Industry News

Pharma Headline News (Drugs.com)

• 1998 to 2015 Saw Increase in Outpatient Depression Treatment
  WEDNESDAY, April 24, 2019 -- From 1998 to 2015, there was an increase in outpatient treatment of depression, according to a study published online April 24 in JAMA Psychiatry. Jason M. Hockenberry, Ph.D., from Emory University in Atlanta, and...
• Nusinersen Promising for Later-Onset Spinal Muscular Atrophy
  WEDNESDAY, April 24, 2019 -- Limited evidence suggests that nusinersen treatment provides long-term benefits for children with later-onset spinal muscular atrophy (SMA), according to a study published online April 24 in Neurology. Basil T. Darras,...
• New York City Measles Cases Increase to 390
  WEDNESDAY, April 24, 2019 -- The number of measles cases in New York City has risen to 390, the health department said Wednesday. Of those cases, 323 (83 percent) have been in Williamsburg (ZIP codes 11205, 11206, 11211, 11249), where an emergency...
• Many Seniors Will Be Unable to Afford Care They Need by 2029
  WEDNESDAY, April 24, 2019 -- The number of middle-income seniors is projected to almost double by 2029, and many will have inadequate financial resources to afford the level of care they need, according to a report published online April 24 in...
• CDC Provides Clarification of Opioid Prescribing Guideline
  WEDNESDAY, April 24, 2019 -- Implementation of the U.S. Centers for Disease Control and Prevention opioid prescribing recommendations should be consistent with the guideline's intent, according to a perspective piece published online April 24 in the...
• AAP Updates Guidance for Care in Neurofibromatosis Type 1
  WEDNESDAY, April 24, 2019 -- Guidance has been updated for the health supervision of children with neurofibromatosis type 1 (NF1), according to a clinical report from the American Academy of Pediatrics published online April 22 in Pediatrics. David...
• Risk-Based Screening Improves Cardiovascular Disease Prevention
  WEDNESDAY, April 24, 2019 -- Cardiovascular risk screening intervals based on risk category-specific progression rates would perform better and improve cost-effectiveness compared with established five-year screening intervals, according to a study...
• Over Half of Seniors Initiating Dialysis Die Within One Year
  WEDNESDAY, April 24, 2019 -- More than half of Medicare beneficiaries initiating dialysis die within one year, according to a research letter published online April 22 in JAMA Internal Medicine. Melissa W. Wachterman, M.D., from the Veterans Affairs...
• Sucking Ice Chips Cuts Oral Side Effects of Oxaliplatin Chemo
  WEDNESDAY, April 24, 2019 -- Chemotherapy patients who suck on ice chips during treatment with oxaliplatin infusion have less trouble with eating and drinking cold things, fewer negative effects on quality of life due to oral symptoms, and a shorter...
• Personalizing Breast Cancer Tx Could Cut Initial Costs of Care
  WEDNESDAY, April 24, 2019 -- Personalizing breast cancer treatment based on Oncotype DX recurrence scores could result in small decreases in costs in the initial 12 months of care, according to a study published online April 24 in the Journal of the...
• Sleeping Pill Use Tied to Greater Need for BP Meds in Older Adults
  WEDNESDAY, April 24, 2019 -- Consumption of sleeping pills is linked to a subsequent increase in the number of antihypertensive drugs taken among older adults, according to a study published online March 25 in Geriatrics & Gerontology...
• Low Socioeconomic Position Linked to Poor End-of-Life Care
  WEDNESDAY, April 24, 2019 -- Low socioeconomic position (SEP) is a risk factor for potentially poor-quality end-of-life care, including hospital death, according to research published online April 23 in PLOS Medicine. Joanna M. Davies, from King's...
• Some Children With Asthma Miss Critical Step in Inhaler Use
  WEDNESDAY, April 24, 2019 -- Many children with asthma, especially older children using a spacer with mouthpiece, miss a critical step in inhaler technique, according to a study published online April 8 in the Journal of Hospital Medicine. Waheeda...
• Risk Factors ID'd for Rheumatoid Arthritis Complications
  WEDNESDAY, April 24, 2019 -- A new study published online April 11 in the International Journal of Rheumatic Diseases identifies factors tied to hospitalization and infections among patients with rheumatoid arthritis (RA). S. Chandrashekara,...
• PCI Beneficial for All Categories of Older AMI Patients
  WEDNESDAY, April 24, 2019 -- For older patients with acute myocardial infarction (AMI), percutaneous coronary intervention (PCI) is beneficial across age strata, according to a research letter published online April 23 in Circulation: Cardiovascular...
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New Drug Approvals (Drugs.com)

• FDA Approves Skyrizi (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis
  NORTH CHICAGO, Ill., April 23, 2019 /PRNewswire/ -- AbbVie today announced that the U.S. Food and Drug Administration (FDA) approved Skyrizi (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque...
• FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC
  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 an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as...
• FDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer
  April 12, 2019 -- The U.S. Food and Drug Administration today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration...
• FDA Approves Evenity (romosozumab-aqqg) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk of Fracture
  April 9, 2019 -- The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or...
• FDA Approves Dovato (dolutegravir/lamivudine) for HIV-1 Infection
  LONDON--(BUSINESS WIRE) April 08, 2019 --ViiV Healthcare today announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the...
• FDA Approves Ibrance (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer
  April 4, 2019 -- Pfizer (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indications for Ibrance (palbociclib) in combination with an aromatase inhibitor or...
• FDA Approves Avaclyr (acyclovir ophthalmic ointment) for the Treatment of Herpetic Keratitis
  NEW YORK–(BUSINESS WIRE) April 01, 2019 –The US Food and Drug Administration (FDA) has approved Fera Pharmaceuticals' New Drug Application (NDA) for Avaclyr (acyclovir ophthalmic ointment) 3% for the treatment of herpetic keratitis....
• FDA Approves the Reintroduction of Zelnorm (tegaserod) for Irritable Bowel Syndrome with Constipation (IBS-C) in Women Under 65
  LOUISVILLE, Ken., April 1, 2019 /PRNewswire/ -- US WorldMeds has announced that Sloan Pharma, S.a.r.l., a subsidiary of US WorldMeds Holdings, LLC, has received approval from the U.S. Food and Drug Administration (FDA) for the reintroduction of...
• FDA Approves Asceniv (immune globulin intravenous, human) for Primary Humoral Immunodeficiency
  RAMSEY, N.J. and BOCA RATON, Fla., April 01, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company...
• FDA Approves Duaklir Pressair (aclidinium bromide and formoterol fumarate) for Maintenance Treatment of Chronic Obstructive Pulmonary Disease
  Oxford, UK – 1 April 2019: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US Food and Drug Administration...
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NDAs (Drugs.com)

• Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
  Basel, April 15, 2019 - Novartis announced that the US Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also...
• Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA
  Dublin – April 9, 2019 – Cosmo Pharmaceuticals NV (SIX: COPN) today informed that the Remimazolam NDA has been submitted to FDA. Electronic acknowledgment of the submission shows April 5 as the official date of submission. Therefore...
• Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application
  EMERYVILLE, Calif., April 08, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug...
• Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA
  SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE) April 05, 2019 -- Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that Celgene has submitted a Biologics License Application (BLA) for luspatercept, an...
• Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US
  TOKYO--(BUSINESS WIRE)--Apr 4, 2019--Kyowa Hakko Kirin Co., Ltd. (TOKYO:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug...
• Evoke Pharma Receives Complete Response Letter and Recommendations to Address Deficiencies from FDA for Gimoti NDA
  SOLANA BEACH, Calif., April 02, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has received a Complete Response Letter...
• Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis
  SUMMIT, N.J.--(BUSINESS WIRE)--March 25, 2019 Celgene Corporation (NASDAQ:CELG) today announced that the Company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for ozanimod for the treatment of adults with...
• FDA Issues Complete Response Letter for Zynquista (sotagliflozin)
  PARIS and THE WOODLANDS, TX –  March 22, 2019 -  The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista (sotagliflozin)*, a dual SGLT1 and...
• Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA
  SOLANA BEACH, Calif., March 14, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has submitted its response to the U.S....
• Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application
  NEWTON, Mass., March 14, 2019 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act...
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Clinical Trial Results (Drugs.com)

• Pfizer and Lilly Announce Top-Line Results From Long-Term Phase 3 Study of Tanezumab in Patients With Osteoarthritis
  NEW YORK & INDIANAPOLIS--(BUSINESS WIRE) April 18, 2019 -- Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced top-line results from a Phase 3 study evaluating tanezumab 2.5 mg and 5 mg. The objective of the study was to...
• AveXis Data Reinforce Effectiveness of Zolgensma in Treating Spinal Muscular Atrophy (SMA) Type 1
  Basel, April 16, 2019 - AveXis, a Novartis company, today announced that interim data from its Phase 3 STR1VE trial of Zolgensma® (onasemnogene abeparvovec-xioi; AVXS-101)[1] in spinal muscular atrophy (SMA) Type 1 showed prolonged event-free...
• MediciNova Announces Plans to Move Forward with a Phase 3 Trial of MN-166 (ibudilast) in ALS
  LA JOLLA, Calif., April 15, 2019 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the U.S....
• TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Marginal Zone Lymphoma
  NEW YORK, April 15, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to its phosphoinositide-3-kinase (PI3K) delta inhibitor, umbralisib...
• Pfizer Announces Presentation of Data from a Phase 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older
  April 13, 2019 - Pfizer Inc. (NYSE: PFE) announced today the presentation of data from a Phase 2 study of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and...
• Albireo Announces FDA Clearance of IND to Commence Phase 2 Trial of Elobixibat for the Treatment of NAFLD/NASH
  BOSTON, April 11, 2019 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that its Investigational New Drug application (IND) has...
• FDA Orders Important Safety Labeling Changes for Addyi Regarding Alcohol Consumption
  April 11, 2019 -- The U.S. Food and Drug Administration today issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi (flibanserin), that requires the company to revise important safety information that women and their...
• Provention Bio Initiates Phase 3 PROTECT Clinical Trial with PRV-031 (Teplizumab) in Patients with Recent Onset Type 1 Diabetes
  OLDWICK, N.J., April 9, 2019 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that it has dosed the first patient in...
• Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
  Tokyo and Basking Ridge, NJ – (April 4, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application...
• Immunocore’s Lead Asset Tebentafusp Gains Fast Track Designation for Metastatic Uveal Melanoma
  OXFORD, England & CONSHOHOCKEN, Pa.--April 03, 2019 --Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its...
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