Daiichi Sankyo Group Value Report 2018
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Information About Cough Medicine (DXM)
Myth: Abusing Over-The-Counter Drugs Are Safe Vancouver Island Information Teens may mistakenly believe that cough Youth & Family medicines sold in stores are less dangerous than about Cough street drugs. Even parents may underestimate Addiction Services the seriousness of DXM abuse and feel relief Medicine (DXM) that their children are "only abusing cough syrup, not illegal drugs." Although cough What is Dextromethorphan (DXM)? medicine is sold in stores and is a regulated product, the reality is that taking large quantities of DXM has the potential to be extremely Dextromethorphan (DXM) is a cough dangerous and even fatal. When taken in suppressant ingredient contained in over-the-counter medicines. combination with other medicines or illicit drugs DXM is found the risk increases significantly. in more than 100 over-the-counter If A Teen Is Using cough and cold medications in syrup, tablet, lozenge Sit down with the youth and openly voice your and capsule form. Taken in suspicions but avoid direct accusations. Do not suggested doses, DXM is have this conversation when the youth is under generally a safe and the influence of a substance. Stay calm and effective rational. cough medication. Seek medical attention immediately if the youth is unresponsive to your voice, vomiting, very Dextromethorphan is found in over-the-counter pale or has a bluish tinge to the skin. cough medicines, including Alka-Seltzer Plus Cold and Cough, Dimetapp DM, For More Information Sudafed cough medicine, Robitussin, Tylenol Cough and Cold medicine, Vicks 44 Cough To find out about services in your community, Relief medicine and many more. -
A Phase I Study of Pexidartinib, a Colony-Stimulating Factor 1 Receptor Inhibitor, in Asian Patients with Advanced Solid Tumors
Investigational New Drugs https://doi.org/10.1007/s10637-019-00745-z PHASE I STUDIES A phase I study of pexidartinib, a colony-stimulating factor 1 receptor inhibitor, in Asian patients with advanced solid tumors Jih-Hsiang Lee1 & Tom Wei-Wu Chen2 & Chih-Hung Hsu2,3 & Yu-Hsin Yen2 & James Chih-Hsin Yang2,3 & Ann-Lii Cheng2,3 & Shun-ichi Sasaki4 & LiYin (Lillian) Chiu5 & Masahiro Sugihara4 & Tomoko Ishizuka4 & Toshihiro Oguma4 & Naoyuki Tajima4 & Chia-Chi Lin2,6 Received: 15 January 2019 /Accepted: 7 February 2019 # The Author(s) 2019 Summary Background Pexidartinib, a novel, orally administered small-molecule tyrosine kinase inhibitor, has strong selectivity against colony- stimulating factor 1 receptor. This phase I, nonrandomized, open-label multiple-dose study evaluated pexidartinib safety and efficacy in Asian patients with symptomatic, advanced solid tumors. Materials and Methods Patients received pexidartinib: cohort 1, 600 mg/d; cohort 2, 1000 mg/d for 2 weeks, then 800 mg/d. Primary objectives assessed pexidartinib safety and tolerability, and determined the recommended phase 2 dose; secondary objectives evaluated efficacy and pharmacokinetic profile. Results All11patients(6males,5 females; median age 64, range 23–82; cohort 1 n = 3; cohort 2 n = 8) experienced at least one treatment-emergent adverse event; 5 experienced at least one grade ≥ 3 adverse event, most commonly (18%) for each of the following: increased aspartate aminotransfer- ase, blood alkaline phosphatase, gamma-glutamyl transferase, and anemia. Recommended phase 2 dose was 1000 mg/d for 2 weeks and800mg/dthereafter.Pexidartinibexposure,areaundertheplasmaconcentration-timecurvefromzeroto8h(AUC0-8h), and maximum observed plasma concentration (Cmax) increased on days 1 and 15 with increasing pexidartinib doses, and time at Cmax (Tmax) was consistent throughout all doses. -
Press Release
Press Release Daiichi Sankyo and AstraZeneca Announce Global Development and Commercialization Collaboration for Daiichi Sankyo’s HER2 Targeting Antibody Drug Conjugate [Fam-] Trastuzumab Deruxtecan (DS-8201) Collaboration combines Daiichi Sankyo’s scientific and technological excellence with AstraZeneca’s global experience and resources in oncology to accelerate and expand the potential of [fam-] trastuzumab deruxtecan as monotherapy and combination therapy across a spectrum of HER2 expressing cancers AstraZeneca to pay Daiichi Sankyo up to $6.90 billion in total consideration, including $1.35 billion upfront payment and up to an additional $5.55 billion contingent upon achievement of future regulatory and sales milestones as well as other contingencies Companies to share equally development and commercialization costs as well as profits worldwide from [fam-] trastuzumab deruxtecan with Daiichi Sankyo maintaining exclusive rights in Japan Daiichi Sankyo is expected to book sales in U.S., certain countries in Europe, and certain other markets where Daiichi Sankyo has affiliates; AstraZeneca is expected to book sales in all other markets worldwide, including China, Australia, Canada and Russia Tokyo, Munich and Basking Ridge, NJ – (March 28, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has entered into a global development and commercialization agreement with AstraZeneca for Daiichi Sankyo’s lead antibody drug conjugate (ADC), [fam-] trastuzumab deruxtecan (DS-8201), currently in pivotal development for multiple HER2 expressing cancers including breast and gastric cancer, and additional development in non-small cell lung and colorectal cancer. Daiichi Sankyo and AstraZeneca will jointly develop and commercialize [fam-] trastuzumab deruxtecan as a monotherapy or a combination therapy worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. -
Traveler's Diarrhea
THE PRE-TRAVEL CONSULTATION Dr. Becky Reece, MD Lead physician at Lifespan Center of Excellence for Tick-borne Diseases Newport Hospital May 6, 2017 Some Slides from Dr. Kojic, Director of The Miriam Hospital Travel clinic Overview Epidemiology General recommendations The traveller Diseases Diarrhea Vector and animal bite prevention Immunizations Other travel related recommendations Travelers’ Health Risks Of 100,000 travelers to a developing country for 1 month: 50,000 will develop some health problem 8,000 will see a physician 5,000 will be confined to bed 1,100 will be incapacitated in their work 300 will be admitted to hospital 50 will be air evacuated 1 will die Among more than 42,000 ill returned travelers seen between 2007 and 2011 in the GeoSentinel surveillance network, the most common syndromic diagnoses were: gastrointestinal (34%) febrile illnesses (23%) dermatologic illnesses (19%) Asia (32%) and sub-Saharan Africa (25%) were the most common regions where illnesses were acquired. Approximately 40 percent of ill travelers reported pretravel medical visits. Travelers visiting friends and relatives in their country of origin had a disproportionately high burden of serious febrile illness and very low rate of advice prior to travel. Steffen R et al. J Infect Dis 1987. 156:84-91 GeoSentinel Surveillance of Illness in Returned Travelers, 2007–2011Leder K, Torresi J, Libman MD, et al Ann Intern Med. 2013;6(158):456. Causes of death Cardiovascular deaths 49% Cardiovascular Injuries, accidents 22% Medical Injury top on list Egypt, Kenya, Homicide/Suicide India Infectious Disease Other Medical illnesses 13.7% Infectious causes 1% Other Hargarten S et al, Ann Emerg Med, 1991. -
Daiichi Sankyo Group Value Report 2019
External Evaluations (as of June 30,2019) ™ Daiichi Sankyo Group Value Report 2019 Value Daiichi Sankyo Group MSCI Japan Empowering Women Select Index THE INCLUSION OF DAIICHI SANKYO CO.,LTD. IN ANY MSCI INDEX, AND THE USE OF MSCI LOGOS, TRADEMARKS, SERVICE MARKS OR INDEX NAMES HEREIN, DO NOT CONSTITUTE A SPONSORSHIP, ENDORSEMENT OR PROMOTION OF DAIICHI SANKYO CO.,LTD. BY MSCI OR ANY OF ITS AFFILIATES. THE MSCI INDEXES ARE THE EXCLUSIVE PROPERTY OF MSCI. MSCI AND THE MSCI INDEX NAMES AND LOGOS ARE TRADE- MARKS OR SERVICE MARKS OF MSCI OR ITS AFFILIATES. “Eruboshi” Certification Mark “Kurumin” Certification Mark Logo given to Certified Health and Productivity Management Organization (White500) This report uses FSC® certified paper, which indicates that the paper used to print this Paper report was produced from properly managed forests. 3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan This report was printed using 100% Inks biodegradable printing inks from vegetable Corporate Communications Department oil. Daiichi Sankyo Group Tel: +81-3-6225-1126 CSR Department The waterless printing method used for this Value Report 2019 Tel: +81-3-6225-1067 Printing report minimized the use and release of harmful liquid wastes. https://www.daiichisankyo.com/ Printed in Japan 005_7045687911909.indd 1 2019/09/27 18:22:19 Introduction Our Mission The Core Values and Commitments serve as the criteria for business activities and In addition, we have established the DAIICHI SANKYO Group Corporate Conduct Charter . decision-making used by executive officers and employees in working to fulfill Our Mission . This charter calls on us to fulfill our social responsibilities by acting with the highest ethical Our Corporate Slogan succinctly explains the spirit of Our Mission, Core Values and standards and a good social conscience appropriate for a company engaged in business Commitments. -
The Tumor Microenvironment and Overcoming Immune Escape Arsen Osipov1, May Tun Saung1, Lei Zheng1 and Adrian G
Osipov et al. Journal for ImmunoTherapy of Cancer (2019) 7:224 https://doi.org/10.1186/s40425-019-0667-0 REVIEW Open Access Small molecule immunomodulation: the tumor microenvironment and overcoming immune escape Arsen Osipov1, May Tun Saung1, Lei Zheng1 and Adrian G. Murphy1,2* Abstract Immunotherapy has led to a paradigm shift in the treatment of many advanced malignancies. Despite the success in treatment of tumors like non-small cell lung cancer (NSCLC) and melanoma, checkpoint inhibition-based immunotherapy has limitations. Many tumors, such as pancreatic cancer, are less responsive to checkpoint inhibitors, where patients tend to have a limited duration of benefit and where clinical responses are more robust in patients who are positive for predictive biomarkers. One of the critical factors that influence the efficacy of immunotherapy is the tumor microenvironment (TME), which contains a heterogeneous composition of immunosuppressive cells. Myeloid-derived suppressor cells (MDSCs) and tumor-associated macrophages (TAMs) alter the immune landscape of the TME and serve as facilitators of tumor proliferation, metastatic growth and immunotherapy resistance. Small molecule inhibitors that target these components of the TME have been developed. This special issue review focuses on two promising classes of immunomodulatory small molecule inhibitors: colony stimulating factor-1 receptor (CSF-1R) and focal adhesion kinase (FAK). Small molecule inhibitors of CSF-1R reprogram the TME and TAMs, and lead to enhanced T-cell-mediated tumor eradication. FAK small molecule inhibitors decrease the infiltration MDSCs, TAMs and regulatory T-cells. Additionally, FAK inhibitors are implicated as modulators of stromal density and cancer stem cells, leading to a TME more conducive to an anti-tumor immune response. -
Tanibirumab (CUI C3490677) Add to Cart
5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor -
Phase Ib Study of the Combination of Pexidartinib (PLX3397), a CSF-1R Inhibitor, and Paclitaxel in Patients with Advanced Solid
TAM0010.1177/1758835919854238Therapeutic Advances in Medical OncologyR Wesolowski, N Sharma 854238research-article20192019 Therapeutic Advances in Medical Oncology Original Research Ther Adv Med Oncol Phase Ib study of the combination of 2019, Vol. 11: 1 –13 DOI:https://doi.org/10.1177/1758835919854238 10.1177/ pexidartinib (PLX3397), a CSF-1R inhibitor, 1758835919854238https://doi.org/10.1177/1758835919854238 © The Author(s), 2019. Article reuse guidelines: and paclitaxel in patients with advanced sagepub.com/journals- solid tumors permissions Robert Wesolowski, Neelesh Sharma, Laura Reebel, Mary Beth Rodal, Alexandra Peck, Brian L. West, Adhirai Marimuthu, Paul Severson, David A. Karlin, Afshin Dowlati, Mai H. Le, Lisa M. Coussens and Hope S. Rugo Abstract Purpose: To evaluate the safety, recommended phase II dose (RP2D) and efficacy of pexidartinib, a colony stimulating factor receptor 1 (CSF-1R) inhibitor, in combination with weekly paclitaxel in patients with advanced solid tumors. Patients and Methods: In part 1 of this phase Ib study, 24 patients with advanced solid tumors received escalating doses of pexidartinib with weekly paclitaxel (80 mg/m2). Pexidartinib was administered at 600 mg/day in cohort 1. For subsequent cohorts, the dose was increased by ⩽50% using a standard 3+3 design. In part 2, 30 patients with metastatic solid tumors were enrolled to examine safety, tolerability and efficacy of the RP2D. Pharmacokinetics and biomarkers were also assessed. Results: A total of 51 patients reported ≥1 adverse event(s) (AEs) that were at least possibly related to either study drug. Grade 3–4 AEs, including anemia (26%), neutropenia (22%), lymphopenia (19%), fatigue (15%), and hypertension (11%), were Correspondence to: Robert Wesolowski recorded in 38 patients (70%). -
BUFFERIN Light Search
Read this sheet in full before using, and keep for later reference. Find more product info online Search BUFFERIN Light Light formula designed to be easy on the body* <Pain reliever/fever reducer> BUFFERIN Light Designated Class 2 OTC drugs Some BUFFERIN brand products contain different active ingredients. The pain relieving/fever reducing ingredient in this product is acetylsalicylic acid. When consulting a doctor, dentist, pharmacist or registered seller about this product, specify that the product you are asking about contains acetylsalicylic acid. BUFFERIN Light Formula Mild effectiveness* Contains no drowsiness-inducing ingredients Easy on the stomach Caffeine-free * The BUFFERIN Light formula contains a lower dose of analgesic ingredients than BUFFERIN A and contains ingredients that help protect the stomach Warnings Do not (Failure to comply with these instructions increases the likelihood of current symptoms worsening, side effects occurring, and other potentially serious risks) 1. Do not use this product if you (1) Have ever had an allergic reaction to this product or any of its ingredients (2) Have ever had an asthma attack after using this product, any other pain reliever/fever reducer, or a cold medicine (3) Are under 15 years old (4) Are pregnant and expecting to give birth within 12 weeks 2. Do not take any of the following pharmaceuticals while using this product Other pain relievers/fever reducers, cold medicines, sedatives 3. Do not consume alcohol before or after taking this product 4. Do not use this product continuously for extended periods Seek advice 1. Ask a doctor, dentist, pharmacist or registered seller before use if you are (1) Currently receiving treatment from a doctor or dentist (2) Pregnant or suspect you may be pregnant (3) Breast-feeding (4) Elderly 1 (5) Have ever shown allergic symptoms when taking a drug or medicine (6) Have been diagnosed with any of the following conditions: Heart disease; kidney disease; liver disease; stomach or duodenal ulcer 2. -
Drug Alliance Information Alert Stackers, DMX: Coricidin & Robitussin Abuse and Ephedrine
Drug Alliance Information Alert Stackers, DMX: Coricidin & Robitussin Abuse and Ephedrine • STACKERS are legal; over the counter dietary supplements used to assist in weight loss and muscle enhancement. These supplements can be extremely dangerous to your teenager's health . They are available at local drug and vitamin stores and gas stations. Ephedrine, the main ingredient, is a natural herb and therefore not currently regulated by the FDA. The FDA is now considering regulation, as a result of many young, health -conscious people suffering from strokes, heart conditions, and other serious illnesses related to stacker use. It has also been linked to anxiety, sleeplessness, migraines, high blood pressure, and seizures and in some instances ephedra has been link ed with death. • DMX: CORICIDIN & ROBITUSSIN ABUSE - Teens are abusing over - the -counter cold pills to get high The latest craze among teens is using over -the -counter cold medicines and cough syrup in excessive doses as recreational drugs b+ deliberately ing esting large amounts of Coricidin HBP -Cough & Cold Pills or Robitussin b+ as many as 15 tablets at once. The ingredient is DXM or dextromethorphan: a legal cough medicine ingredient which is uncontrolled by the government and is available in over 125 diffe rent products. These medicines can be purchased off the drugstore or supermarket counter. When used correctly, DXM suppresses coughs safely, but in large amounts it produces a chemical imbalance in the brain that allows the kids to get high. The DEA says abusers report an LSD -like high: a heightened sense of perceptual awareness, altered time perception and visual hallucinations. -
Important Pharmacy Information There Is No Copay When Your Primary Care Provider (PCP) Or Unitedhealthcare Community Plan Specialist Writes You a Covered Prescription
Important Pharmacy Information There is no copay when your Primary Care Provider (PCP) or UnitedHealthcare Community Plan Specialist writes you a covered prescription. But you can get many over-the-counter (OTC) medicines free when you have a prescription. You can get the medications listed on the following pages when they are medically necessary and you get a written prescription from your UnitedHealthcare Community Plan doctor and take it to a UnitedHealthcare Community Plan pharmacy. To get your medicine: • Take your prescription to a UnitedHealthcare Community Plan pharmacy. To find a pharmacy, call 1-800-903-5253 or go to UHCCommunityPlan.com. • For your safety, we urge you to select a single pharmacy from which to get your drugs. • Get to know the pharmacist and build a relationship. If the UnitedHealthcare Community Plan pharmacy says they cannot fill your covered prescription or you have to pay more than your copay: Do not leave the pharmacy. Do not pay for it yourself. Ask the pharmacy why they cannot fill your prescription. Response Your Solution Not Covered • Ask them to call OptumRx right away to find out which medicine is covered. • Ask them to call your doctor to see if you can get the covered medicine instead. Prior • Ask them to call your doctor for a prior authorization. Authorization • You can call your doctor and ask that a prior authorization be sent to: Needed UnitedHealthcare Pharmacy Prior Notification Service Fax 1-866-940-7328 Phone 1-800-310-6826 Refill Too Soon • Ask what day it can be filled. • Pick your prescription up the day it can be filled. -
CDER Breakthrough Therapy Designation Approvals Data As of December 31, 2020 Total of 190 Approvals
CDER Breakthrough Therapy Designation Approvals Data as of December 31, 2020 Total of 190 Approvals Submission Application Type and Proprietary Approval Use Number Number Name Established Name Applicant Date Treatment of patients with previously BLA 125486 ORIGINAL-1 GAZYVA OBINUTUZUMAB GENENTECH INC 01-Nov-2013 untreated chronic lymphocytic leukemia in combination with chlorambucil Treatment of patients with mantle cell NDA 205552 ORIGINAL-1 IMBRUVICA IBRUTINIB PHARMACYCLICS LLC 13-Nov-2013 lymphoma (MCL) Treatment of chronic hepatitis C NDA 204671 ORIGINAL-1 SOVALDI SOFOSBUVIR GILEAD SCIENCES INC 06-Dec-2013 infection Treatment of cystic fibrosis patients age VERTEX PHARMACEUTICALS NDA 203188 SUPPLEMENT-4 KALYDECO IVACAFTOR 21-Feb-2014 6 years and older who have mutations INC in the CFTR gene Treatment of previously untreated NOVARTIS patients with chronic lymphocytic BLA 125326 SUPPLEMENT-60 ARZERRA OFATUMUMAB PHARMACEUTICALS 17-Apr-2014 leukemia (CLL) for whom fludarabine- CORPORATION based therapy is considered inappropriate Treatment of patients with anaplastic NOVARTIS lymphoma kinase (ALK)-positive NDA 205755 ORIGINAL-1 ZYKADIA CERITINIB 29-Apr-2014 PHARMACEUTICALS CORP metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Treatment of relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients NDA 206545 ORIGINAL-1 ZYDELIG IDELALISIB GILEAD SCIENCES INC 23-Jul-2014 for whom rituximab alone would be considered appropriate therapy due to other co-morbidities