Industry News

Pharma Headline News (Drugs.com)

• CDC: First U.S. Case of Rat-Borne Andes Virus Diagnosed
  FRIDAY, Oct. 19, 2018 -- The first confirmed U.S. case of a virus carried by South American rodents occurred earlier this year, the U.S. Centers for Disease Control and Prevention says. Doctors at a Delaware hospital diagnosed Andes virus in a...
• Physical Therapy an Option for Nonobstructive Meniscal Tears
  FRIDAY, Oct. 19, 2018 -- Physical therapy (PT) is non-inferior to arthroscopic partial meniscectomy (APM) for patients with nonobstructive meniscal tears, according to a study published in the Oct. 2 issue of the Journal of the American Medical...
• Limited Success for Changing Diet and Exercise Among Nurses
  FRIDAY, Oct. 19, 2018 -- Implementation of a workplace intervention to change diet and physical activity (PA) behavior was partially successful among nurses, with the ability to change both diet and PA at the same time described as challenging,...
• CDC: Vaccination Rates More Than 95 Percent for Kindergartners
  FRIDAY, Oct. 19, 2018 -- Overall vaccination coverage is high among the nation's kindergarten students, according to research published in the Oct. 12 issue of the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly...
• Variability in Geographic Availability of New Antibiotics
  FRIDAY, Oct. 19, 2018 -- There is considerable variability in the geographic availability of antibiotics, according to a study published online Oct. 16 in PLOS ONE. Cecilia Kållberg, from the University of Oslo in Norway, and colleagues examined...
• Triple Combo Regimens May Address Cause of Cystic Fibrosis
  FRIDAY, Oct. 19, 2018 -- Triple therapy with VX-659 or VX-445 combined with tezacaftor-ivacaftor shows promise for the treatment of adult patients with cystic fibrosis who have mutations in the cystic fibrosis transmembrane conductance regulator...
• 2014 to 2016 Saw 470 Percent Increase in HIV PrEP Use in U.S.
  FRIDAY, Oct. 19, 2018 -- From 2014 to 2016 there was an increase in the annual number of HIV preexposure prophylaxis (PrEP) users in the United States, although only about 7 percent of those with indications for PrEP were prescribed PrEP in 2016,...
• Light Use of Topical Skin Tx Before Radiotherapy Seems Safe
  FRIDAY, Oct. 19, 2018 -- Contrary to the advice most cancer patients receive, light or moderate use of topical agents before radiation treatment does not appear to increase the radiation dose to the skin, according to a study published online Oct....
• Asthma May Raise Obesity Risk Later in Childhood
  FRIDAY, Oct. 19, 2018 -- Early-onset asthma and wheezing may contribute to an increased risk of developing obesity later in childhood, according to a study published in the Sept. 1 issue of the European Respiratory Journal. Zuelma A. Contreras, from...
• Bioinformatics Tool Can ID Source of Bloodstream Pathogens
  FRIDAY, Oct. 19, 2018 -- A streamlined bioinformatics tool can match bloodstream pathogens to a candidate source, according to a study published online Oct. 15 in Nature Medicine. Fiona B. Tamburini, from Stanford University in California, and...
• Aspirin, Anticoagulants Similarly Prevent VTE After TKA
  FRIDAY, Oct. 19, 2018 -- Among patients undergoing total knee arthroplasty (TKA), aspirin alone may provide protection against postoperative venous thromboembolism (VTE) that is similar to that of other anticoagulants, according to a study published...
• ASA: Dorsal Root Ganglion Stimulation Disrupts Back Pain
  FRIDAY, Oct. 19, 2018 -- Dorsal root ganglion (DRG) neurostimulation therapy may reduce pain and disability in patients with chronic lower extremity and back pain, according to a study presented at the annual meeting of the American Society of...
• Transcatheter Mitral Valve Repair Benefits Some With Heart Failure
  FRIDAY, Oct. 19, 2018 -- Transcatheter mitral-valve repair results in a lower rate of hospitalization and lower all-cause mortality than medical therapy alone among patients with heart failure and moderate-to-severe secondary mitral regurgitation...
• Poor Experience With PCP Linked to Hospitalization in CKD
  FRIDAY, Oct. 19, 2018 -- For Hispanic patients with chronic kidney disease (CKD), lower perceived quality of the patient experience with their primary care physician is associated with increased risk of hospitalization, according to a study...
• HPV Vaccination Not Tied to Risky Sexual Behavior in Teen Girls
  THURSDAY, Oct. 18, 2018 -- Implementation of a school-based human papillomavirus (HPV) vaccination program in Canada did not lead to an increase in sexual risk-taking behaviors among adolescent girls, according to a study published in the Oct. 15...
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New Drug Approvals (Drugs.com)

• FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
  On October 16, 2018, the Food and Drug Administration approved talazoparib (Talzenna, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm),...
• FDA Approves Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Five Years
  DUBLIN and SAN FRANCISCO October 16, 2018 – Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Medicines360, a global nonprofit women’s health pharmaceutical company with a mission of expanding access to quality medicines,...
• FDA Approves Yutiq (fluocinolone acetonide intravitreal implant) for Chronic Non-Infectious Posterior Segment Uveitis
  WATERTOWN, Mass., Oct. 15, 2018 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, announced today that the U. S. Food...
• FDA Approves Xarelto to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD)
  TITUSVILLE, NJ, October 11, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) to reduce the risk of major cardiovascular (CV)...
• FDA Approves Accelerated 7-Day Vaccine Dosing Schedule for Ixiaro
  GAITHERSBURG, Md.--(BUSINESS WIRE) October 05, 2018 --Valneva USA, the U.S. subsidiary of global vaccine biotech company Valneva SE, today announced U.S. Food and Drug Administration (FDA) approval of an accelerated dosing regimen for Ixiaro...
• FDA Approves Tegsedi (inotersen) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis
  BOSTON and CARLSBAD, Calif., Oct. 05, 2018 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ: AKCA), an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), announced today that the U.S. Food and Drug...
• FDA Approves Revcovi (elapegademase-lvlr) for Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)
  GAITHERSBURG, Md.--(BUSINESS WIRE) October 05, 2018 --Leadiant Biosciences, Inc. today announced that the Food and Drug Administration (FDA) has granted approval to Revcovi™ (elapegademase-lvlr) injection in the U.S. Revcovi is a new enzyme...
• FDA Approves Expanded Use of Gardasil 9 to Include Individuals 27 Through 45 Years Old
  October 5, 2018 -- The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27...
• FDA Approves Genentech’s Hemlibra (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors
  South San Francisco, CA -- October 4, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to...
• FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and Acute Skin and Skin Structure Infections
  BOSTON, Oct. 02, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that the U.S. Food and Drug Administration (FDA) has approved Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial...
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NDAs (Drugs.com)

• FDA Advisory Committee Recommends Approval of Dsuvia for the Treatment of Moderate-to-Severe Acute Pain
  REDWOOD CITY, Calif., Oct. 12, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, announced today that the...
• Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome
  October 11, 2018 -- Trevena, Inc. (NASDAQ: TRVN), today announced the outcome of the meeting of the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to review and discuss oliceridine. At the...
• Bausch Health's Bryhali (halobetasol propionate) Lotion, 0.01%, Receives Tentative FDA Approval For Plaque Psoriasis In Adults
  LAVAL, Quebec, Oct. 8, 2018 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the U.S. Food and...
• Novartis Announces FDA and EMA Filing Acceptance of Siponimod for Secondary Progressive Multiple Sclerosis (SPMS)
  Basel, October 08, 2018 - Novartis today announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company's New Drug Application (NDA) and Marketing Authorization Application (MAA)...
• FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys
  Cambridge, UK and Indianapolis, US – 8 October 2018: Acacia Pharma Group plc (“Acacia Pharma”), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that it has received a...
• U.S. FDA Accepts Karyopharm’s New Drug Application for Selinexor and Grants Priority Review
  NEWTON, Mass., Oct. 05, 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 accepted for filing with Priority Review its...
• Shield Therapeutics Announces Submission of a New Drug Application (NDA) for Feraccru for the treatment of Iron Deficiency
  London, UK, 1st October 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients’ unmet medical needs, today announces that it has received confirmation...
• Intra-Cellular Therapies Completes Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia
  NEW YORK, Sept. 28, 2018 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the Company has...
• Neurelis Files New Drug Application for Valtoco (diazepam nasal spray), an Investigational Treatment for Pediatric, Adolescent and Adult Epilepsy Patients
  SAN DIEGO, CA – Sept. 25, 2018 -- Neurelis, Inc. today announced that the company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Valtoco (diazepam nasal spray) as a treatment for epilepsy patients...
• Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer
  HORSHAM, Pa., Sept. 18, 2018 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of...
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Clinical Trial Results (Drugs.com)

• Alnylam Announces Plan to Initiate Rolling Submission of a New Drug Application and Pursue Full Approval for Givosiran
  CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 15, 2018-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company plans to...
• Oryzon Announces First Patient Enrolled in REIMAGINE: a Phase IIa Clinical Trial with Vafidemstat (ORY-2001) in Aggressiveness
  MADRID, Spain and CAMBRIDGE, Mass., Oct. 09, 2018 (GLOBE NEWSWIRE) -- Oryzon Genomics S.A. (ISIN Code: ES0167733015, ORY), (“Oryzon”), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with...
• Novartis Analysis Shows Crizanlizumab (SEG101) Increased the Number of Patients Free of Sickle Cell Pain Crises vs Placebo During SUSTAIN Study
  Basel, October 9, 2018 - Results from a post hoc analysis of the Phase II SUSTAIN study of crizanlizumab, a humanized anti-P-selectin monoclonal antibody being investigated for the treatment of sickle cell disease (SCD), have been published in the...
• ObsEva SA Presents Clinical Data from Phase III IMPLANT 2 Trial of Nolasiban in IVF at the American Society of Reproductive Medicine (ASRM) Annual Meeting
  Geneva, Switzerland and Boston, MA – October 9, 2018 - ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a Swiss clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that...
• Menlo Therapeutics Announces Results from a Phase 2 Clinical Trial of Serlopitant for the Treatment of Refractory Chronic Cough
  REDWOOD CITY, Calif., Oct. 08, 2018 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (NASDAQ: MNLO) a late-stage biopharmaceutical company focused on the development of serlopitant for the treatment of pruritus associated with various conditions, today...
• Lilly's Investigational Dual GIP and GLP-1 Receptor Agonist Shows Significant Reduction in HbA1c and Body Weight in People With Type 2 Diabetes
  INDIANAPOLIS, Oct. 4, 2018 /PRNewswire/ -- Results from a phase 2b clinical trial of Eli Lilly and Company's (NYSE: LLY) dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA, LY3298176) showed strong and clinically meaningful blood sugar reduction and...
• Genentech Announces New Data for Risdiplam in Spinal Muscular Atrophy (SMA) at the World Muscle Society Congress
  South San Francisco, CA -- October 3, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today interim clinical data from the dose-finding parts of the pivotal FIREFISH and SUNFISH studies investigating risdiplam...
• FDA Grants Rare Pediatric Disease Designation to Pegzilarginase for Arginase 1 Deficiency
  AUSTIN, Texas, Oct. 01, 2018 (GLOBE NEWSWIRE) -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer,...
• Orphazyme Reports Encouraging Arimoclomol Clinical Trial Top-Line Data in Niemann-Pick Disease Type C (NPC)
  Copenhagen, September 28, 2018 – Orphazyme A/S, a biopharmaceutical company dedicated to developing treatments for patients living with rare diseases, today announced encouraging top-line results for its clinical Phase II/III trial with orally...
• Pfizer Granted FDA Breakthrough Therapy Designation for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older
  September 20, 2018 -- Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy1 designation from the US Food and Drug Administration (FDA) for the...
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