2018 Medicines in Development for Skin Diseases
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(PDCO) Minutes of the Meeting on 29 January - 01 February 2019
1 March 2019 EMA/PDCO/56017/2019 Inspections, Human Medicines Pharmacovigilance and Committees Division Paediatric Committee (PDCO) Minutes of the meeting on 29 January - 01 February 2019 Chair: Dirk Mentzer – Vice-Chair: Koenraad Norga 29 January 2019, 14:00- 19:00, room 3A 30 January 2019, 08:30- 19:00, room 3A 31 January 2019, 08:30- 19:00, room 3A 01 February 2019, 08:30- 13:00, room 3A Disclaimers Some of the information contained in this set of minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the PDCO Committee meeting reports (after the PDCO Opinion is adopted), and on the Opinions and decisions on paediatric investigation plans webpage (after the EMA Decision is issued). Of note, this set of minutes is a working document primarily designed for PDCO members and the work the Committee undertakes. Further information with relevant explanatory notes can be found at the end of this document. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on-going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). -
FDA Approved Antibacterial Drugs in 2018 and 2019
DISCOVERIES 2019, Oct-Dec, 7(4): e102 DOI: 10.15190/d.2019.15 FDA Approved Antibacterial Drugs in 2018 and 2019 Focused REVIEW FDA approved antibacterial drugs: 2018-2019 Stefan Andrei1,2,3,*, Gabriela Droc,1,2,Gabriel Stefan,2,4 1Department of Anesthesia and Intensive Care, Fundeni Clinical Institute, Bucharest, Romania 2Carol Davila University of Medicine and Pharmacy, Bucharest, Romania 3Université Paris Sud XI, Faculté de Médecine, Le Kremlin-Bicêtre, France 4Dr. Davila Teaching Hospital of Nephrology, Bucharest, Romania * Corresponding authors: Stefan Andrei, MD, Department of Anesthesia and Intensive Care, Fundeni Clinical Institute, 258 Soseaua Fundeni, Bucharest, 022328, Romania; Carol Davila University of Medicine and Pharmacy, Bucharest, Romania; Université Paris Sud XI, Faculté de Médecine, 63 Rue Gabriel Péri, 94270 Le Kremlin-Bicêtre, France; [email protected] Submission: Dec. 29, 2019; Revised: Dec. 31, 2019; Accepted: Dec. 31, 2019; Published: Dec. 31, 2019; Citation: Andrei S, Droc G, Stefan G. FDA approved antibacterial drugs: 2018-2019. Discoveries 2019, October-December; 7(4); e102. DOI:10.15190/d.2019.15 ABSTRACT noninvasive Escherichia Coli-caused travelers' Bacterial resistance to existent antibiotherapy is a diarrhea. Two combinatorial strategies were perpetual internationally-recognized problem. Year approved for complicated urinary tract infections, after year, there is a continuous need for novel complicated intra-abdominal infections (imipenem, antibacterial drugs and this research and cilastatin and relebactam) and lung tuberculosis development efforts recently resulted in few new (pretomanid in combination with bedaquiline and drugs or combination of drugs proposed for the use linezolid). Lefamulin is a semisynthetic into the clinic. pleuromutilin antibiotic for community-acquired This review focuses on the novel US FDA bacterial pneumonia, while cefiderocol, a approved antibacterial agents in the last two years cephalosporin antibiotic is the last antibacterial drug (2018-2019). -
Role of Corticosteroids in Treatment of Vitiligo
Chapter 9 Role of Corticosteroids in Treatment of Vitiligo Nooshin Bagherani Additional information is available at the end of the chapter http://dx.doi.org/10.5772/48384 1. Introduction Vitiligo is the most frequent pigmentary disorder ( Bagherani et al., 2011; Nazer et al., 2011;Yaghoobi et al., 2011a; as cited in Wolff et al., 2007). It is an acquired, idiopathic and progressive skin disease (Bagherani et al., 2011; Shameer et al., 2005; Yaghoobi et al., 2011a), characterized by sharply demarcated depigmented lesions on any part of the body (Van Geel et al., 2004). This disease can also affect hair and mucosal areas such as mouth and genitalia (Gawkrodger et al., 2010). Vitiligo usually begins after birth (Gawkrodger et al., 2010). Regarding the studies retrieved from PubMed since 1995, it has been shown that approximately 50% of the vitiligo cases have its onset before the age of 20 years and 25% before the age of 14 years (Kakourou, 2009). The incidence rate of vitiligo is between 0.1-2% of the world population ( Bagherani et al., 20011; Yaghoobi et al., 2011a,b; as cited in Alkhateeb et al., 2003). Its incidence in those with racially pigmented skin is higher, although reliable figures are not available (Burns et al., 2004; Howitz et al., 1977) . The prevalence has been reported as high as 4% in some South Asian, Mexican and American populations ( Parsad et al., 2003; Sehgal & Srivastava, 2007; Szczurko & Boon, 2008). Both sexes are equally afflicted by vitiligo (Krϋger et al., 2011; Njoo & Westerhof, 2001; Wolf et al.,2007) . In some studies, a female preponderance has been reported ( Burns at al., 2004; Howitz et al. -
Effects of the Nicotinic Agonist Varenicline, Nicotinic Antagonist R-Bpidi, and DAT Inhibitor R-Modafinil on Co-Use of Ethanol and Nicotine in Female P Rats
HHS Public Access Author manuscript Author ManuscriptAuthor Manuscript Author Psychopharmacology Manuscript Author (Berl) Manuscript Author . Author manuscript; available in PMC 2019 May 01. Published in final edited form as: Psychopharmacology (Berl). 2018 May ; 235(5): 1439–1453. doi:10.1007/s00213-018-4853-4. Effects of the nicotinic agonist varenicline, nicotinic antagonist r-bPiDI, and DAT inhibitor R-modafinil on co-use of ethanol and nicotine in female P rats. Sarah E. Maggio1, Meredith A. Saunders1, Thomas A. Baxter1, Kimberly Nixon2, Mark A. Prendergast1, Guangrong Zheng3, Peter Crooks3, Linda P. Dwoskin2, Rachel D. Slack4, Amy H. Newman4, Richard L. Bell5, and Michael T. Bardo1 1Department of Psychology, University of Kentucky, Lexington, KY 40536, USA. 2Department of Pharmaceutical Sciences, College of Pharmacy, University of Kentucky, Lexington, KY 40536, USA. 3Department of Pharmaceutical Sciences, College of Pharmacy, University of Arkansas, Little Rock, AR 72205, USA. 4Molecular Targets and Medications Discovery Branch, National Institute on Drug Abuse- Intramural Research Program, National Institutes of Health, Baltimore, Maryland 21224, USA. 5Department of Psychiatry, Institute of Psychiatric Research, Indiana University School of Medicine, Indianapolis, IN 46202, USA. Abstract Rationale: Co-users of alcohol and nicotine are the largest group of polysubstance users worldwide. Commonalities in mechanisms of action for ethanol (EtOH) and nicotine proposes the possibility of developing a single pharmacotherapeutic to treat co-use. Objectives: Toward developing a preclinical model of co-use, female alcohol-preferring (P) rats were trained for voluntary EtOH drinking and i.v. nicotine self-administration in three phases: (1) EtOH alone (0 vs. 15%, 2-bottle choice); (2) nicotine alone (0.03 mg/kg/infusion, active vs. -
(CD-P-PH/PHO) Report Classification/Justifica
COMMITTEE OF EXPERTS ON THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY (CD-P-PH/PHO) Report classification/justification of medicines belonging to the ATC group D07A (Corticosteroids, Plain) Table of Contents Page INTRODUCTION 4 DISCLAIMER 6 GLOSSARY OF TERMS USED IN THIS DOCUMENT 7 ACTIVE SUBSTANCES Methylprednisolone (ATC: D07AA01) 8 Hydrocortisone (ATC: D07AA02) 9 Prednisolone (ATC: D07AA03) 11 Clobetasone (ATC: D07AB01) 13 Hydrocortisone butyrate (ATC: D07AB02) 16 Flumetasone (ATC: D07AB03) 18 Fluocortin (ATC: D07AB04) 21 Fluperolone (ATC: D07AB05) 22 Fluorometholone (ATC: D07AB06) 23 Fluprednidene (ATC: D07AB07) 24 Desonide (ATC: D07AB08) 25 Triamcinolone (ATC: D07AB09) 27 Alclometasone (ATC: D07AB10) 29 Hydrocortisone buteprate (ATC: D07AB11) 31 Dexamethasone (ATC: D07AB19) 32 Clocortolone (ATC: D07AB21) 34 Combinations of Corticosteroids (ATC: D07AB30) 35 Betamethasone (ATC: D07AC01) 36 Fluclorolone (ATC: D07AC02) 39 Desoximetasone (ATC: D07AC03) 40 Fluocinolone Acetonide (ATC: D07AC04) 43 Fluocortolone (ATC: D07AC05) 46 2 Diflucortolone (ATC: D07AC06) 47 Fludroxycortide (ATC: D07AC07) 50 Fluocinonide (ATC: D07AC08) 51 Budesonide (ATC: D07AC09) 54 Diflorasone (ATC: D07AC10) 55 Amcinonide (ATC: D07AC11) 56 Halometasone (ATC: D07AC12) 57 Mometasone (ATC: D07AC13) 58 Methylprednisolone Aceponate (ATC: D07AC14) 62 Beclometasone (ATC: D07AC15) 65 Hydrocortisone Aceponate (ATC: D07AC16) 68 Fluticasone (ATC: D07AC17) 69 Prednicarbate (ATC: D07AC18) 73 Difluprednate (ATC: D07AC19) 76 Ulobetasol (ATC: D07AC21) 77 Clobetasol (ATC: D07AD01) 78 Halcinonide (ATC: D07AD02) 81 LIST OF AUTHORS 82 3 INTRODUCTION The availability of medicines with or without a medical prescription has implications on patient safety, accessibility of medicines to patients and responsible management of healthcare expenditure. The decision on prescription status and related supply conditions is a core competency of national health authorities. -
United States Securities and Exchange Commission Form
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) February 5, 2020 Merck & Co., Inc. (Exact name of registrant as specified in its charter) New Jersey 1-6571 22-1918501 (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 2000 Galloping Hill Road, Kenilworth, NJ 07033 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code (908) 740-4000 Not Applicable (Former name or former address, if changed since last report.) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ¨ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. -
LAG-3: from Molecular Functions to Clinical Applications
Open access Review J Immunother Cancer: first published as 10.1136/jitc-2020-001014 on 13 September 2020. Downloaded from LAG-3: from molecular functions to clinical applications Takumi Maruhashi , Daisuke Sugiura , Il- mi Okazaki , Taku Okazaki To cite: Maruhashi T, Sugiura D, ABSTRACT (PD-1) and cytotoxic T lymphocyte antigen Okazaki I, et al. LAG-3: from To prevent the destruction of tissues owing to excessive 4 (CTLA-4) significantly improved the molecular functions to clinical and/or inappropriate immune responses, immune outcomes of patients with diverse cancer applications. Journal for cells are under strict check by various regulatory ImmunoTherapy of Cancer types, revolutionizing cancer treatment. The mechanisms at multiple points. Inhibitory coreceptors, 2020;8:e001014. doi:10.1136/ success of these therapies verified that inhib- including programmed cell death 1 (PD-1) and cytotoxic jitc-2020-001014 itory coreceptors serve as critical checkpoints T lymphocyte antigen 4 (CTLA-4), serve as critical checkpoints in restricting immune responses against for immune cells to not attack the tumor Accepted 29 July 2020 self- tissues and tumor cells. Immune checkpoint inhibitors cells as well as self-tissues. However, response that block PD-1 and CTLA-4 pathways significantly rates are typically lower and immune-related improved the outcomes of patients with diverse cancer adverse events (irAEs) are also observed in types and have revolutionized cancer treatment. However, patients administered with immune check- response rates to such therapies are rather limited, and point inhibitors. This is indicative of the immune-rela ted adverse events are also observed in a continued need to decipher the complex substantial patient population, leading to the urgent need biology of inhibitory coreceptors to increase for novel therapeutics with higher efficacy and lower response rates and prevent such unwanted toxicity. -
FDA-Approved Pre-Mixed Bag of Ibuprofen
Corporate Presentation Nasdaq CPIX Safe Harbor Statement This presentation contains forward-looking statements Important factors that could cause actual results to differ concerning our approved products and product materially from those indicated by such forward-looking development, our technology, our competitors, our statements include, among others, those set forth under intellectual property, our financial condition and our plans the headings "Risk factors" and "Management's discussion for research and development programs that involve risks, and analysis of financial condition and results of uncertainties and assumptions. These statements are operations" in our Form 10-K and Form 10-Q Reports on based on the current estimates and assumptions of the file with the SEC. The Company does not undertake any management of Cumberland Pharmaceuticals as of the obligation to release publicly any revisions to these date of this presentation and are subject to uncertainty and forward-looking statements to reflect events or changes in circumstances. Given these uncertainties, you circumstances after the date hereof or to reflect the should not place undue reliance upon these forward- occurrence of unanticipated events. All statements looking statements. Such forward-looking statements are contained in this presentation are made only as of the date subject to risks, uncertainties, assumptions and other of this presentation. For more information on our brands, factors that may cause the actual results of Cumberland including full prescribing and -
9.0 Bn 23 000 200 +
42 | Novartis Annual Report 2017 Innovation The Novartis Institutes for BioMedical Research works in concert with our Global Drug Development group to bring innovative treatments to patients around the world. In 2017, we advanced our drug discovery and development efforts by encouraging greater collaboration and out-of-the-box thinking, exploring new approaches that could improve how we work, and investing in promising tools and technologies. We made progress in priority disease areas with high unmet medical needs. We also marked several key milestones, including US FDA approval – the first of its kind – for a type of personalized cell therapy that could change the course of cancer care. 9.0 bn 23 000 200 + Research and development Scientists, physicians and business Projects in clinical development spending in 2017, amounting to professionals working in research 18.3% of net sales (USD) and development worldwide Collaborative Efficient, effective Progress in important science drug development disease areas We are increasing collaboration We are using digital technology We highlight areas of our work where in research as we try to leverage and data analysis to make drug we are driving significant innovation, innovation from a variety of sources. development swifter and more or where we can potentially have an We are also exploring ways to effective. And we are taking steps important impact on patients and harness digital technology in drug to strengthen our pipeline. public health. discovery, as well as new therapeutic k page 46 k Immuno-oncology page 48 approaches such as cell therapies. k Multiple sclerosis page 50 k page 43 k Liver disease page 52 k Ophthalmology page 53 k Asthma page 55 k Malaria page 56 INNOVATION Novartis Annual Report 2017 | 43 Discovery For new treatments, the journey from laboratory to patient Promoting open innovation starts in the discovery phase where researchers try to Our efforts to increase the flow of ideas between identify potentially groundbreaking therapies. -
SEYSARA™ (Sarecycline) Tablets for Oral Use
• If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) HIGHLIGHTS OF PRESCRIBING INFORMATION occurs, discontinue SEYSARA. (5.2) These highlights do not include all the information needed to use • Central nervous system side effects, including light-headedness, SEYSARA™ safely and effectively. See full prescribing information for dizziness or vertigo, have been reported with tetracycline use. Patients SEYSARA™. who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery. These symptoms may disappear SEYSARA™ (sarecycline) tablets for oral use. during therapy and may disappear when the drug is discontinued. (5.3) Initial U.S. Approval: 2018 • SEYSARA may cause intracranial hypertension. Discontinue SEYSARA if symptoms occur. (5.4) • Photosensitivity can occur with SEYSARA. Patients should minimize or -----------------------------INDICATIONS AND USAGE-------------------------- avoid exposure to natural or artificial sunlight. (5.5) SEYSARA™ is a tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in -------------------------------ADVERSE REACTIONS------------------------------ patients 9 years of age and older. (1) Most common adverse reaction (incidence ≥ 1%) is nausea. (6.1) Limitations of Use To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1- Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have 800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. not been established. SEYSARA has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to ------------------------------DRUG INTERACTIONS------------------------------- maintain the effectiveness of other antibacterial drugs, SEYSARA should be • Oral retinoids: avoid coadministration. (5.4, 7.1) used only as indicated [see Warnings and Precautions (5.6)]. -
Omadacycline
Late Stage, Novel Antibiotics September, 2015 10/28/2015 1 Third-party information included herein has been obtained from sources believed to be reliable, but the accuracy or completeness of such information is not guaranteed by, and should not be construed as a representation by, Paratek Pharmaceuticals, Inc. (“Paratek”). The information contained in this presentation is accurate only as of the date hereof. “Paratek” and the Paratek logo are trademarks and service marks of Paratek. All other trademarks, service marks, trade names, logos and brand names identified in this presentation are the property of their respective owners. Forward-Looking Statements / Risk Factors This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about our strategy, future operations, future financial position, future revenue, clinical development plans and timing, projected costs, prospects, plans, objectives of management, potential use and effectiveness of our product candidates, expected market growth, the market opportunity for and the market acceptance of our product candidates, and the strength of, and protection offered by, our intellectual property position. Examples of such statements include, but are not limited to, statements relating to the potential clinical risks and efficacy of, and market opportunities for, our product candidates, including Omadacycline and Sarecycline, the timing of clinical development of, and regulatory approval for, our product candidates, and the nature and timing of our collaboration agreements with respect to our product candidates. The words “anticipate,” “estimate,” “expect,” “potential,” “believe,” “will” and similar terms and phrases are used to identify forward-looking statements. -
Cognitive, Behavioral, and Physiologic Responses John T
Combined Nicotinic and Muscarinic Blockade in Elderly Normal Volunteers: Cognitive, Behavioral, and Physiologic Responses John T. Little, M.D., Douglas N. Johnson, Ph.D., Marcia Minichiello, M.A., Herb Weingartner, Ph.D., and Trey Sunderland, M.D. Establishing a pharmacologic model of the memory deficits scopolamine alone. Increased impairment was also seen for of Alzheimer’s disease could be an important tool in the mecamylamine 1 scopolamine condition as compared to understanding how memory fails. We examined the scopolamine alone in selected behavioral ratings. Pupil size combined effects of the muscarinic antagonist scopolamine increased when mecamylamine was added to scopolamine, and the nicotinic antagonist mecamylamine in eight normal while systolic blood pressure and pulse changed in elderly volunteers (age 61.9 6 8.3 yrs, SD). Each received concordance with ganglionic blockade. These data together four separate drug challenges (scopolamine (0.4 mg IV), with previous brain-imaging results suggest that this mecamylamine (0.2 mg/kg up to 15 mg PO), muscarinic–nicotinic drug combination may better model mecamylamine 1 scopolamine, and placebo). There was a Alzheimer’s disease than either drug alone. trend toward increased impairment in explicit memory for [Neuropsychopharmacology 19:60–69, 1998] the mecamylamine 1 scopolamine condition as compared to Published by Elsevier Science Inc. KEY WORDS: Scopolamine; Mecamylamine; Cognitive; al. 1985; Shimohama et al. 1986; Whitehouse and Au Geriatrics; Muscarinic antagonist; Nicotinic antagonist 1986; D’Amato et al. 1987; Zubenko et al. 1988), many cognitive dysfunction modeling studies have focused Given the limited animal models of Alzheimer’s disease on this system (Beatty et al.