Appendix B - Product Name Sorted by Applicant
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From the Academy
FROM THE ACADEMY Joint American Academy of DermatologyeNational Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy Craig A. Elmets, MD (Co-Chair),a HenryW.Lim,MD,b Benjamin Stoff, MD, MA,c Cody Connor, MD,a Kelly M. Cordoro, MD,d Mark Lebwohl, MD,e AprilW.Armstrong,MD,MPH,f Dawn M. R. Davis, MD,g Boni E. Elewski, MD,a Joel M. Gelfand, MD, MSCE,h Kenneth B. Gordon, MD,i AliceB.Gottlieb,MD,PhD,j Daniel H. Kaplan, MD, PhD,k Arthur Kavanaugh, MD,l Matthew Kiselica, BA/BS,m Dario Kivelevitch, MD,n Neil J. Korman, MD, PhD,o Daniela Kroshinsky, MD, MPH,p Craig L. Leonardi, MD,q Jason Lichten, MD,m NehalN.Mehta,MD,MSCE,r Amy S. Paller, MD,s Sylvia L. Parra, MD,t Arun L. Pathy, MD,u Elizabeth A. Farley Prater, MD,v Reena N. Rupani, MD,e Michael Siegel, PhD,m BruceE.Strober,MD,PhD,w,x Emily B. Wong, MD,y Jashin J. Wu, MD,z Vidhya Hariharan, PhD,aa and Alan Menter, MD (Co-Chair)n Birmingham, Alabama; Detroit, Michigan; Atlanta, Georgia; San Francisco, Los Angeles, San Diego, and Irvine, California; New York, New York; Rochester, Minnesota; Philadelphia and Pittsburgh, Pennsylva- nia; Milwaukee, Wisconsin; Portland, Oregon; Dallas and San Antonio, Texas; Cleveland, Ohio; Boston, Massachusetts; St. Louis, Missouri; Bethesda, Maryland; Chicago and Rosemont, Illinois; Sumter, South Carolina; Centennial, Colorado; Oklahoma City, Oklahoma; Farmington, Connecticut; and Waterloo, Ontario, Canada Psoriasis is a chronic inflammatory disease involving multiple organ systems and affecting approximately 3.2% of the world’s population. -
Abbvie Allergan Acquisition
Creating a New Diversified Biopharmaceutical Company The Combination of AbbVie and Allergan Investor Presentation June 25, 2019 NO OFFER OR SOLICITATION This presentation is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. In particular, this presentation is not an offer of securities for sale into the United States. No offer of securities shall be made in the United States absent registration under the U.S. Securities Act of 1933, as amended, or pursuant to an exemption from, or in a transaction not subject to, such registration requirements. Any securities issued in the acquisition are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S. Securities Act of 1933, as amended. The acquisition will be made solely by means of the Scheme Document (or, if applicable, the Takeover Offer document), which will contain the full terms and conditions of the acquisition, including details with respect to the AbbVie shareholder vote in respect of the acquisition. Any decision in respect of, or other response to, the acquisition, should be made only on the basis of the information contained in the Scheme Document. IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC In connection with the proposed Acquisition, Allergan will file with the Securities Exchange Commission (the “SEC”) a Proxy Statement, which will include the Scheme Document. -
A Study of Abemaciclib (LY2835219)
A Study of Abemaciclib (LY2835219) in Combination With Temozolomide and Irinotecan and Abemaciclib in Combination With Temozolomide in Children and Young Adult Participants With Solid Tumors Status: Not yet recruiting Eligibility Criteria Sex: All Age: up to 18 Years old This study is NOT accepting healthy volunteers Inclusion Criteria: • Body weight ≥10 kilograms and body surface area (BSA) ≥0.5 meters squared. • Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies and, in the judgment of the investigator, are appropriate candidates for the experimental therapy combination in the study part that is currently enrolling. • Participants must have at least one measurable (per Response Criteria in Solid Tumors [RECIST v1.1; [Eisenhauer et al. 2009] or Response Assessment in Neuro-Oncology (RANO) for central nervous system (CNS) tumors [Wen et al. 2010]) or evaluable lesion. • Participants must have had histologic verification of malignancy at original diagnosis or relapse, except: • Participants with extra-cranial germ-cell tumors who have elevations of serum tumor markers including alpha-fetoprotein or beta- human chorionic gonadotropin (HCG). • Participants with intrinsic brain stem tumors or participants with CNS-germ cell tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG. • A Lansky score ≥50 for participants ≤16 years of age or Karnofsky score ≥50 for participants >16 years of age. • Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade ≤1 at the time of enrollment. -
Information for the User ZYTIGA 500 Mg Film-Coated Tablets Abiraterone
Package leaflet: Information for the user ZYTIGA 500 mg film-coated tablets abiraterone acetate Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What ZYTIGA is and what it is used for 2. What you need to know before you take ZYTIGA 3. How to take ZYTIGA 4. Possible side effects 5. How to store ZYTIGA 6. Contents of the pack and other information 1. What ZYTIGA is and what it is used for ZYTIGA contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. ZYTIGA stops your body from making testosterone; this can slow the growth of prostate cancer. When ZYTIGA is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy ). When you take this medicine your doctor will also prescribe another medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood. -
Annual Report on Annual Reports 2016
ANNUAL REPORT ON ANNUAL REPORTS 2016 TOP 400 ANNUAL REPORTS WHO RANKS WHERE? 100 ANNUALS IN BRIEF BEST REPORTING PRACTICES Company Value > Report Value Annual Report on Annual Reports 2016 Contents Report rating scale 3 Top 400 annual reports 4 Who ranks where? 25 From ABB to ZTE 100 annuals in brief 58 From Abbott to Yamaha How important is the annual report today? 92 Views from Cecilia Ketels, Kellie Friery, Renee Carter, David Robinson, Kaevan Gazdar, Elena Moskvina, Thomas Rosenmayr, Rob Stangroom, Andrey Kozhevnikov, Ana Santamarina, Katie Holcomb, Ananda Jagoda Best practices on key report attibutes 100 Strategy, message, investor information, risks, style, online… How we make it 121 How is your report doing? The report scan 127 The report rating panel 128 Robert Berick, Susan Blesener, Renee Carter, Vero Escarmelle, Helena Fournial, Kaevan Gazdar, Mike Guillaume, Pradip Seth, Eva Wolosiuk Making reports pay off 133 e.com – ReportWatch 135 2 Report rating scale A+ ééééé First-rate A éééé(é) Excellent A- éééé Very good B+ ééé(é) Sound B ééé Average B- éé(é) Uneven C+ éé Common C é(é) Substandard C- é Poor D (é) Uncompetitive 3 Top 400 annual reports AkzoNobel (No. 1) Electrolux (No. 2 ) SCA (No. 3) Volvo (No. 4) 4 Report rank Company Country Report rating Compare 1 AKZONOBEL Netherlands A+ DUPONT 2 ELECTROLUX Sweden A+ WHIRLPOOL 3 SCA Sweden A+ KIMBERLY-CLARK 4 VOLVO Sweden A+ DAIMLER 5 POTASHCORP Canada A+ AGRIUM 6 ATLAS COPCO Sweden A SANDVIK 7 STORA ENSO Finland A UPM 8 BOLIDEN Sweden A GLENCORE 9 WIENERBERGER Austria A BORAL 10 -
AHFS Pharmacologic-Therapeutic Classification System
AHFS Pharmacologic-Therapeutic Classification System Abacavir 48:24 - Mucolytic Agents - 382638 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Acitretin 84:92 - Skin and Mucous Membrane Agents, Abaloparatide 68:24.08 - Parathyroid Agents - 317036 Aclidinium Abatacept 12:08.08 - Antimuscarinics/Antispasmodics - 313022 92:36 - Disease-modifying Antirheumatic Drugs - Acrivastine 92:20 - Immunomodulatory Agents - 306003 4:08 - Second Generation Antihistamines - 394040 Abciximab 48:04.08 - Second Generation Antihistamines - 394040 20:12.18 - Platelet-aggregation Inhibitors - 395014 Acyclovir Abemaciclib 8:18.32 - Nucleosides and Nucleotides - 381045 10:00 - Antineoplastic Agents - 317058 84:04.06 - Antivirals - 381036 Abiraterone Adalimumab; -adaz 10:00 - Antineoplastic Agents - 311027 92:36 - Disease-modifying Antirheumatic Drugs - AbobotulinumtoxinA 56:92 - GI Drugs, Miscellaneous - 302046 92:20 - Immunomodulatory Agents - 302046 92:92 - Other Miscellaneous Therapeutic Agents - 12:20.92 - Skeletal Muscle Relaxants, Miscellaneous - Adapalene 84:92 - Skin and Mucous Membrane Agents, Acalabrutinib 10:00 - Antineoplastic Agents - 317059 Adefovir Acamprosate 8:18.32 - Nucleosides and Nucleotides - 302036 28:92 - Central Nervous System Agents, Adenosine 24:04.04.24 - Class IV Antiarrhythmics - 304010 Acarbose Adenovirus Vaccine Live Oral 68:20.02 - alpha-Glucosidase Inhibitors - 396015 80:12 - Vaccines - 315016 Acebutolol Ado-Trastuzumab 24:24 - beta-Adrenergic Blocking Agents - 387003 10:00 - Antineoplastic Agents - 313041 12:16.08.08 - Selective -
Abiraterone Acetate for Chemotherapy-Naive
Fan et al. BMC Urology (2018) 18:110 https://doi.org/10.1186/s12894-018-0416-6 RESEARCHARTICLE Open Access Abiraterone acetate for chemotherapy- naive metastatic castration-resistant prostate cancer: a single-centre prospective study of efficacy, safety, and prognostic factors Liancheng Fan†, Baijun Dong†, Chenfei Chi†, Yanqing Wang†, Yiming Gong†, Jianjun Sha, Jiahua Pan, Xun Shangguan, Yiran Huang, Lixin Zhou* and Wei Xue* Abstract Background: To evaluate the efficacy and safety of abiraterone acetate (AA) plus prednisone compared with prednisone alone in Asian patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC), and to identify predictive factors. Methods: We reviewed the medical records of 60 patients with chemotherapy-naive mCRPC at Renji Hospital who were treated with AA plus prednisone (n = 43) or prednisone alone (n = 17). All patients were assessed for prostate- specific antigen (PSA) response, PSA progression-free survival (PSA PFS), radiographic progression-free survival (rPFS), and overall survival (OS). The ability of several parameters to predict PSA PFS, rPFS, and OS was studied. Results: The median follow-up time was 14.0 months (range 7.0–18.5 months), at which time 19 death events had been reported: 11 in the AA + prednisone group and 8 in the prednisone group. The AA + prednisone group had significantly longer median PSA PFS (10.3 vs 3.0 months, P < 0.001), rPFS (13.9 vs 3.9 months, P < 0.001), and OS (23. 3 vs 17.5 months, P = 0.016) than the prednisone-alone group. The most frequently reported grade 3 or 4 adverse event in both the AA + prednisone and prednisone-alone groups was elevated alanine aminotransferase level in 5 of 43 patients (11.6%) and 2 of 17 patients (11.8%), respectively. -
Reference List of Drugs with Potential Anticholinergic Effects 1, 2, 3, 4, 5
ANTICHOLINERGICS: Reference List of Drugs with Potential Anticholinergic Effects 1, 2, 3, 4, 5 J Bareham BSP © www.RxFiles.ca Aug 2021 WHENEVER POSSIBLE, AVOID DRUGS WITH MODERATE TO HIGH ANTICHOLINERGIC ACTIVITY IN OLDER ADULTS (>65 YEARS OF AGE) Low Anticholinergic Activity; Moderate/High Anticholinergic Activity -B in combo Beers Antibiotics Antiparkinsonian Cardiovascular Agents Immunosuppressants ampicillin *ALL AVAILABLE AS amantadine SYMMETREL atenolol TENORMIN azaTHIOprine IMURAN cefOXitin GENERIC benztropine mesylate COGENTIN captopril CAPOTEN cyclosporine NEORAL clindamycin bromocriptine PARLODEL chlorthalidone GENERIC ONLY hydrocortisone CORTEF gentamicin (Oint & Sol’n NIHB covered) carbidopa/levodopa SINEMET digoxin LANOXIN, TOLOXIN methylprednisolone MEDROL piperacillin entacapone COMTAN dilTIAZem CARDIZEM, TIAZAC prednisone WINPRED dipyridamole PERSANTINE, ethopropazine PARSITAN vancomycin phenelzine NARDIL AGGRENOX disopyramide RYTHMODAN Muscle Relaxants pramipexole MIRAPEX Antidepressants baclofen LIORESAL ( on intrathecal only) procyclidine KEMADRIN furosemide LASIX amitriptyline ELAVIL cyclobenzaprine FLEXERIL selegiline ELDEPRYL hydrALAZINE APRESOLINE clomiPRAMINE ANAFRANIL isosorbide ISORDIL methocarbamol ROBAXIN OTC trihexyphenidyl ARTANE desipramine NORPRAMIN metoprolol LOPRESOR orphenadrine NORFLEX OTC doxepin >6mg SINEQUAN Antipsychotics NIFEdipine ADALAT tiZANidine ZANAFLEX A imipramine TOFRANIL quiNIDine GENERIC ONLY C ARIPiprazole ABILIFY & MAINTENA -
Faculty Disclosure
Faculty Disclosure In accordance with the ACCME Standards for Commercial Support, course directors, planning committees, faculty and all others in control of the educational content of the CME activity must disclose all relevant financial relationships with any commercial interest that they or their spouse/partner may have had within the past 12 months. If an individual refuses to disclose relevant financial relationships, they will be disqualified from being a part of the planning and implementation of this CME activity. Owners and/or employees of a commercial interest with business lines or products relating to the content of the CME activity will not be permitted to participate in the planning or execution of any accredited activity. Nature of Relevant Financial Relationship Last Name Commercial Interest What Was Received For What Role AbbVie, Allergan/ Tobira Therapeutics Inc, Gilead Research Grant Research Balart Sciences Inc, Pfizer, Salix Pharmaceuticals AbbVie, Merck Honorarium Advisory Board Bau None N/A N/A Benz None N/A N/A AbbVie, Arbutus Biopharma, Dieterich Gilead Sciences, Inc., Bristol- Research Grant Consultant Myers Squibb, Merck Bayer HealthCare Pharmaceuticals, Gilead Sciences Honorarium Speaking, Consultant Inc. Bristol-Myers Squibb, Gilead Speaking, Advisory Sciences, Inc, Salix Honorarium Frenette Board Pharmaceuticals, Inc, Merck Intercept Pharmaceuticals Honorarium Advisor Conatus Pharmaceuticals Inc Honorarium Consulting Principle Investigator, Research Grant, Han Gilead Sciences, -
Cancer Drug Pharmacology Table
CANCER DRUG PHARMACOLOGY TABLE Cytotoxic Chemotherapy Drugs are classified according to the BC Cancer Drug Manual Monographs, unless otherwise specified (see asterisks). Subclassifications are in brackets where applicable. Alkylating Agents have reactive groups (usually alkyl) that attach to Antimetabolites are structural analogues of naturally occurring molecules DNA or RNA, leading to interruption in synthesis of DNA, RNA, or required for DNA and RNA synthesis. When substituted for the natural body proteins. substances, they disrupt DNA and RNA synthesis. bendamustine (nitrogen mustard) azacitidine (pyrimidine analogue) busulfan (alkyl sulfonate) capecitabine (pyrimidine analogue) carboplatin (platinum) cladribine (adenosine analogue) carmustine (nitrosurea) cytarabine (pyrimidine analogue) chlorambucil (nitrogen mustard) fludarabine (purine analogue) cisplatin (platinum) fluorouracil (pyrimidine analogue) cyclophosphamide (nitrogen mustard) gemcitabine (pyrimidine analogue) dacarbazine (triazine) mercaptopurine (purine analogue) estramustine (nitrogen mustard with 17-beta-estradiol) methotrexate (folate analogue) hydroxyurea pralatrexate (folate analogue) ifosfamide (nitrogen mustard) pemetrexed (folate analogue) lomustine (nitrosurea) pentostatin (purine analogue) mechlorethamine (nitrogen mustard) raltitrexed (folate analogue) melphalan (nitrogen mustard) thioguanine (purine analogue) oxaliplatin (platinum) trifluridine-tipiracil (pyrimidine analogue/thymidine phosphorylase procarbazine (triazine) inhibitor) -
1 Azbil Telstar Tecnologies S.L.U
AZBIL TELSTAR TECHNOLOGIES, S.L.U. 1 www.telstar-lifesciences.com Tel/Fax: +34 937 361 600 / +34 937 861 380 AUDIT PLAN 2020 AZBIL TELSTAR TECNOLOGIES S.L.U Manufacturer Country Address AARTI INDUSTRIES LTD. India Unit IV - Plot No. E-50, MIDC, Tarapur, Tal-Palghar Dist. Thane, Maharashtra 401506 - India Commercial Hub road,Near APIIC Pump House,Plot No:2, Road No:21,J.N.Pharma City (Ramky),Tadi ACACIA LIFE SCIENCES Pvt. Ltd. (BIOCON) India Village, IDA Paravada,Visakhapatnam, India - 531 021 Unit-III Plot No. 842-843, Village-Karakhadi, Taluk-Padra, District-Panchmahal, Vadodara-391 450, ALEMBIC PHARMACEUTICALS LTD. India Gujarat, INDIA ALEMBIC PHARMACEUTICALS LTD. India Village Panelav, Near Baska. Taluka Halol, District Panchmahal - 389 350 Gujarat - India AMI LIFE SCIENCES PVT. LTD. India Block No 82/B, ECP Road, At & Post : Karakhadi-391 450 Ta: Padra, Dist. Baroda, Gujarat, INDIA. AMINO CHEMICALS (MOEHS) Malta MRA 050X, Industrial Estate. Marsa MRS 3000 Malta. AMINO CHEMICALS (MOEHS) Malta MRA 050X, Industrial Estate. Marsa MRS 3000 Malta. ANUGRAHA CHEMICALS India D-46-50 &C-62 & 63 KSSIDC Indl Estate Doddaballpura, Bangalore 561 203 INDIA Nº D47 to D50, C62 & C 63, KSSIDC Industrial State, Doddaballapur, Bangalore, Karnataka, 561203 ANUGRAHA CHEMICALS India INDIA ARCH UK BIOCIDES UK Wheldon Road, Castelford, West Yorkshire - WF 102JT, England Consultancy Department March_2020 AZBIL TELSTAR TECHNOLOGIES, S.L.U. 2 www.telstar-lifesciences.com Tel/Fax: +34 937 361 600 / +34 937 861 380 AURO LABORATORIES LIMITED India K-56, M.I.D.C. Tarapur, Boisar, Dist. Thane, Maharashtra – 401 506, INDIA AUROBINDO UNIT IX India Unit IX. -
United States Court of Appeals for The
Case 14-4353, Document 100-1, 05/16/2016, 1772362, Page1 of 37 14‐4353‐cv Apotex Inc., et al., v. Acorda Therapeutics, Inc. UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT August Term, 2015 (Argued: November 12, 2015 Decided: May 16, 2016) Docket No. 14‐4353‐cv ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐x APOTEX INC., et al., Plaintiffs‐Appellants, ‐ v.‐ ACORDA THERAPEUTICS, INC., Defendant‐Appellee. ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐x Before: JACOBS, LIVINGSTON and DRONEY, Circuit Judges. This appeal concerns two distinct questions: the circumstances under which the filing of a citizen petition with the Food and Drug Administration provides grounds for an antitrust claim, and the scope of false advertising Case 14-4353, Document 100-1, 05/16/2016, 1772362, Page2 of 37 liability under the Lanham Act. Plaintiffs Apotex Incorporated and Apotex Corporation appeal from the judgment of the United States District Court for the Southern District of New York (Swain, J.) that granted defendant Acorda Therapeutics, Inc.’s motion to dismiss plaintiffs’ Sherman Act claim and that granted summary judgment in favor of defendant on the Lanham Act claims (Torres, J.). Because each of these conclusions was sound, we affirm. KEITH D. PARR (with Joseph N. Froehlich, Scott B. Feder, Hugh S. Balsam, James T. Peterka, and Andy J. Miller on the brief), Locke Lord LLP, Chicago, Illinois, for Appellants Apotex Incorporated & Apotex Corporation. JOHN W. NIELDS, JR. (with Jason C. Raofield and Colin P. Watson on the brief), Covington & Burling LLP, Washington, D.C. for Appellee Acorda Therapeutics, Inc. DENNIS JACOBS, Circuit Judge: The parties are rival manufacturers of tizanidine, a drug for treating spasticity.