Industry News

Pharma Headline News (Drugs.com)

• American Diabetes Association, June 7-11
  The American Diabetes Association 79th Scientific Sessions The annual meeting of the American Diabetes Association was held from June 7 to 11 in San Francisco and attracted approximately 14,000 participants from around the world, including...
• WHO: Congo Ebola Outbreak Still Not Global Emergency
  MONDAY, June 17, 2019 -- Even though the Ebola outbreak in Congo recently caused deaths in neighboring Uganda, it is still not a global emergency, the World Health Organization says. The outbreak has resulted in more than 1,400 deaths since it was...
• CDC: U.S. Measles Cases Reach 1,044
  MONDAY, June 17, 2019 -- The number of measles cases in the United States so far this year has reached 1,044 in 28 states, the U.S. Centers for Disease Control and Prevention says. That number is the highest number of cases since 1992 and since the...
• Cognitive Decline Faster After Incident Coronary Heart Disease Event
  MONDAY, June 17, 2019 -- Incident coronary heart disease (CHD) is associated with accelerated cognitive decline after, but not before, the event, according to a study published in the June 25 issue of the Journal of the American College of...
• Drug Makers Challenge New Rule Requiring Drug Prices in TV Ads
  MONDAY, June 17, 2019 -- Three large drug makers have launched a legal challenge against the Trump administration's rule requiring the prices of drugs to be included in television ads. A lawsuit against the rule, set to take effect July 9, was filed...
• High Soy Intake May Cut Fracture Risk in Younger Breast Cancer Survivors
  MONDAY, June 17, 2019 -- Higher soy consumption is linked to fewer osteoporotic fractures in younger breast cancer survivors, according to a study published online May 21 in JNCI Cancer Spectrum. Neil Zheng, from Yale University in New Haven,...
• Study Examines Use of Electronic Consults for Allergy/Immunology
  MONDAY, June 17, 2019 -- Implementation of an electronic consult (e-consult) program at an academic allergy/immunology practice showed increasing use of e-consults for new consults, according to a study published online June 3 in the Journal of...
• Glucocorticoid Tapering Feasible for Rheumatoid Arthritis Patients
  MONDAY, June 17, 2019 -- For patients with rheumatoid arthritis (RA) achieving low disease activity or remission with tocilizumab (TCZ), glucocorticoid (GC) tapering (GCtaper) is associated with a small but significant increase in disease activity...
• U.S. Travelers Should Be Aware of Measles Risk in Europe
  MONDAY, June 17, 2019 -- U.S. travelers need to be aware of measles in Europe and should ensure children are adequately vaccinated, according to a study published online June 17 in Pediatrics. Kristina M. Angelo, D.O., from the U.S. Centers for...
• Review Suggests More Sleep May Lower Cardiometabolic Risk
  MONDAY, June 17, 2019 -- Increasing the length of nightly sleep may help reduce the risk for cardiovascular disease and metabolic disorders, according to a review published online June 5 in the Journal of Sleep Research. Rob H.P. Henst, from the...
• Recommendations Developed to Prepare Children for Camp
  MONDAY, June 17, 2019 -- In a policy statement issued by the American Academy of Pediatrics and published online June 17 in Pediatrics, recommendations are presented for the preparation of children for summer camps. Michael J. Ambrose, M.D., from...
• Nilvadipine Increases Cerebral Blood Flow in the Hippocampus
  MONDAY, June 17, 2019 -- For patients with mild-to-moderate Alzheimer disease, treatment with nilvadipine lowers systolic blood pressure and increases cerebral blood flow (CBF) in the hippocampus, according to a study published online June 17 in...
• Triple-Negative Breast Cancer Varies by Birthplace for Black Women
  MONDAY, June 17, 2019 -- Among black women in the United States, the prevalence of triple-negative breast cancer varies by birthplace, according to a study published online June 13 in Cancer. Hyuna Sung, Ph.D., from the American Cancer Society in...
• Feelings of Powerlessness Tied to Delays in Seeking Care for Acute MI
  MONDAY, June 17, 2019 -- Patients' perceived inability to act is associated with a delay in seeking medical care for acute myocardial infarction, according to a study published online May 27 in the European Journal of Cardiovascular Nursing. Carolin...
• PPI Use for Up to Three Years Safe During Anticoagulant Tx
  MONDAY, June 17, 2019 -- Use of pantoprazole for up to three years to prevent upper gastrointestinal events in patients receiving anticoagulant therapy with aspirin and/or rivaroxaban has a similar safety profile to placebo except for an increased...
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New Drug Approvals (Drugs.com)

• FDA Approves Victoza (liraglutide) for the Treatment of Pediatric Patients 10 Years or Older with Type 2 Diabetes
  June 17, 2019 -- The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza is the first non-insulin drug approved to treat type 2 diabetes...
• FDA Approves Kanjinti (trastuzumab-anns), a Biosimilar to Herceptin
  THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Kanjinti (trastuzumab-anns) for all approved indications of the...
• FDA Approves Keytruda (pembrolizumab) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma
  KENILWORTH, N.J.--(BUSINESS WIRE) June 11, 2019 --Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as...
• FDA Grants Genentech’s Polivy (polatuzumab vedotin-piiq) Accelerated Approval for Adults With Previously Treated Aggressive Lymphoma
  South San Francisco, CA -- June 10, 2019 -- Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with...
• PTC Therapeutics Receives FDA Approval for the Expansion of the Emflaza (deflazacort) Labeling to Include Patients 2-5 Years of Age
  SOUTH PLAINFIELD, N.J., June 7, 2019 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Emflaza (deflazacort)...
• Nucala (mepolizumab) Gains FDA Approval for Two New Self-Administration Options
  London UK – 06 June 2019 -- GlaxoSmithKline (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe,...
• Exeltis USA, Inc. Announces the Approval of Slynd (drospirenone), the First and Only Progestin-Only Pill Providing Pregnancy Prevention with a 24/4 Dosing Regimen and 24-hour Missed Pill Window
  FLORHAM PARK, N.J., June 6, 2019 /PRNewswire/ -- Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced today that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Slynd...
• FDA Approves Emgality (galcanezumab-gnlm) for the Treatment of Episodic Cluster Headache
  INDIANAPOLIS, June 04, 2019 – Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Emgality (galcanezumab-gnlm) injection (300 mg) for the treatment of episodic cluster headache in...
• FDA Approves Zerbaxa (ceftolozane and tazobactam) 3g Dose for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
  Monday, June 3, 2019 -- KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Merck’s supplemental New Drug...
• FDA Approves Revlimid (lenalidomide) In Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma
  SUMMIT, N.J.--(BUSINESS WIRE) May 28, 2019 -- Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) approved Revlimid (lenalidomide) in combination with a rituximab product (R²) for the treatment of...
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NDAs (Drugs.com)

• Blueprint Medicines Submits New Drug Application to U.S. Food and Drug Administration for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
  CAMBRIDGE, Mass., June 14, 2019 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced it has submitted a New Drug...
• Xeris Pharmaceuticals Receives Notification of PDUFA Date Extension for Gvoke
  CHICAGO, June 06, 2019 (GLOBE NEWSWIRE) — Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug...
• US FDA and EMA Accept Applications for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis
  SUMMIT, N.J.--(BUSINESS WIRE) June 06, 2019 -- Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for ozanimod for the treatment of people with...
• Celgene Corporation and Acceleron Pharma Announce U.S. FDA Accepts Luspatercept Biologics License Application in Myelodysplastic Syndromes and Beta-Thalassemia
  SUMMIT, N.J. & CAMBRIDGE, Mass.June 04, 2019 --(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted Celgene’s Biologics...
• Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma
  CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 30, 2019-- Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and...
• Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla
  PRINCETON, N.J., May 17, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced it has resubmitted to the U.S. Food and Drug Administration (FDA) the NDA for its lead product candidate,...
• Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019
  SALT LAKE CITY, May 14, 2019 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has...
• RedHill Biopharma Submits New Drug Application for Talicia for H. pylori Infection
  TEL-AVIV, Israel and RALEIGH, N.C., May 7, 2019 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on...
• Zynerba Pharmaceuticals Receives Fast Track Designation for Zygel for the Treatment of Behavioral Symptoms Associated with Fragile X Syndrome (FXS)
  Devon, PA, May 6, 2019 — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced that the U.S. Food...
• Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review
  ANN ARBOR, Mich., May 05, 2019 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) announced today that the U.S. Food and Drug Administration (FDA) has accepted both New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination...
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Clinical Trial Results (Drugs.com)

• Boehringer Ingelheim and OSE Immunotherapeutics Announce Dosing Of the First Patient in a Phase 1 Trial of SIRPα Antagonist Monoclonal Antibody, BI 765063, in Patients with Advanced Solid Tumors
  Ingelheim, Germany and Nantes, France  –  June 17, 2019, 6:00 p.m. CET - Boehringer Ingelheim and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) today announce that the first patient has been dosed in the...
• Protalix BioTherapeutics Completes Enrollment in the Phase III BRIGHT Clinical Trial of pegunigalsidase alfa (PRX 102) for the Treatment of Fabry Disease
  CARMIEL, Israel, June 17, 2019 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its...
• Sunesis Pharmaceuticals Announces Presentation of Preliminary Data from Phase 1b/2 Trial of Vecabrutinib in Patients with CLL and Other B-Cell Malignancies at EHA Annual Meeting
  SOUTH SAN FRANCISCO, Calif., June 15, 2019 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced the presentation of results from the Company’s Phase 1b/2 clinical trial of its non-covalent BTK inhibitor vecabrutinib...
• GBT Announces Updated 24-Week Efficacy Data from All Patients Enrolled in Phase 3 HOPE Study Showing Statistically Significant and Sustained Improvements in Hemoglobin with Voxelotor
  AMSTERDAM, The Netherlands, June 14, 2019 (GLOBE NEWSWIRE) -- Global Blood Therapeutics, Inc. (GBT) (Nasdaq: GBT) today announced new results from its Phase 3 HOPE Study of voxelotor in patients ages 12 and older with sickle cell disease (SCD). The...
• New Long-Term Data from Upadacitinib Phase 3 Studies in Rheumatoid Arthritis Including Results on Clinical Remission at 48 Weeks Presented at EULAR
  NORTH CHICAGO, Ill., June 12, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new results from the Phase 3 clinical trials SELECT-EARLY and SELECT-COMPARE showing that patients receiving...
• TG Therapeutics Confirms Registration Path for Umbralisib in Marginal Zone Lymphoma Following FDA Meeting
  NEW YORK, June 11, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the Company has confirmed its path to submit umbralisib for accelerated approval based on data from the marginal zone lymphoma (MZL) cohort of the...
• Lilly's Tirzepatide Demonstrates Benefits in Data Presented at the American Diabetes Association's® 79ᵗʰ Scientific Sessions
  INDIANAPOLIS, June 8, 2019 /PRNewswire/ -- Results from several studies of Eli Lilly and Company's (NYSE: LLY) investigational dual GIP and GLP-1 receptor agonist (RA), tirzepatide, reinforce its potential in lowering A1C and body weight in...
• Novartis Presents First-of-its-Kind Histology Data with Iscalimab (CFZ533) Suggesting the Extended Survival of Transplanted Organs May be Possible
  Basel, June 6, 2019 - Novartis announced today new early stage histology data in kidney transplantation, suggesting that with investigational compound iscalimab (CFZ533) it may be possible to prolong the durability of transplanted kidneys as well as...
• Motif Bio Announces Path Forward for Iclaprim following Receipt of FDA Meeting Minutes
  NEW YORK, June 06, 2019 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the Company has received the official minutes of the Type A...
• Astex Pharmaceuticals and Otsuka Announce Results of the Phase 3 ASCERTAIN Study of the Novel Oral Cedazuridine and Decitabine Fixed-Dose Combination (ASTX727) in Patients with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
  Pleasanton, CA and Tokyo, Japan, June 6th, 2019. Astex Pharmaceuticals, Inc. a member of the Otsuka group of companies, and Otsuka Pharmaceutical Co. Ltd., announce top-line results from the ASCERTAIN phase 3 study evaluating cedazuridine and...
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