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Fly News Breaks for March 10, 2015
Mar 10, 2015 | 08:08 EDT
Jefferies says AbbVie (ABBV) remains its Top Global Pick in Pharmaceuticals on its belief the Pharmacyclics (PCYC) deal will be an inflection point for the stock. Pfizer (PFE) remains the firm's second pick and AstraZeneca (AZN) third, with the latter being promoted to Top European Pick. Roche (RHHBY) is in the fourth spot and Eli Lilly (LLY) has been moved to fifth in place of Bayer (BAYRY) which dropped to eighth. Bristol-Myers (BMY) and GlaxoSmithKline (GSK) are Jefferies' least preferred stocks in the space.
May 22, 2018 | 13:41 EDT
Pfizer announced that results from a study analyzing real-world effectiveness data found that Prevnar 13 reduced the risk of hospitalization from vaccine-type pneumococcal community-acquired pneumonia by 73% in adults aged 65 and older. Importantly, Prevnar 13 worked under real-world conditions where people received pneumococcal vaccination as advised by their health care providers, and many had underlying medical conditions that increase the risk for pneumococcal pneumonia.1 The results were published in Clinical Infectious Diseases. The study, conducted jointly between the University of Louisville School of Medicine and Pfizer, was designed as a test-negative case-control study and provides evidence supporting the findings of the landmark randomized, controlled Community-Acquired Pneumonia Immunization Trial in Adults. CAPiTA was one of the largest vaccine efficacy trials ever conducted in older adults and demonstrated a significant reduction by 45.6% in vaccine-type pneumococcal CAP in adults vaccinated with PCV13. The Community-Acquired Pneumonia Immunization Trial in Adults excluded people with high-risk medical conditions.2The safety profile of PCV13 in CAPiTA was consistent with studies previously conducted in adults. The study was nested within a population-based surveillance study of adults in Louisville, Kentucky, United States, who were hospitalized with CAP. The population-based surveillance study prospectively enrolled adults in Louisville, Kentucky who were hospitalized with CAP in one of nine adult acute-care hospitals between October 7, 2013 and September 30, 2016. The nested case-control sub-study analyzed a subset of CAP patients enrolled between April 1, 2015 and April 30, 2016. The study used an established measure of vaccine effectiveness known as a test-negative design. In this study, patients hospitalized with CAP had routine cultures performed as well as a urine antigen detection test to determine if they had infections with pneumococcal serotypes included in the vaccine, PCV13. Patients with pneumonias caused by pneumococcal serotypes included in PCV13 were considered "cases," and "control" subjects were patients with CAP who tested negative for PCV13 serotypes. In the study period, there were a total of 2,034 CAP hospitalizations with a median age of 76 years. Researchers identified PCV13 serotypes in 68 of patients who served as the case subjects. Cases were less likely to have received PCV13 vs. controls. This indicated that PCV13 use in adults aged 65 and older can prevent 73% of CAP caused by PCV13 serotypes.
May 22, 2018 | 08:32 EDT
Eli Lilly and Company announced that the FDA has approved a label update for Taltz injection 80 mg/mL to include data in psoriasis involving the genital area. Taltz is the first and only treatment approved by the FDA for moderate-to-severe plaque psoriasis that includes such data in its label. Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In December 2017, Taltz was also approved for the treatment of adults with active psoriatic arthritis.
May 22, 2018 | 08:06 EDT
Pfizer announced that it has started a Phase 1/2 trial of its respiratory syncytial virus, or RSV, vaccine candidate in healthy adult volunteers. RSV is a common respiratory virus that affects the lungs and airways, with significant impact on young children and older adults. The highest risk of severe outcome from RSV occurs in the first months of life. Currently available prophylactic treatments for RSV are limited for use in high risk young children and infants, including very premature infants. If successful, Pfizer's investigational RSV vaccine could help protect young infants through the immunity created following vaccination of pregnant women. The maternal vaccine candidate is intended to raise RSV neutralizing antibody levels in pregnant women who then pass these protective antibodies to their unborn child and provide immunity during the early months of an infant's life. Pfizer is also advancing a maternal vaccine candidate against Group B streptococcus, or GBS, currently in Phase 1/2 trials. For older adults, RSV is the second leading cause of moderate to severe respiratory illness, following influenza. The risk of serious infection increases with age and for those with chronic heart or lung disease or a weakened immune system. There is no specific treatment for RSV and currently no licensed vaccine to prevent the disease. The trial is designed as a Phase 1/2 randomized, placebo-controlled, observer-blind, dose-ranging study with two age groups enrolled in parallel to support both the maternal and older adult indications. One age group includes males and females 18-49 years of age; the other includes males and females 50-85 years of age. The study's primary endpoints are safety and tolerability, and its secondary endpoint is immunogenicity.
May 22, 2018 | 07:45 EDT
May 21, 2018 | 10:46 EDT
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Bristol-Myers (BMY) downgraded to Neutral from Buy at UBS. 2. Campbell Soup (CPB) downgraded to Underperform from Neutral at BofA/Merrill with analyst Bryan Spillane saying he expects 2019 to be a transition year and for operating profits and earnings to decline modestly. 3. American Eagle (AEO) downgraded to Hold from Buy at SunTrust with analyst Pamela Quintilliano saying the fundamentals are not catching up to the continued advance in the stock price. 4. Andeavor Logistics (ANDX) downgraded to Neutral from Overweight at JPMorgan with analyst Jeremy Tonet citing the new drop outlook following the parent merger announcement as well as lower than expected Q1 estimates. 5. Williams Partners (WPZ) downgraded to Hold from Buy at Stifel and to Outperform from Strong Buy at Raymond James. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
May 21, 2018 | 07:16 EDT
2018 World Congress of World Federation of Hemophilia: WFH 2018 will be held in Glasgow, Scotland on May 20-24.
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