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LON100:AZN, Jul 17, 07:22 UTC

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Monday, July 15


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AstraZeneca's Farxiga Gets CRL from FDA for Type I Diabetes

AZN AZN

The company will meet with the FDA to discuss the CRL and seek the path forward for the sNDA. Please note that, in March, the FDA also issued a CRL to Lexicon Pharmaceuticals, Inc.’s LXRX new drug application seeking approval for Zynquista, a dual SGLT1 and SGLT2 inhibitor, in combination with insulin as a treatment for type I diabetes. There is no approved SGLT inhibitor for type I diabetes in the United States. AstraZeneca’s stock has increased 5.8% this year so far, outperforming the industry’s decrease of 1.6%. Other SGLT2 inhibitors available in the market are Johnson & Johnson’s JNJ Invokana and Lilly’s Jardiance, Synjardy (a fixed dose combination of Jardiance and metformin) and Glyxambi (a fixed dose combination of Jardiance and Tradjenta). AstraZeneca PLC Price. AstraZeneca PLC price | AstraZeneca PLC Quote.

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AstraZeneca's Farxiga fails to get U.S. approval for Type-1 diabetes

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(Reuters) - British drugmaker AstraZeneca Plc said on Monday the U.S. Food and Drug Administration declined to approve its diabetes treatment, Farxiga, for use as a supplement to insulin in adults with a rare-type of the condition. The company said the regulator issued a complete response letter, declining its application for using the drug in patients with Type-1 diabetes where insulin alone has not been able to control blood sugar levels. Farxiga is already approved in the United States for use in Type-2 diabetes, the more common form of the condition. AstraZeneca did not specify the concerns FDA had raised for not approving the drug for Type-1 diabetes. Type-1 diabetes is a condition in which the pancreas produces little or no insulin hormone and affects about 5% of patients with diabetes. AstraZeneca said it would closely work with the FDA to chart out its next course of action.

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Sunday, July 14


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GSK turns to former AstraZeneca exec to lead £80bn break-up

AZN AZN +1 more AZN AZN GSK

Britain's second-biggest drug-maker is turning to a former chief financial officer of AstraZeneca, its London-listed rival, to steer it through an £81bn break-up. Sky News has learnt that GlaxoSmithKline (GSK) is in advanced talks about appointing Jonathan Symonds as its next non-executive chairman. City sources said this weekend that Mr Symonds' recruitment was likely to be announced in the coming weeks. If confirmed, it would spell the end of a seven-month search to replace Sir Philip Hampton, the former Royal Bank of Scotland chairman, who will step down later this year. In alighting on Mr Symonds as its new chairman, GSK has identified a businessman with significant pharmaceuticals and capital markets experience.

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Friday, July 12


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AstraZeneca's Imfinzi Gains Orphan Drug Status for SCLC

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ZacksJuly 12, 2019, 3:28 PM UTC. AstraZeneca PLC AZN announced that the FDA has granted an orphan drug designation to its PD-L1 inhibitor, Imfinzi (durvalumab), for the treatment of patients with extensive-stage small cell lung cancer (SCLC), the most aggressive type of the indication. The analysis met the primary endpoint as Imfinzi when combined with the standard-of-care medicine, etoposide and platinum-based chemotherapy, demonstrated a statistically significant and clinically meaningful improvement in OS as compared to chemotherapy alone. SCLC constitutes about 15% of all lung cancer diagnosis and is a difficult disease to address as only 6% of patients is able to survive after five years of treatment. Other than lung cancer, key phase III probes are evaluating Imfinzi in combination with tremelimumab for hepatocellular carcinoma, metastatic urothelial cancer and head and neck squamous cell carcinoma. However, Imfinzi is significantly lagging other approved PD-L1 inhibitors, namely Bristol-Myers’ BMY Opdivo and Merck’s MRK Keytruda in terms of recognized indications and sales. While Imfinzi recorded sales of $295 million in the first quarter of 2019, Opdivo and Keytruda generated $1.8 billion and $2.27 billion, respectively, in the period.

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Friday, June 28


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Global Pericarditis Drugs Market Research Report 2019-2023 - Key Players are AstraZeneca, Bayer, Johnson & Johnson Services, Pfizer, and Takeda Pharmaceutical Co

BAYN AZN +1 more BAYN AZN AZN

Global Pericarditis Drugs Market Research Report 2019-2023 - Key Players are AstraZeneca, Bayer, Johnson & Johnson Services, Pfizer, and Takeda Pharmaceutical Co. Dublin, June 28, 2019 (GLOBE NEWSWIRE) -- The "Global Pericarditis Drugs Market 2019-2023" report has been added to ResearchAndMarkets.com's offering.The pericarditis drugs market will register a CAGR of over 4% by 2023. It is the cause for 5% of the total emergency visits to healthcare professionals for chest pain, whereas, in Western Hemisphere, idiopathic pericarditis is the underlying cause for more than 90% cases.Acute pericarditis is diagnosed in 90% cases and is idiopathic in nature, whereas the remaining 10% cases of the total pericarditis diagnosed patients are secondary to bacterial and viral infections, myocardial infarction, autoimmune diseases, uremia, cardiac surgery, trauma, radiation, and any malignancy. Thus, the rising prevalence of pericarditis increases the demand for pericarditis drugs, which drives market growth.Increasing incidence of recurrent pericardial effusion post cardiac surgeryRecurrent pericardial effusion is the most common complication that occurs after cardiac surgery. Hence, the rising cases of PPS increase the demand for pericarditis drugs, which contributes to market growth.Side effects associated with pericarditis drugsThe global pericarditis drugs market is predominantly led by NSAIDs and colchicine, owing to their therapeutic benefits. However, they are related to potential side effects. For instance, the US FDA had issued warnings on the use of NSAIDs, stating that they increase the risk of cardiovascular and cerebrovascular events in patients who had a history of coronary artery disease and are being simultaneously receiving NSAIDs.These adverse events are related to the long-term use of these drugs and their escalating dosage.

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The AstraZeneca share price continues to soar. Time to buy?

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I’ve been optimistic on the prospects for AstraZeneca (LSE: AZN) for some years now. That’s ever since the fightback against the loss of some key patents and increasing competition from generic manufacturers started to put a serious dent in the firm’s earnings growth. I’m very much a believer in limited pharmaceuticals patents, as it does help get much-needed drugs out to people who need them at cheaper prices. But at the same time, we need companies like AstraZeneca to make enough profits to provide the incentive for research and development in the first place. As a potential investor, I wouldn’t mind a bit of that for myself. That’s was always going to be a long-term and expensive process, though it’s taken longer than I’d expected to start to turn round the firm’s slowing earnings.

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Friday, June 21


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Pharma Stock Roundup: PFE to Buy ARRY, RHHBY, MRK, AZN Drugs Get Regulatory Nod

AZN AZN +2 more AZN AZN PFE MRK

Array, which makes targeted small molecule drugs for treating cancer, launched its only commercial medicine, Braftovi plus Mektovi, as a treatment for BRAF-mutant melanoma, last year. The approval was based on clinical response data from SCLC cohorts of the phase Ib KEYNOTE-028 and phase II KEYNOTE-158 studies. While Keytruda already holds a strong position in the non-small cell lung cancer market, this is the first approval for the drug in the SCLC indication, which accounts for 10% to 15% of all lung cancers. The regulatory filing was based on data from the phase III SOLO-1 study. AstraZeneca also won approval from Japan’s regulatory body for PT010, its investigational triple-combo inhaler and Bevespi Aerosphere, its fixed-dose LABA/LAMA inhaler, both to treat COPD. Roche’s Personalized Medicine Entrectinib Gets Approval in Japan: Japan’s regulatory authority granted marketing approval to Roche’s personalized medicine entrectinib for adult and pediatric patients with NTRK fusion-positive advanced recurrent solid tumors.

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Thursday, June 20


News

NCCN and AstraZeneca Seek Opportunities to Improve Outcomes in Advanced Ovarian Cancer

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PLYMOUTH MEETING, Pa., June 20, 2019 /PRNewswire/ -- The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) is collaborating with AstraZeneca, a global, science-led biopharmaceutical company, to further quality in cancer care for people with advanced ovarian cancer. "Advanced and recurrent ovarian cancer remains a treatment challenge," explained Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "It's currently the deadliest gynecologic cancer, and requires a coordinated, multi-disciplinary approach. With this project, we're looking for research that focuses on how to optimize multiple facets of management effectiveness by harnessing innovative technologies or addressing knowledge gaps." Some areas of particular interest for proposals include:. The NCCN Member Institutions are: Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA; Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope National Medical Center, Duarte, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL; Roswell Park Comprehensive Cancer Center, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Rogel Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Wisconsin Carbone Cancer Center, Madison, WI; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT. Clinicians, visit NCCN.org.

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AstraZeneca's Imfinzi (durvalumab) Drug Profile 2017-2026: A Human Monoclonal Antibody Directed Against Programmed Death-Ligand 1 (PD-L1)

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Dublin, June 20, 2019 (GLOBE NEWSWIRE) -- The "Imfinzi" drug pipelines has been added to ResearchAndMarkets.com's offering. Imfinzi (durvalumab; AstraZeneca) is a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1). The interaction between PD-L1 and its receptor, programmed death-1 (PD-1), regulates complex signaling pathways that affect T-cell activation, proliferation, and survival, and can induce apoptosis of tumor-specific T cells. By inhibiting the PD-1/PD-L1 interaction, Imfinzi reduces the ability of the tumor to evade immune system targeting and enables the activation of T cells and the adaptive immune system.

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