activator Program and inaugurate the $300K Genetic Medicine Grand Challenge.
  • BOSTON, Jan. 5, 2023 /PRNewswire-PRWeb/ -- Nucleate , a nonprofit organization led by academic trainees and dedicated to empowering future biotech leaders, today announced that Eli Lilly and Company (NYSE: LLY) will become a Platinum Level Sponsor of the 2023 Activator Program.
  • Nucleate's equity-free Activator program has supported more than 100 venture teams in their earliest stages of development, including Glyphic, NextRNA, and Manifold Bio.
  • Lilly will be providing $300,000 in grants to promising technologies as part of the inaugural Eli Lilly and Company Genetic Medicine Grand Challenge.

Lilly to Participate in the J.P. Morgan Healthcare Conference

Retrieved on: 
Wednesday, January 4, 2023
LLY, NYSE, Obesity, Biotechnology, Eli Lilly and Company, Conference, Multimedia, Alzheimer's disease, Cancer, Chemistry, Pharmaceutical industry, Lilly

INDIANAPOLIS, Jan. 4, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will attend the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 10, 2023.

Key Points: 
  • INDIANAPOLIS, Jan. 4, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will attend the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 10, 2023.
  • David A. Ricks, Lilly's chair and CEO, will participate in a fireside chat at 6:45 p.m. Eastern time.
  • A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly's Investor website at https://investor.lilly.com/webcasts-and-presentations .
  • Lilly unites caring with discovery to create medicines that make life better for people around the world.

EQS-News: Chinese Lockdown Effects Ripple Marketwide; A Solution Urgently Needed

Retrieved on: 
Sunday, December 18, 2022
Acquisition, R, Sunlight, Pancreatic cancer, NYSE, Health, Advertising, AAPL, Safety, Cancer, Regeneron Pharmaceuticals, Tesla, McGill, COVID-19, Vaccine, General Hospital, Eli Lilly and Company, RNA transfection, Squamous cell carcinoma, Breast cancer, LLY, Apple, Growth, TSLA, Immune system, Research, University, Combined small-cell lung carcinoma, Patient, Drug resistance, PFE, COVID, Pharmaceutical industry, Pfizer

Chinese Lockdown Effects Ripple Marketwide; A Solution Urgently Needed

Key Points: 
  • Chinese Lockdown Effects Ripple Marketwide; A Solution Urgently Needed
    Protests have mounted in intensity across China in the past weeks, as more and more citizens become frustrated with the country’s radical “Zero-Covid” policies.
  • Sunshine Biopharma, Inc. (NASDAQ: SBFM) is a Canada-based pharmaceutical company combating COVID-19 through the development of SBFM-PL4, an antiviral treatment.
  • The company is confident that, in a Covid-19 vaccine market worth $13.6 billion , its drug candidate could provide a welcome solution.
  • Studies using non-transformed (normal) human cells (HMEC) have shown that K1.1 mRNA had little or no cytotoxic effects.

Phase III trial demonstrated Jardiance is the first SGLT2 inhibitor to show statistically significant reduction in blood sugar levels in children and adolescents with type 2 diabetes

Retrieved on: 
Wednesday, December 7, 2022
Health, Diabetes, Clinical Trials, Research, Pharmaceutical, Science, Lykke, Eli Lilly and Company, Insulin, LLY, Ageing, Exercise, Linagliptin, Pediatrics, International Diabetes Federation, Risk, Adolescence, Empagliflozin, Prevalence, Fasting, Joslin Diabetes Center, NYSE, World Diabetes Day, Diabetes, International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Type 2 diabetes, Obesity, Face, Multimedia, Diet, Metformin, Safety, SGLT2, Harvard Medical School, Boehringer Ingelheim, IDF, New product development, Pharmaceutical industry, Glycated hemoglobin

View the full release here: https://www.businesswire.com/news/home/20221207005405/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20221207005405/en/
    The DINAMO (DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents) trial included youth aged 10-17 years with type 2 diabetes and HbA1c 6.5% and 10.5%.
  • Participants were randomly assigned treatment with empagliflozin (10 or 25 mg) (n=52), linagliptin (5 mg) (n=53) or placebo (n=53) once daily.
  • Todays results from the DINAMO global clinical trial demonstrated that the SGLT2 inhibitor empagliflozin compared with placebo significantly improved overall blood sugar control in children and adolescents with type 2 diabetes.
  • A numerical reduction of 0.34% (P=0.2935) was observed.1
    The findings have been submitted for publication in a peer-reviewed journal.

Lilly and EVA Pharma Announce Collaboration to Enhance Sustainable Access to Affordable Insulin in Africa

Retrieved on: 
Wednesday, December 14, 2022
Biotechnology, Degenerative disease, Reproductive health, Chemistry, Asa, Insulin, LLY, API, Eli Lilly and Company, Private sector, Alzheimer's disease, Patient, Universal health care, NYSE, Form, Diabetes, Pain, Cancer, Obesity, Ophthalmology, WHO, Safety, Neuroscience, Health, Hope, IDF, Fine chemical, Pharmaceutical industry, Developing country, Lilly

INDIANAPOLIS and CAIRO, Dec. 14, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and EVA Pharma announced today a collaboration to deliver a sustainable supply of high-quality, affordable human and analogue insulin to at least one million people living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa.

Key Points: 
  • In a first for Lilly, the company will supply its active pharmaceutical ingredient (API) for insulin at a significantly reduced price to EVA Pharma.
  • EVA Pharma expects to begin distribution of the African-made insulin products within 18 months and to reach one million people per year by 2030.
  • "Our new collaboration with EVA Pharma reflects Lilly's deep commitment to making equitable and affordable access to insulin a reality for people living with diabetes in low- and middle-income countries," said Ilya Yuffa, president of Lilly International.
  • "EVA Pharma is committed to empowering the fight forhealth and well-being asa human right," said Riad Armanious, CEO of EVA Pharma.

Loxo@Lilly Presents Updated Pirtobrutinib Data from the Phase 1/2 BRUIN Clinical Trial at the 2022 American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 12, 2022
Data, Lymphoid leukemia, Lymphoma, BOR, Chemistry, Recurrence, Bruise, PK, Society, NHL, Mantle cell lymphoma, SLL, BTK, AE, Patient, Hypertension, Pharmacokinetics, Drug combination, Physician, Pharmacology, Bleeding, NYSE, Fatigue, Richter's transformation, Obesity, Multimedia, Clinical trial, University, Biotechnology, Atrial fibrillation, Eli Lilly and Company, Neutropenia, Index (publishing), Alzheimer's disease, IRC, Diarrhea, WM, PFS, Form, Non-Hodgkin lymphoma, Cancer, University of California, ASH, CLL, BCL2, LLY, ORR, MCL, Lymphocytosis, MRR, Chronic lymphocytic leukemia, Progression-free survival, Medicine, Survival, RT, Dor, MTD, Safety, Pharmaceutical industry, Lilly

INDIANAPOLIS, Dec. 12, 2022 /PRNewswire/ -- Loxo@Lilly, the oncology unit of Eli Lilly and Company (NYSE: LLY), today announced updated clinical data from the pirtobrutinib global Phase 1/2 BRUIN trial in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Richter transformation (RT), and Waldenström macroglobulinemia (WM). Pirtobrutinib is an investigational, highly selective, reversible (non-covalent) inhibitor of Bruton's tyrosine kinase (BTK). These data are featured in oral and poster presentations at the 2022 American Society of Hematology (ASH) Annual Meeting. 

Key Points: 
  • These data are featured in oral and poster presentations at the 2022 American Society of Hematology (ASH) Annual Meeting.
  • The BRUIN Phase 1/2 clinical trial is evaluating pirtobrutinib monotherapy in patients previously treated for MCL, CLL/SLL, or other non-Hodgkin lymphomas (NHL).
  • The BRUIN trial includes one of the largest prospective cohorts of BTK inhibitor pre-treated CLL/SLL patients ever studied.
  • The trial includes a Phase 1 dose-escalation phase, a Phase 1b combination arm, and a Phase 2 dose-expansion phase.