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INX:LLY, Apr 26, 04:42 UTC

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Eli Lilly's Lartruvo is being pulled from the market, but patients who are already taking the drug will still have access under new program

LLY

Eli Lilly and Co. said Thursday it is working with doctors to ensure patients who are currently receiving Lartruvo, a soft-tissue sarcoma therapy being pulled from the market following the failure of a late-stage trial, will still be able to receive the drug if they have been told of the drug's risks and trial outcomes and wish to continue. The company announced in January that a Phase 3 trial of Lartruvo as a combination therapy with doxorubicin in patients with advanced soft-tissue sarcoma did not improve survival compared with standard of care. The drugmaker is now working on facilitating a smooth withdrawal of the drug from the market for advanced soft tissue sarcoma. Shares of Eli Lilly have gained 2% in the year to date, while the S&P 500 has gained 16.8%.

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Tuesday, April 23


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The Daily Biotech Pulse: FDA Accepts Alder's Migraine Drug Application, Gritstone Offering, Lilly's Chinese Sale

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The Daily Biotech Pulse: FDA Accepts Alder's Migraine Drug Application, Gritstone Offering, Lilly's Chinese Sale. Here's a roundup of top developments in the biotech space over the last 24 hours. Moleculin Biotech Inc (NASDAQ: MBRX) (announcement that annamycin, a molecule developed as part of its ongoing sponsored research with the University of Texas MD Anderson Cancer Center, significantly improved survival in an aggressive form of triple negative breast cancer metastasized to the lungs in animal models). Alder Biopharmaceuticals Inc (NASDAQ: ALDR) said the FDA accepted its BLA for eptinezumab, an investigational monoclonal antibody, administered intravenously, for preventing migraine through the targeting of the calcitonin gene-related peptide.

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This Key Aspect Makes This Stock Even More Attractive:: Colgate-Palmolive Company, (NYSE: CL) – Nyse News Room

CL LLY

This Key Aspect Makes This Stock Even More Attractive:: Colgate-Palmolive Company, (NYSE: CL). The USA based company, Colgate-Palmolive Company created a change of 0.33% from opening and finally closed its trading at 69.6 by making a change of 0.36% (Gain, ↑). Earnings per share serve as an indicator of a company’s success / profitability. When E (EPS) increase, P (Market Price) will also raise, but it is point worth mentioning that, EPS of company is reported once every quarter. So for sure an EPS change does not justify every day volatility of stock price. A Quarterly Performance (Q-P) of 11.13%, bringing 06-months performance to 9.52% and year to date performance (Y-D-P) of 16.94%.As of now, Colgate-Palmolive Company has a P/S, P/E and P/B values of 3.88,24.5 and 0 respectively.

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Global Bipolar Disorder Therapeutics Market 2019 Major Provider – AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Astellas Pharma – Market Talk News

LLY AZN +2 more LLY AZN AZN BMY

Global Bipolar Disorder TherapeuticsMarket Research Report 2019-2024 holds the comprehensive study of the Bipolar Disorder Therapeutics market trends as well as an examination of each segment as well as their respective sub-segments present in the market in an all-inclusive manner. It offers an overall weakness that companies in the Bipolar Disorder Therapeutics market must avoid achieving sustainable growth during the forecast years. Moreover, the report includes the list of major companies/competitors and their competition data that helps the user to determine their current position in the market and take corrective measures to maintain or increase their share holds. A regional allotment is done to make the client a better understanding of the overall Bipolar Disorder Therapeutics market outlook at the macro and micro level. As mentioned about the regions, a comprehensive regional classification of the market is also added herein with their production, consumption, revenue, market share and progress rate, covering: Asia-Pacific, North America, Europe, South America, Middle East & Africa.

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Lilly Announces Sale of Legacy Antibiotics Brands and Manufacturing Facility in China

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INDIANAPOLIS, April 22, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY) today announced that it has entered into an agreement to sell the rights in China for two legacy Lilly antibiotic medicines, Ceclor® and Vancocin®, as well as a manufacturing facility in Suzhou, China that produces Ceclor, to Eddingpharm, a China-based specialty pharmaceutical company. "This transaction will enable Lilly China to better focus our resources on the exciting new therapies that we are launching in our core therapeutic areas, so that we can bring more life-changing medicines to patients in China." Mr. Xin Ni, CEO of Eddingpharm, said: "Ceclor and Vancocin have been on the Chinese market for more than two decades, treating numerous patients and earning the trust of patients and physicians alike. Among other things, there can be no guarantee that the sale of assets to Eddingpharm will be completed in the anticipated timeframe or at all, or that Lilly will realize the expected benefits of the transaction. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission.

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Monday, April 22


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Eli Lilly-Pfizer's Non-Opioid Painkiller Faces Safety, Efficacy Concerns

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Eli Lilly And Co (NYSE: LLY) faced a setback following the release of top-line results from a late-stage study of its pain medication candidate. Lilly and partner Pfizer Inc. (NYSE: PFE) said in a Thursday news release the Phase 3 study intended to evaluate tanezumab in 2.5mg and 5mg doses for its long-term safety and 16-week efficacy relative to nonsteroidal anti-inflammatory drugs, or NSAIDs, in patients with moderate-to-severe osteoarthritis of the hip or knee produced mixed results. The non-opioid chronic pain medication was administered subcutaneously every eight weeks for a total of 56 weeks, with a 24-week safety follow-up period. The trial results showed that the 5mg arm met two of the three co-primary endpoints, showing a statistically significant improvement in pain and physical function relative to NSAIDs at 16 weeks. Yet the patients' overall assessment of their osteoarthritis was not significantly different from the NSAIDs.

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Eli Lilly Falls Despite Positive Phase 3 Results From Taltz Study

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sank 1.7% to $113.26 in premarket trading Monday even though the company said its drug Taltz saw positive results from a Phase 3 study. Eli Lilly said the Phase 3 study of Taltz met both primary and secondary endpoints in treating a subset of patients with axial spondyloarthritis, or axSpA, a chronic inflammatory disease affecting predominantly the sacroiliac joints and the axial skeleton and is estimated to affect 4.5 million adults worldwide.

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Eli Lilly stock down 3.4% despite positive Phase 3 findings for Taltz

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Shares of Eli Lilly and Co. were down 3.4% in premarket trade Monday despite the company's announcement that a Phase 3 study of its drug Taltz had met both primary and secondary endpoints in treating a subset of patients with axial spondyloarthritis. Patients on Taltz, a monoclonal antibody, showed a statistically significant improvement in symptoms 16 and 52 weeks after starting treatment, the company said. The drug's safety profile remained the same as before -- Taltz has been shown to increase a person's risk of getting infections and some patients have reported serious hypersensitivity reactions and exacerbations of Crohn's disease and ulcerative colitis. Earlier Monday morning, Lilly announced a licensing and research collaboration with Avidity Biosciences, Inc., a privately-held biotech company that has developed a platform using properties of monoclonal antibodies and oligonucleotide-based therapeutics to target genetic diseases.

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Lilly Announces Positive Top-Line Results for COAST-X, a 52-Week Placebo-Controlled Study of Taltz® (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis

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Taltz also met the major secondary endpoints at week 16 and week 52, including significant improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS), significant improvement in Bath Ankylosing Spondylitis Disease Activity (BASDAI), proportion of patients achieving low disease activity (ASDAS <2.1), significant improvement in sacroiliac joint inflammation (SIJ) as assessed by MRI (week 16) and significant improvement in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score. "Non-radiographic axSpA is a challenging diagnosis that is not only missed in clinics, but also has limited treatment options for physicians to offer patients," said Atul Deodhar, M.D., professor of medicine, Oregon Health & Science University and clinical investigator for the COAST program. Axial spondyloarthritis (axSpA) is a chronic inflammatory disease affecting predominantly the sacroiliac joints and the axial skeleton and is estimated to affect 4.5 million adults worldwide.1,2,3 AxSpA is recognized as a single disease entity, with a patient subset defined by the presence of radiographically defined structural damage of the sacroiliac joints (radiographic axSpA or ankylosing spondylitis [AS]) and a patient subset without clear structural damage radiographically (nr-axSpA).4 These two patient subsets share a similar burden of disease and similar clinical features, such as spinal inflammation and chronic inflammatory back pain.5,6 The COAST-X study is part of a clinical development program that aims to evaluate the efficacy and safety of Taltz across various population subsets of patients with axSpA. "We're encouraged by the results of the COAST-X trial, which support our belief that Taltz could become the first IL-17A antagonist to be approved in the U.S. for people with non-radiographic axSpA," said Christi Shaw, president, Lilly Bio-Medicines.

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Lilly and Avidity Biosciences Announce Licensing and Research Collaboration

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INDIANAPOLIS and LA JOLLA, Calif., April 22, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY) and Avidity Biosciences, Inc. today announced a global licensing and research collaboration focused on the discovery, development and commercialization of potential new medicines in immunology and other select indications. "We are excited to expand our oligonucleotide research and development efforts through this strategic collaboration with Avidity," said Andrew C. Adams, Ph.D., chief scientific officer for RNA therapeutics at Lilly. "This collaboration with Lilly provides an exceptional opportunity to leverage Avidity's proprietary AOC platform in order to generate new therapeutic targets in disease areas that have been challenging to pursue using oligonucleotide-based approaches," said Kent Hawryluk, Avidity's chief business officer. Avidity is also eligible to receive up to approximately $405 million per target for development, regulatory and commercialization milestones, as well as tiered royalties ranging from the mid-single to low-double digits on product sales.

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