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Medical Review(S) Clinical Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 200327 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 200327 Priority or Standard Standard Submit Date(s) December 29, 2009 Received Date(s) December 30, 2009 PDUFA Goal Date October 30, 2010 Division / Office Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Reviewer Name(s) Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD Review Completion October 29, 2010 Date Established Name Ceftaroline fosamil for injection (Proposed) Trade Name Teflaro Therapeutic Class Cephalosporin; ß-lactams Applicant Cerexa, Inc. Forest Laboratories, Inc. Formulation(s) 400 mg/vial and 600 mg/vial Intravenous Dosing Regimen 600 mg every 12 hours by IV infusion Indication(s) Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Community-acquired Bacterial Pneumonia (CABP) Intended Population(s) Adults ≥ 18 years of age Template Version: March 6, 2009 Reference ID: 2857265 Clinical Review Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD NDA 200327: Teflaro (ceftaroline fosamil) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 9 1.1 Recommendation on Regulatory Action ........................................................... 10 1.2 Risk Benefit Assessment.................................................................................. 10 1.3 Recommendations for Postmarketing Risk Evaluation and Mitigation Strategies ........................................................................................................................ -
Use of Ceftaroline Fosamil in Children: Review of Current Knowledge and Its Application
Infect Dis Ther (2017) 6:57–67 DOI 10.1007/s40121-016-0144-8 REVIEW Use of Ceftaroline Fosamil in Children: Review of Current Knowledge and its Application Juwon Yim . Leah M. Molloy . Jason G. Newland Received: November 10, 2016 / Published online: December 30, 2016 Ó The Author(s) 2016. This article is published with open access at Springerlink.com ABSTRACT infections, CABP caused by penicillin- and ceftriaxone-resistant S. pneumoniae and Ceftaroline is a novel cephalosporin recently resistant Gram-positive infections that fail approved in children for treatment of acute first-line antimicrobial agents. However, bacterial skin and soft tissue infections and limited data are available on tolerability in community-acquired bacterial pneumonia neonates and infants younger than 2 months (CABP) caused by methicillin-resistant of age, and on pharmacokinetic characteristics Staphylococcus aureus, Streptococcus pneumoniae in children with chronic medical conditions and other susceptible bacteria. With a favorable and those with invasive, complicated tolerability profile and efficacy proven in infections. In this review, the microbiological pediatric patients and excellent in vitro profile of ceftaroline, its mechanism of action, activity against resistant Gram-positive and and pharmacokinetic profile will be presented. Gram-negative bacteria, ceftaroline may serve Additionally, clinical evidence for use in as a therapeutic option for polymicrobial pediatric patients and proposed place in therapy is discussed. Enhanced content To view enhanced content for this article go to http://www.medengine.com/Redeem/ 1F47F0601BB3F2DD. Keywords: Antibiotic resistance; Ceftaroline J. Yim (&) fosamil; Children; Methicillin-resistant St. John Hospital and Medical Center, Detroit, MI, Staphylococcus aureus; Streptococcus pneumoniae USA e-mail: [email protected] L. -
Infectious Diseases
2013 MEDICINES IN DEVELOPMENT REPORT Infectious Diseases A Report on Diseases Caused by Bacteria, Viruses, Fungi and Parasites PRESENTED BY AMERICA’S BIOPHARMACEUTICAL RESEARCH COMPANIES Biopharmaceutical Research Evolves Against Infectious Diseases with Nearly 400 Medicines and Vaccines in Testing Throughout history, infectious diseases hepatitis C that inhibits the enzyme have taken a devastating toll on the lives essential for viral replication. and well-being of people around the • An anti-malarial drug that has shown Medicines in Development world. Caused when pathogens such activity against Plasmodium falci- For Infectious Diseases as bacteria or viruses enter a body and parum malaria which is resistant to multiply, infectious diseases were the current treatments. Application leading cause of death in the United Submitted States until the 1920s. Today, vaccines • A potential new antibiotic to treat methicillin-resistant Staphylococcus Phase III and infectious disease treatments have proven to be effective treatments in aureus (MRSA). Phase II many cases, but infectious diseases still • A novel treatment that works by Phase I pose a very serious threat to patients. blocking the ability of the smallpox Recently, some infectious pathogens, virus to spread to other cells, thus 226 such as pseudomonas bacteria, have preventing it from causing disease. become resistant to available treatments. Infectious diseases may never be fully Diseases once considered conquered, eradicated. However, new knowledge, such as tuberculosis, have reemerged new technologies, and the continuing as a growing health threat. commitment of America’s biopharma- America’s biopharmaceutical research ceutical research companies can help companies are developing 394 medicines meet the continuing—and ever-changing and vaccines to combat the many threats —threat from infectious diseases. -
NASDAQ Stock Market
Nasdaq Stock Market Friday, December 28, 2018 Name Symbol Close 1st Constitution Bancorp FCCY 19.75 1st Source SRCE 40.25 2U TWOU 48.31 21st Century Fox Cl A FOXA 47.97 21st Century Fox Cl B FOX 47.62 21Vianet Group ADR VNET 8.63 51job ADR JOBS 61.7 111 ADR YI 6.05 360 Finance ADR QFIN 15.74 1347 Property Insurance Holdings PIH 4.05 1-800-FLOWERS.COM Cl A FLWS 11.92 AAON AAON 34.85 Abiomed ABMD 318.17 Acacia Communications ACIA 37.69 Acacia Research - Acacia ACTG 3 Technologies Acadia Healthcare ACHC 25.56 ACADIA Pharmaceuticals ACAD 15.65 Acceleron Pharma XLRN 44.13 Access National ANCX 21.31 Accuray ARAY 3.45 AcelRx Pharmaceuticals ACRX 2.34 Aceto ACET 0.82 Achaogen AKAO 1.31 Achillion Pharmaceuticals ACHN 1.48 AC Immune ACIU 9.78 ACI Worldwide ACIW 27.25 Aclaris Therapeutics ACRS 7.31 ACM Research Cl A ACMR 10.47 Acorda Therapeutics ACOR 14.98 Activision Blizzard ATVI 46.8 Adamas Pharmaceuticals ADMS 8.45 Adaptimmune Therapeutics ADR ADAP 5.15 Addus HomeCare ADUS 67.27 ADDvantage Technologies Group AEY 1.43 Adobe ADBE 223.13 Adtran ADTN 10.82 Aduro Biotech ADRO 2.65 Advanced Emissions Solutions ADES 10.07 Advanced Energy Industries AEIS 42.71 Advanced Micro Devices AMD 17.82 Advaxis ADXS 0.19 Adverum Biotechnologies ADVM 3.2 Aegion AEGN 16.24 Aeglea BioTherapeutics AGLE 7.67 Aemetis AMTX 0.57 Aerie Pharmaceuticals AERI 35.52 AeroVironment AVAV 67.57 Aevi Genomic Medicine GNMX 0.67 Affimed AFMD 3.11 Agile Therapeutics AGRX 0.61 Agilysys AGYS 14.59 Agios Pharmaceuticals AGIO 45.3 AGNC Investment AGNC 17.73 AgroFresh Solutions AGFS 3.85 -
Safety and Efficacy of Ceftaroline Fosamil in the Management of Community-Acquired Bacterial Pneumonia Heather F
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Scholarly Papers 2014 Safety and Efficacy of Ceftaroline Fosamil in the Management of Community-Acquired Bacterial Pneumonia Heather F. DeBellis Kimberly L. Barefield Philadelphia College of Osteopathic Medicine, [email protected] Follow this and additional works at: https://digitalcommons.pcom.edu/scholarly_papers Part of the Medicine and Health Sciences Commons Recommended Citation DeBellis, Heather F. and Barefield, Kimberly L., "Safety and Efficacy of Ceftaroline Fosamil in the Management of Community- Acquired Bacterial Pneumonia" (2014). PCOM Scholarly Papers. 1913. https://digitalcommons.pcom.edu/scholarly_papers/1913 This Article is brought to you for free and open access by DigitalCommons@PCOM. It has been accepted for inclusion in PCOM Scholarly Papers by an authorized administrator of DigitalCommons@PCOM. For more information, please contact [email protected]. Open Access: Full open access to Clinical Medicine Reviews this and thousands of other papers at http://www.la-press.com. in Therapeutics Safety and Efficacy of Ceftaroline Fosamil in the Management of Community- Acquired Bacterial Pneumonia Heather F. DeBellis and Kimberly L. Tackett South University School of Pharmacy, Savannah, GA, USA. ABSTR ACT: Ceftaroline fosamil is a new fifth-generation cephalosporin indicated for the treatment of community-acquired bacterial pneumonia (CABP). It possesses antimicrobial effects against both Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), but not against anaerobes. Organisms covered by this novel agent that are commonly associated with CABP are Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis, and Klebsiella pneumoniae; however, ceftaroline fosamil lacks antimicrobial activity against Pseudomonas and Acinetobacter species. -
Ceftaroline in Complicated Skin and Skin-Structure Infections
Infection and Drug Resistance Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW Ceftaroline in complicated skin and skin-structure infections Paul O Hernandez1 Abstract: Ceftaroline is an advanced-generation cephalosporin antibiotic recently approved by Sergio Lema2 the US Food and Drug Administration for the treatment of complicated skin and skin-structure Stephen K Tyring3 infections (cSSSIs). This intravenous broad-spectrum antibiotic exerts potent bactericidal activity Natalia Mendoza2,4 by inhibiting bacterial cell wall synthesis. A high affinity for the penicillin-binding protein 2a (PBP2a) of methicillin-resistant Staphylococcus aureus (MRSA) makes the drug especially 1University of Texas School of Medicine at San Antonio, beneficial to patients with MRSA cSSSIs. Ceftaroline has proved in multiple well-conducted San Antonio, TX, 2Woodhull clinical trials to have an excellent safety and efficacy profile. In adjusted doses it is also recom- Medical and Mental Health Center, mended for patients with renal or hepatic impairment. Furthermore, the clinical effectiveness Brooklyn, NY, 3Department of Dermatology, University of Texas and high cure rate demonstrated by ceftaroline in cSSSIs, including those caused by MRSA Health Science Center at Houston, and other multidrug-resistant strains, warrants its consideration as a first-line treatment option 4 Houston, TX, USA; Department of for cSSSIs. This article reviews ceftaroline and its pharmacology, efficacy, and safety data to Dermatology, El -
P39262 Alimera Sciences, Inc. Nps 2020 V1
Alimera Sciences, Inc. 6120 Windward Parkway, Suite 290 Alpharetta, Georgia 30005 NOTICE OF ANNUAL MEETING OF STOCKHOLDERS TO BE HELD ON JUNE 18, 2020 To the Stockholders of Alimera Sciences, Inc.: The annual meeting of stockholders (the “Annual Meeting”) of Alimera Sciences, Inc. (the “Company”) will be held exclusively online via the Internet on Thursday, June 18, 2020, at 9:30 a.m. Eastern Time. The purposes of the meeting are: 1. To elect three Class I directors (Proposal 1); 2. To ratify the appointment of Grant Thornton LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2020 (Proposal 2); 3. To approve, on an advisory basis, the compensation of our named executive officers (Proposal 3); and 4. To transact such other business as may properly come before the Annual Meeting or any adjournments or postponements thereof. Our board of directors (the “Board”) has fixed the close of business on April 20, 2020 as the record date (the “record date”) for determining holders of our common stock and preferred stock entitled to notice of, and to vote at, the Annual Meeting or any adjournments or postponements thereof. This year we are again using the Internet as our primary means of furnishing proxy materials to stockholders. Accordingly, most stockholders will not receive printed copies of our proxy materials. We are instead mailing a Notice of Internet Availability of Proxy Materials with instructions for accessing the proxy materials and voting via the Internet (the “Notice”). This delivery method allows us to conserve natural resources and reduce the cost of delivery while also meeting our obligations to you, our stockholders, to provide information relevant to your continued investment in the Company. -
Ceftaroline Fosamil for the Treatment of Gram-Positive Endocarditis: CAPTURE Study Experience
International Journal of Antimicrobial Agents 53 (2019) 644–649 Contents lists available at ScienceDirect International Journal of Antimicrobial Agents journal homepage: www.elsevier.com/locate/ijantimicag Ceftaroline fosamil for the treatment of Gram-positive endocarditis: CAPTURE study experience ∗ Christopher J. Destache a, David J. Guervil b, Keith S. Kaye c, a School of Pharmacy and Health Professions, Creighton University, Omaha, NE, USA b Memorial Hermann-Texas Medical Center, Houston, TX, USA c Wayne State University and Detroit Medical Center, Detroit, MI, USA a r t i c l e i n f o a b s t r a c t Article history: Background: The clinical experience of ceftaroline fosamil (CPT-F) therapy for Gram-positive infective Received 3 October 2018 endocarditis is reported from CAPTURE, a retrospective study conducted in the USA. Accepted 27 January 2019 Methods: Data, including patient demographics, medical history, risk factors, microbiological aetiology and clinical outcomes, were collected by review of patient charts between September 2013 and February Editor: Professor Matthew Falagas 2015. Results: Patients ( n = 55) with Gram-positive endocarditis were treated with CPT-F. The most common Keywords: risk factors were intravascular devices (43.6%), diabetes mellitus (40.0%) and injection drug use (38.2%). Ceftaroline fosamil Gram-positive endocarditis The most commonly isolated pathogens were meticillin-resistant Staphylococcus aureus (MRSA; 80%), Meticillin-resistant Staphylococcus aureus meticillin-susceptible S. aureus (MSSA; 7.3%) and coagulase-negative staphylococci (7.3%). CPT-F was given Meticillin-susceptible Staphylococcus aureus as first-line therapy in 7.3% of patients and as second-line or later therapy in 92.7% of patients, and as CAPTURE study monotherapy in 41.8% of patients and as concurrent therapy in 58.2% of patients. -
Rebateable Manufacturers
Rebateable Labelers – July 2021 Manufacturers are responsible for updating their eligible drugs and pricing with CMS. Montana Healthcare Programs will not pay for an NDC not updated with CMS. Note: Some manufacturers on this list may have some NDCs that are covered and others that are not. Manufacturer ID Manufacturer Name 00002 ELI LILLY AND COMPANY 00003 E.R. SQUIBB & SONS, LLC. 00004 HOFFMANN-LA ROCHE 00006 MERCK & CO., INC. 00007 GLAXOSMITHKLINE 00008 WYETH PHARMACEUTICALS LLC, 00009 PHARMACIA AND UPJOHN COMPANY LLC 00013 PFIZER LABORATORIES DIV PFIZER INC 00015 MEAD JOHNSON AND COMPANY 00023 ALLERGAN INC 00024 SANOFI-AVENTIS, US LLC 00025 PFIZER LABORATORIES DIV PFIZER INC 00026 BAYER HEALTHCARE LLC 00032 ABBVIE INC. 00037 MEDA PHARMACEUTICALS, INC. 00039 SANOFI-AVENTIS, US LLC 00046 WYETH PHARMACEUTICALS INC. 00049 ROERIG 00051 ABBVIE INC 00052 ORGANON USA INC. 00053 CSL BEHRING L.L.C. 00054 HIKMA PHARMACEUTICAL USA, INC. 00056 BRISTOL-MYERS SQUIBB PHARMA CO. 00065 ALCON LABORATORIES, INC. 00068 AVENTIS PHARMACEUTICALS 00069 PFIZER LABORATORIES DIV PFIZER INC 00071 PARKE-DAVIS DIV OF PFIZER 00074 ABBVIE INC 00075 AVENTIS PHARMACEUTICALS, INC. 00078 NOVARTIS 00085 SCHERING CORPORATION 00087 BRISTOL-MYERS SQUIBB COMPANY 00088 AVENTIS PHARMACEUTICALS 00093 TEVA PHARMACEUTICALS USA, INC. 00095 BAUSCH HEALTH US, LLC Page 1 of 19 Manufacturer ID Manufacturer Name 00096 PERSON & COVEY, INC. 00113 L. PERRIGO COMPANY 00115 IMPAX GENERICS 00116 XTTRIUM LABORATORIES, INC. 00121 PHARMACEUTICAL ASSOCIATES, INC. 00131 UCB, INC. 00132 C B FLEET COMPANY INC 00143 HIKMA PHARMACEUTICAL USA, INC. 00145 STIEFEL LABORATORIES, INC, 00168 E FOUGERA AND CO. 00169 NOVO NORDISK, INC. 00172 TEVA PHARMACEUTICALS USA, INC 00173 GLAXOSMITHKLINE 00178 MISSION PHARMACAL COMPANY 00185 EON LABS, INC. -
Off-Label Use of Ceftaroline Fosamil: a Systematic Review
International Journal of Antimicrobial Agents 54 (2019) 562–571 Contents lists available at ScienceDirect International Journal of Antimicrobial Agents journal homepage: www.elsevier.com/locate/ijantimicag Review Off-label use of ceftaroline fosamil: A systematic review ∗ Arianna Pani a,e, , Fabrizio Colombo b, Francesca Agnelli b, Viviana Frantellizzi c, Francesco Baratta d, Daniele Pastori d, Francesco Scaglione a,e a Clinical Pharmacology Unit, ASST Grande Ospedale Metropolitano Niguarda, Italy b Internal Medicine Department, ASST Grande Ospedale Metropolitano Niguarda, Italy c Department of Radiological, Oncological and Anatomical Pathological Sciences, University of Rome Sapienza, Italy d Department of Internal Medicine and Medical Specialties, University of Rome Sapienza, Italy e Department of Oncology and Onco-Hematology, Postgraduate School of Clinical Pharmacology and Toxicology University of Milan Statale, Italy a r t i c l e i n f o a b s t r a c t Article history: Ceftaroline fosamil is a fifth-generation cephalosporin with anti-methicillin-resistant Staphylococcus au- Received 14 December 2018 reus (MRSA) activity. It has been approved by the EMA and FDA for the treatment of adults and children Accepted 28 June 2019 with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure in- fections (ABSSSI). However, ceftaroline fosamil has a broad spectrum of activity, and a good safety and Editor: Stefania Stefani tolerability profile, so is frequently used off-label. The aim of this systematic review was to summarize the safety and efficacy of off-label use of cef- Keywords: Ceftaroline fosamil taroline. MRSA The review was conducted according to PRISMA guidelines. MEDLINE, EMBASE and CENTRAL Bacteremia databases (2010-2018) were searched using as the main term ceftaroline fosamil and its synonyms in Endocarditis combination with names of infectious diseases of interest. -
NDA Multidisciplinary Review and Evaluation
Multidisciplinary Review and Evaluation of Efficacy Supplemental NDA 200327 S-22 Teflaro – ceftaroline fosamil NDA Multidisciplinary Review and Evaluation Application Type sNDA Application Number(s) 200327 Priority or Standard Standard Submit Date(s) November 13, 2018 Received Date(s) November 13, 2018 PDUFA Goal Date September 13, 2019 Division/Office Division of Anti-Infective Products Office of Antimicrobial Products Review Completion Date September 4, 2019 Established/Proper Name Ceftaroline fosamil Trade Name Teflaro Pharmacologic Class Cephalosporin class of beta-lactams Code name PPI-0903 (also known as TAK-599) Applicant Allergan Sales, LLC Dosage form Injection Applicant proposed Dosing 6 mg/kg every 8 hours as a (b) (4)-minute infusion in patients Regimen <2 months of age (b) (4) Applicant Proposed No new proposed indication. Updated labeling in Section 8.4 Indication(s)/Population(s) for patients less than 2 months of age. Regulatory Action Approval Indication(s)/Population(s) Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in (if applicable) pediatric patients 0* to less than 2 months old (*Gestational age 34 weeks and older and postnatal age 12 days and older) Dosing Regimen 6 mg/kg every 8 hours by IV infusion administered over 30 to 60 min Version date: October 12, 2018 1 Reference ID: 4490056 Multidisciplinary Review and Evaluation of Efficacy Supplemental NDA 200327 S-22 Teflaro – ceftaroline fosamil Table of Contents Table of Contents ........................................................................................................ -
Emmett Cunningham, Jr., M.D., Ph.D., M.P.H
2019 - Emmett Cunningham, Jr., M.D., Ph.D., M.P.H. Senior Managing Director Blackstone Life Sciences HEATHEGY TEAM CRAIG SIMAK CRAIG SIMAK DANIELLE SILVA MAUREEN LINNEMANN 1200 OIS@AAO 24 Meetings > 1,150 1000 ~ 13,500 Attendees 800 OIS@ASCRS 600 > 650 400 OIS@ASRS 200 > 300 0 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Registrants 3% 10% OIS@AAO 2019 ( > 1,150) 8% Academia, Government, or Association 41% Adviser, Consultant, or Service Provider Finance/Investment Firm Large Multi-National Corporation Physician/Healthcare Provider 25% Press/Media Start-up/Emerging Growth Company 3% 25 Countries 10% 32 US States Record Number of CDER NME NDA/BLA Approvals in 2018 70 BLA 59 60 NDA 50 45 46 Number 39 41 of 40 35 36 Drugs 30 30 30 27 27 24 26 22 24 21 20 21 22 20 17 18 10 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Source: FDA 1998 - 2018 High Innovation Record Number of • 31 (53%) Orphan CDER NME NDA/BLA Approvals in 2018 • 26 (44%) Priority Review • 16 (27%) Fast Track • 12 (20%) Break Through Designation 59 • 18 (30%) Oncology • 1 (0%) Ophthalmology Cenegermin-bkbj Ophthalmic Solution, (OXERVATE®) Ophthalmic Drugs Streamlined Reporting of Ophthalmology Clinical Group CDER As of January, 2018 Ophthalmology Clinical Group Reported Directly & Independently to Deputy Director Office of New Drugs Peter Stein, MD Five Additional Office of Offices of Drug Antimicrobial Evaluation (ODEs) Products Division of Division of Division of Transplant and Anti-Infective Anti-Viral Ophthalmology Products Products Dr.