Industry News

Pharma Headline News (Drugs.com)

• Hospitalizations Up for Homeless From 2007 to 2013
  TUESDAY, Dec. 18, 2018 -- From 2007 to 2013, hospitalizations among homeless individuals increased and were most frequently for mental illness and substance use disorder, according to a study published in the January issue of Medical Care. Rishi K....
• Delivery Mode Tied to Pelvic Floor Disorder Risk Post-Childbirth
  TUESDAY, Dec. 18, 2018 -- After childbirth, the risk for pelvic floor disorders varies by delivery mode, according to a study published in the Dec. 18 issue of the Journal of the American Medical Association. Joan L. Blomquist, M.D., from the...
• Opioids Offer Small Improvement in Pain, Physical Function
  TUESDAY, Dec. 18, 2018 -- Opioid use is associated with small improvements in pain and physical functioning in patients with chronic noncancer pain, according to research published in the Dec. 18 issue of the Journal of the American Medical...
• Exercise Linked to Reduced Mortality for Patients With Cancer
  TUESDAY, Dec. 18, 2018 -- For patients with cancer, participation in prediagnosis and postdiagnosis recreational physical activity is associated with reduced mortality, according to a study published online Nov. 28 in Cancer Causes &...
• 'Aggressive Steps' Needed to Stop Adolescent Use of E-Cigarettes
  TUESDAY, Dec. 18, 2018 -- "Aggressive steps" must be taken by parents, teachers, health providers, and government officials to prevent children and teens from using electronic cigarettes, U.S. Surgeon General Jerome Adams, M.D., M.P.H., said in an...
• Fall Risk Factors Vary by Gender in Older Adults
  TUESDAY, Dec. 18, 2018 -- Older men and women have different fall risk profiles, according to a study published online Nov. 29 in the Journal of the American Geriatrics Society. Stina Ek, from the Karolinska Institutet in Stockholm, and colleagues...
• Routine Supplements to Prevent Chronic Disease Not Advised
  TUESDAY, Dec. 18, 2018 -- Routine use of vitamin and mineral supplements to prevent chronic disease is not recommended, according to an Academy of Nutrition and Dietetics position paper published in the November issue of the Journal of the Academy...
• Cognitive Decline Similar After Cardiac Surgery, Catheterization
  TUESDAY, Dec. 18, 2018 -- For older adults, declines in memory after heart surgery and cardiac catheterization are similar, according to a study published online Dec. 18 in the Annals of Thoracic Surgery. Elizabeth L. Whitlock, M.D., from the...
• EHR Data ID Differences in HTN Control Across Health Systems
  TUESDAY, Dec. 18, 2018 -- An analysis of electronic health record data reveals considerable differences in hypertension control across health systems, according to a study published in the November-December issue of the Journal of the American Board...
• Palliative Care in MS Inpatients Rises From 2005 to 2014
  TUESDAY, Dec. 18, 2018 -- From 2005 to 2014, trends in palliative care use increased substantially among multiple sclerosis (MS) inpatients, according to a study published in the December issue of the Journal of Clinical Neuroscience. Yong-Jae Lee,...
• Appropriate Use Criteria Released for Peripheral Artery Intervention
  TUESDAY, Dec. 18, 2018 -- Appropriate use criteria have been developed for peripheral artery intervention (PAI) in peripheral artery disease, according to a report published online Dec. 17 in the Journal of the American College of Cardiology. Steven...
• Liver Proton Density Fat Fraction Drops After Bariatric Surgery
  TUESDAY, Dec. 18, 2018 -- The average liver proton density fat fraction (PDFF) normalizes by a mean of 22.5 weeks after bariatric surgery, according to a study published online Dec. 18 in Radiology. B. Dustin Pooler, M.D., from the University of...
• Exclusion of Doctors From Public Health Insurance Up 2007 to 2017
  TUESDAY, Dec. 18, 2018 -- From 2007 to 2017, the number of physicians excluded from Medicare and state public insurance programs increased, according to a study published online Dec. 14 in JAMA Network Open. Alice Chen, Ph.D., M.B.A., from the...
• Chest CT Can ID Respiratory AE Risk in RA Patients on Biologics
  TUESDAY, Dec. 18, 2018 -- Chest computed tomography (CT) findings may identify risk factors for respiratory adverse events (RAEs) in rheumatoid arthritis (RA) patients undergoing long-term biological therapy, according to a study recently published...
• Psychosocial Factors Key in Peds Care for Special-Needs Kids
  TUESDAY, Dec. 18, 2018 -- Pediatric providers need to be aware of the impact of psychosocial factors on the health and wellness of children and youth with special health care needs and their families, according to a clinical report published online...
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New Drug Approvals (Drugs.com)

• FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC)
  Cambridge, Mass. – December 17, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) has announced that the U.S. Food and Drug Administration (FDA) has approved Motegrity™ (prucalopride), a once-daily, oral treatment option for adults with...
• FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin
  INCHEON, South Korea & JERUSALEM--(BUSINESS WIRE) December 14, 2018 --Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Herzuma (trastuzumab-pkrb), a HER2/neu...
• FDA Approves Tolsura (SUBA®-itraconazole capsules) for the Treatment of Certain Fungal Infections
  ADELAIDE, Australia, Dec. 11, 2018 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tolsura™ (SUBA®-itraconazole)...
• FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery
  BEDFORD, Mass.--(BUSINESS WIRE)--Dec. 3, 2018-- Ocular Therapeutix™, Inc. a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today...
• FDA Approves Firdapse (amifampridine) for Lambert-Eaton Myasthenic Syndrome
  November 28, 2018 -- The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection...
• FDA Approves Xospata (gilteritinib) for Acute Myeloid Leukemia (AML) with a FLT3 Mutation
  November 28, 2018 -- The U.S. Food and Drug Administration today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an...
• FDA Approves Truxima (rituximab-abbs), a Biosimilar to Rituxan for Non-Hodgkin’s Lymphoma
  November 28, 2018 -- The U.S. Food and Drug Administration today approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be...
• FDA Approves Vitrakvi (larotrectinib) for TRK Fusion Cancers
  November 26, 2018 -- The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker). This is the second...
• FDA Approves The ACTpen for Actemra, A Single-Dose, Prefilled Autoinjector
  South San Francisco, CA -- November 26, 2018 -- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra...
• FDA Approves Daurismo (glasdegib) for Patients with Acute Myeloid Leukemia
  November 21, 2018 -- The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia...
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NDAs (Drugs.com)

• FDA Accepts Filing of New Estrogen-free Oral Contraceptive Slinda (drospirenone) Developed by Exeltis
  FLORHAM PARK, New Jersey, November 29, 2018 /PRNewswire/ -- The pharmaceutical multinational Exeltis, with a strong position in Women's Health, has received acceptance from the US Food and Drug Administration (FDA) of the filing of Slinda (4mg...
• FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
  Tokyo, Munich and Basking Ridge, NJ – (November 21, 2018) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted...
• Sage Therapeutics Receives Notification of PDUFA Extension for Zulresso (brexanolone) Injection
  CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 20, 2018-- Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the...
• Evolus Receives Conditional FDA Acceptance of Jeuveau Brand Name
  IRVINE, Calif., Nov. 19, 2018 (GLOBE NEWSWIRE) -- Evolus, Inc. (NASDAQ: EOLS), a company dedicated to aesthetic medicine, today announced the conditional acceptance from the U.S. Food and Drug Administration (“FDA”) of the Jeuveau™...
• Glenmark Pharmaceuticals Announces New Data Presentations on Ryaltris at the ACAAI Annual Scientific Meeting 2018
  MAHWAH, N.J., Nov. 15, 2018 /PRNewswire/ -- Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the company is presenting new data for for its leading respiratory pipeline candidate Ryaltris (rye - al' - tris)...
• Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine
  INDIANAPOLIS, Nov. 14, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or...
• Merck Begins Rolling Submission of Licensure Application for V920 (rVSV∆G-ZEBOV-GP) to U.S. Food and Drug Administration
  KENILWORTH, N.J.--(BUSINESS WIRE) November 13, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that it has started the submission of a rolling Biologics License Application (BLA) to the U.S. Food and Drug...
• Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma
  NEWTON, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to selinexor,...
• Acacia Pharma Resubmits Barhemsys New Drug Application
  Cambridge, UK and Indianapolis, US – 6 November 2018: Acacia Pharma Group plc (“Acacia Pharma” or “the Company”), a pharmaceutical company developing and commercialising hospital products for US and international...
• Trevena Receives Complete Response Letter for Oliceridine from FDA
  November 2, 2018 -- Trevena, Inc. (NASDAQ: TRVN) today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine. “While we...
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Clinical Trial Results (Drugs.com)

• Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Dry Age-Related Macular Degeneration with Geographic Atrophy
  BOSTON – December 10, 2018 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has...
• Menlo Therapeutics’ Successful Phase 2 Clinical Trial of Serlopitant Demonstrates Reduction of Pruritus Associated with Psoriasis
  REDWOOD CITY, Calif., Dec. 10, 2018 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (NASDAQ: MNLO), a late-stage biopharmaceutical company focused on the development of serlopitant for the treatment of pruritus (itch), today announced positive top-line...
• Biohaven Announces Positive Results from Ongoing Rimegepant Long-Term Safety Study
  NEW HAVEN, Conn., Dec. 10, 2018 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced initial positive results from its ongoing long-term, open-label safety study of its oral calcitonin gene-related peptide (CGRP)...
• BeyondSpring Announces Phase 3 Study 105 of its Lead Asset Plinabulin for Chemotherapy-Induced Neutropenia Meets Primary Endpoint at Interim Analysis
  NEW YORK, Dec. 06, 2018 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that the Phase 3 portion of its pivotal Study 105, evaluating...
• Ovid Therapeutics Announces Plans to Move into a Phase 3 Trial in Pediatric Patients Based on End-of-Phase 2 Meeting for OV101 in Angelman Syndrome
  NEW YORK, Dec. 06, 2018 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ:OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced plans to move ahead...
• argenx Provides Detailed Data from Phase 2 Clinical Trial of Efgartigimod in Immune Thrombocytopenia and Phase 1/2 Clinical Trial of Cusatuzumab in Acute Myeloid Leukemia
  Breda, the Netherlands / Ghent, Belgium – December 03, 2018 -- argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe...
• Blueprint Medicines Announces Updated Results from Ongoing EXPLORER Clinical Trial of Avapritinib Demonstrating Broad Clinical Activity and Significant Symptom Reductions in Patients with Systemic Mastocytosis
  CAMBRIDGE, Mass., Dec. 2, 2018 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, today announced updated results for the...
• miRagen Therapeutics Announces Final Safety, Biodistribution and Clinical Efficacy Data From Phase 1 Cobomarsen Clinical Trial in Patients With Mycosis Fungoides
  BOULDER, Colo., Dec. 02, 2018 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced data from its Phase 1...
• GBT Announces U.S. FDA Agrees with its Proposal Relating to Accelerated Approval Pathway for Voxelotor for the Treatment of Sickle Cell Disease and GBT Plans to Submit New Drug Application (NDA)
  SOUTH SAN FRANCISCO, Calif., Dec. 03, 2018 (GLOBE NEWSWIRE) -- Global Blood Therapeutics, Inc. (GBT) (Nasdaq: GBT) today announced that the U.S. Food and Drug Administration (FDA) has informed GBT through discussions and written correspondence that...
• Zogenix Announces Positive Phase 3 Trial Results on the Efficacy and Safety of Fintepla (ZX008) in Dravet Syndrome
  EMERYVILLE, Calif., Dec. 03, 2018 (GLOBE NEWSWIRE) --  Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare diseases, announced today that late-breaking data will be presented on the use of its...
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